FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25955262 Type 2
Serious
ONIVYDE, ONIVYDE, OXALIPLATIN (+61 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
Consumer
Literature Reference
--
Company Number
US-IPSEN Group, Research and Development-2023-00478
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
69.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (19)

Diarrhoea (v28.1) Recovered
Hypokalaemia (v28.1) Recovered
Diverticulitis (v28.1) Not Recovered
Leukopenia (v28.1) Not Recovered
Electrolyte imbalance (v28.1) Recovering
Hypokalaemia (v28.1) Recovering
Gastrooesophageal reflux disease (v28.1) Recovering
Arthritis (v28.1) Not Recovered
Anxiety (v28.1) Not Recovered
Dehydration (v28.1) Not Recovered
Fatigue (v28.1) Not Recovered
Nausea (v28.1) Not Recovered
Abdominal pain (v28.1) Not Recovered
Troponin increased (v28.1) Not Recovered
Hyponatraemia (v28.1) Not Recovered
Diarrhoea (v28.1) Not Recovered
Infrequent bowel movements (v28.1) Unknown
Flatulence (v28.1) Unknown
Abdominal pain lower (v28.1) Unknown

Drugs (64)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 50MG/M2, EVERY 14 DAYS | Form: Concentrate for solution for infusion | Indication: Pancreatic carcinoma | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 14.0 day | Cumulative: -- (unit: --)
Start: 12/09/2022 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 42 MG/M2, EVERY 14 DAYS | Form: Concentrate for solution for infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 42.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 14.0 day | Cumulative: -- (unit: --)
Start: 03/21/2023 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Pancreatic carcinoma | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 14.0 day | Cumulative: -- (unit: --)
Start: 12/09/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 14.0 day | Cumulative: -- (unit: --)
Start: 03/21/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Pancreatic carcinoma | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 14.0 day | Cumulative: -- (unit: --)
Start: 12/09/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 14.0 day | Cumulative: -- (unit: --)
Start: 03/21/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Pancreatic carcinoma | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 14.0 day | Cumulative: -- (unit: --)
Start: 12/23/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 14.0 day | Cumulative: -- (unit: --)
Start: 03/21/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OMEPRAZOLE (OMEPRAZOLE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Gastrooesophageal reflux disease | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/01/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LOMOTIL (ATROPINE SULFATE\DIPHENOXYLATE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: PRN | Form: -- | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LOMOTIL (ATROPINE SULFATE\DIPHENOXYLATE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Diarrhoea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DECADRON (DEXAMETHASONE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 8.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 12/10/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ATIVAN (LORAZEPAM) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 0.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ATIVAN (LORAZEPAM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
COMPAZINE (PROCHLORPERAZINE MALEATE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 11/16/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
COMPAZINE (PROCHLORPERAZINE MALEATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
APREPITANT (APREPITANT) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 125.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 12/09/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ZOFRAN (ONDANSETRON HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: PRN | Form: -- | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 8.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CREON (PANCRELIPASE AMYLASE\PANCRELIPASE LIPASE\PANCRELIPASE PROTEASE) Concomitant
Route: 048 | Dosage: 24000 UNITS , 3 TIMES DAILY | Form: -- | Indication: Pancreatic failure | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
IMODIUM (LOPERAMIDE HYDROCHLORIDE) 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: --
SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant
Route: -- | Dosage: AS NEEDED DURING CHEMO | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: 048 | Dosage: 40 MEQ ONCE | Form: -- | Indication: Hypokalaemia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/29/2022 | End: 12/29/2022 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: 048 | Dosage: 20 MEQ TWICE DAILY | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/29/2022 | End: 12/31/2022 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: 048 | Dosage: 10 MEQ TWICE DAILY | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: 01/01/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: 048 | Dosage: 40 MEQ TWICE DAILY | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: 01/06/2023 | Duration: 6.0 day | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: -- | Dosage: 10 MEQ PRN | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: 01/05/2023 | Duration: 5.0 day | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: 048 | Dosage: 40 MEQ ONCE | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/24/2023 | End: 01/24/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: 048 | Dosage: 40 MEQ ONCE | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/07/2022 | End: 02/07/2022 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: 048 | Dosage: 20 ME1 TWICE DAILY | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/07/2022 | End: 02/10/2022 | Duration: 4.0 day | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: -- | Dosage: 40 MEQ ONCE | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/21/2022 | End: 02/21/2022 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: 048 | Dosage: 20 MEQ TWICE DAILY | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/21/2022 | End: 02/24/2022 | Duration: 4.0 day | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: -- | Dosage: 40 MEQ ONCE | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/08/2023 | End: 03/08/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: 048 | Dosage: 20 MEQ | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 03/08/2023 | End: 03/21/2023 | Duration: 14.0 day | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: -- | Dosage: 40 MEQ ONCE | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 03/21/2023 | End: 03/21/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: -- | Dosage: 40 MEQ ONCE | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 03/28/2023 | End: 03/28/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: -- | Dosage: 20 MEQ FOUR TIMES DAILY | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 03/31/2023 | End: 03/31/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: 048 | Dosage: 40 MEQ DAILY | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 03/31/2023 | End: 04/08/2023 | Duration: 9.0 day | Rechallenge: -- | Additional: --
Recurrences: --
MAGNESIUM SULFATE (MAGNESIUM SULFATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: 01/01/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
MAGNESIUM SULFATE (MAGNESIUM SULFATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Hypomagnesaemia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/21/2023 | End: 02/21/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
MAGNESIUM SULFATE (MAGNESIUM SULFATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/08/2023 | End: 03/08/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
MAGNESIUM SULFATE (MAGNESIUM SULFATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/21/2023 | End: 03/21/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
MAGNESIUM SULFATE (MAGNESIUM SULFATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/31/2023 | End: 03/31/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
MAGNESIUM SULFATE (MAGNESIUM SULFATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/31/2023 | End: 03/31/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
UNSPECIFIED INGREDIENT (UNSPECIFIED INGREDIENT) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Diarrhoea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1000.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: 01/01/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ASPIRIN (ASPIRIN) Concomitant
Route: 048 | Dosage: ONCE | Form: -- | Indication: Troponin increased | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 325.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: 01/01/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
FLAGYL (METRONIDAZOLE\METRONIDAZOLE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: 01/01/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
FLAGYL (METRONIDAZOLE\METRONIDAZOLE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 3 TIMES DAILY | Form: -- | Indication: Gastrointestinal disorder | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: 01/05/2023 | Duration: 5.0 day | Rechallenge: -- | Additional: --
Recurrences: --
FLAGYL (METRONIDAZOLE\METRONIDAZOLE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 3 TIMES DAILY | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/01/2023 | End: 04/05/2023 | Duration: 5.0 day | Rechallenge: -- | Additional: --
Recurrences: --
TYLENOL (ACETAMINOPHEN) Concomitant
Route: 048 | Dosage: ONCE | Form: -- | Indication: Abdominal pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 650.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/05/2023 | End: 01/05/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
PROTONIX (PANTOPRAZOLE SODIUM) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Diarrhoea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CIPRO (CIPROFLOXACIN HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: TWICE DAILY | Form: -- | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: 01/05/2023 | Duration: 5.0 day | Rechallenge: -- | Additional: --
Recurrences: --
IMODIUM (LOPERAMIDE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Diarrhoea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: 01/06/2023 | Duration: 6.0 day | Rechallenge: -- | Additional: --
Recurrences: --
IMODIUM (LOPERAMIDE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: PRN | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/01/2023 | End: 04/04/2023 | Duration: 4.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ROCEPHIN (CEFTRIAXONE SODIUM) Concomitant
Route: -- | Dosage: ONCE | Form: -- | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: 01/01/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
OCTREOTIDE (OCTREOTIDE) Concomitant
Route: -- | Dosage: 150 MCG 3 TIMES DAILY | Form: -- | Indication: Diarrhoea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: 01/05/2023 | Duration: 5.0 day | Rechallenge: -- | Additional: --
Recurrences: --
PHOSPHORUS (PHOSPHORUS) Concomitant
Route: 048 | Dosage: 16 MMOL THREE TIMES DAILY | Form: -- | Indication: Hypophosphataemia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/02/2023 | End: 02/03/2023 | Duration: 33.0 day | Rechallenge: -- | Additional: --
Recurrences: --
METAMUCIL (PLANTAGO SEED) Concomitant
Route: 048 | Dosage: DAILY | Form: -- | Indication: Diarrhoea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.85 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/02/2023 | End: 01/05/2023 | Duration: 4.0 day | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM PHOSPHATE (POTASSIUM PHOSPHATE) Concomitant
Route: -- | Dosage: 24 MMOL ONCE | Form: -- | Indication: Hypophosphataemia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/03/2023 | End: 03/03/2023 | Duration: 2.0 mo | Rechallenge: -- | Additional: --
Recurrences: --
SODIUM PHOSPHATE (SODIUM PHOSPHATE) Concomitant
Route: 048 | Dosage: 15 MMOL THREE TIMES | Form: -- | Indication: Hypophosphataemia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/04/2023 | End: 01/04/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
MAGNESIUM OXIDE (MAGNESIUM OXIDE) Concomitant
Route: 048 | Dosage: TWICE DAILY | Form: -- | Indication: Abdominal pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/06/2023 | End: 01/06/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
LOPERAMIDE (LOPERAMIDE) Concomitant
Route: 048 | Dosage: TWICE DAILY | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/01/2023 | End: 04/01/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ROCEPHIN (CEFTRIAXONE SODIUM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Gastrointestinal disorder | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/01/2023 | End: 04/03/2023 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
SIMETHICONE (DIMETHICONE) (DIMETHICONE) Concomitant
Route: 048 | Dosage: TWICE DAILY | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 80.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/02/2023 | End: 04/02/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
AMOXICILLIN\CLAVULANATE POTASSIUM (AMOXICILLIN\CLAVULANATE POTASSIUM) Concomitant
Route: 048 | Dosage: 875-125 MG TWICE DAILY | Form: -- | Indication: Gastrointestinal disorder | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/03/2023 | End: 04/11/2023 | Duration: 9.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230101

Report Duplicates (0)

--

Raw JSON (click to expand)

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"drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ONDANSETRON HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CREON", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "24000 UNITS , 3 TIMES DAILY", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Pancreatic failure", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, 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"CEFTRIAXONE SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SIMETHICONE (DIMETHICONE)", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 80.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TWICE DAILY", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-04-02T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-04-02T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DIMETHICONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AMOXICILLIN\\CLAVULANATE POTASSIUM", 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"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": 1, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955260 Type 2
Serious
ONIVYDE, FLUOROURACIL, LEUCOVORIN (+6 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-SERVIER-S23007347
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
63.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Hepatic function abnormal (v28.1) Not Recovered

Drugs (9)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 033 | Dosage: 60 MG/M2 | Form: Solution for infusion | Indication: Metastatic gastric cancer | Action: Unknown
Auth#: 102799 | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: UNKNOWN | Form: -- | Indication: Metastatic gastric cancer | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/27/2023 | End: 06/29/2023 | Duration: 3.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: UNKNOWN | Form: -- | Indication: Metastatic gastric cancer | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/27/2023 | End: 06/29/2023 | Duration: 3.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: UNKNOWN | Form: -- | Indication: Metastatic gastric cancer | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/27/2023 | End: 06/29/2023 | Duration: 3.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
COLOFIBER (--) Concomitant
Route: 048 | Dosage: 7 MG, QD | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 7.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 21.0 (unit: 003)
Start: 06/27/2023 | End: 06/29/2023 | Duration: 3.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
IMODIUM (LOPERAMIDE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 2 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/27/2023 | End: 06/30/2023 | Duration: 4.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
MOTILIUM (DOMPERIDONE) Concomitant
Route: 048 | Dosage: 10 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/27/2023 | End: 06/30/2023 | Duration: 4.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
MORPHINE SULFATE (MORPHINE SULFATE) Concomitant
Route: 048 | Dosage: 10 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/27/2023 | End: 06/30/2023 | Duration: 4.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
OMEPRAZOLE (OMEPRAZOLE) Concomitant
Route: 048 | Dosage: 40 MG, QD | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 80.0 (unit: 003)
Start: 06/28/2023 | End: 06/30/2023 | Duration: 3.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230629

Report Duplicates (1)

Servier: EU-SERVIER-S23007347

Raw JSON (click to expand)

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25955259 Type 2
Serious
ONIVYDE, OXALIPLATIN, FLUOROURACIL (+7 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-2023-04374
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
71.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
64.4 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Liver abscess (v28.1) Recovered w/ Sequelae
Decreased appetite (v28.1) Unknown
Fatigue (v28.1) Unknown
Asthenia (v28.1) Unknown
Chills (v28.1) Unknown
Enterococcus test positive (v28.1) Unknown

Drugs (10)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: Solution for infusion | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 90.8 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/16/2022 | End: 01/27/2023 | Duration: 43.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: -- | Form: Solution for infusion | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 108.9 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/16/2022 | End: 01/27/2023 | Duration: 43.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: -- | Form: Solution for infusion | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 4356.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/16/2022 | End: 01/27/2023 | Duration: 43.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: -- | Form: Solution for infusion | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/16/2022 | End: 01/27/2023 | Duration: 43.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
VANCOMYCIN (VANCOMYCIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Liver abscess | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: 02/17/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CEFEPIME (CEFEPIME HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Liver abscess | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/17/2023 | End: 02/17/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ENOXAPARIN (ENOXAPARIN) Concomitant
Route: -- | Dosage: Q24H | Form: -- | Indication: Embolism venous | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/17/2023 | End: 02/17/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DAPTOMYCIN (DAPTOMYCIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Liver abscess | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/20/2023 | End: 02/20/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
PIPERACILLIN TAZO (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Liver abscess | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 4.5 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/17/2023 | End: 02/23/2023 | Duration: 7.0 day | Rechallenge: -- | Additional: --
Recurrences: --
PIPERACILLIN TAZO (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 13.5 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230217

Report Duplicates (1)

MISTRAL: US23-000666

Raw JSON (click to expand)

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null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230217" }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MISTRAL", "duplicatenumb": "US23-000666" } ], "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" }
25955258 Type 2
Serious
ONIVYDE, ONIVYDE, FLUOROURACIL (+4 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-SERVIER-S23001856
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
56.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
95.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Diarrhoea (v28.1) Recovered
General physical health deterioration (v28.1) Recovered

Drugs (7)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 143.5 MG/DAY | Form: Solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/08/2023 | End: 02/08/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 101.5 MG/DAY | Form: Solution for infusion | Indication: -- | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/28/2023 | End: -- | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 3940 MG/DAY, UNK FREQUENCY | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 3940.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/08/2023 | End: 02/08/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 400 MG/DAY, UNK FREQUENCY | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/08/2023 | End: 02/08/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
CREON (PANCRELIPASE AMYLASE\PANCRELIPASE LIPASE\PANCRELIPASE PROTEASE) Concomitant
Route: -- | Dosage: 10000 UI, UNK | Form: -- | Indication: Pancreatic failure | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INNOHEP (TINZAPARIN SODIUM) Concomitant
Route: -- | Dosage: 16000 UI, UNK | Form: -- | Indication: Anticoagulation drug level therapeutic | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 10 MG, UNK | Form: -- | Indication: Pain | 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: 20230216

Report Duplicates (1)

SERVIER: EU-SERVIER-S23001856

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c63", "safetyreportid": "25955258", "authoritynumb": null, "companynumb": "EU-SERVIER-S23001856", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 56.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 95.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "General physical health deterioration", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "143.5 MG/DAY", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2023-02-08T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-02-08T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "101.5 MG/DAY", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-02-28T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3940.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3940 MG/DAY, UNK FREQUENCY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2023-02-08T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-02-08T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "400 MG/DAY, UNK FREQUENCY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2023-02-08T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-02-08T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CREON", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10000 UI, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic failure", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PANCRELIPASE AMYLASE\\PANCRELIPASE LIPASE\\PANCRELIPASE PROTEASE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "INNOHEP", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "16000 UI, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Anticoagulation drug level therapeutic", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TINZAPARIN SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OXYCODONE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pain", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "OXYCODONE HYDROCHLORIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230216" }, "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-S23001856" } ], "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" }
25955256 Type 2
Serious
ONIVYDE, LEUCOVORIN CALCIUM, FLUOROURACIL
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-IPSEN Group, Research and Development-2023-07361
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
74.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
110.7 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Pneumonia (v28.1) Not Recovered
Nausea (v28.1) Recovered
Dyspnoea (v28.1) Recovered
Pyrexia (v28.1) Not Recovered
Chills (v28.1) Not Recovered
Mental disorder (v28.1) Not Recovered

Drugs (3)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: Concentrate for solution for infusion | Indication: Adenocarcinoma pancreas | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/06/2021 | End: 07/06/2021 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Adenocarcinoma pancreas | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/06/2021 | End: 07/06/2021 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Adenocarcinoma pancreas | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/06/2021 | End: 07/08/2021 | Duration: 3.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20210707

Report Duplicates (1)

MISTRAL: US23-001081

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c62", "safetyreportid": "25955256", "authoritynumb": null, "companynumb": "US-IPSEN Group, Research and Development-2023-07361", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 74.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 110.7, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pneumonia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pyrexia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Chills", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Mental disorder", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": "Adenocarcinoma pancreas", "drugstartdateformat": "102", "drugstartdate": "2021-07-06T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-07-06T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN CALCIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Adenocarcinoma pancreas", "drugstartdateformat": "102", "drugstartdate": "2021-07-06T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-07-06T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Adenocarcinoma pancreas", "drugstartdateformat": "102", "drugstartdate": "2021-07-06T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-07-08T00:00:00", "drugtreatmentduration": 3.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20210707" }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MISTRAL", "duplicatenumb": "US23-001081" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 1, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955257 Type 2
Serious
ONIVYDE, FLUOROURACIL, FLUOROURACIL (+9 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
KR
Occurrence Country
KR
Reporter Country
KR
Reporter Qualification
Physician
Literature Reference
--
Company Number
KR-SERVIER-S23001857
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
68.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
63.7 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Enterocolitis (v28.1) Recovered

Drugs (12)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 116 MG, EVERY 2 WEEKS | Form: Solution for infusion | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 116.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/01/2023 | End: 02/13/2023 | Duration: 13.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 3178 MG, EVERY 2 WEEKS | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 3178.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/13/2023 | End: -- | Duration: 2.0 wk | Rechallenge: -- | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: DOSE REDUCED BY 80% | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
CITOPCIN (--) Concomitant
Route: -- | Dosage: 500 MG, BID | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 1000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/13/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 6 MG, TID | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 18.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/13/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FOTAGEL (--) Concomitant
Route: -- | Dosage: 60 ML, TID | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 180.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/20/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NALOXONE HYDROCHLORIDE\OXYCODONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE\OXYCODONE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 1 DF, QD | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 09/20/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
NORZYME (--) Concomitant
Route: -- | Dosage: 1 DF, TID | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 3.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 432.0 (unit: 032)
Start: 09/30/2022 | End: 03/23/2023 | Duration: 175.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
MOSAPRIDE CITRATE (MOSAPRIDE CITRATE) Concomitant
Route: -- | Dosage: 1 DF, TID | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 3.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 432.0 (unit: 032)
Start: 09/30/2022 | End: 03/05/2023 | Duration: 157.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
FENTANYL (FENTANYL) Concomitant
Route: -- | Dosage: 1 PATCH EVERY 3 DAYS | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/13/2023 | End: 03/22/2023 | Duration: 38.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
FENTANYL (FENTANYL) Concomitant
Route: -- | Dosage: 1 DF, PRN | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/13/2023 | End: 03/23/2023 | Duration: 39.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
AXIDEXA (--) Concomitant
Route: -- | Dosage: 150 MG, BID | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 43200.0 (unit: 003)
Start: 09/30/2022 | End: 03/10/2023 | Duration: 162.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230220

Report Duplicates (2)

SERVIER: S23001857
SERVIER: KR-SERVIER-S23001857

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c61", "safetyreportid": "25955257", "authoritynumb": null, "companynumb": "KR-SERVIER-S23001857", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "KR", "patient": { "patientonsetage": 68.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 63.7, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Enterocolitis", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 116.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "116 MG, EVERY 2 WEEKS", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2023-02-01T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-02-13T00:00:00", "drugtreatmentduration": 13.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3178.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3178 MG, EVERY 2 WEEKS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2023-02-13T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 2.0, "drugtreatmentdurationunit": 803, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE REDUCED BY 80%", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CITOPCIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1000.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MG, BID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-02-13T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LOPERAMIDE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 18.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "6 MG, TID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-02-13T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LOPERAMIDE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FOTAGEL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 180.0, "drugstructuredosageunit": "012", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "60 ML, TID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-02-20T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NALOXONE HYDROCHLORIDE\\OXYCODONE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-09-20T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "NALOXONE HYDROCHLORIDE\\OXYCODONE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NORZYME", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 432.0, "drugcumulativedosageunit": "032", "drugdosagetext": "1 DF, TID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-09-30T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-03-23T00:00:00", "drugtreatmentduration": 175.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MOSAPRIDE CITRATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 432.0, "drugcumulativedosageunit": "032", "drugdosagetext": "1 DF, TID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-09-30T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-03-05T00:00:00", "drugtreatmentduration": 157.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "MOSAPRIDE CITRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FENTANYL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 PATCH EVERY 3 DAYS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-02-13T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-03-22T00:00:00", "drugtreatmentduration": 38.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FENTANYL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FENTANYL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, PRN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-02-13T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-03-23T00:00:00", "drugtreatmentduration": 39.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FENTANYL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AXIDEXA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 43200.0, "drugcumulativedosageunit": "003", "drugdosagetext": "150 MG, BID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-09-30T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-03-10T00:00:00", "drugtreatmentduration": 162.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230220" }, "primarysource": { "reportercountry": "KR", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "KR", "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": "S23001857" }, { "duplicatesource": "SERVIER", "duplicatenumb": "KR-SERVIER-S23001857" } ], "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" }
25955255 Type 2
Serious
ONIVYDE, TS-1
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
Other Health Professional
Literature Reference
--
Company Number
EU-SERVIER-S22012048
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
77.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Enterocolitis (v28.1) Recovered

Drugs (2)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 70 MG/M2 EVERY TWO WEEKS | Form: Concentrate for solution for infusion | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 70.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 10/27/2022 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
TS-1 (GIMERACIL\OTERACIL POTASSIUM\TEGAFUR) Suspect
Route: -- | Dosage: 25 MG/M2 BID | Form: -- | Indication: Pancreatic carcinoma | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 25.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: 10/27/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20221115

Report Duplicates (1)

Les Laboratoires SERVIER: EU-SERVIER-S22012048

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c60", "safetyreportid": "25955255", "authoritynumb": null, "companynumb": "EU-SERVIER-S22012048", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 77.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Enterocolitis", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 70.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "70 MG/M2 EVERY TWO WEEKS", "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-10-27T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TS-1", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 25.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 12.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "25 MG/M2 BID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-10-27T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "GIMERACIL\\OTERACIL POTASSIUM\\TEGAFUR" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20221115" }, "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": "Les Laboratoires SERVIER", "duplicatenumb": "EU-SERVIER-S22012048" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955253 Type 2
Serious
ONIVYDE, CAPECITABINE
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
KR
Occurrence Country
KR
Reporter Country
KR
Reporter Qualification
Physician
Literature Reference
--
Company Number
KR-SERVIER-S22012114
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
62.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
57.2 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Enteritis (v28.1) Recovered

Drugs (2)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 149 MG,QD | Form: Concentrate for solution for infusion | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 149.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 11/04/2022 | End: 11/04/2022 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
CAPECITABINE (CAPECITABINE) Concomitant
Route: 048 | Dosage: 1600 MG, BID | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 3200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 38400.0 (unit: 003)
Start: 11/04/2022 | End: 11/18/2022 | Duration: 15.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20221115

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c5f", "safetyreportid": "25955253", "authoritynumb": null, "companynumb": "KR-SERVIER-S22012114", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "KR", "patient": { "patientonsetage": 62.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 57.2, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Enteritis", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 149.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "149 MG,QD", "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-11-04T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-11-04T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CAPECITABINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 38400.0, "drugcumulativedosageunit": "003", "drugdosagetext": "1600 MG, BID", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-11-04T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-11-18T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "CAPECITABINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20221115" }, "primarysource": { "reportercountry": "KR", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "KR", "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": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955254 Type 1
Serious
SERETIDE, SERETIDE, SERETIDE
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Consumer
Literature Reference
--
Company Number
CN-GSK-CN2025CHI134661
Authority Number
--
Sender Organization
GLAXOSMITHKLINE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
75.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Chronic obstructive pulmonary disease (v28.1) Recovering
Condition aggravated (v28.1) Unknown
Malaise (v28.1) Unknown
Off label use (v28.1) Unknown
Inappropriate schedule of product administration (v28.1) Unknown
Incorrect dose administered (v28.1) Unknown

Drugs (3)

SERETIDE (FLUTICASONE PROPIONATE\SALMETEROL XINAFOATE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Chronic obstructive pulmonary disease | Action: Unknown
Auth#: 021077 | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
SERETIDE (FLUTICASONE PROPIONATE\SALMETEROL XINAFOATE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Chronic obstructive pulmonary disease | Action: Unknown
Auth#: 021077 | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
SERETIDE (FLUTICASONE PROPIONATE\SALMETEROL XINAFOATE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Chronic obstructive pulmonary disease | Action: Unknown
Auth#: 021077 | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250801

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c5e", "safetyreportid": "25955254", "authoritynumb": null, "companynumb": "CN-GSK-CN2025CHI134661", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 75.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Chronic obstructive pulmonary disease", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Condition aggravated", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Malaise", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Inappropriate schedule of product administration", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Incorrect dose administered", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SERETIDE", "drugauthorizationnumb": "021077", "drugbatchnumb": "UNK", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Chronic obstructive pulmonary disease", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUTICASONE PROPIONATE\\SALMETEROL XINAFOATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SERETIDE", "drugauthorizationnumb": "021077", "drugbatchnumb": "UNK", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Chronic obstructive pulmonary disease", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUTICASONE PROPIONATE\\SALMETEROL XINAFOATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SERETIDE", "drugauthorizationnumb": "021077", "drugbatchnumb": "UNK", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Chronic obstructive pulmonary disease", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUTICASONE PROPIONATE\\SALMETEROL XINAFOATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250801" }, "primarysource": { "reportercountry": "CN", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "GLAXOSMITHKLINE" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955252 Type 2
Serious
LANREOTIDE ACETATE
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
IL
Occurrence Country
IL
Reporter Country
IL
Reporter Qualification
Consumer
Literature Reference
--
Company Number
IL-KOREA IPSEN Pharma-2023-02413
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
75.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Fall (v28.1) Unknown
Back injury (v28.1) Unknown
Gait inability (v28.1) Recovering

Drugs (1)

LANREOTIDE ACETATE (LANREOTIDE ACETATE) Suspect
Route: 058 | Dosage: -- | Form: Solution for injection | Indication: Neuroendocrine tumour | Action: Dose Not Changed
Auth#: -- | Batch#: W20292/U23461 | Structured Dosage: 120.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 28.0 day | Cumulative: -- (unit: --)
Start: 05/02/2019 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230118

Report Duplicates (2)

MEDISON: IP250123SOM
TJIN: 202300733

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c5d", "safetyreportid": "25955252", "authoritynumb": null, "companynumb": "IL-KOREA IPSEN Pharma-2023-02413", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "IL", "patient": { "patientonsetage": 75.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fall", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Back injury", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gait inability", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "LANREOTIDE ACETATE", "drugauthorizationnumb": null, "drugbatchnumb": "W20292/U23461", "drugstructuredosagenumb": 120.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 28.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": "Neuroendocrine tumour", "drugstartdateformat": "102", "drugstartdate": "2019-05-02T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LANREOTIDE ACETATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230118" }, "primarysource": { "reportercountry": "IL", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "IL", "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": "MEDISON", "duplicatenumb": "IP250123SOM" }, { "duplicatesource": "TJIN", "duplicatenumb": "202300733" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }