FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25955352 Type 2
Serious
TAZVERIK, DURVALUMAB, OXYCONTIN (+11 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-EPIZYME, INC.-2022FREPZ64381090
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
57.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
83.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Acute kidney injury (v28.1) Recovered

Drugs (14)

TAZVERIK (TAZEMETOSTAT HYDROBROMIDE) Suspect
Route: 048 | Dosage: 800 MG?CUMULATED DOSE: 60800 MG | Form: Tablet | Indication: Adenocarcinoma pancreas | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/22/2022 | End: 10/21/2022 | Duration: 38.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
DURVALUMAB (DURVALUMAB) Suspect
Route: 042 | Dosage: 1120 MG | Form: Solution for infusion | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 1120.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/12/2022 | End: -- | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
OXYCONTIN (OXYCODONE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 100 MG, EVERY 1DAY(S) | Form: -- | Indication: Abdominal pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LYRICA (PREGABALIN) Concomitant
Route: 048 | Dosage: 25 MG, EVERY 1DAY(S) | Form: -- | Indication: Abdominal pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LANREOTIDE ACETATE (LANREOTIDE ACETATE) Concomitant
Route: 058 | Dosage: UNK | Form: -- | Indication: Abdominal pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 500 MG, | Form: -- | Indication: Diabetes mellitus | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
XARELTO (RIVAROXABAN) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Venous thrombosis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ESIDREX (HYDROCHLOROTHIAZIDE) Concomitant
Route: 048 | Dosage: UNKOWN | Form: Tablet | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
RAMIPRIL (RAMIPRIL) Concomitant
Route: 048 | Dosage: UNK | Form: -- | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DIAMICRON (--) Concomitant
Route: 048 | Dosage: -- | Form: Capsule | Indication: Diabetes mellitus | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PENICILLIN V (PENICILLIN V) Concomitant
Route: 048 | Dosage: -- | 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: --
GEMCITABINE (GEMCITABINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PACLITAXEL (PACLITAXEL) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FLUOROURACIL\IRINOTECAN\LEUCOVORIN\OXALIPLATIN (FLUOROURACIL\IRINOTECAN\LEUCOVORIN\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: --

Clinical Narrative

CASE EVENT DATE: 20220926

Report Duplicates (1)

EPIZYME: EU-EPIZYME, INC.-2022FREPZ64381090

Raw JSON (click to expand)

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"drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MG,", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Diabetes mellitus", "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": "XARELTO", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Venous thrombosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "RIVAROXABAN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ESIDREX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNKOWN", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Hypertension", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, 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"drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PACLITAXEL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FLUOROURACIL\\IRINOTECAN\\LEUCOVORIN\\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": "FLUOROURACIL\\IRINOTECAN\\LEUCOVORIN\\OXALIPLATIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20220926" }, "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": "EPIZYME", "duplicatenumb": "EU-EPIZYME, INC.-2022FREPZ64381090" } ], "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" }
25955351 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
Alvarez-Gallego R, Cubillo A, Pazo-Cid R, Lopez de San Vicente Borja, Macarulla T, Martinez E et al.. Real world effectiveness and safety of second or third- line pegylated liposomal irinotecan plus 5-fluorouracil and folinic acid in pancreatic ductal adenocarcinoma in Spain. Therapeutic Advances in Medical Oncology. 2025;17:1-12. doi:10.1177/17588359241309828
Company Number
EU-SERVIER-S25000326
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
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (27)

Diarrhoea (v28.1) Unknown
Asthenia (v28.1) Unknown
Vomiting (v28.1) Unknown
Neutropenia (v28.1) Unknown
Decreased appetite (v28.1) Unknown
Neuropathy peripheral (v28.1) Unknown
Mucosal inflammation (v28.1) Unknown
Pyrexia (v28.1) Unknown
Hepatotoxicity (v28.1) Unknown
Febrile neutropenia (v28.1) Unknown
Anaemia (v28.1) Unknown
Thrombocytopenia (v28.1) Unknown
Haemorrhage (v28.1) Unknown
Neuropathy peripheral (v28.1) Unknown
Hepatotoxicity (v28.1) Unknown
Neutropenia (v28.1) Unknown
Thrombocytopenia (v28.1) Unknown
Leukopenia (v28.1) Unknown
Asthenia (v28.1) Unknown
Diarrhoea (v28.1) Unknown
Decreased appetite (v28.1) Unknown
Nausea (v28.1) Unknown
Mucosal inflammation (v28.1) Unknown
Vomiting (v28.1) Unknown
Vomiting (v28.1) Unknown
Pyrexia (v28.1) Unknown
Anaemia (v28.1) Unknown

Drugs (3)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: UNK | Form: Solution for infusion | 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) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Ductal adenocarcinoma of pancreas | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Ductal adenocarcinoma of pancreas | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

SERVIER: EU-SERVIER-S25000326

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cc4", "safetyreportid": "25955351", "authoritynumb": null, "companynumb": "EU-SERVIER-S25000326", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Asthenia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neutropenia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Decreased appetite", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neuropathy peripheral", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Mucosal inflammation", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pyrexia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatotoxicity", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Febrile neutropenia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anaemia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Thrombocytopenia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Haemorrhage", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neuropathy peripheral", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatotoxicity", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neutropenia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Thrombocytopenia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Leukopenia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Asthenia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Decreased appetite", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Mucosal inflammation", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pyrexia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anaemia", "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": "UNK", "drugdosageform": "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": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "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": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Ductal adenocarcinoma of pancreas", "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": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Ductal adenocarcinoma of pancreas", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": "Alvarez-Gallego R, Cubillo A, Pazo-Cid R, Lopez de San Vicente Borja, Macarulla T, Martinez E et al.. Real world effectiveness and safety of second or third- line pegylated liposomal irinotecan plus 5-fluorouracil and folinic acid in pancreatic ductal adenocarcinoma in Spain. Therapeutic Advances in Medical Oncology. 2025;17:1-12. doi:10.1177/17588359241309828" }, "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-S25000326" } ], "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" }
25955350 Type 2
Serious
ONIVYDE, ONIVYDE, ONIVYDE (+10 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
JP
Occurrence Country
JP
Reporter Country
JP
Reporter Qualification
Physician
Literature Reference
--
Company Number
JP-SERVIER-S22012641
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
Female
Patient Weight
43.5 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (7)

Compression fracture (v28.1) Recovered
Hypokalaemia (v28.1) Unknown
Blood bilirubin increased (v28.1) Unknown
Aspartate aminotransferase increased (v28.1) Unknown
Alanine aminotransferase increased (v28.1) Unknown
Hypoalbuminaemia (v28.1) Unknown
Blood alkaline phosphatase increased (v28.1) Unknown

Drugs (13)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 95.9 MG/ BODY | Form: Solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 95.9 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 76.7 MG/ BODY | Form: Solution for infusion | Indication: -- | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 76.7 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 58.9 MG/ BODY | Form: Solution for infusion | Indication: -- | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 58.9 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 58.9 MG/ BODY | Form: Solution for infusion | Indication: -- | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 58.9 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
TS-1 (GIMERACIL\OTERACIL POTASSIUM\TEGAFUR) Concomitant
Route: -- | Dosage: 100 MG/BODY, DAY 1-7 | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/10/2022 | End: 11/09/2022 | Duration: 3.0 mo | Rechallenge: -- | Additional: --
Recurrences: --
TS-1 (GIMERACIL\OTERACIL POTASSIUM\TEGAFUR) Concomitant
Route: -- | Dosage: 100 MG/BODY, DAY 1-7 | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DECADRON (DEXAMETHASONE) Concomitant
Route: -- | 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: --
ELDECALCITOL (ELDECALCITOL) Concomitant
Route: -- | Dosage: 75 ?G, QD | Form: Capsule | Indication: Osteoporosis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 75.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/12/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ELDECALCITOL (ELDECALCITOL) Concomitant
Route: -- | Dosage: 75 ?G, QD | Form: Capsule | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 75.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/07/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CALCIUM ASPARTATE (CALCIUM ASPARTATE) Concomitant
Route: -- | Dosage: 400 MG, BID | Form: Tablet | Indication: Osteoporosis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/12/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CALCIUM ASPARTATE (CALCIUM ASPARTATE) Concomitant
Route: -- | Dosage: 400 MG, BID | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/07/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
BONALON (ALENDRONATE SODIUM) Concomitant
Route: -- | Dosage: 35 MG, 1X/WEEK | Form: Tablet | Indication: Osteoporosis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 35.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: 01/12/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
BONALON (ALENDRONATE SODIUM) Concomitant
Route: -- | Dosage: 35 MG, 1X/WEEK | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 35.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: 01/07/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20221205

Report Duplicates (3)

SERVIER: JP-SERVIER-S22012641
SERVIER: 450517_P07
SERVIER: JP-SERVIER-S22012641

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cc3", "safetyreportid": "25955350", "authoritynumb": null, "companynumb": "JP-SERVIER-S22012641", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "JP", "patient": { "patientonsetage": 73.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 43.5, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Compression fracture", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypokalaemia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood bilirubin increased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Aspartate aminotransferase increased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Alanine aminotransferase increased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypoalbuminaemia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood alkaline phosphatase increased", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 95.9, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "95.9 MG/ BODY", "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": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 76.7, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "76.7 MG/ BODY", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 58.9, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "58.9 MG/ BODY", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 58.9, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "58.9 MG/ BODY", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TS-1", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MG/BODY, DAY 1-7", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2022-08-10T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-11-09T00:00:00", "drugtreatmentduration": 3.0, "drugtreatmentdurationunit": 802, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "GIMERACIL\\OTERACIL POTASSIUM\\TEGAFUR" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TS-1", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MG/BODY, DAY 1-7", "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": "GIMERACIL\\OTERACIL POTASSIUM\\TEGAFUR" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DECADRON", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "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": "DEXAMETHASONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ELDECALCITOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 75.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "75 ?G, QD", "drugdosageform": "Capsule", "drugadministrationroute": null, "drugindication": "Osteoporosis", "drugstartdateformat": "102", "drugstartdate": "2022-01-12T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ELDECALCITOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ELDECALCITOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 75.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "75 ?G, QD", "drugdosageform": "Capsule", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-01-07T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ELDECALCITOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CALCIUM ASPARTATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 800.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "400 MG, BID", "drugdosageform": "Tablet", "drugadministrationroute": null, "drugindication": "Osteoporosis", "drugstartdateformat": "102", "drugstartdate": "2022-01-12T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CALCIUM ASPARTATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CALCIUM ASPARTATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 800.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "400 MG, BID", "drugdosageform": "Tablet", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-01-07T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CALCIUM ASPARTATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BONALON", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 35.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "35 MG, 1X/WEEK", "drugdosageform": "Tablet", "drugadministrationroute": null, "drugindication": "Osteoporosis", "drugstartdateformat": "102", "drugstartdate": "2022-01-12T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ALENDRONATE SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BONALON", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 35.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "35 MG, 1X/WEEK", "drugdosageform": "Tablet", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-01-07T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ALENDRONATE SODIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20221205" }, "primarysource": { "reportercountry": "JP", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "JP", "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": "JP-SERVIER-S22012641" }, { "duplicatesource": "SERVIER", "duplicatenumb": "450517_P07" }, { "duplicatesource": "SERVIER", "duplicatenumb": "JP-SERVIER-S22012641" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955349 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-S24010295
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
69.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Terminal ileitis (v28.1) Recovered w/ Sequelae

Drugs (3)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 141.9 MG | Form: Concentrate for solution for infusion | Indication: Gastrooesophageal cancer | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 141.9 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/24/2024 | End: 07/24/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 5000 MG | Form: -- | Indication: Gastrooesophageal cancer | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 5000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/24/2024 | End: 07/26/2024 | Duration: 3.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 800 MG | Form: -- | Indication: Gastrooesophageal cancer | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/24/2024 | End: 07/24/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240808

Report Duplicates (1)

SERVIER: EU-SERVIER-S24010295

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cc2", "safetyreportid": "25955349", "authoritynumb": null, "companynumb": "EU-SERVIER-S24010295", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 69.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Terminal ileitis", "reactionoutcome": 4 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 141.9, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "141.9 MG", "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": "Gastrooesophageal cancer", "drugstartdateformat": "102", "drugstartdate": "2024-07-24T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-07-24T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 5000.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5000 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Gastrooesophageal cancer", "drugstartdateformat": "102", "drugstartdate": "2024-07-24T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-07-26T00:00:00", "drugtreatmentduration": 3.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 800.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "800 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Gastrooesophageal cancer", "drugstartdateformat": "102", "drugstartdate": "2024-07-24T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-07-24T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240808" }, "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-S24010295" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955348 Type 2
Serious
ONIVYDE, FLUOROURACIL, NIVOLUMAB (+1 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-2023-14775
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
Female
Patient Weight
63.96 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (20)

Dyspnoea (v28.1) Unknown
Febrile neutropenia (v28.1) Unknown
Fatigue (v28.1) Unknown
Peripheral swelling (v28.1) Unknown
Diarrhoea (v28.1) Unknown
Febrile neutropenia (v28.1) Recovered
Diarrhoea (v28.1) Unknown
Febrile neutropenia (v28.1) Unknown
Oesophageal abscess (v28.1) Unknown
Oesophageal perforation (v28.1) Unknown
Pancytopenia (v28.1) Recovering
Gastrointestinal haemorrhage (v28.1) Unknown
Mucosal inflammation (v28.1) Unknown
Oral candidiasis (v28.1) Unknown
Dysphagia (v28.1) Unknown
Pleural effusion (v28.1) Unknown
Respiratory failure (v28.1) Unknown
Hypervolaemia (v28.1) Unknown
COVID-19 pneumonia (v28.1) Unknown
Urinary tract infection (v28.1) Unknown

Drugs (4)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 90.3 MG, EVERY 15 DAYS | Form: Concentrate for solution for infusion | Indication: Oesophageal adenocarcinoma | Action: Unknown
Auth#: 129648 | Batch#: -- | Structured Dosage: 50.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 15.0 day | Cumulative: -- (unit: --)
Start: 05/25/2023 | End: 05/25/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 4400 MG, EVERY 15 DAYS | Form: Solution for injection | Indication: Oesophageal adenocarcinoma | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 2400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 15.0 day | Cumulative: -- (unit: --)
Start: 05/25/2023 | End: 05/25/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
NIVOLUMAB (NIVOLUMAB) 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: --

Clinical Narrative

CASE EVENT DATE: 20230606

Report Duplicates (1)

MISTRAL: US23-002658

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cc1", "safetyreportid": "25955348", "authoritynumb": null, "companynumb": "US-IPSEN Group, Research and Development-2023-14775", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 61.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 63.96, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Febrile neutropenia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Peripheral swelling", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Febrile neutropenia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Febrile neutropenia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Oesophageal abscess", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Oesophageal perforation", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pancytopenia", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gastrointestinal haemorrhage", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Mucosal inflammation", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Oral candidiasis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dysphagia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pleural effusion", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Respiratory failure", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypervolaemia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "COVID-19 pneumonia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Urinary tract infection", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "129648", "drugbatchnumb": null, "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 15.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "90.3 MG, EVERY 15 DAYS", "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": "Oesophageal adenocarcinoma", "drugstartdateformat": "102", "drugstartdate": "2023-05-25T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-05-25T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 15.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4400 MG, EVERY 15 DAYS", "drugdosageform": "Solution for injection", "drugadministrationroute": null, "drugindication": "Oesophageal adenocarcinoma", "drugstartdateformat": "102", "drugstartdate": "2023-05-25T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-05-25T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NIVOLUMAB", "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": "NIVOLUMAB" }, "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": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230606" }, "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": "US23-002658" } ], "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" }
25955347 Type 2
Serious
ONIVYDE, OXALIPLATIN, LEUCOVORIN (+13 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-I.R.I.S.-S24004945
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
67.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
107.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Acute kidney injury (v28.1) Recovered
Enteritis (v28.1) Recovered

Drugs (16)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 50.82 MG/M2, UNK | Form: Solution for infusion | Indication: Pancreatic carcinoma | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 50.82 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/29/2024 | End: 04/11/2024 | Duration: 43.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: 59.09 MG/M2, D1 OF 14-DAY CYCLE | Form: Amp im | Indication: Pancreatic carcinoma | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 59.09 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/29/2024 | End: 04/11/2024 | Duration: 43.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 300 MG/M2, D1 OF 14-DAY CYCLE | Form: Amp im | Indication: Pancreatic carcinoma | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 300.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/29/2024 | End: 04/11/2024 | Duration: 43.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 1795.4 MG/M2, UNK | Form: -- | Indication: Pancreatic carcinoma | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 1795.4 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/29/2024 | End: 04/11/2024 | Duration: 43.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
ASPIRIN (ASPIRIN) Concomitant
Route: -- | Dosage: 100 MG, QD | Form: Amp im | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ASPIRIN (ASPIRIN) Concomitant
Route: -- | Dosage: 100 MG, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ASPIRIN (ASPIRIN) Concomitant
Route: -- | Dosage: 100 MG, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PREDNISONE (PREDNISONE) Concomitant
Route: -- | Dosage: 5 MG, QD | Form: Amp im | Indication: Neoplasm | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/22/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PREDNISONE (PREDNISONE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ROSUVASTATIN (ROSUVASTATIN) Concomitant
Route: -- | Dosage: 20 MG, QD | Form: Amp im | Indication: Psoriatic arthropathy | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ROSUVASTATIN (ROSUVASTATIN) Concomitant
Route: -- | Dosage: 20 MG, QD | Form: -- | Indication: Blood cholesterol abnormal | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ROSUVASTATIN (ROSUVASTATIN) Concomitant
Route: -- | Dosage: 20 MG, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PANTOPRAZOLE (PANTOPRAZOLE) Concomitant
Route: -- | Dosage: 40 MG, QD | Form: Amp im | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PANTOPRAZOLE (PANTOPRAZOLE) Concomitant
Route: -- | Dosage: 40 MG, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PANCRELIPASE (PANCRELIPASE) Concomitant
Route: -- | Dosage: 25.000 CAPSULE | Form: Amp im | Indication: Diarrhoea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/11/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SOLIFENACIN SUCCINATE (SOLIFENACIN SUCCINATE) Concomitant
Route: -- | Dosage: 5 MG, QD | Form: Amp im | Indication: Pollakiuria | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/23/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240422

Report Duplicates (1)

SERVIER: EU-I.R.I.S.-S24004945

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cc0", "safetyreportid": "25955347", "authoritynumb": null, "companynumb": "EU-I.R.I.S.-S24004945", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 67.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 107.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Acute kidney injury", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Enteritis", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 50.82, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "50.82 MG/M2, UNK", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2024-02-29T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-04-11T00:00:00", "drugtreatmentduration": 43.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OXALIPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 59.09, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "59.09 MG/M2, D1 OF 14-DAY CYCLE", "drugdosageform": "Amp im", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2024-02-29T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-04-11T00:00:00", "drugtreatmentduration": 43.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "300 MG/M2, D1 OF 14-DAY CYCLE", "drugdosageform": "Amp im", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2024-02-29T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-04-11T00:00:00", "drugtreatmentduration": 43.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1795.4, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1795.4 MG/M2, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2024-02-29T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-04-11T00:00:00", "drugtreatmentduration": 43.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ASPIRIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MG, QD", "drugdosageform": "Amp im", "drugadministrationroute": null, "drugindication": "Hypertension", "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": "ASPIRIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MG, QD", "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": "ASPIRIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ASPIRIN", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MG, QD", "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": "ASPIRIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PREDNISONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG, QD", "drugdosageform": "Amp im", "drugadministrationroute": null, "drugindication": "Neoplasm", "drugstartdateformat": "102", "drugstartdate": "2024-04-22T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PREDNISONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PREDNISONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "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": "PREDNISONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ROSUVASTATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20 MG, QD", "drugdosageform": "Amp im", "drugadministrationroute": null, "drugindication": "Psoriatic arthropathy", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ROSUVASTATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ROSUVASTATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20 MG, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Blood cholesterol abnormal", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ROSUVASTATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ROSUVASTATIN", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20 MG, QD", "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": "ROSUVASTATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PANTOPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MG, QD", "drugdosageform": "Amp im", "drugadministrationroute": null, "drugindication": "Prophylaxis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PANTOPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PANTOPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MG, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PANTOPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PANCRELIPASE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "25.000 CAPSULE", "drugdosageform": "Amp im", "drugadministrationroute": null, "drugindication": "Diarrhoea", "drugstartdateformat": "102", "drugstartdate": "2024-04-11T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PANCRELIPASE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SOLIFENACIN SUCCINATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG, QD", "drugdosageform": "Amp im", "drugadministrationroute": null, "drugindication": "Pollakiuria", "drugstartdateformat": "102", "drugstartdate": "2024-04-23T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SOLIFENACIN SUCCINATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240422" }, "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-I.R.I.S.-S24004945" } ], "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" }
25955345 Type 2
Serious
SKYRIZI
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-ABBVIE-6512249
Authority Number
--
Sender Organization
ABBVIE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
38.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Haemoglobin decreased (v28.1) Recovering

Drugs (1)

SKYRIZI (RISANKIZUMAB-RZAA) Suspect
Route: 041 | Dosage: -- | Form: -- | Indication: Colitis ulcerative | Action: Dose Not Changed
Auth#: 761262 | Batch#: Not Available | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 4.0 wk | Cumulative: -- (unit: --)
Start: 08/22/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251006

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cbe", "safetyreportid": "25955345", "authoritynumb": null, "companynumb": "US-ABBVIE-6512249", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 38.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Haemoglobin decreased", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SKYRIZI", "drugauthorizationnumb": "761262", "drugbatchnumb": "Not Available", "drugstructuredosagenumb": 600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 4.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "041", "drugindication": "Colitis ulcerative", "drugstartdateformat": "102", "drugstartdate": "2025-08-22T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "RISANKIZUMAB-RZAA" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251006" }, "primarysource": { "reportercountry": "US", "qualification": 5, "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": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ABBVIE" }, "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" }
25955346 Type 2
Serious
TAZEMETOSTAT HYDROBROMIDE, IMFINZI
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-IPSEN Group, Research and Development-2024-03483
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
Male
Patient Weight
77.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Cardiogenic shock (v28.1) Recovered
Myocardial infarction (v28.1) Recovered

Drugs (2)

TAZEMETOSTAT HYDROBROMIDE (TAZEMETOSTAT HYDROBROMIDE) Suspect
Route: -- | Dosage: 800 MG | Form: Tablet | Indication: Rectal adenocarcinoma | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/08/2022 | End: 12/18/2022 | Duration: 41.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
IMFINZI (DURVALUMAB) Suspect
Route: 042 | Dosage: 1120 MG | Form: Solution for infusion | Indication: Rectal adenocarcinoma | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 1120.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/28/2022 | End: 11/28/2022 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20221229

Report Duplicates (1)

Eisai tracking number: 202315156

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cbd", "safetyreportid": "25955346", "authoritynumb": null, "companynumb": "EU-IPSEN Group, Research and Development-2024-03483", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 73.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 77.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cardiogenic shock", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Myocardial infarction", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TAZEMETOSTAT HYDROBROMIDE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 800.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "800 MG", "drugdosageform": "Tablet", "drugadministrationroute": null, "drugindication": "Rectal adenocarcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-11-08T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-12-18T00:00:00", "drugtreatmentduration": 41.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "TAZEMETOSTAT HYDROBROMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "IMFINZI", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 1120.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1120 MG", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": "Rectal adenocarcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-11-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-11-28T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "DURVALUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20221229" }, "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": "Eisai tracking number", "duplicatenumb": "202315156" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 1, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25955343 Type 2
Serious
ONIVYDE, IRINOTECAN HYDROCHLORIDE, LEUCOVORIN CALCIUM (+9 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Physician
Literature Reference
--
Company Number
CN-SERVIER-S23007962
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
65.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
57.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Hypotension (v28.1) Recovered
Cardiac arrest (v28.1) Recovered
White blood cell count decreased (v28.1) Recovered
Neutrophil count decreased (v28.1) Recovered
Platelet count decreased (v28.1) Recovered

Drugs (12)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 041 | Dosage: 126 MG, ONE DOSE | Form: Solution for infusion | Indication: Pancreatic carcinoma | Action: Not Applicable
Auth#: -- | Batch#: U17494 | Structured Dosage: 126.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/11/2023 | End: 05/11/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: 4
Recurrences: --
IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 041 | Dosage: 126 G, UNK | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: 221201 | Structured Dosage: 126.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/02/2023 | End: 07/13/2023 | Duration: 42.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) Suspect
Route: 041 | Dosage: 720 MG, UNK | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: 221008AJ | Structured Dosage: 720.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/11/2023 | End: 07/13/2023 | Duration: 64.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: 041 | Dosage: 4320 MG, PUMPED AT 6 ML/H | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: 2209081 | Structured Dosage: 4320.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/11/2023 | End: 07/13/2023 | Duration: 64.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
PEGYLATED RECOMBINANT HUMAN GRANULOCYTE COLONY STIMULATING FACTOR (--) Concomitant
Route: -- | Dosage: 3 MG, QD | Form: -- | Indication: Prophylaxis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 3.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 84.0 (unit: 003)
Start: 06/05/2023 | End: 07/02/2023 | Duration: 28.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
IMIPENEM AND CILASTATIN (CILASTATIN SODIUM\IMIPENEM) Concomitant
Route: 041 | Dosage: 1 G, TID | Form: -- | Indication: Antiinflammatory therapy | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 3.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 07/11/2023 | End: 07/15/2023 | Duration: 5.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: -- | Dosage: 15 ML, QD | Form: -- | Indication: Mineral supplementation | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 15.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 07/11/2023 | End: 07/17/2023 | Duration: 7.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
FAT EMULSION NOS (EGG PHOSPHOLIPIDS\SAFFLOWER OIL\SOYBEAN OIL) Concomitant
Route: -- | Dosage: 250 ML, QD | Form: -- | Indication: Nutritional supplementation | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 250.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 07/11/2023 | End: 07/15/2023 | Duration: 5.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ALBUMIN HUMAN (ALBUMIN HUMAN) Concomitant
Route: 041 | Dosage: 10 G, QD | Form: -- | Indication: Hypoalbuminaemia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 07/11/2023 | End: 07/16/2023 | Duration: 6.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
NADROPARIN (NADROPARIN) Concomitant
Route: -- | Dosage: 4100 UNK | Form: -- | Indication: Thrombosis prophylaxis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/11/2023 | End: 07/11/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ROXATIDINE (ROXATIDINE) Concomitant
Route: -- | Dosage: 75 MG, QD | Form: -- | Indication: Prophylaxis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 07/11/2023 | End: 07/11/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 2 MG, TID | Form: -- | Indication: Antidiarrhoeal supportive care | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 6.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 07/11/2023 | End: 07/17/2023 | Duration: 7.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230709

Report Duplicates (1)

SERVIER: CN-SERVIER-S23007962

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cbc", "safetyreportid": "25955343", "authoritynumb": null, "companynumb": "CN-SERVIER-S23007962", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 65.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 57.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypotension", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cardiac arrest", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "White blood cell count decreased", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neutrophil count decreased", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Platelet count decreased", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": "U17494", "drugstructuredosagenumb": 126.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "126 MG, ONE DOSE", "drugdosageform": "Solution for infusion", "drugadministrationroute": "041", "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2023-05-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-05-11T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "IRINOTECAN HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": "221201", "drugstructuredosagenumb": 126.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "126 G, UNK", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2023-06-02T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-07-13T00:00:00", "drugtreatmentduration": 42.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN CALCIUM", "drugauthorizationnumb": null, "drugbatchnumb": "221008AJ", "drugstructuredosagenumb": 720.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "720 MG, UNK", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2023-05-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-07-13T00:00:00", "drugtreatmentduration": 64.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": "2209081", "drugstructuredosagenumb": 4320.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4320 MG, PUMPED AT 6 ML/H", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2023-05-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-07-13T00:00:00", "drugtreatmentduration": 64.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PEGYLATED RECOMBINANT HUMAN GRANULOCYTE COLONY STIMULATING FACTOR", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 84.0, "drugcumulativedosageunit": "003", "drugdosagetext": "3 MG, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Prophylaxis", "drugstartdateformat": "102", "drugstartdate": "2023-06-05T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-07-02T00:00:00", "drugtreatmentduration": 28.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "IMIPENEM AND CILASTATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 G, TID", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": "Antiinflammatory therapy", "drugstartdateformat": "102", "drugstartdate": "2023-07-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-07-15T00:00:00", "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CILASTATIN SODIUM\\IMIPENEM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "POTASSIUM CHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "012", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "15 ML, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Mineral supplementation", "drugstartdateformat": "102", "drugstartdate": "2023-07-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-07-17T00:00:00", "drugtreatmentduration": 7.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "POTASSIUM CHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FAT EMULSION NOS", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 250.0, "drugstructuredosageunit": "012", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "250 ML, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Nutritional supplementation", "drugstartdateformat": "102", "drugstartdate": "2023-07-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-07-15T00:00:00", "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "EGG PHOSPHOLIPIDS\\SAFFLOWER OIL\\SOYBEAN OIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ALBUMIN HUMAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 G, QD", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": "Hypoalbuminaemia", "drugstartdateformat": "102", "drugstartdate": "2023-07-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-07-16T00:00:00", "drugtreatmentduration": 6.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ALBUMIN HUMAN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NADROPARIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4100 UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Thrombosis prophylaxis", "drugstartdateformat": "102", "drugstartdate": "2023-07-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-07-11T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "NADROPARIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ROXATIDINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 75.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "75 MG, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Prophylaxis", "drugstartdateformat": "102", "drugstartdate": "2023-07-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-07-11T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ROXATIDINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LOPERAMIDE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 6.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2 MG, TID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Antidiarrhoeal supportive care", "drugstartdateformat": "102", "drugstartdate": "2023-07-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-07-17T00:00:00", "drugtreatmentduration": 7.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LOPERAMIDE HYDROCHLORIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230709" }, "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-S23007962" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 1, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25955342 Type 2
Serious
ONIVYDE, OXALIPLATIN, LEUCOVORIN CALCIUM (+4 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Physician
Literature Reference
--
Company Number
CN-SERVIER-S24008998
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
65.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Pain (v28.1) Recovered
Diarrhoea (v28.1) Recovered

Drugs (7)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 041 | Dosage: 83.47 MG, EVERY 2 WEEKS | Form: Solution for infusion | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: 1A220054AA | Structured Dosage: 83.47 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 07/02/2024 | End: 07/02/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: 041 | Dosage: 100 MG, EVERY 2 WEEKS | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 100.0 (unit: 003)
Start: 07/02/2024 | End: 07/02/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) Suspect
Route: 041 | Dosage: 0.668 G, EVERY 2 WEEKS | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 0.668 (unit: 002) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: 0.668 (unit: 002)
Start: 07/02/2024 | End: 07/02/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: 041 | Dosage: 4 G, EVERY 2 WEEKS | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 07/02/2024 | End: 07/02/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
PANCREATIN (PANCRELIPASE) Concomitant
Route: 048 | Dosage: 0.15 G, TID | Form: -- | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 0.45 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 07/03/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 4 MG, BID | Form: -- | Indication: Prophylaxis against diarrhoea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 8.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 07/03/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 100 MG, QD | Form: -- | Indication: Pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 07/03/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240708

Report Duplicates (1)

SERVIER: CN-SERVIER-S24008998

Raw JSON (click to expand)

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