FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25955293 Type 2
Serious
ONIVYDE, FLUOROURACIL, LEUCOVORIN CALCIUM
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-IPSEN Group, Research and Development-2022-33447
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
85.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
53.8 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (13)

Dysphagia (v28.1) Not Recovered
Fall (v28.1) Not Recovered
Nausea (v28.1) Not Recovered
Dizziness (v28.1) Not Recovered
Muscular weakness (v28.1) Not Recovered
Hypokalaemia (v28.1) Recovered
Hyponatraemia (v28.1) Not Recovered
Abdominal pain (v28.1) Not Recovered
Decreased appetite (v28.1) Not Recovered
Dehydration (v28.1) Recovered
Urinary tract infection (v28.1) Recovered
Fatigue (v28.1) Not Recovered
Hyperkalaemia (v28.1) Recovered

Drugs (3)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: Concentrate for solution for infusion | Indication: Adenocarcinoma pancreas | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/05/2022 | End: 11/23/2022 | Duration: 50.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Adenocarcinoma pancreas | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/05/2022 | End: 11/23/2022 | Duration: 50.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/05/2022 | End: 11/23/2022 | Duration: 50.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20221128

Report Duplicates (1)

SERVIER: S22012863

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c87", "safetyreportid": "25955293", "authoritynumb": null, "companynumb": "US-IPSEN Group, Research and Development-2022-33447", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 85.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 53.8, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dysphagia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fall", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dizziness", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Muscular weakness", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypokalaemia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hyponatraemia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Decreased appetite", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dehydration", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Urinary tract infection", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hyperkalaemia", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": "Adenocarcinoma pancreas", "drugstartdateformat": "102", "drugstartdate": "2022-10-05T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-11-23T00:00:00", "drugtreatmentduration": 50.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Adenocarcinoma pancreas", "drugstartdateformat": "102", "drugstartdate": "2022-10-05T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-11-23T00:00:00", "drugtreatmentduration": 50.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN CALCIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2022-10-05T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-11-23T00:00:00", "drugtreatmentduration": 50.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEUCOVORIN CALCIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20221128" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "SERVIER", "duplicatenumb": "S22012863" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955289 Type 2
Serious
ONIVYDE, FLUOROURACIL, FLUOROURACIL (+2 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-SERVIER-S20006510
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
74.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
50.5 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Diarrhoea (v28.1) Recovered
Pyrexia (v28.1) Recovered
Neutropenia (v28.1) Recovered
Mucosal infection (v28.1) Recovered
Nausea (v28.1) Recovered
Leukopenia (v28.1) Recovered

Drugs (5)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: Solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 120.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/02/2020 | End: 06/25/2020 | Duration: 24.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 3600 MG | Form: -- | Indication: Colorectal cancer metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 3600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/02/2020 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 3600 MG, CYCLE 3 | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 3600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/25/2020 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 600 MG | Form: -- | Indication: Colorectal cancer metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 600 MG | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20200702

Report Duplicates (2)

SERVIER: EU-SERVIER-S20006510
SERVIER: S20006510

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c86", "safetyreportid": "25955289", "authoritynumb": null, "companynumb": "EU-SERVIER-S20006510", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 74.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 50.5, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pyrexia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neutropenia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Mucosal infection", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Leukopenia", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 120.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2020-06-02T00:00:00", "drugenddateformat": "102", "drugenddate": "2020-06-25T00:00:00", "drugtreatmentduration": 24.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3600 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Colorectal cancer metastatic", "drugstartdateformat": "102", "drugstartdate": "2020-06-02T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3600 MG, CYCLE 3", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2020-06-25T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "600 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Colorectal cancer metastatic", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "600 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20200702" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "SERVIER", "duplicatenumb": "EU-SERVIER-S20006510" }, { "duplicatesource": "SERVIER", "duplicatenumb": "S20006510" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25955290 Type 2
Serious
ONIVYDE, FLUOROURACIL, LEUCOVORIN (+5 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-SERVIER-S22011767
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
62.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
57.4 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Pain (v28.1) Not Recovered

Drugs (8)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 111.30 MG, OTHER | Form: Solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 111.3 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/02/2022 | End: 11/02/2022 | Duration: 1.0 day | Rechallenge: Unknown | Additional: No
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 3820 MG, OTHER | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 3820.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 325 MG, OTHER | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 325.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
OXYCODONE ACCORD lP (--) Concomitant
Route: -- | Dosage: 45 MG, TID | Form: -- | Indication: Pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 135.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 10 MG, 1 TO 3 DF, QD | Form: -- | Indication: Pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIMPERAN (METOCLOPRAMIDE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 3 DF, QD | Form: -- | Indication: Pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 3.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/27/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PANTOPRAZOLE (PANTOPRAZOLE) Concomitant
Route: -- | Dosage: 40 MG DAILY | Form: -- | Indication: Prophylaxis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) Concomitant
Route: -- | Dosage: 40 MG DAILY | Form: -- | Indication: Antiinflammatory therapy | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20221109

Report Duplicates (1)

SERVIER: EU-SERVIER-S22011767

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c85", "safetyreportid": "25955290", "authoritynumb": null, "companynumb": "EU-SERVIER-S22011767", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 62.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 57.4, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pain", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 111.3, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "111.30 MG, OTHER", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2022-11-02T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-11-02T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 2, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3820.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3820 MG, OTHER", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 325.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "325 MG, OTHER", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OXYCODONE ACCORD lP", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 135.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "45 MG, TID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pain", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OXYCODONE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MG, 1 TO 3 DF, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pain", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "OXYCODONE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PRIMPERAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3 DF, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pain", "drugstartdateformat": "102", "drugstartdate": "2022-10-27T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "METOCLOPRAMIDE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PANTOPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MG DAILY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Prophylaxis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PANTOPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SOLU-MEDROL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MG DAILY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Antiinflammatory therapy", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "METHYLPREDNISOLONE SODIUM SUCCINATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20221109" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "SERVIER", "duplicatenumb": "EU-SERVIER-S22011767" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955288 Type 2
Serious
ONIVYDE, LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM (+10 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Physician
Literature Reference
--
Company Number
CN-SERVIER-S23010327
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
55.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
42.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Ascites (v28.1) Recovering

Drugs (13)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 105 MG, SINGLE | Form: Solution for infusion | Indication: Ductal adenocarcinoma of pancreas | Action: Not Applicable
Auth#: -- | Batch#: 221201 | Structured Dosage: 105.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 105.0 (unit: 003)
Start: 07/25/2023 | End: 07/25/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: 4
Recurrences: --
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 600 MG, SINGLE | Form: -- | Indication: Ductal adenocarcinoma of pancreas | Action: Not Applicable
Auth#: -- | Batch#: 221008AJ | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 600.0 (unit: 003)
Start: 07/11/2023 | End: 07/11/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: 4
Recurrences: --
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 600 MG, SINGLE | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: 221008AJ | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 600.0 (unit: 003)
Start: 07/25/2023 | End: 07/25/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: 4
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 3600 MG, SINGLE | Form: -- | Indication: Ductal adenocarcinoma of pancreas | Action: Not Applicable
Auth#: -- | Batch#: 2209081 | Structured Dosage: 3600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 3600.0 (unit: 003)
Start: 07/11/2023 | End: 07/11/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: 4
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 3600 MG, SINGLE | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: 2209081 | Structured Dosage: 3600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 3600.0 (unit: 003)
Start: 07/25/2023 | End: 07/25/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: 4
Recurrences: --
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM) Concomitant
Route: 048 | Dosage: 40 MG, QD | Form: -- | Indication: Nausea | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 240.0 (unit: 003)
Start: 07/28/2023 | End: 08/02/2023 | Duration: 6.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ERYTHROPOIETIN (ERYTHROPOIETIN) Concomitant
Route: -- | Dosage: 9000 IU, SINGLE | Form: -- | Indication: Anaemia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 9000.0 (unit: 025) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 9000.0 (unit: 025)
Start: 08/11/2023 | End: 08/11/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ERYTHROPOIETIN (ERYTHROPOIETIN) Concomitant
Route: -- | Dosage: 9000 IU, SINGLE | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 9000.0 (unit: 025) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 9000.0 (unit: 025)
Start: 08/16/2023 | End: 08/16/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ERYTHROPOIETIN (ERYTHROPOIETIN) Concomitant
Route: -- | Dosage: 9000 IU, SINGLE | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 9000.0 (unit: 025) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 9000.0 (unit: 025)
Start: 08/18/2023 | End: 08/18/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ALBUMIN HUMAN (ALBUMIN HUMAN) Concomitant
Route: 041 | Dosage: 50 ML, QD | Form: -- | Indication: Hypoproteinaemia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 200.0 (unit: 012)
Start: 08/08/2023 | End: 08/11/2023 | Duration: 4.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: 048 | Dosage: 1 G, BID | Form: -- | Indication: Hypokalaemia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 12.0 (unit: 002)
Start: 08/11/2023 | End: 08/16/2023 | Duration: 6.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
FERRIC POLYSACCHARIDE COMPLEX (FERRIC POLYSACCHARIDE COMPLEX) Concomitant
Route: 048 | Dosage: 3 G, QD | Form: -- | Indication: Anaemia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 3.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 6.0 (unit: 002)
Start: 08/11/2023 | End: 08/12/2023 | Duration: 2.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
MORPHINE HYDROCHLORIDE (MORPHINE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 50 MG, BID | Form: -- | Indication: Cancer pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 07/23/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230821

Report Duplicates (1)

SERVIER: CN-SERVIER-S23010327

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c84", "safetyreportid": "25955288", "authoritynumb": null, "companynumb": "CN-SERVIER-S23010327", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 55.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 42.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Ascites", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": "221201", "drugstructuredosagenumb": 105.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 105.0, "drugcumulativedosageunit": "003", "drugdosagetext": "105 MG, SINGLE", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Ductal adenocarcinoma of pancreas", "drugstartdateformat": "102", "drugstartdate": "2023-07-25T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-07-25T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN CALCIUM", "drugauthorizationnumb": null, "drugbatchnumb": "221008AJ", "drugstructuredosagenumb": 600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 600.0, "drugcumulativedosageunit": "003", "drugdosagetext": "600 MG, SINGLE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Ductal adenocarcinoma of pancreas", "drugstartdateformat": "102", "drugstartdate": "2023-07-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-07-11T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN CALCIUM", "drugauthorizationnumb": null, "drugbatchnumb": "221008AJ", "drugstructuredosagenumb": 600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 600.0, "drugcumulativedosageunit": "003", "drugdosagetext": "600 MG, SINGLE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-07-25T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-07-25T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": "2209081", "drugstructuredosagenumb": 3600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 3600.0, "drugcumulativedosageunit": "003", "drugdosagetext": "3600 MG, SINGLE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Ductal adenocarcinoma of pancreas", "drugstartdateformat": "102", "drugstartdate": "2023-07-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-07-11T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": "2209081", "drugstructuredosagenumb": 3600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 3600.0, "drugcumulativedosageunit": "003", "drugdosagetext": "3600 MG, SINGLE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-07-25T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-07-25T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ESOMEPRAZOLE MAGNESIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 240.0, "drugcumulativedosageunit": "003", "drugdosagetext": "40 MG, QD", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Nausea", "drugstartdateformat": "102", "drugstartdate": "2023-07-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-08-02T00:00:00", "drugtreatmentduration": 6.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ESOMEPRAZOLE MAGNESIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ERYTHROPOIETIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 9000.0, "drugstructuredosageunit": "025", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 9000.0, "drugcumulativedosageunit": "025", "drugdosagetext": "9000 IU, SINGLE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Anaemia", "drugstartdateformat": "102", "drugstartdate": "2023-08-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-08-11T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ERYTHROPOIETIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ERYTHROPOIETIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 9000.0, "drugstructuredosageunit": "025", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 9000.0, "drugcumulativedosageunit": "025", "drugdosagetext": "9000 IU, SINGLE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-08-16T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-08-16T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ERYTHROPOIETIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ERYTHROPOIETIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 9000.0, "drugstructuredosageunit": "025", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 9000.0, "drugcumulativedosageunit": "025", "drugdosagetext": "9000 IU, SINGLE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-08-18T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-08-18T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ERYTHROPOIETIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ALBUMIN HUMAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "012", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 200.0, "drugcumulativedosageunit": "012", "drugdosagetext": "50 ML, QD", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": "Hypoproteinaemia", "drugstartdateformat": "102", "drugstartdate": "2023-08-08T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-08-11T00:00:00", "drugtreatmentduration": 4.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ALBUMIN HUMAN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "POTASSIUM CHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 12.0, "drugcumulativedosageunit": "002", "drugdosagetext": "1 G, BID", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Hypokalaemia", "drugstartdateformat": "102", "drugstartdate": "2023-08-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-08-16T00:00:00", "drugtreatmentduration": 6.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "POTASSIUM CHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FERRIC POLYSACCHARIDE COMPLEX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 6.0, "drugcumulativedosageunit": "002", "drugdosagetext": "3 G, QD", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Anaemia", "drugstartdateformat": "102", "drugstartdate": "2023-08-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-08-12T00:00:00", "drugtreatmentduration": 2.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FERRIC POLYSACCHARIDE COMPLEX" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MORPHINE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "50 MG, BID", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Cancer pain", "drugstartdateformat": "102", "drugstartdate": "2023-07-23T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "MORPHINE HYDROCHLORIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230821" }, "primarysource": { "reportercountry": "CN", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "SERVIER", "duplicatenumb": "CN-SERVIER-S23010327" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25955287 Type 2
Serious
ONIVYDE, ONIVYDE, FLUOROURACIL (+11 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-SERVIER-S22013334
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
67.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
76.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Diarrhoea (v28.1) Recovered
Abdominal pain (v28.1) Recovered
Neutropenia (v28.1) Recovered

Drugs (14)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 132.3 MG | Form: Solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 132.3 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/09/2022 | End: 12/09/2022 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 75.6 MG | Form: Solution for infusion | Indication: -- | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 75.6 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 4540 MG | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 4540.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 3400 MG | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 3400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 375 MG | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 375.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/09/2022 | End: 12/09/2022 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 375 MG | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 375.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
JANUVIA (SITAGLIPTIN PHOSPHATE) Concomitant
Route: -- | Dosage: 100 MG, UNK | Form: -- | Indication: Diabetes mellitus | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ESIDREX (HYDROCHLOROTHIAZIDE) Concomitant
Route: -- | Dosage: 25 MG, UNK | Form: -- | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NEBIVOLOL (NEBIVOLOL) Concomitant
Route: -- | Dosage: 5 MG | Form: -- | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
IRBESARTAN (IRBESARTAN) Concomitant
Route: -- | Dosage: 150 MG | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 150.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
KARDEGIC (ASPIRIN DL-LYSINE) Concomitant
Route: -- | Dosage: 75 MG, UNK | Form: -- | Indication: Anticoagulant therapy | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FOLIC ACID (FOLIC ACID) Concomitant
Route: -- | Dosage: 1 DF, QD | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MOVICOL (POLYETHYLENE GLYCOL 3350\POTASSIUM CHLORIDE\SODIUM BICARBONATE\SODIUM CHLORIDE) Concomitant
Route: -- | Dosage: 1 DF, BID | Form: -- | Indication: Constipation | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PANTOPRAZOLE (PANTOPRAZOLE) Concomitant
Route: -- | Dosage: 2 DF QD | Form: -- | Indication: Dyspepsia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20221221

Report Duplicates (1)

SERVIER: S22013334

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c83", "safetyreportid": "25955287", "authoritynumb": null, "companynumb": "EU-SERVIER-S22013334", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 67.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 76.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neutropenia", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 132.3, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "132.3 MG", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2022-12-09T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-12-09T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 75.6, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "75.6 MG", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4540.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4540 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3400 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 375.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "375 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2022-12-09T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-12-09T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 375.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "375 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "JANUVIA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Diabetes mellitus", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SITAGLIPTIN PHOSPHATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ESIDREX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 25.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "25 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Hypertension", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "HYDROCHLOROTHIAZIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NEBIVOLOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Hypertension", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "NEBIVOLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "IRBESARTAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 150.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "150 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "IRBESARTAN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "KARDEGIC", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 75.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "75 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Anticoagulant therapy", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ASPIRIN DL-LYSINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FOLIC ACID", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FOLIC ACID" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MOVICOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, BID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Constipation", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "POLYETHYLENE GLYCOL 3350\\POTASSIUM CHLORIDE\\SODIUM BICARBONATE\\SODIUM CHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PANTOPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2 DF QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Dyspepsia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PANTOPRAZOLE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20221221" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "SERVIER", "duplicatenumb": "S22013334" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955285 Type 2
Serious
ONIVYDE, LEUCOVORIN CALCIUM, FLUOROURACIL (+4 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-SERVIER-S21005558
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
69.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
78.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Liver disorder (v28.1) Recovered

Drugs (7)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 129.5 MG, EVERY 2 WEEKS | Form: Concentrate for solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 129.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 05/14/2021 | End: 05/27/2021 | Duration: 14.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 740 MG, EVERY 2 WEEKS | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 740.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 05/14/2021 | End: 05/27/2021 | Duration: 14.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 4440 MG, EVERY 2 WEEKS | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 4440.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 05/14/2021 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
TORSEMIDE (TORSEMIDE) Concomitant
Route: 048 | Dosage: 2.5 MG, BID | Form: -- | Indication: Oedema peripheral | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 05/07/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
APIXABAN (APIXABAN) Concomitant
Route: 048 | Dosage: 5 MG, BID | Form: -- | Indication: Thrombosis prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 05/21/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM (POTASSIUM) Concomitant
Route: 048 | Dosage: UNK UNK, QD | Form: -- | Indication: Hypokalaemia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) Concomitant
Route: 048 | Dosage: 40 MG, QD | Form: -- | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20210527

Report Duplicates (1)

SERVIER: S21005558

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c82", "safetyreportid": "25955285", "authoritynumb": null, "companynumb": "EU-SERVIER-S21005558", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 69.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 78.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Liver disorder", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 129.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "129.5 MG, EVERY 2 WEEKS", "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2021-05-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-05-27T00:00:00", "drugtreatmentduration": 14.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN CALCIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 740.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "740 MG, EVERY 2 WEEKS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2021-05-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-05-27T00:00:00", "drugtreatmentduration": 14.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4440.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4440 MG, EVERY 2 WEEKS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2021-05-14T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TORSEMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, BID", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Oedema peripheral", "drugstartdateformat": "102", "drugstartdate": "2021-05-07T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TORSEMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "APIXABAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG, BID", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Thrombosis prophylaxis", "drugstartdateformat": "102", "drugstartdate": "2021-05-21T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "APIXABAN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "POTASSIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK UNK, QD", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Hypokalaemia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "POTASSIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PANTOPRAZOLE SODIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MG, QD", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Prophylaxis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PANTOPRAZOLE SODIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20210527" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "SERVIER", "duplicatenumb": "S21005558" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955286 Type 2
Serious
ONIVYDE, ONIVYDE, FLUOROURACIL (+18 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-IPSEN Group, Research and Development-2022-18812
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
63.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
76.6 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (13)

Neutropenia (v28.1) Recovered
Diverticulitis (v28.1) Recovered
Leukopenia (v28.1) Recovered
Small intestinal obstruction (v28.1) Unknown
Neutropenic colitis (v28.1) Unknown
Lymphocyte count decreased (v28.1) Unknown
Systemic inflammatory response syndrome (v28.1) Unknown
Lactic acidosis (v28.1) Recovered
Iron deficiency anaemia (v28.1) Unknown
Liver function test abnormal (v28.1) Unknown
Hyponatraemia (v28.1) Unknown
Pyrexia (v28.1) Unknown
Abdominal pain (v28.1) Unknown

Drugs (21)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: DOSE REDUCED BY 50% ON 03-NOV-2020 AND WAS TAKEN AT THAT DOSE LEVEL UNTIL 21-MAY-2021. | Form: Concentrate for solution for infusion | Indication: Colon cancer | Action: Dose Reduced
Auth#: 102799 | Batch#: 180061A | Structured Dosage: 103.2 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/28/2020 | End: 10/13/2020 | Duration: 16.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: DOSE REDUCED BY 50% ON 03-NOV-2020 AND WAS TAKEN AT THAT DOSE LEVEL UNTIL 21-MAY-2021. | Form: Concentrate for solution for infusion | Indication: -- | Action: Dose Reduced
Auth#: 102799 | Batch#: -- | Structured Dosage: 51.6 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/03/2020 | End: 05/11/2021 | Duration: 190.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Colon cancer | Action: Dose Reduced
Auth#: -- | Batch#: -- | Structured Dosage: 5000.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/28/2020 | End: 10/13/2020 | Duration: 16.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: Dose Reduced
Auth#: -- | Batch#: -- | Structured Dosage: 2400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/16/2020 | End: 10/21/2020 | Duration: 6.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: Dose Reduced
Auth#: -- | Batch#: -- | Structured Dosage: 2500.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/02/2020 | End: 05/21/2021 | Duration: 201.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
RUCAPARIB (RUCAPARIB) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Colon cancer | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: 09/02/2020 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
RUCAPARIB (RUCAPARIB) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: 10/02/2020 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
RUCAPARIB (RUCAPARIB) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: 10/16/2020 | End: 10/21/2020 | Duration: 6.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: TAKE 2 CAPSULES (4 MG) AT THE ONSET OF DIARRHEA, THEN 1 CAPSULE (2 MG) EVERY 2 HOURS AS NEEDED MAX OF 8 CAPSULES (16 MG) DAILY | Form: Capsule | Indication: Diarrhoea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 16.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 09/28/2020 | End: 07/26/2021 | Duration: 302.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ATIVAN (LORAZEPAM) Concomitant
Route: 048 | Dosage: TAKE 1 TABLET (0.5 MG TOTAL) BY MOUTH EVERY 4 (FOUR) HOURS AS NEEDED | Form: Tablet | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 4.0 hr | Cumulative: -- (unit: --)
Start: 10/09/2020 | End: 07/26/2021 | Duration: 291.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ZOFRAN (ONDANSETRON HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 8.0 hr | Cumulative: -- (unit: --)
Start: 09/28/2020 | End: 07/26/2021 | Duration: 302.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ZOFRAN (ONDANSETRON HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Vomiting | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PERCOCET (ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 5-325 MG PER TABLET TAKE 1-2 TABLETS BY MOUTH EVERY 6 (SIX) HOURS AS NEEDED FOR MODERATE PAIN OR SCORE 4-6 OF 10 | Form: Tablet | Indication: Pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 6.0 hr | Cumulative: -- (unit: --)
Start: 09/28/2020 | End: 06/18/2021 | Duration: 264.0 day | Rechallenge: -- | Additional: --
Recurrences: --
PROTONIX (PANTOPRAZOLE SODIUM) Concomitant
Route: 048 | Dosage: TAKE 40 MG BY MOUTH EVERY MORNING BEFORE BREAKFAST. | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/21/2019 | End: 08/30/2021 | Duration: 953.0 day | Rechallenge: -- | Additional: --
Recurrences: --
COMPAZINE (PROCHLORPERAZINE MALEATE) Concomitant
Route: 048 | Dosage: TAKE 1 TABLET (10 MG TOTAL) BY MOUTH EVERY 6 (SIX) HOURS AS NEEDED | Form: Tablet | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 6.0 hr | Cumulative: -- (unit: --)
Start: 09/28/2020 | End: 07/26/2021 | Duration: 302.0 day | Rechallenge: -- | Additional: --
Recurrences: --
COMPAZINE (PROCHLORPERAZINE MALEATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Vomiting | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PANTOPRAZOLE (PANTOPRAZOLE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE) Concomitant
Route: -- | Dosage: UNK | Form: Injection | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CYANOCOBALAMIN (CYANOCOBALAMIN) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OXYCODONE (OXYCODONE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
RHAMNUS PURSHIANA BARK EXTRACT (RHAMNUS PURSHIANA BARK EXTRACT) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20201010

Report Duplicates (1)

Servier: S22007077

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c81", "safetyreportid": "25955286", "authoritynumb": null, "companynumb": "US-IPSEN Group, Research and Development-2022-18812", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 63.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 76.6, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neutropenia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diverticulitis", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Leukopenia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Small intestinal obstruction", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neutropenic colitis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lymphocyte count decreased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Systemic inflammatory response syndrome", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lactic acidosis", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Iron deficiency anaemia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Liver function test abnormal", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hyponatraemia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pyrexia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": "180061A", "drugstructuredosagenumb": 103.2, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE REDUCED BY 50% ON 03-NOV-2020 AND WAS TAKEN AT THAT DOSE LEVEL UNTIL 21-MAY-2021.", "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": "Colon cancer", "drugstartdateformat": "102", "drugstartdate": "2020-09-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2020-10-13T00:00:00", "drugtreatmentduration": 16.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 2, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 51.6, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE REDUCED BY 50% ON 03-NOV-2020 AND WAS TAKEN AT THAT DOSE LEVEL UNTIL 21-MAY-2021.", "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2020-11-03T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-05-11T00:00:00", "drugtreatmentduration": 190.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 2, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 5000.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Colon cancer", "drugstartdateformat": "102", "drugstartdate": "2020-09-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2020-10-13T00:00:00", "drugtreatmentduration": 16.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 2, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2020-10-16T00:00:00", "drugenddateformat": "102", "drugenddate": "2020-10-21T00:00:00", "drugtreatmentduration": 6.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 2, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2500.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2020-11-02T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-05-21T00:00:00", "drugtreatmentduration": 201.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 2, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "RUCAPARIB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 12.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Colon cancer", "drugstartdateformat": "102", "drugstartdate": "2020-09-02T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RUCAPARIB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "RUCAPARIB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 12.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2020-10-02T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RUCAPARIB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "RUCAPARIB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 12.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2020-10-16T00:00:00", "drugenddateformat": "102", "drugenddate": "2020-10-21T00:00:00", "drugtreatmentduration": 6.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RUCAPARIB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "IMODIUM A-D", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 16.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TAKE 2 CAPSULES (4 MG) AT THE ONSET OF DIARRHEA, THEN 1 CAPSULE (2 MG) EVERY 2 HOURS AS NEEDED MAX OF 8 CAPSULES (16 MG) DAILY", "drugdosageform": "Capsule", "drugadministrationroute": null, "drugindication": "Diarrhoea", "drugstartdateformat": "102", "drugstartdate": "2020-09-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-07-26T00:00:00", "drugtreatmentduration": 302.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LOPERAMIDE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ATIVAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 4.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TAKE 1 TABLET (0.5 MG TOTAL) BY MOUTH EVERY 4 (FOUR) HOURS AS NEEDED", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Nausea", "drugstartdateformat": "102", "drugstartdate": "2020-10-09T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-07-26T00:00:00", "drugtreatmentduration": 291.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LORAZEPAM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ZOFRAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 8.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Nausea", "drugstartdateformat": "102", "drugstartdate": "2020-09-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-07-26T00:00:00", "drugtreatmentduration": 302.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ONDANSETRON HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ZOFRAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Vomiting", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ONDANSETRON HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PERCOCET", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 6.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5-325 MG PER TABLET TAKE 1-2 TABLETS BY MOUTH EVERY 6 (SIX) HOURS AS NEEDED FOR MODERATE PAIN OR SCORE 4-6 OF 10", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Pain", "drugstartdateformat": "102", "drugstartdate": "2020-09-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-06-18T00:00:00", "drugtreatmentduration": 264.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ACETAMINOPHEN\\OXYCODONE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PROTONIX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TAKE 40 MG BY MOUTH EVERY MORNING BEFORE BREAKFAST.", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2019-01-21T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-08-30T00:00:00", "drugtreatmentduration": 953.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PANTOPRAZOLE SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "COMPAZINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 6.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TAKE 1 TABLET (10 MG TOTAL) BY MOUTH EVERY 6 (SIX) HOURS AS NEEDED", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Nausea", "drugstartdateformat": "102", "drugstartdate": "2020-09-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-07-26T00:00:00", "drugtreatmentduration": 302.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PROCHLORPERAZINE MALEATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "COMPAZINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Vomiting", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PROCHLORPERAZINE MALEATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PANTOPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PANTOPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TESTOSTERONE CYPIONATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Injection", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TESTOSTERONE CYPIONATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CYANOCOBALAMIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CYANOCOBALAMIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OXYCODONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "OXYCODONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "RHAMNUS PURSHIANA BARK EXTRACT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "RHAMNUS PURSHIANA BARK EXTRACT" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20201010" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Servier", "duplicatenumb": "S22007077" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955284 Type 2
Serious
ONIVYDE, LEUCOVORIN, FLUOROURACIL (+1 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-SERVIER-S23007130
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
71.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
72.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Fungal oesophagitis (v28.1) Recovered

Drugs (4)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 148 MG, QD | Form: Solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Dose Not Changed
Auth#: 102799 | Batch#: -- | Structured Dosage: 148.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/26/2019 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 740 MG, QD | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 740.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/26/2019 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 4440 MG, QD | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 4440.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/26/2019 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
RAMIPRIL (RAMIPRIL) Concomitant
Route: -- | Dosage: 2.5 MG, BID | Form: -- | Indication: Hypertension | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/01/2011 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20190917

Report Duplicates (1)

SERVIER: EU-SERVIER-S23007130

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c80", "safetyreportid": "25955284", "authoritynumb": null, "companynumb": "EU-SERVIER-S23007130", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 71.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 72.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fungal oesophagitis", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 148.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "148 MG, QD", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2019-08-26T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 740.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "740 MG, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2019-08-26T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4440.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4440 MG, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2019-08-26T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "RAMIPRIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, BID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Hypertension", "drugstartdateformat": "602", "drugstartdate": "2011-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "RAMIPRIL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20190917" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "SERVIER", "duplicatenumb": "EU-SERVIER-S23007130" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955283 Type 2
Serious
ONIVYDE, FLUOROURACIL, OXALIPLATIN (+12 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-SERVIER-S22007173
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
68.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
83.1 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Gastrointestinal inflammation (v28.1) Recovered

Drugs (15)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 50 MG/M2, 1X/2WKS | Form: Solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 50.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 150.0 (unit: 009)
Start: 05/27/2022 | End: 06/24/2022 | Duration: 29.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 2400 MG/M2, 1X/2WKS | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 2400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 7200.0 (unit: 009)
Start: 05/27/2022 | End: 06/24/2022 | Duration: 29.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: 60 MG/M2, 1X/2WKS | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 180.0 (unit: 009)
Start: 05/27/2022 | End: 06/24/2022 | Duration: 29.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 400 MG/M2, 1X/2WKS | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 1200.0 (unit: 009)
Start: 05/27/2022 | End: 06/24/2022 | Duration: 29.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ALDACTONE (SPIRONOLACTONE) Concomitant
Route: -- | Dosage: 12.5 MG, UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 12.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) Concomitant
Route: -- | Dosage: 5 MG, UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INNOHEP (TINZAPARIN SODIUM) Concomitant
Route: -- | Dosage: 14000 IU, UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 14000.0 (unit: 025) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LASIX (FUROSEMIDE) Concomitant
Route: -- | Dosage: 40 MG, UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PANTOMED (--) Concomitant
Route: -- | Dosage: 40 MG, UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ATORVASTATIN (ATORVASTATIN) Concomitant
Route: -- | Dosage: 10 MG, UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FOLIC ACID (FOLIC ACID) Concomitant
Route: -- | Dosage: 4 MG, UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PEGFILGRASTIM (PEGFILGRASTIM) Concomitant
Route: -- | Dosage: 6 MG, UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 6.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OLMESARTAN MEDOXOMIL (OLMESARTAN MEDOXOMIL) Concomitant
Route: -- | Dosage: 10 MG | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/30/2012 | End: 05/27/2022 | Duration: 3619.0 day | Rechallenge: -- | Additional: --
Recurrences: --
OLMESARTAN MEDOXOMIL (OLMESARTAN MEDOXOMIL) Concomitant
Route: -- | Dosage: 5 MG, UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DAFALGAN (ACETAMINOPHEN) Concomitant
Route: -- | Dosage: 1 G, PRN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/27/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20220708

Report Duplicates (2)

Servier: S22007173
Servier: 446354_P07

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c7f", "safetyreportid": "25955283", "authoritynumb": null, "companynumb": "EU-SERVIER-S22007173", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 68.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 83.1, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gastrointestinal inflammation", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 150.0, "drugcumulativedosageunit": "009", "drugdosagetext": "50 MG/M2, 1X/2WKS", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2022-05-27T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-06-24T00:00:00", "drugtreatmentduration": 29.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 7200.0, "drugcumulativedosageunit": "009", "drugdosagetext": "2400 MG/M2, 1X/2WKS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2022-05-27T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-06-24T00:00:00", "drugtreatmentduration": 29.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OXALIPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 180.0, "drugcumulativedosageunit": "009", "drugdosagetext": "60 MG/M2, 1X/2WKS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2022-05-27T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-06-24T00:00:00", "drugtreatmentduration": 29.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 1200.0, "drugcumulativedosageunit": "009", "drugdosagetext": "400 MG/M2, 1X/2WKS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2022-05-27T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-06-24T00:00:00", "drugtreatmentduration": 29.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ALDACTONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 12.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "12.5 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SPIRONOLACTONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AMLODIPINE BESYLATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "INNOHEP", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 14000.0, "drugstructuredosageunit": "025", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "14000 IU, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TINZAPARIN SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LASIX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PANTOMED", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ATORVASTATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ATORVASTATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FOLIC ACID", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FOLIC ACID" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PEGFILGRASTIM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 6.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "6 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PEGFILGRASTIM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OLMESARTAN MEDOXOMIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2012-06-30T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-05-27T00:00:00", "drugtreatmentduration": 3619.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "OLMESARTAN MEDOXOMIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OLMESARTAN MEDOXOMIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "OLMESARTAN MEDOXOMIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DAFALGAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 G, PRN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2022-05-27T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20220708" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Servier", "duplicatenumb": "S22007173" }, { "duplicatesource": "Servier", "duplicatenumb": "446354_P07" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25955282 Type 2
Serious
ONIVYDE, FLUOROURACIL, LEUCOVORIN
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-SERVIER-S23000375
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
65.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Pneumonitis (v28.1) Recovered

Drugs (3)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: UNK | Form: Solution for infusion | Indication: Gastrooesophageal cancer | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/21/2022 | End: 01/04/2023 | Duration: 15.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Gastrooesophageal cancer | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/21/2022 | End: 01/04/2023 | Duration: 15.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Gastrooesophageal cancer | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/21/2022 | End: 01/04/2023 | Duration: 15.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230105

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c7e", "safetyreportid": "25955282", "authoritynumb": null, "companynumb": "EU-SERVIER-S23000375", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 65.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pneumonitis", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Gastrooesophageal cancer", "drugstartdateformat": "102", "drugstartdate": "2022-12-21T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-01-04T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Gastrooesophageal cancer", "drugstartdateformat": "102", "drugstartdate": "2022-12-21T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-01-04T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Gastrooesophageal cancer", "drugstartdateformat": "102", "drugstartdate": "2022-12-21T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-01-04T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230105" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }