FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25955375 Type 1
Serious
IBUPROFEN, HYDROMORPHONE, HYDROMORPHONE (+7 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Physician
Literature Reference
Pinto TE, Mokashi A, Cummings EA.. Central diabetes insipidus and pain medications-a risky combination.. Clinical Diabetes and Endocrinology.. 2021;7(1):11
Company Number
CA-MLMSERVICE-20210624-2967510-1
Authority Number
--
Sender Organization
AUROBINDO
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
10.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Hyponatraemia (v28.1) Recovered
Apnoeic attack (v28.1) Recovered
Seizure (v28.1) Recovered
Unresponsive to stimuli (v28.1) Recovered
Drug interaction (v28.1) Recovered

Drugs (10)

IBUPROFEN (IBUPROFEN) Interacting
Route: 048 | Dosage: 600 MILLIGRAM, 6 HOURS | Form: Unknown | Indication: Pain | Action: Withdrawn
Auth#: 208865 | Batch#: -- | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/28/2018 | End: 02/07/2018 | Duration: 10.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
HYDROMORPHONE (HYDROMORPHONE) Interacting
Route: 065 | Dosage: 1 MILLIGRAM, Q4HR PRN | Form: Unknown | Indication: Pain | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/27/2018 | End: 02/02/2018 | Duration: 6.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
HYDROMORPHONE (HYDROMORPHONE) Interacting
Route: 065 | Dosage: 2 MILLIGRAM Q4HR PRN | Form: Unknown | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/27/2018 | End: 02/02/2018 | Duration: 6.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
DESMOPRESSIN (DESMOPRESSIN) Suspect
Route: 048 | Dosage: 1.6 MILLIGRAM, 6 HOURS | Form: Tablet | Indication: Diabetes insipidus | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 1.6 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
DESMOPRESSIN (DESMOPRESSIN) Suspect
Route: 065 | Dosage: 0.6 MILLIGRAM, AS NECESSARY ON DAY 2, DAY 3, DAY 4 AND DAY 5. | Form: Tablet | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 0.6 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/03/2018 | End: 02/06/2018 | Duration: 4.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
DESMOPRESSIN (DESMOPRESSIN) Suspect
Route: 045 | Dosage: 10 MICROGRAM | Form: Tablet | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 004) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: 02/01/2018 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
SOMATROPIN (SOMATROPIN) Concomitant
Route: 058 | Dosage: 1.3 MILLIGRAM, ONCE A DAY (GROWTH HORMONE) | Form: Injection | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.3 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
HYDROCORTISONE (HYDROCORTISONE) Concomitant
Route: 048 | Dosage: 15 MILLIGRAM, 3 TIMES A DAY | Form: Tablet | Indication: Diabetes insipidus | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 15.0 (unit: 003) | Separate Dosage#: 3.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 3.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
HYDROCORTISONE (HYDROCORTISONE) Concomitant
Route: 065 | Dosage: UNK (DOUBLE MAINTENANCE FOR 2 ADDITIONAL DAYS) | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 2.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
HYDROCORTISONE (HYDROCORTISONE) Concomitant
Route: 048 | Dosage: 6 MILLIGRAM, TWO TIMES A DAY | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 6.0 (unit: 003) | Separate Dosage#: 2.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20180202

Report Duplicates (20)

FERRINGPH: CA-FERRINGPH-2021FE04301
EMA: CA-EMA-DD-20221014-7180171-115157
FERRINGPH: CA-FERRINGPH-2022FE00075
TEVA: CA-TEVA-2022-CA-2049194
EMA: CA-EMA-DD-20220601-216281-155533
EMA: CA-EMA-DD-20230118-6644851-101540
FERRINGPH: CA-FERRINGPH-2022FE00076
002147023: CA-002147023-NVSC2022CA295477
SANDOZ: CA-SANDOZ-NVSC2022CA295477
TEVA: CA-TEVA-2021-CA-1984531
EMA: CA-EMA-DD-20220930-216281-102632
EMA: CA-EMA-DD-20230428-3736665-112211
TEVA: CA-TEVA-2021-CA-1984555
TEVA: CA-TEVA-2021-CA-1984548
EMA: CA-EMA-DD-20231128-7482677-082910
002147023: CA-002147023-NVSC2022CA113630
JNJFOC: CA-JNJFOC-20210706663
EMA: CA-EMA-DD-20240202-7482831-170718
EMA: CA-EMA-DD-20251009-7483181-114525
TEVA: CA-TEVA-2021-CA-1984552

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cde", "safetyreportid": "25955375", "authoritynumb": null, "companynumb": "CA-MLMSERVICE-20210624-2967510-1", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": 10.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hyponatraemia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Apnoeic attack", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Seizure", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Unresponsive to stimuli", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug interaction", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 3, "medicinalproduct": "IBUPROFEN", "drugauthorizationnumb": "208865", "drugbatchnumb": null, "drugstructuredosagenumb": 600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "600 MILLIGRAM, 6 HOURS", "drugdosageform": "Unknown", "drugadministrationroute": "048", "drugindication": "Pain", "drugstartdateformat": "102", "drugstartdate": "2018-01-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2018-02-07T00:00:00", "drugtreatmentduration": 10.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IBUPROFEN" }, "drugrecurrence": [] }, { "drugcharacterization": 3, "medicinalproduct": "HYDROMORPHONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 MILLIGRAM, Q4HR PRN", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Pain", "drugstartdateformat": "102", "drugstartdate": "2018-01-27T00:00:00", "drugenddateformat": "102", "drugenddate": "2018-02-02T00:00:00", "drugtreatmentduration": 6.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "HYDROMORPHONE" }, "drugrecurrence": [] }, { "drugcharacterization": 3, "medicinalproduct": "HYDROMORPHONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2 MILLIGRAM Q4HR PRN", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2018-01-27T00:00:00", "drugenddateformat": "102", "drugenddate": "2018-02-02T00:00:00", "drugtreatmentduration": 6.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "HYDROMORPHONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DESMOPRESSIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.6, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1.6 MILLIGRAM, 6 HOURS", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Diabetes insipidus", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "DESMOPRESSIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DESMOPRESSIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 0.6, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.6 MILLIGRAM, AS NECESSARY ON DAY 2, DAY 3, DAY 4 AND DAY 5.", "drugdosageform": "Tablet", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2018-02-03T00:00:00", "drugenddateformat": "102", "drugenddate": "2018-02-06T00:00:00", "drugtreatmentduration": 4.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "DESMOPRESSIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DESMOPRESSIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MICROGRAM", "drugdosageform": "Tablet", "drugadministrationroute": "045", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "610", "drugenddate": "2018-02-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "DESMOPRESSIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SOMATROPIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.3, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1.3 MILLIGRAM, ONCE A DAY (GROWTH HORMONE)", "drugdosageform": "Injection", "drugadministrationroute": "058", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "SOMATROPIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "HYDROCORTISONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 3.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "15 MILLIGRAM, 3 TIMES A DAY", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Diabetes insipidus", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 3.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "HYDROCORTISONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "HYDROCORTISONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK (DOUBLE MAINTENANCE FOR 2 ADDITIONAL DAYS)", "drugdosageform": "Tablet", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 2.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "HYDROCORTISONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "HYDROCORTISONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 6.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 2.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "6 MILLIGRAM, TWO TIMES A DAY", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "HYDROCORTISONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20180202" }, "primarysource": { "reportercountry": "CA", "qualification": 1, "literaturereference": "Pinto TE, Mokashi A, Cummings EA.. Central diabetes insipidus and pain medications-a risky combination.. Clinical Diabetes and Endocrinology.. 2021;7(1):11" }, "primarysourcecountry": "CA", "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": "FERRINGPH", "duplicatenumb": "CA-FERRINGPH-2021FE04301" }, { "duplicatesource": "EMA", "duplicatenumb": "CA-EMA-DD-20221014-7180171-115157" }, { "duplicatesource": "FERRINGPH", "duplicatenumb": "CA-FERRINGPH-2022FE00075" }, { "duplicatesource": "TEVA", "duplicatenumb": "CA-TEVA-2022-CA-2049194" }, { "duplicatesource": "EMA", "duplicatenumb": "CA-EMA-DD-20220601-216281-155533" }, { "duplicatesource": "EMA", "duplicatenumb": "CA-EMA-DD-20230118-6644851-101540" }, { "duplicatesource": "FERRINGPH", "duplicatenumb": "CA-FERRINGPH-2022FE00076" }, { "duplicatesource": "002147023", "duplicatenumb": "CA-002147023-NVSC2022CA295477" }, { "duplicatesource": "SANDOZ", "duplicatenumb": "CA-SANDOZ-NVSC2022CA295477" }, { "duplicatesource": "TEVA", "duplicatenumb": "CA-TEVA-2021-CA-1984531" }, { "duplicatesource": "EMA", "duplicatenumb": "CA-EMA-DD-20220930-216281-102632" }, { "duplicatesource": "EMA", "duplicatenumb": "CA-EMA-DD-20230428-3736665-112211" }, { "duplicatesource": "TEVA", "duplicatenumb": "CA-TEVA-2021-CA-1984555" }, { "duplicatesource": "TEVA", "duplicatenumb": "CA-TEVA-2021-CA-1984548" }, { "duplicatesource": "EMA", "duplicatenumb": "CA-EMA-DD-20231128-7482677-082910" }, { "duplicatesource": "002147023", "duplicatenumb": "CA-002147023-NVSC2022CA113630" }, { "duplicatesource": "JNJFOC", "duplicatenumb": "CA-JNJFOC-20210706663" }, { "duplicatesource": "EMA", "duplicatenumb": "CA-EMA-DD-20240202-7482831-170718" }, { "duplicatesource": "EMA", "duplicatenumb": "CA-EMA-DD-20251009-7483181-114525" }, { "duplicatesource": "TEVA", "duplicatenumb": "CA-TEVA-2021-CA-1984552" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "AUROBINDO" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 1, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25955374 Type 1
Serious
VISIPAQUE
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
--
Authority Number
CN-NMPACDR-3717251012847202500760
Sender Organization
GE HEALTHCARE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
70.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
60.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Injection site bruising (v28.1) Recovering
Injection site swelling (v28.1) Recovering
Injection site extravasation (v28.1) Recovering

Drugs (1)

VISIPAQUE (IODIXANOL) Suspect
Route: 041 | Dosage: 100 ML, TOTAL | Form: Solution for injection | Indication: Computerised tomogram | Action: Not Applicable
Auth#: 020351 | Batch#: 17278040 | Structured Dosage: 100.0 (unit: 012) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/09/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251009

Report Duplicates (1)

NMPACDR: CN-NMPACDR-3717251012847202500760

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cdd", "safetyreportid": "25955374", "authoritynumb": "CN-NMPACDR-3717251012847202500760", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 70.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 60.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Injection site bruising", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Injection site swelling", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Injection site extravasation", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "VISIPAQUE", "drugauthorizationnumb": "020351", "drugbatchnumb": "17278040", "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "012", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 ML, TOTAL", "drugdosageform": "Solution for injection", "drugadministrationroute": "041", "drugindication": "Computerised tomogram", "drugstartdateformat": "102", "drugstartdate": "2025-10-09T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "IODIXANOL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251009" }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "NMPACDR", "duplicatenumb": "CN-NMPACDR-3717251012847202500760" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "GE HEALTHCARE" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955370 Type 1
Serious
AMOXICILLIN, LISINOPRIL, SERTRALINE (+2 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
GB
Occurrence Country
GB
Reporter Country
GB
Reporter Qualification
Physician
Literature Reference
--
Company Number
GB-MHRA-TPP39151540C10739351YC1757943014360
Authority Number
--
Sender Organization
AUROBINDO
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
78.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
60.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Nausea (v28.1) Recovered
Lethargy (v28.1) Recovered

Drugs (5)

AMOXICILLIN (AMOXICILLIN) Suspect
Route: 065 | Dosage: UNK | Form: Capsule | Indication: Product used for unknown indication | Action: Unknown
Auth#: 65271 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LISINOPRIL (LISINOPRIL) Concomitant
Route: 065 | Dosage: 1 DOSAGE FORM, DAILY (TAKE ONE DAILY) | Form: Unknown | Indication: Ill-defined disorder | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/16/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SERTRALINE (SERTRALINE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: 25 MILLIGRAM, DAILY (TAKE HALF A TABLET (25MG) DAILY) | Form: Tablet | Indication: Ill-defined disorder | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/16/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ATORVASTATIN (ATORVASTATIN) Concomitant
Route: 065 | Dosage: 1 DOSAGE FORM, DAILY (TAKE ONE DAILY) | Form: Unknown | Indication: Ill-defined disorder | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/16/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LANSOPRAZOLE (LANSOPRAZOLE) Concomitant
Route: 065 | Dosage: 1 DOSAGE FORM, DAILY (TAKE ONE ONCE DAILY) | Form: Unknown | Indication: Ill-defined disorder | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/16/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cdb", "safetyreportid": "25955370", "authoritynumb": null, "companynumb": "GB-MHRA-TPP39151540C10739351YC1757943014360", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": 78.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 60.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lethargy", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "AMOXICILLIN", "drugauthorizationnumb": "65271", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Capsule", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "AMOXICILLIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LISINOPRIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DOSAGE FORM, DAILY (TAKE ONE DAILY)", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2025-05-16T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LISINOPRIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SERTRALINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 25.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "25 MILLIGRAM, DAILY (TAKE HALF A TABLET (25MG) DAILY)", "drugdosageform": "Tablet", "drugadministrationroute": "065", "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2025-05-16T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "SERTRALINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ATORVASTATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DOSAGE FORM, DAILY (TAKE ONE DAILY)", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2025-05-16T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ATORVASTATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LANSOPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DOSAGE FORM, DAILY (TAKE ONE ONCE DAILY)", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2025-05-16T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LANSOPRAZOLE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "GB", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "AUROBINDO" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 1, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955369 Type 2
Serious
ONIVYDE, ONIVYDE, ONIVYDE (+26 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
JP
Occurrence Country
JP
Reporter Country
JP
Reporter Qualification
Physician
Literature Reference
UNKNOWN, UNKNOWN, IMAOKA H, IKEDA M, OZAKA M, et al. 1521P Efficacy and safety of liposomal irinotecan plus S-1 in patients with metastatic pancreaticcancer after failure of first-line gemcitabine-based chemotherapy: Result of a phase I/II study. Annals of Oncology. 2024;35((S2)): S929.
Company Number
JP-SERVIER-S22010122
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
70.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
76.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (15)

Sepsis (v28.1) Recovered
Embolism (v28.1) Recovering
Hypokalaemia (v28.1) Recovered
Blood creatinine increased (v28.1) Recovered
Hyponatraemia (v28.1) Recovered
Diarrhoea (v28.1) Recovering
Decreased appetite (v28.1) Recovering
Neutrophil count decreased (v28.1) Not Recovered
Malaise (v28.1) Not Recovered
Aspartate aminotransferase increased (v28.1) Recovered
Alanine aminotransferase increased (v28.1) Recovered
Blood creatinine increased (v28.1) Recovered
Platelet count decreased (v28.1) Recovering
Hypoalbuminaemia (v28.1) Recovering
Hyponatraemia (v28.1) Recovered

Drugs (29)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 041 | Dosage: 130 MG, 1X/2WKS | Form: Solution for infusion | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 130.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 06/07/2022 | End: 06/07/2022 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 041 | Dosage: 50 MG/M2, 1X/2WKS | Form: Solution for infusion | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 06/29/2022 | End: 06/29/2022 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 041 | Dosage: 50 MG/M2, 1X/2WKS | Form: Solution for infusion | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 07/14/2022 | End: 01/01/2022 | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 041 | Dosage: 50 MG/M2, 1X/2WKS | Form: Solution for infusion | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 08/18/2022 | End: 01/01/2022 | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 041 | Dosage: 50 MG/M2, 1X/2WKS | Form: Solution for infusion | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 09/29/2022 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
TS-1 (GIMERACIL\OTERACIL POTASSIUM\TEGAFUR) Suspect
Route: 048 | Dosage: 60 MG, BID | Form: -- | Indication: Pancreatic carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 120.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 120.0 (unit: 003)
Start: 06/07/2022 | End: 06/01/2022 | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
TS-1 (GIMERACIL\OTERACIL POTASSIUM\TEGAFUR) Suspect
Route: 048 | Dosage: 60 MG, BID | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 120.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 120.0 (unit: 003)
Start: 06/29/2022 | End: 01/01/2022 | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
TS-1 (GIMERACIL\OTERACIL POTASSIUM\TEGAFUR) Suspect
Route: 048 | Dosage: 60 MG, BID | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 120.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 120.0 (unit: 003)
Start: 07/14/2022 | End: 01/01/2022 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
TS-1 (GIMERACIL\OTERACIL POTASSIUM\TEGAFUR) Suspect
Route: 048 | Dosage: 60 MG, BID | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 120.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 120.0 (unit: 003)
Start: 08/18/2022 | End: 01/01/2022 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
TS-1 (GIMERACIL\OTERACIL POTASSIUM\TEGAFUR) Suspect
Route: 048 | Dosage: 60 MG, BID | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 120.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 120.0 (unit: 003)
Start: 09/29/2022 | End: -- | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
NOVORAPID (INSULIN ASPART) Concomitant
Route: 058 | Dosage: 16 UNITS AT MORNING, 18 UNITS AT NOON, 18 UNITS AT EVENING | Form: Injection | Indication: Diabetes mellitus | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NOVORAPID (INSULIN ASPART) Concomitant
Route: -- | Dosage: 16 UNITS AT MORNING, 18 UNITS AT NOON, 18 UNITS AT EVENING | Form: Injection | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LANTUS (INSULIN GLARGINE) Concomitant
Route: 058 | Dosage: 16 UNITS BEFORE BEDTIME | Form: Injection | Indication: Diabetes mellitus | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LANTUS (INSULIN GLARGINE) Concomitant
Route: 058 | Dosage: 16 UNITS BEFORE BEDTIME | Form: Injection | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TADALAFIL (TADALAFIL) Concomitant
Route: 048 | Dosage: 5 MG, QD, AFTER DINNER | Form: Tablet | Indication: Benign prostatic hyperplasia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DAYVIGO (LEMBOREXANT) Concomitant
Route: 048 | Dosage: 5 MG, QD, BEFORE BEDTIME | Form: Tablet | Indication: Insomnia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) Concomitant
Route: 048 | Dosage: 10 MG, QD, BEFORE BEDTIME | Form: Orodispersible tablet | Indication: Insomnia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) Concomitant
Route: 048 | Dosage: 10 MG, QD, BEFORE BEDTIME | Form: Orodispersible tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/03/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LOPERAMIDE (LOPERAMIDE) Concomitant
Route: -- | Dosage: 1 MG, WHEN DIARRHOEA DEVELOPED | Form: Tablet | Indication: Diarrhoea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MICARDIS (TELMISARTAN) Concomitant
Route: 048 | Dosage: 20 MG, QD, AFTER BREAKFAST | Form: Tablet | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MICARDIS (TELMISARTAN) Concomitant
Route: 048 | Dosage: 20 MG, QD, AFTER BREAKFAST | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/04/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OMEPRAZOLE (OMEPRAZOLE) Concomitant
Route: 048 | Dosage: 20 MG, QD, AFTER BREAKFAST | Form: Tablet | Indication: Gastritis prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OMEPRAZOLE (OMEPRAZOLE) Concomitant
Route: 048 | Dosage: 20 MG, QD, AFTER BREAKFAST | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/04/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LIPIDIL (FENOFIBRATE) Concomitant
Route: 048 | Dosage: 80 MG, QD, AFTER BREAKFAST | Form: Tablet | Indication: Dyslipidaemia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 80.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/04/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LIPIDIL (FENOFIBRATE) Concomitant
Route: 048 | Dosage: 80 MG, QD, AFTER BREAKFAST | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 80.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 500 MG, TID, BEFORE BREAKFAST, LUNCH AND DINNER | Form: Tablet | Indication: Diabetes mellitus | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/03/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 500 MG, TID, BEFORE BREAKFAST, LUNCH AND DINNER | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CANAGLIFLOZIN\TENELIGLIPTIN (CANAGLIFLOZIN\TENELIGLIPTIN) Concomitant
Route: 048 | Dosage: 1 TABLET, QD, AFTER BREAKFAST | Form: Tablet | Indication: Diabetes mellitus | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CANAGLIFLOZIN\TENELIGLIPTIN (CANAGLIFLOZIN\TENELIGLIPTIN) Concomitant
Route: 048 | Dosage: 1 TABLET, QD, AFTER BREAKFAST | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/04/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20220613

Report Duplicates (1)

Servier: JP-SERVIER-S22010122

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cd8", "safetyreportid": "25955369", "authoritynumb": null, "companynumb": "JP-SERVIER-S22010122", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "JP", "patient": { "patientonsetage": 70.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 76.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Sepsis", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Embolism", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypokalaemia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood creatinine increased", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hyponatraemia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Decreased 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{ "activesubstancename": "METFORMIN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CANAGLIFLOZIN\\TENELIGLIPTIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 TABLET, QD, AFTER BREAKFAST", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Diabetes mellitus", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CANAGLIFLOZIN\\TENELIGLIPTIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CANAGLIFLOZIN\\TENELIGLIPTIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 TABLET, QD, AFTER BREAKFAST", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-10-04T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CANAGLIFLOZIN\\TENELIGLIPTIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20220613" }, "primarysource": { "reportercountry": "JP", "qualification": 1, "literaturereference": "UNKNOWN, UNKNOWN, IMAOKA H, IKEDA M, OZAKA M, et al. 1521P Efficacy and safety of liposomal irinotecan plus S-1 in patients with metastatic pancreaticcancer after failure of first-line gemcitabine-based chemotherapy: Result of a phase I/II study. Annals of Oncology. 2024;35((S2)): S929." }, "primarysourcecountry": "JP", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Servier", "duplicatenumb": "JP-SERVIER-S22010122" } ], "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" }
25955367 Type 1
Serious
DOXORUBICIN, DOCETAXEL, TRASTUZUMAB (+2 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CA-TEVA-VS-3384594
Authority Number
--
Sender Organization
TEVA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
Adult
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Hepatitis B (v28.1) Unknown
Acute hepatic failure (v28.1) Unknown

Drugs (5)

DOXORUBICIN (DOXORUBICIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Breast cancer | Action: Unknown
Auth#: 203622 | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DOCETAXEL (DOCETAXEL) Suspect
Route: 065 | Dosage: DOSE FORM:NOT SPECIFIED | Form: -- | Indication: Breast cancer | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TRASTUZUMAB (TRASTUZUMAB) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Breast cancer | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect
Route: 065 | Dosage: DOSE FORM:NOT SPECIFIED | Form: -- | Indication: Breast cancer | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DEXAMETHASONE (DEXAMETHASONE) Suspect
Route: 065 | Dosage: DOSE FORM:NOT SPECIFIED | Form: -- | Indication: Breast cancer | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (2)

Health Canada: E2B_08138186
Market Authorization Holder AER Number: 2025AP008472

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cd7", "safetyreportid": "25955367", "authoritynumb": null, "companynumb": "CA-TEVA-VS-3384594", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatitis B", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Acute hepatic failure", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DOXORUBICIN", "drugauthorizationnumb": "203622", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Breast cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DOXORUBICIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DOCETAXEL", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE FORM:NOT SPECIFIED", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Breast cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DOCETAXEL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TRASTUZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Breast cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TRASTUZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CYCLOPHOSPHAMIDE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE FORM:NOT SPECIFIED", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Breast cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CYCLOPHOSPHAMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DEXAMETHASONE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE FORM:NOT SPECIFIED", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Breast cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DEXAMETHASONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CA", "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": "Health Canada", "duplicatenumb": "E2B_08138186" }, { "duplicatesource": "Market Authorization Holder AER Number", "duplicatenumb": "2025AP008472" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TEVA" }, "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" }
25955368 Type 2
Serious
ONIVYDE, ONIVYDE, BEVACIZUMAB (+16 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-IPSEN Group, Research and Development-2024-14447
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
68.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
95.3 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Sepsis (v28.1) Unknown
Confusional state (v28.1) Recovered
Leukocytosis (v28.1) Recovered

Drugs (19)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 041 | Dosage: DAYS 1 AND 15 OF 28 DAY CYCLE | Form: Concentrate for solution for infusion | Indication: Rectal cancer metastatic | Action: Dose Not Changed
Auth#: 102799 | Batch#: -- | Structured Dosage: 111.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 14.0 day | Cumulative: -- (unit: --)
Start: 04/30/2024 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: Concentrate for solution for infusion | Indication: -- | Action: Dose Not Changed
Auth#: 102799 | Batch#: -- | Structured Dosage: 40.0 (unit: 010) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
BEVACIZUMAB (BEVACIZUMAB) Suspect
Route: 041 | Dosage: DAYS 1 AND 15 OF 28 DAY CYCLE | Form: -- | Indication: Rectal cancer metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 450.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 14.0 day | Cumulative: -- (unit: --)
Start: 04/30/2024 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
LONSURF (TIPIRACIL HYDROCHLORIDE\TRIFLURIDINE) Suspect
Route: 048 | Dosage: TWICE DAILY DAY 1 - 5 AND 15 - 19 OF A 28 DAY CYCLE | Form: -- | Indication: Rectal cancer metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 80.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
LONSURF (TIPIRACIL HYDROCHLORIDE\TRIFLURIDINE) Suspect
Route: 048 | Dosage: TWICE DAILY DAY 1 - 5 AND 15 - 19 OF A 28 DAY CYCLE | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
TYLENOL (ACETAMINOPHEN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE 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 D3 (CHOLECALCIFEROL) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NEURONTIN (GABAPENTIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NORCO (ACETAMINOPHEN\HYDROCODONE BITARTRATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LAXATIVE STOOL SOFTNER (--) 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: --
OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PRILOSEC (OMEPRAZOLE 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: --
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: --
SENOKOT (SENNOSIDES) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FULPHILA (PEGFILGRASTIM-JMDB) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/05/2024 | End: 06/25/2024 | Duration: 52.0 day | Rechallenge: -- | Additional: --
Recurrences: --
FOLATE SODIUM (FOLATE 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: --
METOPROLOL (METOPROLOL) 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: 20240717

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cd6", "safetyreportid": "25955368", "authoritynumb": null, "companynumb": "US-IPSEN Group, Research and Development-2024-14447", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 68.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 95.3, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Sepsis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Confusional state", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Leukocytosis", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 111.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 14.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DAYS 1 AND 15 OF 28 DAY CYCLE", "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": "041", "drugindication": "Rectal cancer metastatic", "drugstartdateformat": "102", "drugstartdate": "2024-04-30T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "010", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BEVACIZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 450.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 14.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DAYS 1 AND 15 OF 28 DAY CYCLE", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": "Rectal cancer metastatic", "drugstartdateformat": "102", "drugstartdate": "2024-04-30T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "BEVACIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LONSURF", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 80.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TWICE DAILY DAY 1 - 5 AND 15 - 19 OF A 28 DAY CYCLE", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Rectal cancer metastatic", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "TIPIRACIL HYDROCHLORIDE\\TRIFLURIDINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LONSURF", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TWICE DAILY DAY 1 - 5 AND 15 - 19 OF A 28 DAY CYCLE", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "TIPIRACIL HYDROCHLORIDE\\TRIFLURIDINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TYLENOL", "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" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AMITRIPTYLINE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, 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"activesubstance": { "activesubstancename": "CYANOCOBALAMIN\\DEXPANTHENOL\\NIACINAMIDE\\PYRIDOXINE HYDROCHLORIDE\\RIBOFLAVIN 5^-PHOSPHATE SODIUM\\THIA" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SENOKOT", "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": "SENNOSIDES" }, "drugrecurrence": [] }, { "drugcharacterization": 2, 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"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": "METOPROLOL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240717" }, "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": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25955366 Type 2
Serious
ONIVYDE, ONIVYDE, ONIVYDE (+10 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
JP
Occurrence Country
JP
Reporter Country
JP
Reporter Qualification
Physician
Literature Reference
UNKNOWN, IMAOKA H, IKEDA M, OZAKA M, OSHIMA K, OKANO N, et al. 1521P Efficacy and safety of liposomal irinotecan plus S-1 in patients with metastatic pancreaticcancer after failure of first-line gemcitabine-based chemotherapy: Result of a phase I/II study. Annals of Oncology. 2024;35(2): S929.
Company Number
JP-SERVIER-S23000605
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
80.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
38.4 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Pneumonitis (v28.1) Recovering
Hypokalaemia (v28.1) Recovering
Hypernatraemia (v28.1) Not Recovered
Urinary tract infection (v28.1) Unknown
Decreased appetite (v28.1) Recovered
Hypoalbuminaemia (v28.1) Unknown

Drugs (13)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 042 | Dosage: 80 MG/BODY | Form: Solution for infusion | Indication: Pancreatic carcinoma recurrent | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 80.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 042 | Dosage: 70 MG/BODY | Form: Solution for infusion | Indication: -- | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 70.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 042 | Dosage: 70 MG/BODY | Form: Solution for infusion | Indication: -- | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 70.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/03/2022 | End: 01/01/2022 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 042 | Dosage: 70 MG/BODY | Form: Solution for infusion | Indication: -- | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 70.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/12/2022 | End: 01/01/2022 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 042 | Dosage: 70 MG/BODY | Form: Solution for infusion | Indication: -- | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 70.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/28/2022 | End: 01/01/2022 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: 042 | Dosage: 70 MG/BODY | Form: Solution for infusion | Indication: -- | Action: Withdrawn
Auth#: 102799 | Batch#: -- | Structured Dosage: 70.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/06/2023 | End: 01/06/2023 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
GIMERACIL\OTERACIL\TEGAFUR (GIMERACIL\OTERACIL POTASSIUM\TEGAFUR) Suspect
Route: 048 | Dosage: 80 MG/BODY | Form: -- | Indication: Pancreatic carcinoma recurrent | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 80.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/28/2022 | End: 01/13/2023 | Duration: 351.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LOXOPROFEN SODIUM (LOXOPROFEN SODIUM) Concomitant
Route: -- | Dosage: 60 MG, TID (AFTER MEALS) | Form: Tablet | Indication: Pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 180.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 12/03/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FENTANYL CITRATE (FENTANYL CITRATE) Concomitant
Route: 003 | Dosage: 2 MG, QD | Form: Cutaneous patch | Indication: Pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/21/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FENTANYL CITRATE (FENTANYL CITRATE) Concomitant
Route: -- | Dosage: 1 MG, QD | Form: Cutaneous patch | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/21/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INDOMETHACIN (INDOMETHACIN) Concomitant
Route: 003 | Dosage: 70 MG, BID | Form: Cutaneous patch | Indication: Pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 140.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/31/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NEXIUM (ESOMEPRAZOLE MAGNESIUM) Concomitant
Route: -- | Dosage: 10 MG, QD (AFTER BREAKFAST) | Form: Capsule | Indication: Prophylaxis against gastrointestinal ulcer | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 12/03/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OXINORM (--) Concomitant
Route: -- | Dosage: 2.5 MG (WHEN PAIN OCCURRED) | Form: Powder | Indication: Pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230106

Report Duplicates (1)

SERVIER: JP-SERVIER-S23000605

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cd5", "safetyreportid": "25955366", "authoritynumb": null, "companynumb": "JP-SERVIER-S23000605", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "JP", "patient": { "patientonsetage": 80.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 38.4, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pneumonitis", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypokalaemia", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypernatraemia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Urinary tract infection", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Decreased appetite", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypoalbuminaemia", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 80.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "80 MG/BODY", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": "Pancreatic carcinoma recurrent", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 70.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "70 MG/BODY", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 70.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "70 MG/BODY", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-06-03T00:00:00", "drugenddateformat": "602", "drugenddate": "2022-01-01T00:00:00", "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": 70.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "70 MG/BODY", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-08-12T00:00:00", "drugenddateformat": "602", "drugenddate": "2022-01-01T00:00:00", "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": 70.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "70 MG/BODY", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-10-28T00:00:00", "drugenddateformat": "602", "drugenddate": "2022-01-01T00:00:00", "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": 70.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "70 MG/BODY", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-01-06T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-01-06T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "GIMERACIL\\OTERACIL\\TEGAFUR", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 80.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "80 MG/BODY", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Pancreatic carcinoma recurrent", "drugstartdateformat": "102", "drugstartdate": "2022-01-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-01-13T00:00:00", "drugtreatmentduration": 351.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "GIMERACIL\\OTERACIL POTASSIUM\\TEGAFUR" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LOXOPROFEN SODIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 180.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "60 MG, TID (AFTER MEALS)", "drugdosageform": "Tablet", "drugadministrationroute": null, "drugindication": "Pain", "drugstartdateformat": "102", "drugstartdate": "2021-12-03T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LOXOPROFEN SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FENTANYL CITRATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2 MG, QD", "drugdosageform": "Cutaneous patch", "drugadministrationroute": "003", "drugindication": "Pain", "drugstartdateformat": "102", "drugstartdate": "2022-01-21T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FENTANYL CITRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FENTANYL CITRATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 MG, QD", "drugdosageform": "Cutaneous patch", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-01-21T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FENTANYL CITRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "INDOMETHACIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 140.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "70 MG, BID", "drugdosageform": "Cutaneous patch", "drugadministrationroute": "003", "drugindication": "Pain", "drugstartdateformat": "102", "drugstartdate": "2022-01-31T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "INDOMETHACIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NEXIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MG, QD (AFTER BREAKFAST)", "drugdosageform": "Capsule", "drugadministrationroute": null, "drugindication": "Prophylaxis against gastrointestinal ulcer", "drugstartdateformat": "102", "drugstartdate": "2021-12-03T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ESOMEPRAZOLE MAGNESIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OXINORM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG (WHEN PAIN OCCURRED)", "drugdosageform": "Powder", "drugadministrationroute": null, "drugindication": "Pain", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230106" }, "primarysource": { "reportercountry": "JP", "qualification": 1, "literaturereference": "UNKNOWN, IMAOKA H, IKEDA M, OZAKA M, OSHIMA K, OKANO N, et al. 1521P Efficacy and safety of liposomal irinotecan plus S-1 in patients with metastatic pancreaticcancer after failure of first-line gemcitabine-based chemotherapy: Result of a phase I/II study. Annals of Oncology. 2024;35(2): S929." }, "primarysourcecountry": "JP", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "SERVIER", "duplicatenumb": "JP-SERVIER-S23000605" } ], "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" }
25955365 Type 2
Serious
ONIVYDE, LEUCOVORIN, FLUOROURACIL
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
CA
Occurrence Country
EU
Reporter Country
CA
Reporter Qualification
Other Health Professional
Literature Reference
Vogel, Arndt, Saborowski, Anna, Wenzel, Patrick, et al. ^Nanoliposomal irinotecan and fluorouracil plus leucovorin versus fluorouracil plus leucovorin in patients with cholangiocarcinoma and gallbladder carcinoma previously treated with gemcitabine-based therapies (AIO NALIRICC): a multicentre, open-label, randomised, phase 2 trial^, The lancet. Gastroenterology + hepatology, 01-Jan-2024, Vol. nan, Iss. nan, Pp. nan. doi:10.1016/S2468-1253(24)00119-5
Company Number
CA-IPSEN Group, Research and Development-2024-12548
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
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (25)

Neutropenia (v28.1) Unknown
Anaemia (v28.1) Unknown
Leukopenia (v28.1) Unknown
Lymphopenia (v28.1) Unknown
Diarrhoea (v28.1) Unknown
Nausea (v28.1) Unknown
Fatigue (v28.1) Unknown
Stomatitis (v28.1) Unknown
Pain (v28.1) Unknown
Decreased appetite (v28.1) Unknown
Abdominal pain (v28.1) Unknown
Ascites (v28.1) Unknown
Dehydration (v28.1) Unknown
Dyspnoea (v28.1) Unknown
Weight decreased (v28.1) Unknown
Bile duct stenosis (v28.1) Unknown
Acute kidney injury (v28.1) Unknown
Alanine aminotransferase increased (v28.1) Unknown
Pyrexia (v28.1) Unknown
Hypokalaemia (v28.1) Unknown
Urinary tract infection (v28.1) Unknown
Vomiting (v28.1) Unknown
Gamma-glutamyltransferase (v28.1) Unknown
General physical condition (v28.1) Unknown
Sepsis (v28.1) Unknown

Drugs (3)

ONIVYDE (IRINOTECAN HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: Concentrate for solution for infusion | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 70.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: -- | Form: Concentrate for solution for infusion | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 2400.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cd4", "safetyreportid": "25955365", "authoritynumb": null, "companynumb": "CA-IPSEN Group, Research and Development-2024-12548", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neutropenia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anaemia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Leukopenia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lymphopenia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Stomatitis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pain", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Decreased appetite", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Ascites", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dehydration", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Weight decreased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Bile duct stenosis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Acute kidney injury", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Alanine aminotransferase increased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pyrexia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypokalaemia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Urinary tract infection", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gamma-glutamyltransferase", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "General physical condition", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Sepsis", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 70.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 3, "literaturereference": "Vogel, Arndt, Saborowski, Anna, Wenzel, Patrick, et al. ^Nanoliposomal irinotecan and fluorouracil plus leucovorin versus fluorouracil plus leucovorin in patients with cholangiocarcinoma and gallbladder carcinoma previously treated with gemcitabine-based therapies (AIO NALIRICC): a multicentre, open-label, randomised, phase 2 trial^, The lancet. Gastroenterology + hepatology, 01-Jan-2024, Vol. nan, Iss. nan, Pp. nan. doi:10.1016/S2468-1253(24)00119-5" }, "primarysourcecountry": "CA", "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" }
25955363 Type 2
Serious
TAZEMETOSTAT HYDROBROMIDE, DURVALUMAB
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
EU-IPSEN Group, Research and Development-2024-03481
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
65.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
75.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Disease progression (v28.1) Unknown
Night sweats (v28.1) Recovered

Drugs (2)

TAZEMETOSTAT HYDROBROMIDE (TAZEMETOSTAT HYDROBROMIDE) Suspect
Route: -- | Dosage: -- | Form: Tablet | Indication: Adenocarcinoma of colon | 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: -- | Form: Tablet | Indication: Adenocarcinoma of colon | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1120.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230201

Report Duplicates (1)

Eisai tracking number: 202315157

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cd3", "safetyreportid": "25955363", "authoritynumb": null, "companynumb": "EU-IPSEN Group, Research and Development-2024-03481", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 65.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 75.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Disease progression", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Night sweats", "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": null, "drugdosageform": "Tablet", "drugadministrationroute": null, "drugindication": "Adenocarcinoma of colon", "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": null, "drugdosageform": "Tablet", "drugadministrationroute": "042", "drugindication": "Adenocarcinoma of colon", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DURVALUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230201" }, "primarysource": { "reportercountry": "EU", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Eisai tracking number", "duplicatenumb": "202315157" } ], "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" }
25955362 Type 2
Serious
IRINOTECAN, PANITUMUMAB, LONSURF
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
AU
Occurrence Country
AU
Reporter Country
AU
Reporter Qualification
Physician
Literature Reference
--
Company Number
AU-SERVIER-S24007004
Authority Number
--
Sender Organization
IPSEN BIOPHARMACEUTICALS, INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
65.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Neutropenic sepsis (v28.1) Fatal
Multiple organ dysfunction syndrome (v28.1) Fatal
Cerebrovascular accident (v28.1) Fatal

Drugs (3)

IRINOTECAN (IRINOTECAN) Suspect
Route: 042 | Dosage: 340 MG, QD | Form: Solution for infusion | Indication: Colorectal cancer metastatic | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 340.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 32400.0 (unit: 009)
Start: 09/27/2021 | End: 03/25/2022 | Duration: 180.0 day | Rechallenge: Unknown | Additional: 4
Recurrences: --
PANITUMUMAB (PANITUMUMAB) Suspect
Route: -- | Dosage: 462 MG, QD, ON DAY 1 OF EVERY 14-DAY CYCLE | Form: -- | Indication: Colorectal cancer metastatic | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 462.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 83160.0 (unit: 003)
Start: 09/27/2021 | End: 03/25/2022 | Duration: 180.0 day | Rechallenge: Unknown | Additional: 4
Recurrences: --
LONSURF (TIPIRACIL HYDROCHLORIDE\TRIFLURIDINE) Suspect
Route: 048 | Dosage: 90 MG/M2, BID, ON DAYS 1-5 OF EVERY 14 DAY CYCLE. | Form: Tablet | Indication: Colorectal cancer metastatic | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 180.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 9200.0 (unit: 009)
Start: 09/27/2021 | End: 03/29/2022 | Duration: 184.0 day | Rechallenge: Unknown | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20220401

Report Duplicates (1)

SERVIER: AU-SERVIER-S24007004

Raw JSON (click to expand)

{ "_id": "69d435953b3830196fa55cd1", "safetyreportid": "25955362", "authoritynumb": null, "companynumb": "AU-SERVIER-S24007004", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "AU", "patient": { "patientonsetage": 65.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neutropenic sepsis", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Multiple organ dysfunction syndrome", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cerebrovascular accident", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "IRINOTECAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 340.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 32400.0, "drugcumulativedosageunit": "009", "drugdosagetext": "340 MG, QD", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": "Colorectal cancer metastatic", "drugstartdateformat": "102", "drugstartdate": "2021-09-27T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-03-25T00:00:00", "drugtreatmentduration": 180.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "IRINOTECAN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PANITUMUMAB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 462.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 83160.0, "drugcumulativedosageunit": "003", "drugdosagetext": "462 MG, QD, ON DAY 1 OF EVERY 14-DAY CYCLE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Colorectal cancer metastatic", "drugstartdateformat": "102", "drugstartdate": "2021-09-27T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-03-25T00:00:00", "drugtreatmentduration": 180.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "PANITUMUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LONSURF", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 180.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 9200.0, "drugcumulativedosageunit": "009", "drugdosagetext": "90 MG/M2, BID, ON DAYS 1-5 OF EVERY 14 DAY CYCLE.", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Colorectal cancer metastatic", "drugstartdateformat": "102", "drugstartdate": "2021-09-27T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-03-29T00:00:00", "drugtreatmentduration": 184.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "TIPIRACIL HYDROCHLORIDE\\TRIFLURIDINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20220401" }, "primarysource": { "reportercountry": "AU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "AU", "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": "AU-SERVIER-S24007004" } ], "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" }