FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25955312 Type 2
Serious
ONIVYDE, PEMBROLIZUMAB, FLUOROURACIL (+2 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
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-2023-14783
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
--
Patient Weight
35.59 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Diarrhoea (v28.1) Recovering
Decreased appetite (v28.1) Unknown
Colitis (v28.1) Unknown

Drugs (5)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: Concentrate for solution for infusion | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
PEMBROLIZUMAB (PEMBROLIZUMAB) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Oesophageal carcinoma | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 42.0 day | Cumulative: -- (unit: --)
Start: 03/15/2023 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TRASTUZUMAB (TRASTUZUMAB) 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: 20230601

Report Duplicates (1)

MISTRAL: US23-002141

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c9d", "safetyreportid": "25955312", "authoritynumb": null, "companynumb": "US-IPSEN Group, Research and Development-2023-14783", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 67.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 35.59, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Decreased appetite", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Colitis", "reactionoutcome": 6 } ], "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": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PEMBROLIZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 42.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Oesophageal carcinoma", "drugstartdateformat": "102", "drugstartdate": "2023-03-15T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PEMBROLIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "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": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OXALIPLATIN", "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": "OXALIPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TRASTUZUMAB", "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": "TRASTUZUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230601" }, "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": "MISTRAL", "duplicatenumb": "US23-002141" } ], "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" }
25955310 Type 2
Serious
IRINOTECAN HYDROCHLORIDE, LEUCOVORIN, FLUOROURACIL
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
TW
Occurrence Country
TW
Reporter Country
TW
Reporter Qualification
Physician
Literature Reference
CHIANG C, CHIANG C, CHIANG C, CHIU J, CHEN BS, LUAN Y, et al. The Efficacy of Liposomal Irinotecan Plus Fluorouracil/Leucovorin as First-Line Therapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma: A Single-Center Real-World Study. Pancreas. 2022 Sep;51 (8): E107-E109. doi:http://dx.doi.org/10.1097/MPA.0000000000002125.
Company Number
TW-IPSEN Group, Research and Development-2023-00974
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
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Hyperbilirubinaemia (v28.1) Unknown
Hypokalaemia (v28.1) Unknown
Anaemia (v28.1) Unknown
Aspartate aminotransferase increased (v28.1) Unknown
Alanine aminotransferase increased (v28.1) Unknown

Drugs (3)

IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: Concentrate for solution for infusion | Indication: Ductal adenocarcinoma of pancreas | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Ductal adenocarcinoma of pancreas | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Ductal adenocarcinoma of pancreas | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c9a", "safetyreportid": "25955310", "authoritynumb": null, "companynumb": "TW-IPSEN Group, Research and Development-2023-00974", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "TW", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hyperbilirubinaemia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypokalaemia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anaemia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Aspartate aminotransferase increased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Alanine aminotransferase increased", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "IRINOTECAN HYDROCHLORIDE", "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": "Ductal adenocarcinoma of pancreas", "drugstartdateformat": null, "drugstartdate": null, "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": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Ductal adenocarcinoma of pancreas", "drugstartdateformat": null, "drugstartdate": null, "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": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Ductal adenocarcinoma of pancreas", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "TW", "qualification": 1, "literaturereference": "CHIANG C, CHIANG C, CHIANG C, CHIU J, CHEN BS, LUAN Y, et al. The Efficacy of Liposomal Irinotecan Plus Fluorouracil/Leucovorin as First-Line Therapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma: A Single-Center Real-World Study. Pancreas. 2022 Sep;51 (8): E107-E109. doi:http://dx.doi.org/10.1097/MPA.0000000000002125." }, "primarysourcecountry": "TW", "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": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25955308 Type 2
Serious
ONIVYDE, ONIVYDE, 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-S23010933
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
50.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Gastrointestinal inflammation (v28.1) Recovered
Vomiting (v28.1) Recovered
Abdominal pain upper (v28.1) Recovered

Drugs (15)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 50 MG/M2, EVERY 2 WEEKS | Form: Solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 50.0 (unit: 009)
Start: 09/14/2023 | End: 09/14/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 43 MG/M2, EVERY 2 WEEKS | Form: Solution for infusion | Indication: -- | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 43.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 50.0 (unit: 009)
Start: 10/12/2023 | End: 10/12/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: 60 MG/M2, EVERY 2 WEEKS | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 60.0 (unit: 009)
Start: 09/14/2023 | End: 09/14/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: 48 MG/M2, EVERY 2 WEEKS | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 48.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 60.0 (unit: 009)
Start: 10/12/2023 | End: 10/12/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 2400 MG/M2, EVERY 2 WEEKS | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 2400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 2400.0 (unit: 009)
Start: 09/14/2023 | End: 09/14/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 1800 MG/M2, EVERY 2 WEEKS | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 1800.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 2400.0 (unit: 009)
Start: 10/12/2023 | End: 10/12/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 400 MG/M2, EVERY 2 WEEKS | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 400.0 (unit: 009)
Start: 09/14/2023 | End: 09/14/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 400 MG/M2, EVERY 2 WEEKS | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 400.0 (unit: 009)
Start: 10/12/2023 | End: 10/12/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 850 MG | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 850.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
JARDIANCE (EMPAGLIFLOZIN) Concomitant
Route: 048 | 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: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ASPIRIN (ASPIRIN) Concomitant
Route: 048 | Dosage: 100 MG | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
BISOPROLOL FUMARATE\PERINDOPRIL ARGININE (BISOPROLOL FUMARATE\PERINDOPRIL ARGININE) Concomitant
Route: 048 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SIMVASTATIN (SIMVASTATIN) Concomitant
Route: 048 | Dosage: 20 MG | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TRESIBA (INSULIN DEGLUDEC) Concomitant
Route: 058 | Dosage: 10 IU | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 025) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CREON (PANCRELIPASE AMYLASE\PANCRELIPASE LIPASE\PANCRELIPASE PROTEASE) Concomitant
Route: 048 | Dosage: 35000 IU | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 35000.0 (unit: 025) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230921

Report Duplicates (1)

SERVIER: EU-SERVIER-S23010933

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c99", "safetyreportid": "25955308", "authoritynumb": null, "companynumb": "EU-SERVIER-S23010933", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 63.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 50.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gastrointestinal inflammation", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain upper", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 50.0, "drugcumulativedosageunit": "009", "drugdosagetext": "50 MG/M2, EVERY 2 WEEKS", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2023-09-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-09-14T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 43.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 50.0, "drugcumulativedosageunit": "009", "drugdosagetext": "43 MG/M2, EVERY 2 WEEKS", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-10-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-10-12T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OXALIPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 60.0, "drugcumulativedosageunit": "009", "drugdosagetext": "60 MG/M2, EVERY 2 WEEKS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2023-09-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-09-14T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OXALIPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 48.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 60.0, "drugcumulativedosageunit": "009", "drugdosagetext": "48 MG/M2, EVERY 2 WEEKS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-10-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-10-12T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 2400.0, "drugcumulativedosageunit": "009", "drugdosagetext": "2400 MG/M2, EVERY 2 WEEKS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2023-09-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-09-14T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1800.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 2400.0, "drugcumulativedosageunit": "009", "drugdosagetext": "1800 MG/M2, EVERY 2 WEEKS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-10-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-10-12T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 400.0, "drugcumulativedosageunit": "009", "drugdosagetext": "400 MG/M2, EVERY 2 WEEKS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2023-09-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-09-14T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 400.0, "drugcumulativedosageunit": "009", "drugdosagetext": "400 MG/M2, EVERY 2 WEEKS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-10-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-10-12T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METFORMIN HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 850.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "850 MG", "drugdosageform": null, "drugadministrationroute": "048", "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": "METFORMIN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "JARDIANCE", "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": "048", "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": "EMPAGLIFLOZIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ASPIRIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MG", "drugdosageform": null, "drugadministrationroute": "048", "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": "ASPIRIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BISOPROLOL FUMARATE\\PERINDOPRIL ARGININE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "048", "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": "BISOPROLOL FUMARATE\\PERINDOPRIL ARGININE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SIMVASTATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20 MG", "drugdosageform": null, "drugadministrationroute": "048", "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": "SIMVASTATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TRESIBA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "025", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 IU", "drugdosageform": null, "drugadministrationroute": "058", "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": "INSULIN DEGLUDEC" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CREON", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 35000.0, "drugstructuredosageunit": "025", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "35000 IU", "drugdosageform": null, "drugadministrationroute": "048", "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": "PANCRELIPASE AMYLASE\\PANCRELIPASE LIPASE\\PANCRELIPASE PROTEASE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230921" }, "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-S23010933" } ], "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" }
25955309 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
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-IPSEN Group, Research and Development-2023-18188
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
73.0 yr
Patient Age Group
Elderly
Patient Sex
--
Patient Weight
70.4 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Small intestinal obstruction (v28.1) Recovered

Drugs (3)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: Concentrate for solution for infusion | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 102799 | Batch#: -- | Structured Dosage: 125.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 28.0 day | Cumulative: -- (unit: --)
Start: 06/28/2023 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: 4
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 4400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 28.0 day | Cumulative: -- (unit: --)
Start: 06/28/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 735.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 28.0 day | Cumulative: -- (unit: --)
Start: 06/28/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230714

Report Duplicates (1)

MISTRAL: US23-002611

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c97", "safetyreportid": "25955309", "authoritynumb": null, "companynumb": "US-IPSEN Group, Research and Development-2023-18188", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 73.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 70.4, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Small intestinal obstruction", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 125.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 28.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2023-06-28T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 28.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2023-06-28T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 735.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 28.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2023-06-28T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230714" }, "primarysource": { "reportercountry": "US", "qualification": 1, "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": "MISTRAL", "duplicatenumb": "US23-002611" } ], "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": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25955307 Type 2
Serious
ONIVYDE, FLUOROURACIL, LEUCOVORIN
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-S20008473
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
75.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
63.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Gastrointestinal infection (v28.1) Recovered
Abdominal infection (v28.1) Recovered

Drugs (3)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 124.35 MG, EVERY 2 WEEKS | Form: Concentrate for solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 124.35 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 08/04/2020 | End: 08/18/2020 | Duration: 15.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 4263.52 MG, EVERY 2 WEEKS | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 4263.52 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 8527.04 (unit: 003)
Start: 08/04/2020 | End: 08/18/2020 | Duration: 15.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 710.6 MG, EVERY 2 WEEKS | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 710.6 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 1421.2 (unit: 003)
Start: 08/04/2020 | End: 08/18/2020 | Duration: 15.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20200819

Report Duplicates (1)

SERVIER: EU-SERVIER-S20008473

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c98", "safetyreportid": "25955307", "authoritynumb": null, "companynumb": "EU-SERVIER-S20008473", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 75.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 63.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gastrointestinal infection", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal infection", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 124.35, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "124.35 MG, EVERY 2 WEEKS", "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2020-08-04T00:00:00", "drugenddateformat": "102", "drugenddate": "2020-08-18T00:00:00", "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": 4263.52, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 8527.04, "drugcumulativedosageunit": "003", "drugdosagetext": "4263.52 MG, EVERY 2 WEEKS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2020-08-04T00:00:00", "drugenddateformat": "102", "drugenddate": "2020-08-18T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 710.6, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 1421.2, "drugcumulativedosageunit": "003", "drugdosagetext": "710.6 MG, EVERY 2 WEEKS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2020-08-04T00:00:00", "drugenddateformat": "102", "drugenddate": "2020-08-18T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20200819" }, "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-S20008473" } ], "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" }
25955305 Type 2
Serious
ONIVYDE, FLUOROURACIL, LEUCOVORIN (+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-S23009862
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
61.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
57.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

General physical health deterioration (v28.1) Recovered

Drugs (14)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 123.20 MG, OTHER | Form: Solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 123.2 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 4200 MG, OTHER | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 4200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 350 MG, OTHER | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 350.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
POLYETHYLENE GLYCOLS (POLYETHYLENE GLYCOLS) Concomitant
Route: -- | Dosage: 1 DF, BID | Form: -- | Indication: Constipation | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 05/15/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INDAPAMIDE\PERINDOPRIL (INDAPAMIDE\PERINDOPRIL) Concomitant
Route: -- | Dosage: UNKNOWN | Form: -- | Indication: Hypertension | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ESOMEPRAZOLE (ESOMEPRAZOLE) Concomitant
Route: -- | Dosage: UNKNOWN | Form: -- | Indication: Gastrooesophageal reflux disease | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OXYCODONE (OXYCODONE) Concomitant
Route: -- | Dosage: 20 MG, BID | Form: -- | Indication: Pain | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/01/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 5 MG, QID | Form: -- | Indication: Pain | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/01/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Concomitant
Route: -- | Dosage: 1 G, QID | Form: -- | Indication: Pain | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/01/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VOGALENE (METOPIMAZINE) Concomitant
Route: -- | Dosage: 7.5 MG | Form: -- | Indication: Nausea | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 7.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PRIMPERAN (METOCLOPRAMIDE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 10 MG, TID | Form: -- | Indication: Nausea | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 30.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 05/15/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
IMODIUM (LOPERAMIDE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 2 MG | Form: -- | Indication: Diarrhoea | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SODIUM BICARBONATE (SODIUM BICARBONATE) Concomitant
Route: -- | Dosage: UNKNOWN | Form: -- | Indication: Prophylaxis | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 05/15/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ONDANSETRON (ONDANSETRON) Concomitant
Route: -- | Dosage: 8 MG, BID | Form: -- | Indication: Nausea | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 16.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 05/15/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230516

Report Duplicates (1)

Servier: EU-SERVIER-S23009862

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c95", "safetyreportid": "25955305", "authoritynumb": null, "companynumb": "EU-SERVIER-S23009862", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 61.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 57.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "General physical health deterioration", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 123.2, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "123.20 MG, OTHER", "drugdosageform": "Solution for infusion", "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": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4200 MG, OTHER", "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": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 350.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "350 MG, OTHER", "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": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "POLYETHYLENE GLYCOLS", "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": "102", "drugstartdate": "2023-05-15T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "POLYETHYLENE GLYCOLS" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "INDAPAMIDE\\PERINDOPRIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNKNOWN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Hypertension", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INDAPAMIDE\\PERINDOPRIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ESOMEPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNKNOWN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Gastrooesophageal reflux disease", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "ESOMEPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OXYCODONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20 MG, BID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pain", "drugstartdateformat": "610", "drugstartdate": "2023-04-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "OXYCODONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OXYCODONE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG, QID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pain", "drugstartdateformat": "610", "drugstartdate": "2023-04-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "OXYCODONE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ACETAMINOPHEN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 G, QID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pain", "drugstartdateformat": "610", "drugstartdate": "2023-04-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VOGALENE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 7.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "7.5 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Nausea", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "METOPIMAZINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PRIMPERAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 30.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MG, TID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Nausea", "drugstartdateformat": "102", "drugstartdate": "2023-05-15T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "METOCLOPRAMIDE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "IMODIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Diarrhoea", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LOPERAMIDE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SODIUM BICARBONATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNKNOWN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Prophylaxis", "drugstartdateformat": "102", "drugstartdate": "2023-05-15T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "SODIUM BICARBONATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ONDANSETRON", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 16.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "8 MG, BID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Nausea", "drugstartdateformat": "102", "drugstartdate": "2023-05-15T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "ONDANSETRON" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230516" }, "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-S23009862" } ], "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" }
25955306 Type 2
Serious
ONIVYDE, LEUCOVORIN CALCIUM, FLUOROURACIL (+3 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Physician
Literature Reference
--
Company Number
CN-SERVIER-S23007121
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
60.1 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Dizziness (v28.1) Recovering

Drugs (6)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 43 MG/10 ML (119 MG), 14-28 DAYS/TIME | Form: Solution for infusion | Indication: Pancreatic carcinoma | Action: Unknown
Auth#: 207793 | Batch#: U17494 | Structured Dosage: 119.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: UNK, 14-28 DAYS/TIME | Form: -- | Indication: Pancreatic carcinoma | Action: Unknown
Auth#: -- | Batch#: 221008AJ | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 4080 MG, 14-28 DAYS/TIME | Form: -- | Indication: Pancreatic carcinoma | Action: Unknown
Auth#: -- | Batch#: 2209081 | Structured Dosage: 4080.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 119 MG | Form: -- | Indication: Pancreatic carcinoma | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 119.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/07/2023 | End: 06/09/2023 | Duration: 3.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
DIETARY SUPPLEMENT (DIETARY SUPPLEMENT) Concomitant
Route: 048 | Dosage: 1 DF, TID | Form: -- | Indication: Dyspepsia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 06/01/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
NIFEDIPINE (NIFEDIPINE) Concomitant
Route: 048 | Dosage: 20 MG, BID | Form: -- | Indication: Hypertension | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 06/01/2022 | End: 06/12/2023 | Duration: 377.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230610

Report Duplicates (1)

Servier: CN-SERVIER-S23007121

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c96", "safetyreportid": "25955306", "authoritynumb": null, "companynumb": "CN-SERVIER-S23007121", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 62.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 60.1, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dizziness", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "207793", "drugbatchnumb": "U17494", "drugstructuredosagenumb": 119.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "43 MG/10 ML (119 MG), 14-28 DAYS/TIME", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN CALCIUM", "drugauthorizationnumb": null, "drugbatchnumb": "221008AJ", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, 14-28 DAYS/TIME", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": "2209081", "drugstructuredosagenumb": 4080.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4080 MG, 14-28 DAYS/TIME", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "IRINOTECAN HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 119.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "119 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2023-06-07T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-06-09T00:00:00", "drugtreatmentduration": 3.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DIETARY SUPPLEMENT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, TID", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Dyspepsia", "drugstartdateformat": "610", "drugstartdate": "2022-06-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DIETARY SUPPLEMENT" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NIFEDIPINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20 MG, BID", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Hypertension", "drugstartdateformat": "610", "drugstartdate": "2022-06-01T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-06-12T00:00:00", "drugtreatmentduration": 377.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "NIFEDIPINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230610" }, "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-S23007121" } ], "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" }
25955304 Type 2
Serious
ONIVYDE, FLUOROURACIL, LEUCOVORIN (+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-S23004139
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
59.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
58.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (7)

Constipation (v28.1) Recovered
General physical health deterioration (v28.1) Recovered
Abdominal pain (v28.1) Recovered
Nausea (v28.1) Recovered
Vomiting (v28.1) Recovered
Nausea (v28.1) Recovered
Vomiting (v28.1) Recovered

Drugs (5)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 81.39 MG | Form: Solution for infusion | Indication: Pancreatic carcinoma | Action: Dose Not Changed
Auth#: 102799 | Batch#: -- | Structured Dosage: 81.39 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/14/2023 | End: 04/12/2023 | Duration: 30.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 3606.89 MG, QD | Form: -- | Indication: Pancreatic carcinoma | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 3606.89 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 108206.7 (unit: 003)
Start: 03/14/2023 | End: 04/12/2023 | Duration: 30.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 656.99 MG, QD | Form: -- | Indication: Pancreatic carcinoma | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 656.99 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 19709.7 (unit: 003)
Start: 03/14/2023 | End: 04/12/2023 | Duration: 30.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: 99.5 MG, QD | Form: -- | Indication: Pancreatic carcinoma | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 99.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 99.5 (unit: 003)
Start: 03/14/2023 | End: 03/14/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
EQUIZYM MCA (--) Concomitant
Route: -- | Dosage: UNKNOWN, QD | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 03/13/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230415

Report Duplicates (1)

SERVIER: EU-SERVIER-S23004139

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c94", "safetyreportid": "25955304", "authoritynumb": null, "companynumb": "EU-SERVIER-S23004139", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 59.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 58.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Constipation", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "General physical health deterioration", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 81.39, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "81.39 MG", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2023-03-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-04-12T00:00:00", "drugtreatmentduration": 30.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3606.89, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 108206.7, "drugcumulativedosageunit": "003", "drugdosagetext": "3606.89 MG, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2023-03-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-04-12T00:00:00", "drugtreatmentduration": 30.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 656.99, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 19709.7, "drugcumulativedosageunit": "003", "drugdosagetext": "656.99 MG, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2023-03-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-04-12T00:00:00", "drugtreatmentduration": 30.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OXALIPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 99.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 99.5, "drugcumulativedosageunit": "003", "drugdosagetext": "99.5 MG, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2023-03-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-03-14T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "EQUIZYM MCA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNKNOWN, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2023-03-13T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230415" }, "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-S23004139" } ], "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" }
25955302 Type 2
Serious
ONIVYDE, LEUCOVORIN CALCIUM, FLUOROURACIL
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Physician
Literature Reference
--
Company Number
CN-SERVIER-S23010009
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
45.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
53.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Intestinal obstruction (v28.1) Recovered
Febrile neutropenia (v28.1) Recovered

Drugs (3)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 041 | Dosage: 112 MG | Form: Solution for infusion | Indication: Pancreatic carcinoma | Action: Not Applicable
Auth#: -- | Batch#: U17494 | Structured Dosage: 112.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/08/2023 | End: 08/08/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: 4
Recurrences: --
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) Suspect
Route: 041 | Dosage: 640 MG | Form: -- | Indication: Pancreatic carcinoma | Action: Dose Not Changed
Auth#: -- | Batch#: 221008 | Structured Dosage: 640.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/08/2023 | End: 08/25/2023 | Duration: 18.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: 041 | Dosage: 3840 MG | Form: -- | Indication: Pancreatic carcinoma | Action: Dose Not Changed
Auth#: -- | Batch#: 2209081 | Structured Dosage: 3840.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/08/2023 | End: 08/25/2023 | Duration: 18.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230819

Report Duplicates (1)

Servier: CN-SERVIER-S23010009

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c93", "safetyreportid": "25955302", "authoritynumb": null, "companynumb": "CN-SERVIER-S23010009", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 45.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 53.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Intestinal obstruction", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Febrile neutropenia", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": "U17494", "drugstructuredosagenumb": 112.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "112 MG", "drugdosageform": "Solution for infusion", "drugadministrationroute": "041", "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2023-08-08T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-08-08T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN CALCIUM", "drugauthorizationnumb": null, "drugbatchnumb": "221008", "drugstructuredosagenumb": 640.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "640 MG", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2023-08-08T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-08-25T00:00:00", "drugtreatmentduration": 18.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": "2209081", "drugstructuredosagenumb": 3840.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3840 MG", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2023-08-08T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-08-25T00:00:00", "drugtreatmentduration": 18.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230819" }, "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-S23010009" } ], "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" }
25955303 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-S23014688
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
70.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
74.5 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (7)

General physical health deterioration (v28.1) Recovered
Asthenia (v28.1) Recovered
Diarrhoea (v28.1) Recovered
Nausea (v28.1) Recovered
Vomiting (v28.1) Recovered
Weight decreased (v28.1) Recovered
Decreased appetite (v28.1) Recovered

Drugs (3)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 133.3 MG, EVERY 2 WEEKS | Form: Solution for infusion | Indication: Ductal adenocarcinoma of pancreas | Action: Unknown
Auth#: 207793 | Batch#: -- | Structured Dosage: 133.3 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 266.6 (unit: 003)
Start: 11/22/2023 | End: 12/06/2023 | Duration: 15.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 4600 MG, EVERY 2 WEEKS | Form: Solution for injection | Indication: Ductal adenocarcinoma of pancreas | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 4600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 9200.0 (unit: 003)
Start: 11/22/2023 | End: 12/06/2023 | Duration: 15.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Concomitant
Route: -- | Dosage: 384 MG, EVERY 2 WEEKS | Form: -- | Indication: Ductal adenocarcinoma of pancreas | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 384.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 768.0 (unit: 003)
Start: 11/22/2023 | End: 12/06/2023 | Duration: 15.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20231209

Report Duplicates (1)

SERVIER: EU-SERVIER-S23014688

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c92", "safetyreportid": "25955303", "authoritynumb": null, "companynumb": "EU-SERVIER-S23014688", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 70.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 74.5, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "General physical health deterioration", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Asthenia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Weight decreased", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Decreased appetite", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "207793", "drugbatchnumb": null, "drugstructuredosagenumb": 133.3, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 266.6, "drugcumulativedosageunit": "003", "drugdosagetext": "133.3 MG, EVERY 2 WEEKS", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Ductal adenocarcinoma of pancreas", "drugstartdateformat": "102", "drugstartdate": "2023-11-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-12-06T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 9200.0, "drugcumulativedosageunit": "003", "drugdosagetext": "4600 MG, EVERY 2 WEEKS", "drugdosageform": "Solution for injection", "drugadministrationroute": null, "drugindication": "Ductal adenocarcinoma of pancreas", "drugstartdateformat": "102", "drugstartdate": "2023-11-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-12-06T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 384.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 768.0, "drugcumulativedosageunit": "003", "drugdosagetext": "384 MG, EVERY 2 WEEKS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Ductal adenocarcinoma of pancreas", "drugstartdateformat": "102", "drugstartdate": "2023-11-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-12-06T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20231209" }, "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-S23014688" } ], "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" }