FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25955364 Type 2
Serious
ONIVYDE, ONIVYDE, LONSURF (+30 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
Consumer
Literature Reference
--
Company Number
US-China IPSEN SC-2023-25859
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
66.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
85.5 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (11)

Enteritis (v28.1) Recovered
Nausea (v28.1) Unknown
Vomiting (v28.1) Unknown
Hypomagnesaemia (v28.1) Recovered
Hypokalaemia (v28.1) Recovered
Hypertension (v28.1) Unknown
Colon cancer metastatic (v28.1) Unknown
Duodenal ulcer (v28.1) Recovering
Anaemia (v28.1) Recovering
Hypertension (v28.1) Recovered
Headache (v28.1) Recovered

Drugs (33)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 104MG, Q2 WEEKS 28 DAY CYCLE | Form: Concentrate for solution for infusion | Indication: Rectal cancer metastatic | Action: Dose Reduced
Auth#: 102799 | Batch#: -- | Structured Dosage: 104.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 28.0 day | Cumulative: -- (unit: --)
Start: 10/30/2023 | End: 11/13/2023 | Duration: 15.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 50 MG/M2, Q2 WEEKS 28 DAY CYCLE | Form: Concentrate for solution for infusion | Indication: -- | Action: Dose Reduced
Auth#: 102799 | Batch#: -- | Structured Dosage: 50.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 28.0 day | Cumulative: -- (unit: --)
Start: 11/13/2023 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LONSURF (TIPIRACIL HYDROCHLORIDE\TRIFLURIDINE) Suspect
Route: 048 | Dosage: STRENGTH (15 TO 6.14MG PER TAB) 75 TO 30.7 MG (DOSE), TWICE DAILY DAYS 1-5 AND 15-19 (FREQUENCY) | Form: -- | Indication: Rectal cancer metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
BEVACIZUMAB (BEVACIZUMAB) Suspect
Route: -- | Dosage: 400 MG, Q2 WEEKS 28 DAY CYCLE | Form: -- | Indication: Rectal cancer metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 28.0 day | Cumulative: -- (unit: --)
Start: 10/30/2023 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
ASPIRIN (ASPIRIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/24/2010 | End: 12/05/2023 | Duration: 4913.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ATORVASTATIN (ATORVASTATIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CHROMIUM PICOLINATE (CHROMIUM PICOLINATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CIMETIDINE (CIMETIDINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VITAMIN D3 ADULT (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ESCITALOPRAM OXALATE (ESCITALOPRAM OXALATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
GARCINIA CABOGIA- CHROMIUM (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
GLUCOSAMINE SULFATE (GLUCOSAMINE SULFATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
HERBAL TRIPLE MUSHROOM COMPLEX (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LISINOPRIL (LISINOPRIL) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LORATADINE (LORATADINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LORAZEPAM (LORAZEPAM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MAGNESIUM (MAGNESIUM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MELATONIN (MELATONIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METFORMIN (METFORMIN HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VITAMIN B COMPLEX (CYANOCOBALAMIN\DEXPANTHENOL\NIACINAMIDE\PYRIDOXINE HYDROCHLORIDE\RIBOFLAVIN 5^-PHOSPHATE SODIUM\THIA) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MENAQUINONE 6 (MENAQUINONE 6) 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 HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
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: --
APREPITANT (APREPITANT) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ATROPINE SULPHATE INJECTION (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MAGNESIUM SULFATE (MAGNESIUM SULFATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/30/2023 | End: 10/30/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
BENTYL (DICYCLOMINE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/04/2023 | End: 11/10/2023 | Duration: 7.0 day | Rechallenge: -- | Additional: --
Recurrences: --
PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CARAFATE (SUCRALFATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LASIX (FUROSEMIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/15/2023 | End: 12/30/2023 | Duration: 16.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20231103

Report Duplicates (1)

MISTRAL: US23-004411

Raw JSON (click to expand)

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metastatic", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Duodenal ulcer", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anaemia", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypertension", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Headache", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 104.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 28.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "104MG, Q2 WEEKS 28 DAY CYCLE", "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": "Rectal cancer metastatic", "drugstartdateformat": 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"BEVACIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ASPIRIN", "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": "102", "drugstartdate": "2010-06-24T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-12-05T00:00:00", "drugtreatmentduration": 4913.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ASPIRIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ATORVASTATIN", "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": "ATORVASTATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CHROMIUM PICOLINATE", "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": "CHROMIUM PICOLINATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CIMETIDINE", "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, 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"activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DOXYCYCLINE HYCLATE", "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": "DOXYCYCLINE HYCLATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ESCITALOPRAM OXALATE", "drugauthorizationnumb": null, "drugbatchnumb": null, 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"activesubstancename": "MELATONIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METFORMIN", "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": "METFORMIN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VITAMIN B COMPLEX", "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": "CYANOCOBALAMIN\\DEXPANTHENOL\\NIACINAMIDE\\PYRIDOXINE HYDROCHLORIDE\\RIBOFLAVIN 5^-PHOSPHATE SODIUM\\THIA" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MENAQUINONE 6", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, 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"drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DEXAMETHASONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "APREPITANT", "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": "APREPITANT" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ATROPINE SULPHATE INJECTION", "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": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PROCHLORPERAZINE MALEATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, 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"drugenddate": "2023-10-30T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "MAGNESIUM SULFATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BENTYL", "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": "102", "drugstartdate": "2023-11-04T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-11-10T00:00:00", "drugtreatmentduration": 7.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DICYCLOMINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PANTOPRAZOLE SODIUM", "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": "PANTOPRAZOLE SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CARAFATE", 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"drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-12-15T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-12-30T00:00:00", "drugtreatmentduration": 16.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20231103" }, "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": "MISTRAL", "duplicatenumb": "US23-004411" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25955361 Type 2
Serious
TAZEMETOSTAT HYDROBROMIDE, CYCLOPHOSPHAMIDE\DOXORUBICIN\PREDNISONE\RITUXIMAB\VINCRISTINE, TRUXIMA (+21 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-IPSEN Group, Research and Development-2023-21817
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
62.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
111.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Death (v28.1) Fatal
Acute myeloid leukaemia (v28.1) Recovered
Pulmonary hypertension (v28.1) Recovered
Asthenia (v28.1) Unknown
Dyspnoea exertional (v28.1) Unknown

Drugs (24)

TAZEMETOSTAT HYDROBROMIDE (TAZEMETOSTAT HYDROBROMIDE) Suspect
Route: -- | Dosage: 1600 MG, DAILY | Form: Tablet | Indication: Follicular lymphoma | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/25/2021 | End: 01/24/2022 | Duration: 334.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
CYCLOPHOSPHAMIDE\DOXORUBICIN\PREDNISONE\RITUXIMAB\VINCRISTINE (CYCLOPHOSPHAMIDE\DOXORUBICIN\PREDNISONE\RITUXIMAB\VINCRISTINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Follicular lymphoma | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/24/2021 | End: 06/08/2021 | Duration: 105.0 day | Rechallenge: -- | Additional: --
Recurrences: --
TRUXIMA (RITUXIMAB-ABBS) Concomitant
Route: 058 | Dosage: -- | Form: -- | Indication: Follicular lymphoma | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/29/2021 | End: 06/06/2023 | Duration: 708.0 day | Rechallenge: -- | Additional: --
Recurrences: --
FILGRASTIM (FILGRASTIM) Concomitant
Route: -- | Dosage: 03-MAR-2021 TO 07-MAR-2021; 23-MAR-2021 TO 27-MAR-2021; 14-APR-2021 TO UNK; 04-MAY-2021 TO 08-MAY-2021; 25-MAY-2021 TO UNK; 15-JUN-2021 TO 19-JUN-2021; UNK TO 06-JUL-2023; 18-JUL-2023 TO 20-JUL-2023; 25-JUL-2023 TO 25-AUG-2023 | Form: -- | Indication: Neutropenia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/03/2021 | End: 08/25/2023 | Duration: 906.0 day | Rechallenge: -- | Additional: --
Recurrences: --
NICARDIPINE DCI (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CICLOSPORINE PCH (--) Concomitant
Route: -- | Dosage: TWICE PER DAY | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.5 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
AMOXICILLIN (AMOXICILLIN) Concomitant
Route: -- | Dosage: ONCE PER DAY | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) Concomitant
Route: -- | Dosage: NORMALLY ONCE PER DAY BUT INTERRUPTED | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PENTACARINAT (PENTAMIDINE ISETHIONATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CHOLECALCIFEROL (CHOLECALCIFEROL) Concomitant
Route: -- | Dosage: ONCE PER MONTH | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100000.0 (unit: 025) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
URSODIOL (URSODIOL) Concomitant
Route: -- | Dosage: 250 MG, 3 TIMES PER DAY | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 250.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.33 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SEVELAMER (SEVELAMER) Concomitant
Route: -- | Dosage: 800 MG, TWICE PER DAY | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.5 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SODIUM BICARBONATE (SODIUM BICARBONATE) Concomitant
Route: -- | Dosage: 1.4 % MOUTHWASH, 4TIMES PER DAY | Form: Mouth wash | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.4 (unit: 030) | Separate Dosage#: 1.0 | Interval: 0.25 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FUNGIZONE (AMPHOTERICIN B) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FUROSEMIDE (FUROSEMIDE) Concomitant
Route: -- | Dosage: 40 MG, 5/DAYS (THREE PILLS IN THE MORNING, TWO DURING THE MIDDAY) | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.2 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ZOPICLONE (ZOPICLONE) Concomitant
Route: -- | Dosage: 3.75 MG, EVERY 1 DAYS | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 3.75 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LANSOPRAZOLE (LANSOPRAZOLE) Concomitant
Route: -- | Dosage: 15 MG, EVERY 1 DAYS | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 15.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EPREX (ERYTHROPOIETIN) Concomitant
Route: -- | Dosage: TWICE PER WEEK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 30000.0 (unit: 025) | Separate Dosage#: 1.0 | Interval: 0.5 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FOLIC ACID (FOLIC ACID) Concomitant
Route: -- | Dosage: 5 MG, 2/DAYS | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.5 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MOVICOL (POLYETHYLENE GLYCOL 3350\POTASSIUM CHLORIDE\SODIUM BICARBONATE\SODIUM CHLORIDE) Concomitant
Route: -- | Dosage: 3350 U, ONCE A DAY | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 3350.0 (unit: 025) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MONTMORILLONITE (MONTMORILLONITE) Concomitant
Route: -- | Dosage: 3 TIMES PER DAY | Form: -- | Indication: Diarrhoea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 0.33 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
RACECADOTRIL (RACECADOTRIL) Concomitant
Route: -- | Dosage: 100 MG, 3 TIMES PER DAY | Form: -- | Indication: Diarrhoea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.33 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METOCLOPRAMIDE (METOCLOPRAMIDE) Concomitant
Route: -- | Dosage: 10 MG, 3 TIMES PER DAY | Form: -- | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.33 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ACUPAN (NEFOPAM HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 20 MG, 3 TIMES PER DAY | Form: -- | Indication: Pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.33 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230801

Report Duplicates (0)

--

Raw JSON (click to expand)

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"drugbatchnumb": null, "drugstructuredosagenumb": 1600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1600 MG, DAILY", "drugdosageform": "Tablet", "drugadministrationroute": null, "drugindication": "Follicular lymphoma", "drugstartdateformat": "102", "drugstartdate": "2021-02-25T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-01-24T00:00:00", "drugtreatmentduration": 334.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TAZEMETOSTAT HYDROBROMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CYCLOPHOSPHAMIDE\\DOXORUBICIN\\PREDNISONE\\RITUXIMAB\\VINCRISTINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, 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"drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Follicular lymphoma", "drugstartdateformat": "102", "drugstartdate": "2021-06-29T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-06-06T00:00:00", "drugtreatmentduration": 708.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "RITUXIMAB-ABBS" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FILGRASTIM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "03-MAR-2021 TO 07-MAR-2021; 23-MAR-2021 TO 27-MAR-2021; 14-APR-2021 TO UNK; 04-MAY-2021 TO 08-MAY-2021; 25-MAY-2021 TO UNK; 15-JUN-2021 TO 19-JUN-2021; UNK TO 06-JUL-2023; 18-JUL-2023 TO 20-JUL-2023; 25-JUL-2023 TO 25-AUG-2023", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Neutropenia", "drugstartdateformat": "102", "drugstartdate": "2021-03-03T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-08-25T00:00:00", "drugtreatmentduration": 906.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FILGRASTIM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NICARDIPINE DCI", "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": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CICLOSPORINE PCH", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 75.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.5, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TWICE PER DAY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AMOXICILLIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "ONCE PER DAY", "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": "AMOXICILLIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VALACYCLOVIR HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "NORMALLY ONCE PER DAY BUT INTERRUPTED", "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": "VALACYCLOVIR HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PENTACARINAT", "drugauthorizationnumb": null, "drugbatchnumb": null, 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"drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "URSODIOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SEVELAMER", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 800.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.5, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "800 MG, TWICE PER DAY", "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": "SEVELAMER" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SODIUM BICARBONATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.4, "drugstructuredosageunit": "030", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.25, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1.4 % MOUTHWASH, 4TIMES PER DAY", "drugdosageform": "Mouth wash", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SODIUM BICARBONATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FUNGIZONE", "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": "AMPHOTERICIN B" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FUROSEMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.2, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MG, 5/DAYS (THREE PILLS IN THE MORNING, TWO DURING THE MIDDAY)", "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": "FUROSEMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ZOPICLONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3.75, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3.75 MG, EVERY 1 DAYS", "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": "ZOPICLONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LANSOPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "15 MG, EVERY 1 DAYS", "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": "LANSOPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "EPREX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 30000.0, "drugstructuredosageunit": "025", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.5, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TWICE PER WEEK", "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": "ERYTHROPOIETIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FOLIC ACID", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.5, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG, 2/DAYS", "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": "FOLIC ACID" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MOVICOL", "drugauthorizationnumb": null, "drugbatchnumb": null, 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"activesubstancename": "NEFOPAM HYDROCHLORIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230801" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 1, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955360 Type 2
Serious
ONIVYDE, ONIVYDE, OXALIPLATIN (+13 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-SERVIER-S24001280
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
56.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Diarrhoea haemorrhagic (v28.1) Recovered

Drugs (16)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 100.84 MG/M2, D1 OF 14-DAY CYCLE | Form: Solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 100.84 (unit: 009) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/23/2024 | End: 01/23/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 100.84 MG/M2, D1 OF 14-DAY CYCLE | Form: Solution for infusion | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 100.84 (unit: 009) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/14/2024 | End: 02/14/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: 121.01 MG/M2, D1 OF 14-DAY CYCLE | Form: Amp im | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 121.01 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/23/2024 | End: 01/23/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: 121.01 MG/M2, D1 OF 14-DAY CYCLE | Form: Amp im | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 121.01 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/14/2024 | End: 02/14/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 806.74 MG/M2, D1 OF 14-DAY CYCLE | Form: Amp im | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 806.74 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/23/2024 | End: 01/23/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 806.74 MG/M2, D1 OF 14-DAY CYCLE | Form: Amp im | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 806.74 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/14/2024 | End: 02/14/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 4840.41 MG/M2, D1-D2 OF 14-DAY CYCLE | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 4840.41 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/23/2024 | End: 01/23/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: 042 | Dosage: 4840.41 MG/M2, D1-D2 OF 14-DAY CYCLE | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 4840.41 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/14/2024 | End: 02/14/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
CETIRIZINE (CETIRIZINE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: UNK | Form: Amp im | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TADALAFIL (TADALAFIL) Concomitant
Route: -- | Dosage: UNK | Form: Amp im | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PANTOPRAZOLE (PANTOPRAZOLE) Concomitant
Route: -- | Dosage: 1 DF, QD | Form: Amp im | Indication: Gastrooesophageal reflux disease | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/12/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TILIDINE (TILIDINE) Concomitant
Route: -- | Dosage: 1 DF, QD | Form: Amp im | Indication: Pain | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/18/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ONDANSETRON (ONDANSETRON) Concomitant
Route: -- | Dosage: UNK | Form: Amp im | Indication: Product used for unknown indication | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LOPERAMIDE (LOPERAMIDE) Concomitant
Route: -- | Dosage: UNK | Form: Amp im | Indication: Product used for unknown indication | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VOLTAREN (DICLOFENAC SODIUM) Concomitant
Route: 048 | Dosage: 1 DF, BID | Form: -- | Indication: Pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/05/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NOVALGIN (--) Concomitant
Route: 048 | Dosage: 1 DF, QD | Form: -- | Indication: Pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/18/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240202

Report Duplicates (1)

SERVIER: EU-SERVIER-S24001280

Raw JSON (click to expand)

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"drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TADALAFIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PANTOPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, QD", "drugdosageform": "Amp im", "drugadministrationroute": null, "drugindication": "Gastrooesophageal reflux disease", "drugstartdateformat": "102", "drugstartdate": "2024-01-12T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "PANTOPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TILIDINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, QD", "drugdosageform": "Amp im", "drugadministrationroute": null, "drugindication": "Pain", "drugstartdateformat": "102", "drugstartdate": "2024-01-18T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "TILIDINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ONDANSETRON", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Amp im", "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": 4, "activesubstance": { "activesubstancename": "ONDANSETRON" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LOPERAMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Amp im", "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": 4, "activesubstance": { "activesubstancename": "LOPERAMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VOLTAREN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, BID", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Pain", "drugstartdateformat": "102", "drugstartdate": "2024-01-05T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DICLOFENAC SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NOVALGIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, QD", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Pain", "drugstartdateformat": "102", "drugstartdate": "2024-01-18T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240202" }, "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-S24001280" } ], "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" }
25955359 Type 2
Serious
ONIVYDE, LEUCOVORIN, OXALIPLATIN (+8 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-2023-09387
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
75.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
53.8 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (7)

Enterocolitis (v28.1) Recovered
Chills (v28.1) Unknown
Diarrhoea (v28.1) Recovered
Pyrexia (v28.1) Recovered
Abdominal pain (v28.1) Recovered
Abdominal discomfort (v28.1) Recovered
Enteritis (v28.1) Unknown

Drugs (11)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: Concentrate for solution for infusion | Indication: Pancreatic carcinoma | Action: Withdrawn
Auth#: 207793 | Batch#: -- | Structured Dosage: 40.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/12/2022 | End: 03/04/2023 | Duration: 83.0 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: 12/12/2022 | End: 03/04/2023 | Duration: 83.0 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: 12/12/2022 | End: 03/04/2023 | Duration: 83.0 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: 12/12/2022 | End: 03/04/2023 | Duration: 83.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
PIPERACILLIN TAZO (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Enterocolitis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 4.5 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: -- | Dosage: 40 MEQ | Form: -- | Indication: Diarrhoea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CEFDINIR (CEFDINIR) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Enterocolitis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ONDANSETRON (ONDANSETRON) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ONDANSETRON (ONDANSETRON) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Vomiting | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
UNSPECIFIED INGREDIENT (UNSPECIFIED INGREDIENT) 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: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230414

Report Duplicates (1)

MISTRAL: US23-001450

Raw JSON (click to expand)

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"reactionmeddrapt": "Enteritis", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "207793", "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-12-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-03-04T00:00:00", "drugtreatmentduration": 83.0, "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": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-12-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-03-04T00:00:00", "drugtreatmentduration": 83.0, "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": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-12-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-03-04T00:00:00", "drugtreatmentduration": 83.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma", "drugstartdateformat": "102", "drugstartdate": "2022-12-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-03-04T00:00:00", "drugtreatmentduration": 83.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PIPERACILLIN TAZO", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4.5, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Enterocolitis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "POTASSIUM CHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MEQ", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Diarrhoea", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "POTASSIUM CHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CEFDINIR", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Enterocolitis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CEFDINIR" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ONDANSETRON", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Nausea", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ONDANSETRON" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ONDANSETRON", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Vomiting", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ONDANSETRON" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "UNSPECIFIED INGREDIENT", "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": "UNSPECIFIED INGREDIENT" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OXYCODONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "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": "OXYCODONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230414" }, "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": "US23-001450" } ], "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" }
25955358 Type 2
Serious
ONIVYDE, ONIVYDE, FLUOROURACIL (+3 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-2023-17222
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
73.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
59.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Embolism arterial (v28.1) Recovering
Ascites (v28.1) Recovering

Drugs (6)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 81 MG, 1 CYCLICAL | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 81.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/21/2023 | End: 06/21/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 81 MG, 1 CYCLICAL | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 81.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/22/2023 | End: 06/22/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 3865.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/21/2023 | End: 06/21/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 3865 MG | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 3865.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/22/2023 | End: 06/24/2023 | Duration: 2.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 645.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/21/2023 | End: 06/21/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 645 MG | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 645.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/22/2023 | End: 06/22/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230707

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55ccb", "safetyreportid": "25955358", "authoritynumb": null, "companynumb": "US-IPSEN Group, Research and Development-2023-17222", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 73.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 59.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Embolism arterial", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Ascites", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 81.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "81 MG, 1 CYCLICAL", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2023-06-21T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-06-21T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 81.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "81 MG, 1 CYCLICAL", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-06-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-06-22T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3865.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2023-06-21T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-06-21T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3865.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3865 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-06-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-06-24T00:00:00", "drugtreatmentduration": 2.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN CALCIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 645.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2023-06-21T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-06-21T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN CALCIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 645.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "645 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-06-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-06-22T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEUCOVORIN CALCIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230707" }, "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": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25955357 Type 2
Serious
TAZEMETOSTAT HYDROBROMIDE, MONJUVI, LENALIDOMIDE
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-IPSEN Group, Research and Development-2024-14451
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
75.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
55.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Pruritus (v28.1) Recovered
Neutrophil count decreased (v28.1) Recovered

Drugs (3)

TAZEMETOSTAT HYDROBROMIDE (TAZEMETOSTAT HYDROBROMIDE) Suspect
Route: -- | Dosage: 600 MG TWICE DAILY | Form: Tablet | Indication: Diffuse large B-cell lymphoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: 06/13/2024 | End: 07/04/2024 | Duration: 22.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
MONJUVI (TAFASITAMAB-CXIX) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Diffuse large B-cell lymphoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/13/2024 | End: 06/28/2024 | Duration: 16.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LENALIDOMIDE (LENALIDOMIDE) Suspect
Route: -- | Dosage: UNKNOWN | Form: -- | Indication: Diffuse large B-cell lymphoma | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/13/2024 | End: 07/04/2024 | Duration: 22.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240613

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cca", "safetyreportid": "25955357", "authoritynumb": null, "companynumb": "US-IPSEN Group, Research and Development-2024-14451", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 75.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 55.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pruritus", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neutrophil count decreased", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TAZEMETOSTAT HYDROBROMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 12.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "600 MG TWICE DAILY", "drugdosageform": "Tablet", "drugadministrationroute": null, "drugindication": "Diffuse large B-cell lymphoma", "drugstartdateformat": "102", "drugstartdate": "2024-06-13T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-07-04T00:00:00", "drugtreatmentduration": 22.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "TAZEMETOSTAT HYDROBROMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "MONJUVI", "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": "Diffuse large B-cell lymphoma", "drugstartdateformat": "102", "drugstartdate": "2024-06-13T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-06-28T00:00:00", "drugtreatmentduration": 16.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "TAFASITAMAB-CXIX" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LENALIDOMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNKNOWN", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Diffuse large B-cell lymphoma", "drugstartdateformat": "102", "drugstartdate": "2024-06-13T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-07-04T00:00:00", "drugtreatmentduration": 22.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LENALIDOMIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240613" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "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" }
25955356 Type 2
Serious
TAZEMETOSTAT HYDROBROMIDE, TAZEMETOSTAT HYDROBROMIDE, DURVALUMAB (+3 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-EPIZYME, INC.-2022FREPZ64381108
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
59.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
67.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

General physical health deterioration (v28.1) Fatal
Disease progression (v28.1) Fatal
Cholangitis (v28.1) Recovered
Pneumonia (v28.1) Recovered

Drugs (6)

TAZEMETOSTAT HYDROBROMIDE (TAZEMETOSTAT HYDROBROMIDE) Suspect
Route: 048 | Dosage: 1600 MG | Form: Tablet | Indication: Small intestine carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/11/2022 | End: 10/12/2022 | Duration: 63.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
TAZEMETOSTAT HYDROBROMIDE (TAZEMETOSTAT HYDROBROMIDE) Suspect
Route: 048 | Dosage: 800 MG. CUMULATIVE DOSE 82400 MG | Form: Tablet | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
DURVALUMAB (DURVALUMAB) Suspect
Route: 042 | Dosage: 1120 MG | Form: -- | Indication: Small intestine carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 1120.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/01/2022 | End: 09/01/2022 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LERCANIDIPINE HYDROCHLORIDE (LERCANIDIPINE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LATANOPROST (LATANOPROST) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ACETAMINOPHEN\OPIUM (ACETAMINOPHEN\OPIUM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20221002

Report Duplicates (2)

EPIZYME: EU-EPIZYME, INC.-2022FREPZ64381108
EISAI: 202400128

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cc9", "safetyreportid": "25955356", "authoritynumb": null, "companynumb": "EU-EPIZYME, INC.-2022FREPZ64381108", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 59.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 67.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "General physical health deterioration", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Disease progression", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cholangitis", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pneumonia", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TAZEMETOSTAT HYDROBROMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 800.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1600 MG", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Small intestine carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2022-08-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-10-12T00:00:00", "drugtreatmentduration": 63.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "TAZEMETOSTAT HYDROBROMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TAZEMETOSTAT HYDROBROMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 800.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "800 MG. CUMULATIVE DOSE 82400 MG", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "TAZEMETOSTAT HYDROBROMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DURVALUMAB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1120.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1120 MG", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Small intestine carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2022-09-01T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-09-01T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "DURVALUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LERCANIDIPINE HYDROCHLORIDE", "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": "LERCANIDIPINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LATANOPROST", "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": "LATANOPROST" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ACETAMINOPHEN\\OPIUM", "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": "ACETAMINOPHEN\\OPIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20221002" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "EPIZYME", "duplicatenumb": "EU-EPIZYME, INC.-2022FREPZ64381108" }, { "duplicatesource": "EISAI", "duplicatenumb": "202400128" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25955353 Type 2
Serious
ONIVYDE, LEUCOVORIN, FLUOROURACIL (+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-S22007293
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
72.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
65.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

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

Drugs (4)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 042 | Dosage: 129 MG, UNK | Form: Concentrate for solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 129.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/14/2022 | End: 07/12/2022 | Duration: 29.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: 042 | Dosage: 770 MG | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 770.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/14/2022 | End: 06/28/2022 | Duration: 15.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: 042 | Dosage: 4610 MG | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 4610.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/14/2022 | End: 06/28/2022 | Duration: 15.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: 042 | Dosage: 163 MG | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 163.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/28/2022 | End: 06/28/2022 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20220712

Report Duplicates (1)

SERVIER: EU-SERVIER-S22007293

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cc8", "safetyreportid": "25955353", "authoritynumb": null, "companynumb": "EU-SERVIER-S22007293", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 72.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 65.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Acute kidney injury", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 129.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "129 MG, UNK", "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": "042", "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2022-06-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-07-12T00:00:00", "drugtreatmentduration": 29.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 770.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "770 MG", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2022-06-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-06-28T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4610.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4610 MG", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2022-06-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-06-28T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OXALIPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 163.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "163 MG", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2022-06-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-06-28T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20220712" }, "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-S22007293" } ], "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" }
25955354 Type 2
Serious
ONIVYDE, FLUOROURACIL, LEUCOVORIN
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-SERVIER-S24001502
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
75.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Euthanasia (v28.1) Fatal
Malaise (v28.1) Not Recovered
Diarrhoea (v28.1) Not Recovered

Drugs (3)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 103 MG | Form: Solution for infusion | Indication: Gastrooesophageal cancer | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 103.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/18/2024 | End: 02/01/2024 | Duration: 15.0 day | Rechallenge: Unknown | Additional: No
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: 3530 MG, UNK | Form: Amp im | Indication: Gastrooesophageal cancer | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 3530.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/18/2024 | End: 02/01/2024 | Duration: 15.0 day | Rechallenge: Unknown | Additional: No
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: 590 MG, UNK | Form: Amp im | Indication: Gastrooesophageal cancer | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 590.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/18/2024 | End: 02/01/2024 | Duration: 15.0 day | Rechallenge: Unknown | Additional: No
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240209

Report Duplicates (1)

SERVIER: EU-SERVIER-S24001502

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cc7", "safetyreportid": "25955354", "authoritynumb": null, "companynumb": "EU-SERVIER-S24001502", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 75.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Euthanasia", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Malaise", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 103.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "103 MG", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Gastrooesophageal cancer", "drugstartdateformat": "102", "drugstartdate": "2024-01-18T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-02-01T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 2, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3530.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3530 MG, UNK", "drugdosageform": "Amp im", "drugadministrationroute": null, "drugindication": "Gastrooesophageal cancer", "drugstartdateformat": "102", "drugstartdate": "2024-01-18T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-02-01T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 2, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 590.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "590 MG, UNK", "drugdosageform": "Amp im", "drugadministrationroute": null, "drugindication": "Gastrooesophageal cancer", "drugstartdateformat": "102", "drugstartdate": "2024-01-18T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-02-01T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 2, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240209" }, "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-S24001502" } ], "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" }
25955355 Type 2
Serious
ONIVYDE, FLUOROURACIL, LEUCOVORIN
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-I.R.I.S.-S24009751
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
82.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
54.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

General physical health deterioration (v28.1) Not Recovered
Pyrexia (v28.1) Not Recovered
Hyponatraemia (v28.1) Not Recovered

Drugs (3)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 042 | Dosage: 70 MG/M2, EVERY 2 WEEKS | Form: Solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 70.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 07/22/2024 | End: 07/22/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: 042 | Dosage: 2400 MG/M2, EVERY 2 WEEKS | 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: 07/22/2024 | End: 07/22/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: 042 | Dosage: 200 MG/M2, EVERY 2 WEEKS | 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: 07/22/2024 | End: 07/22/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240701

Report Duplicates (1)

SERVIER: EU-I.R.I.S.-S24009751

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cc6", "safetyreportid": "25955355", "authoritynumb": null, "companynumb": "EU-I.R.I.S.-S24009751", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 82.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 54.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "General physical health deterioration", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pyrexia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hyponatraemia", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 70.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "70 MG/M2, EVERY 2 WEEKS", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2024-07-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-07-22T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2400 MG/M2, EVERY 2 WEEKS", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2024-07-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-07-22T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200 MG/M2, EVERY 2 WEEKS", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Pancreatic carcinoma metastatic", "drugstartdateformat": "102", "drugstartdate": "2024-07-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-07-22T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240701" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "SERVIER", "duplicatenumb": "EU-I.R.I.S.-S24009751" } ], "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" }