FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25955344 Type 2
Serious
ONIVYDE, OXALIPLATIN, FLUOROURACIL (+11 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-SERVIER-S24003055
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
70.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
69.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Nausea (v28.1) Recovered
Dehydration (v28.1) Recovered
Oesophageal candidiasis (v28.1) Recovered
Infection (v28.1) Recovered

Drugs (14)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 042 | Dosage: 50 MG/M2, D1 OF 14-DAY CYCLE | Form: Solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/01/2024 | End: 03/22/2024 | Duration: 51.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: 042 | Dosage: 60 MG/M2, D1 OF 14-DAY CYCLE | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/01/2024 | End: 03/22/2024 | Duration: 51.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: 042 | Dosage: 2400 MG/M2, D1-D2 OF 14-DAY CYCLE | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 2400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/01/2024 | End: 03/22/2024 | Duration: 51.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: 042 | Dosage: 400 MG/M2, D1 OF 14-DAY CYCLE | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/01/2024 | End: 03/22/2024 | Duration: 51.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) Concomitant
Route: 048 | Dosage: 5 MG, QD | Form: -- | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/01/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CANDESARTAN (CANDESARTAN) Concomitant
Route: 048 | Dosage: 8 MG, QD | Form: -- | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 8.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/04/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
HYDROMORPHONE (HYDROMORPHONE) Concomitant
Route: -- | Dosage: 16 MG, BID | Form: -- | Indication: Pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 32.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/01/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METAMIZOLE (METAMIZOLE) Concomitant
Route: 048 | Dosage: 500 MG, BID | Form: -- | Indication: Pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 03/17/2024 | End: 03/17/2024 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
TAMSULOSIN (TAMSULOSIN) Concomitant
Route: 048 | Dosage: 0.4 MG, QD | Form: -- | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 0.4 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/01/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
POLYETHYLENE GLYCOLS (POLYETHYLENE GLYCOLS) Concomitant
Route: 048 | Dosage: UNK, BID | Form: -- | Indication: Constipation | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/01/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INNOHEP (TINZAPARIN SODIUM) Concomitant
Route: 058 | Dosage: 4500 IU, ONE DOSE | Form: -- | Indication: Thrombosis prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 4500.0 (unit: 025) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/17/2024 | End: 03/17/2024 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
PANTOPRAZOLE (PANTOPRAZOLE) Concomitant
Route: 048 | Dosage: 40 MG, QD | Form: -- | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/01/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ONDANSETRON (ONDANSETRON) Concomitant
Route: 048 | Dosage: 4 MG, PRN | Form: -- | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METOCLOPRAMIDE (METOCLOPRAMIDE) Concomitant
Route: 048 | Dosage: 10 MG, PRN | Form: -- | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240313

Report Duplicates (1)

SERVIER: EU-SERVIER-S24003055

Raw JSON (click to expand)

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"drugstructuredosagenumb": 1000.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MG, BID", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Pain", "drugstartdateformat": "102", "drugstartdate": "2024-03-17T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-03-17T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "METAMIZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TAMSULOSIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 0.4, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 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"activesubstance": { "activesubstancename": "PANTOPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ONDANSETRON", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4 MG, PRN", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Nausea", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ONDANSETRON" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METOCLOPRAMIDE", "drugauthorizationnumb": null, 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"receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "SERVIER", "duplicatenumb": "EU-SERVIER-S24003055" } ], "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" }
25955340 Type 2
Serious
ONIVYDE, ONIVYDE, OXALIPLATIN (+14 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-SERVIER-S24013986
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
59.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
65.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Enterocolitis (v28.1) Fatal
Enteritis (v28.1) Recovered

Drugs (17)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 042 | Dosage: 50 MG/M2, QD | Form: Solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 1450.0 (unit: 009)
Start: 10/01/2024 | End: 10/15/2024 | Duration: 15.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 042 | Dosage: 50 MG/M2, QD | Form: Solution for infusion | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 1450.0 (unit: 009)
Start: 11/19/2024 | End: 01/15/2025 | Duration: 58.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: 042 | Dosage: 60 MG/M2, QD | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 1740.0 (unit: 009)
Start: 10/01/2024 | End: 01/15/2025 | Duration: 29.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: 042 | Dosage: 60 MG/M2, QD | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 1740.0 (unit: 009)
Start: 11/19/2024 | End: 01/15/2025 | Duration: 58.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: 042 | Dosage: 400 MG/M2, QD | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 6000.0 (unit: 009)
Start: 10/01/2024 | End: 01/15/2025 | Duration: 15.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: 042 | Dosage: 400 MG/M2, QD | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 6000.0 (unit: 009)
Start: 11/19/2024 | End: 01/15/2025 | Duration: 58.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: 042 | Dosage: 2400 MG/M2, QD | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 2400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 34800.0 (unit: 009)
Start: 10/01/2024 | End: 01/15/2025 | Duration: 107.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: 042 | Dosage: 2400 MG/M2, QD | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 2400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 34800.0 (unit: 009)
Start: 11/19/2024 | End: 01/15/2025 | Duration: 58.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
AMLODIPINE (AMLODIPINE BESYLATE) Concomitant
Route: 048 | Dosage: 5 MG, BID | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MORPHINE SULFATE (MORPHINE SULFATE) Concomitant
Route: -- | Dosage: 10 MG, IN THE MORNING | Form: -- | Indication: Pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MORPHINE SULFATE (MORPHINE SULFATE) Concomitant
Route: -- | Dosage: 20 MG, QD, IN THE EVENING | Form: -- | Indication: -- | 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: --
MORPHINE SULFATE (MORPHINE SULFATE) Concomitant
Route: 048 | Dosage: 10 MG, TID | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 30.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DIETARY SUPPLEMENT (DIETARY SUPPLEMENT) Concomitant
Route: -- | Dosage: 200 ML, TID | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 600.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METOPROLOL SUCCINATE (METOPROLOL SUCCINATE) Concomitant
Route: 048 | Dosage: 47.5 MG, QD | Form: -- | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 47.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
RAMIPRIL (RAMIPRIL) Concomitant
Route: 048 | Dosage: 5 MG, BID | Form: -- | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) Concomitant
Route: -- | Dosage: 40 MG, QD | Form: -- | Indication: Product used for unknown 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: --
METAMIZOL (METAMIZOLE SODIUM) Concomitant
Route: -- | Dosage: 1 G, QID | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20241029

Report Duplicates (1)

SERVIER: EU-SERVIER-S24013986

Raw JSON (click to expand)

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"drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PANTOPRAZOLE SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METAMIZOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 G, QID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "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": "METAMIZOLE SODIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20241029" }, "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-S24013986" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955341 Type 2
Serious
ONIVYDE, FLUOROURACIL, LEUCOVORIN (+9 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-SERVIER-S24002076
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
81.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
68.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Cardiac arrest (v28.1) Fatal
Hypokalaemia (v28.1) Recovering
Acute kidney injury (v28.1) Recovering
Diarrhoea (v28.1) Recovering

Drugs (12)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 69.38 MG | Form: Solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 69.38 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 3330 MG | Form: Solution for injection | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 3330.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 370 MG | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 370.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: 83.25 MG | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 83.25 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
AMLODIPINE (AMLODIPINE BESYLATE) Concomitant
Route: -- | Dosage: 10 MG, QD | Form: -- | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/01/2001 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
AMLODIPINE (AMLODIPINE BESYLATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Angina pectoris | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ASPIRIN (ASPIRIN) Concomitant
Route: -- | Dosage: 80 MG, QD | Form: -- | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 80.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/01/2001 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CRESTOR (ROSUVASTATIN CALCIUM) Concomitant
Route: -- | Dosage: 40 MG, QD | Form: -- | Indication: Hypercholesterolaemia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/01/2001 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EZETIMIBE (EZETIMIBE) Concomitant
Route: -- | Dosage: 10 MG, QD | Form: -- | Indication: Hypercholesterolaemia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/01/2001 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METOPROLOL (METOPROLOL) Concomitant
Route: -- | Dosage: 190 MG, QD | Form: -- | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 190.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ALLOPURINOL (ALLOPURINOL) Concomitant
Route: -- | Dosage: 300 MG, EVERY 2 DAYS | Form: -- | Indication: Gout | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 850 MG, BID | Form: -- | Indication: Type 2 diabetes mellitus | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1700.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/01/2018 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240224

Report Duplicates (0)

--

Raw JSON (click to expand)

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"drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "80 MG, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Prophylaxis", "drugstartdateformat": "602", "drugstartdate": "2001-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ASPIRIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CRESTOR", "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", 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null, "actiondrug": null, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ALLOPURINOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "300 MG, EVERY 2 DAYS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Gout", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ALLOPURINOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METFORMIN HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1700.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "850 MG, BID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Type 2 diabetes mellitus", "drugstartdateformat": "602", "drugstartdate": "2018-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "METFORMIN HYDROCHLORIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240224" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955339 Type 2
Serious
ONIVYDE, ONIVYDE, OXALIPLATIN (+5 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-IPSEN Group, Research and Development-2023-09870
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
107.3 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (18)

Diarrhoea (v28.1) Recovering
Pyrexia (v28.1) Recovered
Adult failure to thrive (v28.1) Recovering
Dysphagia (v28.1) Unknown
Electrolyte imbalance (v28.1) Unknown
Colitis ischaemic (v28.1) Recovered
Abdominal pain (v28.1) Unknown
Abdominal discomfort (v28.1) Unknown
Enteritis (v28.1) Unknown
Hyponatraemia (v28.1) Unknown
Neutropenia (v28.1) Unknown
Constipation (v28.1) Unknown
Asthenia (v28.1) Unknown
Hypomagnesaemia (v28.1) Unknown
Dehydration (v28.1) Unknown
Hypokalaemia (v28.1) Unknown
Hypoalbuminaemia (v28.1) Unknown
Hypophosphataemia (v28.1) Unknown

Drugs (8)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: DAY: 1 + 15 OF EVERY 28 DAY CYCLE FOR ALL | Form: Solution for infusion | Indication: Adenocarcinoma gastric | Action: Not Applicable
Auth#: 102799 | Batch#: -- | Structured Dosage: 50.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/13/2023 | End: 04/13/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: 4
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: DAY: 1 + 15 OF EVERY 28 DAY CYCLE FOR ALL | Form: Solution for infusion | Indication: -- | Action: Not Applicable
Auth#: 102799 | Batch#: -- | Structured Dosage: 42.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/11/2023 | End: 05/11/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: 4
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: Adenocarcinoma gastric | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/13/2023 | End: 04/13/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/11/2023 | End: 05/11/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: Adenocarcinoma gastric | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 2400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/13/2023 | End: 04/13/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 2400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/11/2023 | End: 05/11/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
NIVOLUMAB (NIVOLUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: Adenocarcinoma gastric | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 240.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/13/2023 | End: 04/13/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
NIVOLUMAB (NIVOLUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 240.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 05/11/2023 | End: 05/11/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230419

Report Duplicates (3)

MISTRAL: US23-001556
MISTRAL: US23-001664
MISTRAL: US23-001962

Raw JSON (click to expand)

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"reactionmeddrapt": "Hypoalbuminaemia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypophosphataemia", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DAY: 1 + 15 OF EVERY 28 DAY CYCLE FOR ALL", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Adenocarcinoma gastric", "drugstartdateformat": "102", "drugstartdate": "2023-04-13T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-04-13T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 42.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DAY: 1 + 15 OF EVERY 28 DAY CYCLE FOR ALL", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": null, "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": "OXALIPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": null, "drugindication": "Adenocarcinoma gastric", "drugstartdateformat": "102", "drugstartdate": "2023-04-13T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-04-13T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OXALIPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-05-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-05-11T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": null, "drugindication": "Adenocarcinoma gastric", "drugstartdateformat": "102", "drugstartdate": "2023-04-13T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-04-13T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-05-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-05-11T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "NIVOLUMAB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 240.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": null, "drugindication": "Adenocarcinoma gastric", "drugstartdateformat": "102", "drugstartdate": "2023-04-13T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-04-13T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "NIVOLUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "NIVOLUMAB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 240.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-05-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-05-11T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "NIVOLUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230419" }, "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": "US23-001556" }, { "duplicatesource": "MISTRAL", "duplicatenumb": "US23-001664" }, { "duplicatesource": "MISTRAL", "duplicatenumb": "US23-001962" } ], "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" }
25955338 Type 2
Serious
ONIVYDE, OXALIPLATIN, LEUCOVORIN (+1 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
Other Health Professional
Literature Reference
--
Company Number
EU-SERVIER-S24016334
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 (1)

Dermatitis (v28.1) Recovered

Drugs (4)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 60 MG/M2 | Form: Solution for infusion | Indication: Rectal cancer | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: 60 MG/M2 | Form: -- | Indication: Rectal cancer | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 400 MG/M2 | Form: -- | Indication: Rectal cancer | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 2400 MG/M2 | Form: -- | Indication: Rectal cancer | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 2400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20200402

Report Duplicates (1)

SERVIER: EU-SERVIER-S24016334

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cb6", "safetyreportid": "25955338", "authoritynumb": null, "companynumb": "EU-SERVIER-S24016334", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dermatitis", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "60 MG/M2", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Rectal cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OXALIPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "60 MG/M2", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Rectal cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "400 MG/M2", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Rectal cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2400 MG/M2", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Rectal cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20200402" }, "primarysource": { "reportercountry": "EU", "qualification": 3, "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-S24016334" } ], "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" }
25955337 Type 2
Serious
TAZEMETOSTAT HYDROBROMIDE, CYCLOPHOSPHAMIDE\DOXORUBICIN\PREDNISONE\RITUXIMAB\VINCRISTINE, MABTHERA
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-EPIZYME, INC.-2022FREPZ64381020
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
64.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
73.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Pancytopenia (v28.1) Recovered
General physical health deterioration (v28.1) Not Recovered

Drugs (3)

TAZEMETOSTAT HYDROBROMIDE (TAZEMETOSTAT HYDROBROMIDE) Suspect
Route: 048 | Dosage: 1600 MG (800 MG TWICE DAILY)? CYCLE: C6 D27 | Form: Tablet | Indication: Follicular lymphoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: 01/15/2022 | End: 05/16/2022 | Duration: 122.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
CYCLOPHOSPHAMIDE\DOXORUBICIN\PREDNISONE\RITUXIMAB\VINCRISTINE (CYCLOPHOSPHAMIDE\DOXORUBICIN\PREDNISONE\RITUXIMAB\VINCRISTINE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Follicular lymphoma | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/14/2022 | End: 04/28/2022 | Duration: 105.0 day | Rechallenge: -- | Additional: --
Recurrences: --
MABTHERA (RITUXIMAB) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Follicular lymphoma | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20220524

Report Duplicates (2)

EPIZYME: EU-EPIZYME, INC.-2022FREPZ64381020
EISAI: 202401317

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cb5", "safetyreportid": "25955337", "authoritynumb": null, "companynumb": "EU-EPIZYME, INC.-2022FREPZ64381020", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 64.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 73.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pancytopenia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "General physical health deterioration", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TAZEMETOSTAT HYDROBROMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 800.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 12.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1600 MG (800 MG TWICE DAILY)? CYCLE: C6 D27", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Follicular lymphoma", "drugstartdateformat": "102", "drugstartdate": "2022-01-15T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-05-16T00:00:00", "drugtreatmentduration": 122.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "TAZEMETOSTAT HYDROBROMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CYCLOPHOSPHAMIDE\\DOXORUBICIN\\PREDNISONE\\RITUXIMAB\\VINCRISTINE", "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": "Follicular lymphoma", "drugstartdateformat": "102", "drugstartdate": "2022-01-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-04-28T00:00:00", "drugtreatmentduration": 105.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CYCLOPHOSPHAMIDE\\DOXORUBICIN\\PREDNISONE\\RITUXIMAB\\VINCRISTINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MABTHERA", "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": "Follicular lymphoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "RITUXIMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20220524" }, "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.-2022FREPZ64381020" }, { "duplicatesource": "EISAI", "duplicatenumb": "202401317" } ], "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" }
25955336 Type 2
Serious
TAZVERIK
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/19/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-IPSEN Group, Research and Development-2023-17090
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
72.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
64.3 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Abdominal pain upper (v28.1) Unknown
Vomiting (v28.1) Recovered
Gastrointestinal wall thickening (v28.1) Unknown
Constipation (v28.1) Unknown
Faeces discoloured (v28.1) Unknown
Nausea (v28.1) Recovered

Drugs (1)

TAZVERIK (TAZEMETOSTAT HYDROBROMIDE) Suspect
Route: -- | Dosage: -- | Form: Tablet | Indication: Non-Hodgkin^s lymphoma recurrent | Action: Unknown
Auth#: 211723 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230701

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cb4", "safetyreportid": "25955336", "authoritynumb": null, "companynumb": "US-IPSEN Group, Research and Development-2023-17090", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 72.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 64.3, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain upper", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gastrointestinal wall thickening", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Constipation", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Faeces discoloured", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TAZVERIK", "drugauthorizationnumb": "211723", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": null, "drugindication": "Non-Hodgkin^s lymphoma recurrent", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TAZEMETOSTAT HYDROBROMIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230701" }, "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": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-19T00:00:00", "transmissiondateformat": "102" }
25955335 Type 2
Serious
TAZEMETOSTAT, DURVALUMAB
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
Other Health Professional
Literature Reference
--
Company Number
EU-IPSEN Group, Research and Development-2024-06034
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
75.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Analgesic therapy (v28.1) Recovered

Drugs (2)

TAZEMETOSTAT (TAZEMETOSTAT) Suspect
Route: 048 | Dosage: SAE CYCLE: 06?CUMULATIVE DOSE: 163200 MG | Form: Tablet | Indication: Adenocarcinoma of colon | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
DURVALUMAB (DURVALUMAB) Suspect
Route: 042 | Dosage: SAE CYCLE: 06?CUMULATIVE DOSE: 4480 MG | Form: -- | Indication: Adenocarcinoma of colon | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1120.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230413

Report Duplicates (1)

EISAI: 202400669

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cb3", "safetyreportid": "25955335", "authoritynumb": null, "companynumb": "EU-IPSEN Group, Research and Development-2024-06034", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 65.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 75.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Analgesic therapy", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TAZEMETOSTAT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 800.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "SAE CYCLE: 06?CUMULATIVE DOSE: 163200 MG", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Adenocarcinoma of colon", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TAZEMETOSTAT" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DURVALUMAB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1120.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "SAE CYCLE: 06?CUMULATIVE DOSE: 4480 MG", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Adenocarcinoma of colon", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DURVALUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230413" }, "primarysource": { "reportercountry": "EU", "qualification": 3, "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", "duplicatenumb": "202400669" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25955334 Type 2
Serious
ONIVYDE, TIPIRACIL HYDROCHLORIDE\TRIFLURIDINE, VITAMINS (+21 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
Physician
Literature Reference
--
Company Number
US-IPSEN Group, Research and Development-2022-27261
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
69.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
63.5 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (15)

Diarrhoea (v28.1) Unknown
Abdominal pain (v28.1) Unknown
Blood electrolytes abnormal (v28.1) Unknown
Pyrexia (v28.1) Unknown
Nausea (v28.1) Unknown
Dehydration (v28.1) Unknown
Neutropenia (v28.1) Unknown
Dehydration (v28.1) Recovered
Pulmonary oedema (v28.1) Recovered
Asthenia (v28.1) Recovered
Hypokalaemia (v28.1) Recovered
Tricuspid valve incompetence (v28.1) Unknown
Mitral valve incompetence (v28.1) Unknown
Diastolic dysfunction (v28.1) Unknown
Respiratory distress (v28.1) Recovered

Drugs (24)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: Concentrate for solution for infusion | Indication: Pancreatic carcinoma | Action: Unknown
Auth#: 102799 | Batch#: -- | Structured Dosage: 106.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 09/15/2022 | End: 09/15/2022 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
TIPIRACIL HYDROCHLORIDE\TRIFLURIDINE (TIPIRACIL HYDROCHLORIDE\TRIFLURIDINE) Suspect
Route: 048 | Dosage: DAYS 1 TO 5 | Form: -- | Indication: Pancreatic carcinoma | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: 09/15/2022 | End: 09/20/2022 | Duration: 6.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
VITAMINS (VITAMINS) Concomitant
Route: 048 | Dosage: 1 TAB | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
APIXABAN (APIXABAN) Concomitant
Route: 048 | Dosage: Q12HR | Form: -- | Indication: Atrial fibrillation | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LOMOTIL (ATROPINE SULFATE\DIPHENOXYLATE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: PRN | Form: -- | Indication: Diarrhoea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LIDOCAINE (LIDOCAINE) Concomitant
Route: 061 | Dosage: 1 PATCH, PRN | Form: -- | Indication: Pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LOPERAMIDE (LOPERAMIDE) Concomitant
Route: 048 | Dosage: PRN | Form: -- | Indication: Diarrhoea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METOPROLOL (METOPROLOL) Concomitant
Route: 048 | Dosage: QAM | Form: -- | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ONDANSETRON (ONDANSETRON) Concomitant
Route: 048 | Dosage: PRN | Form: -- | Indication: Vomiting | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 8.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ONDANSETRON (ONDANSETRON) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DEXAMETHASONE (DEXAMETHASONE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FUROSEMIDE (FUROSEMIDE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 day | Cumulative: -- (unit: --)
Start: -- | End: 02/10/2022 | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DULOXETINE (DULOXETINE) Concomitant
Route: 048 | Dosage: QHS | Form: -- | Indication: Neuropathy peripheral | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 30.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Concomitant
Route: 048 | Dosage: Q6HR, PRN | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 325.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/10/2022 | End: 12/10/2022 | Duration: 10.0 mo | Rechallenge: -- | Additional: --
Recurrences: --
HYDROMORPHONE (HYDROMORPHONE) Concomitant
Route: -- | Dosage: PRN | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 0.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/27/2022 | End: 10/01/2022 | Duration: 5.0 day | Rechallenge: -- | Additional: --
Recurrences: --
SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant
Route: -- | Dosage: ONCE | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/11/2022 | End: 11/11/2022 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: -- | Dosage: 20MEQ, ONCE | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/11/2022 | End: 11/11/2022 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
MAGNESIUM SULFATE (MAGNESIUM SULFATE) Concomitant
Route: -- | Dosage: 4 G, ONCE | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant
Route: -- | Dosage: 75 ML/HR | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/12/2022 | End: 11/17/2022 | Duration: 6.0 day | Rechallenge: -- | Additional: --
Recurrences: --
AZITHROMYCIN (AZITHROMYCIN) Concomitant
Route: -- | Dosage: Q24HR | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/12/2022 | End: 11/17/2022 | Duration: 6.0 day | Rechallenge: -- | Additional: --
Recurrences: --
CEFTRIAXONE (CEFTRIAXONE) Concomitant
Route: -- | Dosage: ONCE | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/11/2022 | End: 11/11/2022 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
CEFTRIAXONE (CEFTRIAXONE) Concomitant
Route: -- | Dosage: Q25HR | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/12/2022 | End: 11/17/2022 | Duration: 6.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ALBUTEROL\IPRATROPIUM (ALBUTEROL\IPRATROPIUM) Concomitant
Route: 045 | Dosage: Q6HR | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 3.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/13/2022 | End: 11/17/2022 | Duration: 5.0 day | Rechallenge: -- | Additional: --
Recurrences: --
FUROSEMIDE (FUROSEMIDE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 11/17/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20220927

Report Duplicates (2)

SERVIER: S22010212
MISTRAL: US23-001367

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cb2", "safetyreportid": "25955334", "authoritynumb": null, "companynumb": "US-IPSEN Group, Research and Development-2022-27261", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 69.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 63.5, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood electrolytes abnormal", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pyrexia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dehydration", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neutropenia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dehydration", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pulmonary oedema", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Asthenia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypokalaemia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Tricuspid valve incompetence", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Mitral valve incompetence", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diastolic dysfunction", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Respiratory distress", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 106.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-09-15T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-09-15T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TIPIRACIL HYDROCHLORIDE\\TRIFLURIDINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 12.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DAYS 1 TO 5", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-09-15T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-09-20T00:00:00", "drugtreatmentduration": 6.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIPIRACIL HYDROCHLORIDE\\TRIFLURIDINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VITAMINS", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 TAB", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "VITAMINS" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "APIXABAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "Q12HR", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Atrial fibrillation", "drugstartdateformat": null, 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"actiondrug": null, "activesubstance": { "activesubstancename": "ATROPINE SULFATE\\DIPHENOXYLATE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LIDOCAINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 PATCH, PRN", "drugdosageform": null, "drugadministrationroute": "061", "drugindication": "Pain", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LIDOCAINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LOPERAMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "PRN", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Diarrhoea", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LOPERAMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 25.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "QAM", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Hypertension", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ONDANSETRON", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 8.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "PRN", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Vomiting", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ONDANSETRON" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ONDANSETRON", "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": "Nausea", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ONDANSETRON" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DEXAMETHASONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "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": "FUROSEMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "102", "drugenddate": "2022-02-10T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DULOXETINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 30.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, 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"drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-02-10T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-12-10T00:00:00", "drugtreatmentduration": 10.0, "drugtreatmentdurationunit": 802, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "HYDROMORPHONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 0.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "PRN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-09-27T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-10-01T00:00:00", "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "HYDROMORPHONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SODIUM CHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1000.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "ONCE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-11-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-11-11T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SODIUM CHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "POTASSIUM CHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20MEQ, ONCE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-11-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-11-11T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "POTASSIUM CHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MAGNESIUM SULFATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4 G, ONCE", "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": "MAGNESIUM SULFATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SODIUM CHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 75.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "75 ML/HR", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-11-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-11-17T00:00:00", "drugtreatmentduration": 6.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SODIUM CHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AZITHROMYCIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, 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"drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CEFTRIAXONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ALBUTEROL\\IPRATROPIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "Q6HR", "drugdosageform": null, "drugadministrationroute": "045", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-11-13T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-11-17T00:00:00", "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ALBUTEROL\\IPRATROPIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FUROSEMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-11-17T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20220927" }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "SERVIER", "duplicatenumb": "S22010212" }, { "duplicatesource": "MISTRAL", "duplicatenumb": "US23-001367" } ], "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" }
25955332 Type 2
Serious
ONIVYDE, ONIVYDE, FLUOROURACIL (+5 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/19/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-SERVIER-S23010570
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
57.4 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Vomiting (v28.1) Recovering
Tachycardia (v28.1) Recovering
Hypotension (v28.1) Not Recovered
Malaise (v28.1) Recovered
Fatigue (v28.1) Not Recovered

Drugs (8)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 50, MG/M2, ONCE EVERY TWO WEEKS (Q2W) | Form: Solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Dose Reduced
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 08/22/2023 | End: 09/05/2023 | Duration: 15.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 43, MG/M2, ONCE EVERY TWO WEEKS (Q2W) | Form: Solution for infusion | Indication: -- | Action: Dose Reduced
Auth#: -- | Batch#: -- | Structured Dosage: 43.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 10/03/2023 | End: 10/03/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 2400 MG/M2, Q2W | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 2400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/22/2023 | End: 09/05/2023 | Duration: 15.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 1800 MG/M2, Q2W | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1800.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 10/03/2023 | End: 10/03/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 200 MG/M2, Q2W | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 200.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/22/2023 | End: 09/05/2023 | Duration: 15.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 200 MG/M2, Q2W | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 200.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 10/03/2023 | End: 10/03/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: 60 MG/M2, Q2W | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/22/2023 | End: 09/05/2023 | Duration: 15.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: 45 MG/M2, Q2W | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 45.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 10/03/2023 | End: 10/03/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230909

Report Duplicates (1)

SERVIER: EU-SERVIER-S23010570

Raw JSON (click to expand)

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"drugstartdateformat": "102", "drugstartdate": "2023-10-03T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-10-03T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200 MG/M2, Q2W", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2023-08-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-09-05T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200 MG/M2, Q2W", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-10-03T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-10-03T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OXALIPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "60 MG/M2, Q2W", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2023-08-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-09-05T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OXALIPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 45.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "45 MG/M2, Q2W", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-10-03T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-10-03T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230909" }, "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-S23010570" } ], "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": "2026-01-19T00:00:00", "transmissiondateformat": "102" }