FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25955271 Type 2
Serious
ONIVYDE, LEUCOVORIN, OXALIPLATIN (+10 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
Physician
Literature Reference
--
Company Number
US-IPSEN Group, Research and Development-2023-10313
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
57.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
81.2 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (8)

Enterocolitis (v28.1) Recovered
Abdominal pain (v28.1) Unknown
Diarrhoea (v28.1) Unknown
Nausea (v28.1) Unknown
Vomiting (v28.1) Unknown
Haematochezia (v28.1) Unknown
Oedema (v28.1) Unknown
Erythema (v28.1) Unknown

Drugs (13)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: Solution for infusion | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 50.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/13/2023 | End: 04/19/2023 | Duration: 38.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/13/2023 | End: 04/19/2023 | Duration: 38.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/13/2023 | End: 04/19/2023 | Duration: 38.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 2400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/19/2023 | End: 04/19/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
CEFTRIAXONE (CEFTRIAXONE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ONDANSETRON (ONDANSETRON) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OXYCODONE (OXYCODONE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
APIXABAN (APIXABAN) Concomitant
Route: -- | Dosage: 2.5 MG/TABLETS BID | Form: -- | Indication: Antibiotic prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 05/11/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LOPERAMIDE (LOPERAMIDE) Concomitant
Route: -- | Dosage: 2MG/CAPSULES/QID FOR 30DAYS | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 05/11/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PACLITAXEL (PACLITAXEL) Concomitant
Route: -- | Dosage: 185 MG/IV, EVERY 14 DAYS | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 185.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 14.0 day | Cumulative: -- (unit: --)
Start: 05/11/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: -- | Dosage: 20 MEQ/TABLET BID | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 05/11/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FLAGYL (METRONIDAZOLE\METRONIDAZOLE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: BID | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CEFPODOXIME (CEFPODOXIME) Concomitant
Route: -- | Dosage: BID | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230430

Report Duplicates (1)

MISTRAL: US23-001657

Raw JSON (click to expand)

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"summary_narrativeincludeclinical": "CASE EVENT DATE: 20230430" }, "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": "US23-001657" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955270 Type 2
Serious
ONIVYDE, CYCLOPHOSPHAMIDE, MEGACE (+33 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-MERRIMACK PHARMACEUTICALS, INC.-MER-2016-000172
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
6.0 yr
Patient Age Group
Child
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Disease progression (v28.1) Fatal
Pneumocystis jirovecii infection (v28.1) Recovered
Dyspnoea (v28.1) Unknown
Cough (v28.1) Unknown

Drugs (36)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 0.95 MG/M2, UNK | Form: Solution for infusion | Indication: Rhabdomyosarcoma | Action: Unknown
Auth#: 102799 | Batch#: -- | Structured Dosage: 0.95 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/07/2015 | End: 02/24/2016 | Duration: 141.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect
Route: -- | Dosage: 5.60 MG/DAY X 141 DAYS | Form: -- | Indication: Neoplasm | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.6 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/05/2015 | End: 02/26/2016 | Duration: 145.0 day | Rechallenge: -- | Additional: --
Recurrences: --
MEGACE (MEGESTROL ACETATE) Concomitant
Route: -- | Dosage: 40 MG, TID | Form: -- | Indication: Increased appetite | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.33 day | Cumulative: -- (unit: --)
Start: 03/07/2016 | End: 03/09/2016 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DIPHENHYDRAMINE (DIPHENHYDRAMINE) Concomitant
Route: -- | Dosage: 12.5 MG, Q6H PRN | Form: -- | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 12.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.25 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 2 MG, Q6H PRN | Form: -- | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.25 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MIRALAX (POLYETHYLENE GLYCOL 3350) Concomitant
Route: -- | Dosage: 0.25 CAPFUL, BID PRN | Form: -- | Indication: Constipation | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 0.5 day | Cumulative: -- (unit: --)
Start: 03/11/2016 | End: 03/18/2016 | Duration: 8.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DAPSONE (DAPSONE) Concomitant
Route: -- | Dosage: 62.5 MG, QWK | Form: -- | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 62.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: 11/16/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MORPHINE SULFATE (MORPHINE SULFATE) Concomitant
Route: -- | Dosage: 4 MG, Q4 TO 6 HR PRN | Form: -- | Indication: Pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/10/2016 | End: 04/18/2016 | Duration: 40.0 day | Rechallenge: -- | Additional: --
Recurrences: --
SULFAMETHOXAZOLE (SULFAMETHOXAZOLE) Concomitant
Route: -- | Dosage: 60 MG, Q6H | Form: -- | Indication: Pneumocystis jirovecii infection | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.25 day | Cumulative: -- (unit: --)
Start: 03/09/2016 | End: 03/29/2016 | Duration: 21.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DEXAMETHASONE (DEXAMETHASONE) Concomitant
Route: -- | Dosage: 8.4 MG, UNK | Form: -- | Indication: Pneumocystis jirovecii infection | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 8.4 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/20/2016 | End: 03/20/2016 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DEXAMETHASONE (DEXAMETHASONE) Concomitant
Route: -- | Dosage: 50 MCG, 3 DOSES | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/10/2016 | End: 03/12/2016 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
FENTANYL (FENTANYL) Concomitant
Route: -- | Dosage: 50 UG, UNK | Form: -- | Indication: Sedation | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/10/2016 | End: 03/12/2016 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
FENTANYL (FENTANYL) Concomitant
Route: -- | Dosage: 28 ?G, QH PRN | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 28.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 hr | Cumulative: -- (unit: --)
Start: 03/11/2016 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 12.5 MG, UNK | Form: -- | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 12.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/22/2016 | End: 03/28/2016 | Duration: 7.0 day | Rechallenge: -- | Additional: --
Recurrences: --
LASIX (FUROSEMIDE) Concomitant
Route: -- | Dosage: UNK UNK, Q8H | Form: -- | Indication: Polyuria | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 0.33 day | Cumulative: -- (unit: --)
Start: 03/13/2016 | End: 03/28/2016 | Duration: 16.0 day | Rechallenge: -- | Additional: --
Recurrences: --
LASIX (FUROSEMIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: -- | Dosage: 14 MEQ, QH PRN | Form: -- | Indication: Hypokalaemia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 14.0 (unit: 029) | Separate Dosage#: 1.0 | Interval: 1.0 hr | Cumulative: -- (unit: --)
Start: 03/14/2016 | End: 03/18/2016 | Duration: 5.0 day | Rechallenge: -- | Additional: --
Recurrences: --
AZITHROMYCIN (AZITHROMYCIN) Concomitant
Route: -- | Dosage: 140 MG, UNK | Form: -- | Indication: Pneumonia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 140.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
AZITHROMYCIN (AZITHROMYCIN) Concomitant
Route: -- | Dosage: 70 MG, UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 70.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/10/2016 | End: 03/11/2016 | Duration: 2.0 day | Rechallenge: -- | Additional: --
Recurrences: --
CEFEPIME (CEFEPIME HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 100 MG, Q8H | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.33 day | Cumulative: -- (unit: --)
Start: 03/20/2016 | End: 03/23/2016 | Duration: 4.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Concomitant
Route: -- | Dosage: 140 MG, 2 DOSES | Form: -- | Indication: Pyrexia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 140.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/09/2016 | End: 03/10/2016 | Duration: 2.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Concomitant
Route: -- | Dosage: 106 MG, Q4H | Form: -- | Indication: Pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 106.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.17 day | Cumulative: -- (unit: --)
Start: 03/19/2016 | End: 03/20/2016 | Duration: 2.0 day | Rechallenge: -- | Additional: --
Recurrences: --
CEFTRIAXONE (CEFTRIAXONE) Concomitant
Route: -- | Dosage: 1000 MG, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 03/09/2016 | End: 03/11/2016 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ACETAZOLAMIDE (ACETAZOLAMIDE) Concomitant
Route: -- | Dosage: 10 MG, UNK | Form: -- | Indication: Polyuria | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ACETAZOLAMIDE (ACETAZOLAMIDE) Concomitant
Route: -- | Dosage: 70 MG, 2 DOSES | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 70.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/15/2016 | End: 03/15/2016 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ALBUTEROL (ALBUTEROL) Concomitant
Route: -- | Dosage: 2.5 MG, Q4H PRN | Form: -- | Indication: Wheezing | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.17 day | Cumulative: -- (unit: --)
Start: 03/10/2016 | End: 03/20/2016 | Duration: 11.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ATIVAN (LORAZEPAM) Concomitant
Route: -- | Dosage: 1 MG, UNK | Form: -- | Indication: Anxiety | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/09/2016 | End: 03/11/2016 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
KEPPRA (LEVETIRACETAM) Concomitant
Route: -- | Dosage: 140 MG, Q12H | Form: -- | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 140.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.5 day | Cumulative: -- (unit: --)
Start: 03/20/2016 | End: 03/21/2016 | Duration: 9.0 day | Rechallenge: -- | Additional: --
Recurrences: --
VANCOMYCIN (VANCOMYCIN) Concomitant
Route: -- | Dosage: 275 MG, Q6H | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 275.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.25 day | Cumulative: -- (unit: --)
Start: 03/20/2016 | End: 03/21/2016 | Duration: 2.0 day | Rechallenge: -- | Additional: --
Recurrences: --
KETAMINE (KETAMINE) Concomitant
Route: -- | Dosage: 2 MG, UNK | Form: -- | Indication: Sedation | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/12/2016 | End: 03/14/2016 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
OMEPRAZOLE (OMEPRAZOLE) Concomitant
Route: -- | Dosage: 15 MG, FEED TUBE | Form: -- | Indication: Gastritis prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 15.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/17/2016 | End: 03/29/2016 | Duration: 13.0 day | Rechallenge: -- | Additional: --
Recurrences: --
METHADONE (METHADONE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Sedation | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
AMPHOTERICIN B (AMPHOTERICIN B) Concomitant
Route: -- | Dosage: 45 MG, Q24 HR | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 45.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/10/2016 | End: 03/12/2016 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
AMPHOTERICIN B (AMPHOTERICIN B) Concomitant
Route: -- | Dosage: 45 MG, Q24 HR | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 70.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/10/2016 | End: 03/12/2016 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
CISATRACURIUM (CISATRACURIUM) Concomitant
Route: -- | Dosage: 20 ML, 1 DOSE | Form: -- | Indication: Endotracheal intubation | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/10/2016 | End: 03/10/2016 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ROBINUL (GLYCOPYRROLATE) Concomitant
Route: -- | Dosage: Q4 HR PRN | Form: -- | Indication: Sedation | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 0.075 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/15/2016 | End: 04/19/2016 | Duration: 5.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20160101

Report Duplicates (3)

QUINTILES: US-MERRIMACK PHARMACEUTICALS, INC.-MER-2016-000172
SERVIER: US-BAXALTA-2016BLT009262AA
MISTRAL: US23-002827

Raw JSON (click to expand)

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"drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.95 MG/M2, UNK", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Rhabdomyosarcoma", "drugstartdateformat": "102", "drugstartdate": "2015-10-07T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-02-24T00:00:00", "drugtreatmentduration": 141.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CYCLOPHOSPHAMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 5.6, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5.60 MG/DAY X 141 DAYS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Neoplasm", "drugstartdateformat": "102", "drugstartdate": "2015-10-05T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-02-26T00:00:00", "drugtreatmentduration": 145.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CYCLOPHOSPHAMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MEGACE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.33, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MG, TID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Increased appetite", "drugstartdateformat": "102", "drugstartdate": "2016-03-07T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-09T00:00:00", "drugtreatmentduration": 3.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "MEGESTROL ACETATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DIPHENHYDRAMINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 12.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.25, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "12.5 MG, Q6H PRN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Nausea", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DIPHENHYDRAMINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ONDANSETRON HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.25, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2 MG, Q6H PRN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Nausea", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ONDANSETRON HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MIRALAX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.5, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.25 CAPFUL, BID PRN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Constipation", "drugstartdateformat": "102", "drugstartdate": "2016-03-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-18T00:00:00", "drugtreatmentduration": 8.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "POLYETHYLENE GLYCOL 3350" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DAPSONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 62.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "62.5 MG, QWK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Prophylaxis", "drugstartdateformat": "102", "drugstartdate": "2015-11-16T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DAPSONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MORPHINE SULFATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4 MG, Q4 TO 6 HR PRN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pain", "drugstartdateformat": "102", "drugstartdate": "2016-03-10T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-04-18T00:00:00", "drugtreatmentduration": 40.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "MORPHINE SULFATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SULFAMETHOXAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.25, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "60 MG, Q6H", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pneumocystis jirovecii infection", "drugstartdateformat": "102", "drugstartdate": "2016-03-09T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-29T00:00:00", "drugtreatmentduration": 21.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SULFAMETHOXAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DEXAMETHASONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 8.4, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "8.4 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pneumocystis jirovecii infection", "drugstartdateformat": "102", "drugstartdate": "2016-03-20T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-20T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DEXAMETHASONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DEXAMETHASONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "50 MCG, 3 DOSES", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2016-03-10T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-12T00:00:00", "drugtreatmentduration": 3.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DEXAMETHASONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FENTANYL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "50 UG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Sedation", "drugstartdateformat": "102", "drugstartdate": "2016-03-10T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-12T00:00:00", "drugtreatmentduration": 3.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FENTANYL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FENTANYL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 28.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "28 ?G, QH PRN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2016-03-11T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FENTANYL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BENADRYL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 12.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "12.5 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Nausea", "drugstartdateformat": "102", "drugstartdate": "2016-03-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-28T00:00:00", "drugtreatmentduration": 7.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DIPHENHYDRAMINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LASIX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.33, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK UNK, Q8H", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Polyuria", "drugstartdateformat": "102", "drugstartdate": "2016-03-13T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-28T00:00:00", "drugtreatmentduration": 16.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LASIX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "POTASSIUM CHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 14.0, "drugstructuredosageunit": "029", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "14 MEQ, QH PRN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Hypokalaemia", "drugstartdateformat": "102", "drugstartdate": "2016-03-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-18T00:00:00", "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "POTASSIUM CHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AZITHROMYCIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 140.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "140 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pneumonia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "AZITHROMYCIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AZITHROMYCIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 70.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "70 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2016-03-10T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-11T00:00:00", "drugtreatmentduration": 2.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "AZITHROMYCIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CEFEPIME", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.33, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MG, Q8H", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2016-03-20T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-23T00:00:00", "drugtreatmentduration": 4.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CEFEPIME HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ACETAMINOPHEN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 140.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "140 MG, 2 DOSES", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pyrexia", "drugstartdateformat": "102", "drugstartdate": "2016-03-09T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-10T00:00:00", "drugtreatmentduration": 2.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ACETAMINOPHEN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 106.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.17, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "106 MG, Q4H", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pain", "drugstartdateformat": "102", "drugstartdate": "2016-03-19T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-20T00:00:00", "drugtreatmentduration": 2.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CEFTRIAXONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1000.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1000 MG, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2016-03-09T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-11T00:00:00", "drugtreatmentduration": 3.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CEFTRIAXONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ACETAZOLAMIDE", "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": "Polyuria", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ACETAZOLAMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ACETAZOLAMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 70.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "70 MG, 2 DOSES", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2016-03-15T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-15T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ACETAZOLAMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ALBUTEROL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.17, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, Q4H PRN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Wheezing", "drugstartdateformat": "102", "drugstartdate": "2016-03-10T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-20T00:00:00", "drugtreatmentduration": 11.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ALBUTEROL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ATIVAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Anxiety", "drugstartdateformat": "102", "drugstartdate": "2016-03-09T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-11T00:00:00", "drugtreatmentduration": 3.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LORAZEPAM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "KEPPRA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 140.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.5, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "140 MG, Q12H", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Prophylaxis", "drugstartdateformat": "102", "drugstartdate": "2016-03-20T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-21T00:00:00", "drugtreatmentduration": 9.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LEVETIRACETAM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VANCOMYCIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 275.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.25, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "275 MG, Q6H", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2016-03-20T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-21T00:00:00", "drugtreatmentduration": 2.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "VANCOMYCIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "KETAMINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2 MG, UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Sedation", "drugstartdateformat": "102", "drugstartdate": "2016-03-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-14T00:00:00", "drugtreatmentduration": 3.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "KETAMINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OMEPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "15 MG, FEED TUBE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Gastritis prophylaxis", "drugstartdateformat": "102", "drugstartdate": "2016-03-17T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-29T00:00:00", "drugtreatmentduration": 13.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "OMEPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METHADONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Sedation", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "METHADONE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AMPHOTERICIN B", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 45.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "45 MG, Q24 HR", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2016-03-10T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-12T00:00:00", "drugtreatmentduration": 3.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "AMPHOTERICIN B" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AMPHOTERICIN B", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 70.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "45 MG, Q24 HR", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2016-03-10T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-12T00:00:00", "drugtreatmentduration": 3.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "AMPHOTERICIN B" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CISATRACURIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "012", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20 ML, 1 DOSE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Endotracheal intubation", "drugstartdateformat": "102", "drugstartdate": "2016-03-10T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-03-10T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CISATRACURIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ROBINUL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 0.075, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "Q4 HR PRN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Sedation", "drugstartdateformat": "102", "drugstartdate": "2016-04-15T00:00:00", "drugenddateformat": "102", "drugenddate": "2016-04-19T00:00:00", "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "GLYCOPYRROLATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20160101" }, "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": "QUINTILES", "duplicatenumb": "US-MERRIMACK PHARMACEUTICALS, INC.-MER-2016-000172" }, { "duplicatesource": "SERVIER", "duplicatenumb": "US-BAXALTA-2016BLT009262AA" }, { "duplicatesource": "MISTRAL", "duplicatenumb": "US23-002827" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25955269 Type 2
Serious
ONIVYDE, ONIVYDE, ONIVYDE (+8 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
JP
Occurrence Country
JP
Reporter Country
JP
Reporter Qualification
Physician
Literature Reference
--
Company Number
JP-SERVIERJAP-S21010093AA
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
79.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
60.6 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Diarrhoea (v28.1) Recovered
Enterocolitis (v28.1) Recovered
Pyrexia (v28.1) Recovered

Drugs (11)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 60 MG/M2 | Form: Solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Dose Not Changed
Auth#: 129648 | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/03/2021 | End: 06/03/2021 | Duration: 1.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 60 MG/M2 | Form: Solution for infusion | Indication: -- | Action: Dose Not Changed
Auth#: 129648 | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 60 MG/M2 | Form: Solution for infusion | Indication: -- | Action: Dose Not Changed
Auth#: 129648 | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
GIMERACIL\OTERACIL\TEGAFUR (GIMERACIL\OTERACIL POTASSIUM\TEGAFUR) Suspect
Route: 048 | Dosage: 40 MG, BID | Form: Buccal Tablet | Indication: Pancreatic carcinoma metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 80.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 06/03/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MAGNESIUM OXIDE (MAGNESIUM OXIDE) Suspect
Route: 048 | Dosage: 660 MG, TID | Form: Tablet | Indication: Constipation | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 1980.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 06/11/2021 | End: 01/01/2021 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
OLMESARTAN MEDOXOMIL (OLMESARTAN MEDOXOMIL) Concomitant
Route: 048 | Dosage: 10 MG, BID | Form: Orodispersible tablet | Indication: Hypertension | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/01/2017 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ZETIA (EZETIMIBE) Concomitant
Route: 048 | Dosage: 10 MG, BID | Form: Tablet | Indication: Dyslipidaemia | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VILDAGLIPTIN (VILDAGLIPTIN) Concomitant
Route: 048 | Dosage: 50 MG, BID | Form: Tablet | Indication: Diabetes mellitus | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/01/2017 | End: 01/01/2021 | Duration: 4.0 yr | Rechallenge: -- | Additional: Yes
Recurrences: --
METGLUCO (METFORMIN HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 500 MG, BID | Form: Tablet | Indication: Diabetes mellitus | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 1000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/01/2017 | End: 01/01/2021 | Duration: 4.0 yr | Rechallenge: -- | Additional: Yes
Recurrences: --
CHLORPROMAZINE (CHLORPROMAZINE) Concomitant
Route: 048 | Dosage: UNK UNK, AS REQ^D | Form: Coated tablet | Indication: Hiccups | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SILODOSIN (SILODOSIN) Concomitant
Route: 048 | Dosage: 4 MG, BID | Form: Tablet | Indication: Benign prostatic hyperplasia | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 8.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 06/14/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20210911

Report Duplicates (1)

servier: JP-SERVIERJAP-S21010093AA

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c6f", "safetyreportid": "25955269", "authoritynumb": null, "companynumb": "JP-SERVIERJAP-S21010093AA", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "JP", "patient": { "patientonsetage": 79.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 60.6, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Enterocolitis", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pyrexia", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "129648", "drugbatchnumb": null, "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "60 MG/M2", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2021-06-03T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-06-03T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "129648", "drugbatchnumb": null, "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "60 MG/M2", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "129648", "drugbatchnumb": null, "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "60 MG/M2", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "GIMERACIL\\OTERACIL\\TEGAFUR", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 80.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MG, BID", "drugdosageform": "Buccal Tablet", "drugadministrationroute": "048", "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2021-06-03T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "GIMERACIL\\OTERACIL POTASSIUM\\TEGAFUR" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "MAGNESIUM OXIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1980.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "660 MG, TID", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Constipation", "drugstartdateformat": "102", "drugstartdate": "2021-06-11T00:00:00", "drugenddateformat": "602", "drugenddate": "2021-01-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "MAGNESIUM OXIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OLMESARTAN MEDOXOMIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MG, BID", "drugdosageform": "Orodispersible tablet", "drugadministrationroute": "048", "drugindication": "Hypertension", "drugstartdateformat": "602", "drugstartdate": "2017-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "OLMESARTAN MEDOXOMIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ZETIA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MG, BID", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Dyslipidaemia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "EZETIMIBE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VILDAGLIPTIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "50 MG, BID", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Diabetes mellitus", "drugstartdateformat": "602", "drugstartdate": "2017-01-01T00:00:00", "drugenddateformat": "602", "drugenddate": "2021-01-01T00:00:00", "drugtreatmentduration": 4.0, "drugtreatmentdurationunit": 801, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "VILDAGLIPTIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METGLUCO", "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": "Tablet", "drugadministrationroute": "048", "drugindication": "Diabetes mellitus", "drugstartdateformat": "602", "drugstartdate": "2017-01-01T00:00:00", "drugenddateformat": "602", "drugenddate": "2021-01-01T00:00:00", "drugtreatmentduration": 4.0, "drugtreatmentdurationunit": 801, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "METFORMIN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CHLORPROMAZINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK UNK, AS REQ^D", "drugdosageform": "Coated tablet", "drugadministrationroute": "048", "drugindication": "Hiccups", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "CHLORPROMAZINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SILODOSIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 8.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4 MG, BID", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Benign prostatic hyperplasia", "drugstartdateformat": "102", "drugstartdate": "2021-06-14T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "SILODOSIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20210911" }, "primarysource": { "reportercountry": "JP", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "JP", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "servier", "duplicatenumb": "JP-SERVIERJAP-S21010093AA" } ], "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" }
25955267 Type 2
Serious
ONIVYDE, OXALIPLATIN, LEVOLEUCOVORIN (+1 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-SERVIER-S23000914
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
57.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Acute kidney injury (v28.1) Recovered
Platelet count decreased (v28.1) Recovered

Drugs (4)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 100 MG (50 MG/M2), IV, OVER 90 MINUTES | Form: Solution for infusion | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: 1A200049AC | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: 120 MG (60 MG/M2), IV, IN 120 MINUTES | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 120.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEVOLEUCOVORIN (LEVOLEUCOVORIN) Suspect
Route: -- | Dosage: 400 MG (200 MG/M2), IV, OVER 30 MINUTES | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 4800 MG (2400 MG/M2), IV, OVER 46 HOURS ON DAY 1 AND ON DAY 15 OF A 28 DAYS CYCLE | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 4800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20211214

Report Duplicates (1)

SERVIER: EU-SERVIER-S23000914

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c6d", "safetyreportid": "25955267", "authoritynumb": null, "companynumb": "EU-SERVIER-S23000914", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 57.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Acute kidney injury", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Platelet count decreased", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": "1A200049AC", "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MG (50 MG/M2), IV, OVER 90 MINUTES", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OXALIPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 120.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "120 MG (60 MG/M2), IV, IN 120 MINUTES", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEVOLEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "400 MG (200 MG/M2), IV, OVER 30 MINUTES", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEVOLEUCOVORIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4800.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4800 MG (2400 MG/M2), IV, OVER 46 HOURS ON DAY 1 AND ON DAY 15 OF A 28 DAYS CYCLE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20211214" }, "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-S23000914" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955265 Type 2
Serious
ONIVYDE, FLUOROURACIL, LEUCOVORIN CALCIUM
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
Consumer
Literature Reference
--
Company Number
US-IPSEN Group, Research and Development-2022-31854
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
85.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
55.5 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Anaemia (v28.1) Recovered
Hypokalaemia (v28.1) Recovered
Urinary tract infection (v28.1) Recovering
Pyrexia (v28.1) 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: 81.7 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Adenocarcinoma pancreas | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Adenocarcinoma pancreas | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 656.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20221111

Report Duplicates (1)

Servier: S22012233

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c6c", "safetyreportid": "25955265", "authoritynumb": null, "companynumb": "US-IPSEN Group, Research and Development-2022-31854", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 85.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 55.5, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anaemia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypokalaemia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Urinary tract infection", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pyrexia", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 81.7, "drugstructuredosageunit": "003", "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": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Adenocarcinoma pancreas", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN CALCIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 656.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Adenocarcinoma pancreas", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LEUCOVORIN CALCIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20221111" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Servier", "duplicatenumb": "S22012233" } ], "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" }
25955263 Type 2
Serious
ONIVYDE, CAPECITABINE, NORUMO (+1 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-S23000615
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
62.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
60.65 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Enterocolitis (v28.1) Recovered

Drugs (4)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 120 MG, DAILY | Form: Solution for infusion | Indication: Pancreatic carcinoma | Action: Dose Not Changed
Auth#: 207793 | Batch#: -- | Structured Dosage: 120.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 12/09/2022 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
CAPECITABINE (CAPECITABINE) Suspect
Route: 048 | Dosage: 1300 MG, BID | Form: -- | Indication: Pancreatic carcinoma | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 2600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 12/09/2022 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
NORUMO (--) Concomitant
Route: 048 | Dosage: 11.6 G, TID | Form: -- | Indication: Prophylaxis | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 34.8 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 11/08/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MOSAPRIDE CITRATE (MOSAPRIDE CITRATE) Concomitant
Route: 048 | Dosage: 5 MG, TID | Form: -- | Indication: Prophylaxis | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 15.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 11/08/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230111

Report Duplicates (1)

SERVIER: KR-SERVIER-S23000615

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c6b", "safetyreportid": "25955263", "authoritynumb": null, "companynumb": "KR-SERVIER-S23000615", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "KR", "patient": { "patientonsetage": 62.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 60.65, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Enterocolitis", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "207793", "drugbatchnumb": null, "drugstructuredosagenumb": 120.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "120 MG, DAILY", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-12-09T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CAPECITABINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1300 MG, BID", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-12-09T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "CAPECITABINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NORUMO", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 34.8, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "11.6 G, TID", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Prophylaxis", "drugstartdateformat": "102", "drugstartdate": "2022-11-08T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MOSAPRIDE CITRATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG, TID", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Prophylaxis", "drugstartdateformat": "102", "drugstartdate": "2022-11-08T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "MOSAPRIDE CITRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230111" }, "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": "KR-SERVIER-S23000615" } ], "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" }
25955264 Type 2
Serious
ONIVYDE, LEUCOVORIN, FLUOROURACIL (+4 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-SERVIER-S23004577
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
65.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Respiratory distress (v28.1) Fatal

Drugs (7)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 141 MG EVERY 1 CYCLE | Form: Concentrate for solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 141.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 800 MG EVERY 1 CYCLE | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 4800 MG EVERY 1 CYCLE | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 4800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/12/2023 | End: 04/14/2023 | Duration: 3.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
ELIQUIS (APIXABAN) Concomitant
Route: -- | Dosage: UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
COVERAM (AMLODIPINE\PERINDOPRIL) Concomitant
Route: -- | Dosage: UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TAHOR (ATORVASTATIN CALCIUM) Concomitant
Route: -- | Dosage: UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SILODOSIN (SILODOSIN) Concomitant
Route: -- | Dosage: UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230425

Report Duplicates (1)

SERVIER: EU-SERVIER-S23004577

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c6a", "safetyreportid": "25955264", "authoritynumb": null, "companynumb": "EU-SERVIER-S23004577", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 65.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Respiratory distress", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 141.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "141 MG EVERY 1 CYCLE", "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 800.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "800 MG EVERY 1 CYCLE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4800.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4800 MG EVERY 1 CYCLE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2023-04-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-04-14T00:00:00", "drugtreatmentduration": 3.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ELIQUIS", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNKNOWN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "APIXABAN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "COVERAM", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNKNOWN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "AMLODIPINE\\PERINDOPRIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TAHOR", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNKNOWN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SILODOSIN", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNKNOWN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "SILODOSIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230425" }, "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-S23004577" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955266 Type 2
Serious
ONIVYDE, LEUCOVORIN, OXALIPLATIN (+1 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-IPSEN Group, Research and Development-2023-06396
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
66.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
65.7 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Gastritis (v28.1) Recovered

Drugs (4)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 048 | Dosage: Q2W | Form: Concentrate for solution for infusion | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 11/11/2022 | End: 02/22/2023 | Duration: 104.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: 048 | Dosage: Q2W | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 11/11/2022 | End: 02/22/2023 | Duration: 104.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: 048 | Dosage: Q2W | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 11/11/2022 | End: 02/22/2023 | Duration: 104.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: 048 | Dosage: Q2W | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 2.4 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 11/11/2022 | End: 02/22/2023 | Duration: 104.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230228

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c69", "safetyreportid": "25955266", "authoritynumb": null, "companynumb": "US-IPSEN Group, Research and Development-2023-06396", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 66.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 65.7, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gastritis", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "Q2W", "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": "048", "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-11-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-02-22T00:00:00", "drugtreatmentduration": 104.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "Q2W", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-11-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-02-22T00:00:00", "drugtreatmentduration": 104.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OXALIPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "Q2W", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-11-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-02-22T00:00:00", "drugtreatmentduration": 104.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.4, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "Q2W", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-11-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-02-22T00:00:00", "drugtreatmentduration": 104.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230228" }, "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": [], "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" }
25955268 Type 2
Serious
ONIVYDE, TS-1
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
EU-SERVIER-S23002922
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
65.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Colitis (v28.1) Not Recovered

Drugs (2)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 70 MG/M2 | Form: Concentrate for solution for infusion | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 70.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: No
Recurrences: --
TS-1 (GIMERACIL\OTERACIL POTASSIUM\TEGAFUR) Suspect
Route: -- | Dosage: 50 MG/M2 | Form: -- | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: No
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230318

Report Duplicates (1)

SERVIER: EU-SERVIER-S23002922

Raw JSON (click to expand)

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25955261 Type 2
Serious
IRINOTECAN HYDROCHLORIDE, FLUOROURACIL, LEUCOVORIN (+1 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
JP
Occurrence Country
JP
Reporter Country
JP
Reporter Qualification
Other Health Professional
Literature Reference
UENO M, IKEDA M, OKUSAKA T, TENG Z, FURUYA M, IOKA T. Liposomal irinotecan with fluorouracil and leucovorin after gemcitabine-based therapy in Japanese patients with metastatic pancreatic cancer: additional safety analysis of a randomized phase 2 trial. JJCO. 2022;1-8. doi:https://doi.org/10.1093/jjco/hyac177.
Company Number
JP-China IPSEN SC-2022-32752
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (17)

Leukopenia (v28.1) Recovered
Neutropenia (v28.1) Recovered
Thrombocytopenia (v28.1) Recovered
Acute kidney injury (v28.1) Recovered
Neuropathy peripheral (v28.1) Recovered
Peripheral sensory neuropathy (v28.1) Recovered
Decreased appetite (v28.1) Recovered
Nausea (v28.1) Recovered
Vomiting (v28.1) Recovered
Malaise (v28.1) Recovered
Diarrhoea (v28.1) Recovered
Fatigue (v28.1) Recovered
Hepatic function abnormal (v28.1) Recovered
Alopecia (v28.1) Not Recovered
Infection (v28.1) Recovered
Anaemia (v28.1) Recovered
Infusion related reaction (v28.1) Recovered

Drugs (4)

IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: Concentrate for solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 80.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 2400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 200.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
DEXAMETHASONE (DEXAMETHASONE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

SERVIER: S22012643

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55c67", "safetyreportid": "25955261", "authoritynumb": null, "companynumb": "JP-China IPSEN SC-2022-32752", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "JP", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Leukopenia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neutropenia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Thrombocytopenia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Acute kidney injury", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neuropathy peripheral", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Peripheral sensory neuropathy", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Decreased appetite", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Malaise", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatic function abnormal", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Alopecia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Infection", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anaemia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Infusion related reaction", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "IRINOTECAN HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 80.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DEXAMETHASONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DEXAMETHASONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "JP", "qualification": 3, "literaturereference": "UENO M, IKEDA M, OKUSAKA T, TENG Z, FURUYA M, IOKA T. Liposomal irinotecan with fluorouracil and leucovorin after gemcitabine-based therapy in Japanese patients with metastatic pancreatic cancer: additional safety analysis of a randomized phase 2 trial. JJCO. 2022;1-8. doi:https://doi.org/10.1093/jjco/hyac177." }, "primarysourcecountry": "JP", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "SERVIER", "duplicatenumb": "S22012643" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }