FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25935924 Type 1
Serious
CAPECITABINE
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
--
Literature Reference
--
Company Number
--
Authority Number
782177
Sender Organization
FDA-CTU
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
3
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Pneumonia (v28.1) --
Gastrointestinal haemorrhage (v28.1) --
Haemoglobin decreased (v28.1) --
Blood glucose increased (v28.1) --

Drugs (1)

CAPECITABINE (CAPECITABINE) Suspect
Route: 048 | Dosage: FREQUENCY : TWICE A DAY;? | Form: -- | Indication: Breast cancer | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1500.0 (unit: 003) | Separate Dosage#: 2.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/07/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4352f3b3830196fa50d6e", "safetyreportid": "25935924", "authoritynumb": "782177", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pneumonia", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gastrointestinal haemorrhage", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Haemoglobin decreased", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood glucose increased", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CAPECITABINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 2.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FREQUENCY : TWICE A DAY;?", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Breast cancer", "drugstartdateformat": "102", "drugstartdate": "2025-02-07T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CAPECITABINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": null, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25935922 Type 1
Serious
TICE BCG
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
--
Literature Reference
--
Company Number
--
Authority Number
FDA-CDER-CTU-2025-70529
Sender Organization
FDA-CTU
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
3
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Bladder cancer recurrent (v28.1) --
Urinary incontinence (v28.1) --

Drugs (1)

TICE BCG (BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4352f3b3830196fa50d6c", "safetyreportid": "25935922", "authoritynumb": "FDA-CDER-CTU-2025-70529", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Bladder cancer recurrent", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Urinary incontinence", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TICE BCG", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": null, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "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" }
25935921 Type 1
Serious
REPATHA, HERBALS\SAW PALMETTO, ELIQUIS (+9 more)
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
--
Authority Number
FDA-CDER-CTU-2025-70528
Sender Organization
FDA-CTU
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
3
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
72.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
77.2 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Renal neoplasm (v28.1) --
Bladder neoplasm (v28.1) --

Drugs (12)

REPATHA (EVOLOCUMAB) Suspect
Route: 058 | Dosage: OTHER FREQUENCY : EVERY TWO WEEKS;? | Form: -- | Indication: Hypercholesterolaemia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 140.0 (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/27/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
HERBALS\SAW PALMETTO (HERBALS\SAW PALMETTO) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ELIQUIS (APIXABAN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VARENICLINE (VARENICLINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DUTASTERIDE (DUTASTERIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NITRO-TIME (NITROGLYCERIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LOSARTAN (LOSARTAN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Mettormin (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METOPROLOL (METOPROLOL) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SPIRONOLACTONE (SPIRONOLACTONE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TAMSULOSIN (TAMSULOSIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TEMAZEPAM (TEMAZEPAM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250930

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4352f3b3830196fa50d6a", "safetyreportid": "25935921", "authoritynumb": "FDA-CDER-CTU-2025-70528", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 72.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 77.2, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Renal neoplasm", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Bladder neoplasm", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "REPATHA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 140.0, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "OTHER FREQUENCY : EVERY TWO WEEKS;?", "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Hypercholesterolaemia", "drugstartdateformat": "102", "drugstartdate": "2024-08-27T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": null, "activesubstance": { "activesubstancename": "EVOLOCUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "HERBALS\\SAW PALMETTO", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "HERBALS\\SAW PALMETTO" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ELIQUIS", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "APIXABAN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VARENICLINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "VARENICLINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DUTASTERIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DUTASTERIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NITRO-TIME", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "NITROGLYCERIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LOSARTAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LOSARTAN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Mettormin", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SPIRONOLACTONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SPIRONOLACTONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TAMSULOSIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TAMSULOSIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TEMAZEPAM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TEMAZEPAM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250930" }, "primarysource": { "reportercountry": "US", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "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" }
25935920 Type 1
Non-Serious
WIXELA INHUB
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-MYLANLABS-2025M1084028
Authority Number
--
Sender Organization
MYLAN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
97.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Circumstance or information capable of leading to medication error (v28.1) Unknown
Device issue (v28.1) Unknown
Device malfunction (v28.1) Unknown

Drugs (1)

WIXELA INHUB (FLUTICASONE PROPIONATE\SALMETEROL XINAFOATE) Suspect
Route: -- | Dosage: 250 PER 50 MICROGRAM, BID (TWICE A DAY) | Form: -- | Indication: Chronic obstructive pulmonary disease | Action: Not Applicable
Auth#: 208891 | Batch#: 62004591 | Structured Dosage: 250.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 07/01/2025 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250701

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4352f3b3830196fa50d69", "safetyreportid": "25935920", "authoritynumb": null, "companynumb": "US-MYLANLABS-2025M1084028", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 97.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Circumstance or information capable of leading to medication error", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device issue", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device malfunction", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "WIXELA INHUB", "drugauthorizationnumb": "208891", "drugbatchnumb": "62004591", "drugstructuredosagenumb": 250.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "250 PER 50 MICROGRAM, BID (TWICE A DAY)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Chronic obstructive pulmonary disease", "drugstartdateformat": "610", "drugstartdate": "2025-07-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "FLUTICASONE PROPIONATE\\SALMETEROL XINAFOATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250701" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MYLAN" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25935918 Type 2
Non-Serious
MITAPIVAT
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-AGIOS-2510US04514
Authority Number
--
Sender Organization
AGIOS PHARMACEUTICALS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Heart rate increased (v28.1) Unknown

Drugs (1)

MITAPIVAT (MITAPIVAT) Suspect
Route: 048 | Dosage: 50 MILLIGRAM, BID | Form: Tablet | Indication: Pyruvate kinase deficiency anaemia | Action: Dose Not Changed
Auth#: 216196 | Batch#: W078285 | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/05/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4352f3b3830196fa50d64", "safetyreportid": "25935918", "authoritynumb": null, "companynumb": "US-AGIOS-2510US04514", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Heart rate increased", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MITAPIVAT", "drugauthorizationnumb": "216196", "drugbatchnumb": "W078285", "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "50 MILLIGRAM, BID", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Pyruvate kinase deficiency anaemia", "drugstartdateformat": "102", "drugstartdate": "2022-05-05T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "MITAPIVAT" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "AGIOS PHARMACEUTICALS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25935916 Type 2
Serious
BEVACIZUMAB, BEVACIZUMAB, SINTILIMAB (+4 more)
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/18/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
Xu L, Efficacy and safety analysis of transvascular intervention combined with sintilimab and bevacizumab in first-line treatment of unresectable hepatocellular carcinoma. 2025;5 (30):1-67.
Company Number
CN-ROCHE-10000411649
Authority Number
--
Sender Organization
ROCHE
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 (28)

Diarrhoea (v28.1) Unknown
Pneumonia (v28.1) Unknown
Palmar-plantar erythrodysaesthesia syndrome (v28.1) Unknown
Neutrophil count decreased (v28.1) Unknown
Platelet count decreased (v28.1) Unknown
Aspartate aminotransferase increased (v28.1) Unknown
Alanine aminotransferase increased (v28.1) Unknown
Blood bilirubin increased (v28.1) Unknown
Blood albumin decreased (v28.1) Unknown
Abdominal discomfort (v28.1) Unknown
Pyrexia (v28.1) Unknown
Nausea (v28.1) Unknown
Vomiting (v28.1) Unknown
Haemorrhage (v28.1) Unknown
Oesophageal varices haemorrhage (v28.1) Fatal
Gastric varices haemorrhage (v28.1) Unknown
Hypertension (v28.1) Unknown
Proteinuria (v28.1) Unknown
Hypothyroidism (v28.1) Unknown
Hyperthyroidism (v28.1) Unknown
Rash (v28.1) Unknown
Pruritus (v28.1) Unknown
White blood cell count decreased (v28.1) Unknown
Fatigue (v28.1) Unknown
Decreased appetite (v28.1) Unknown
Gastroduodenal haemorrhage (v28.1) Unknown
Gingival bleeding (v28.1) Unknown
Epistaxis (v28.1) Unknown

Drugs (7)

BEVACIZUMAB (BEVACIZUMAB) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Hepatocellular carcinoma | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 7.5 (unit: 007) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
BEVACIZUMAB (BEVACIZUMAB) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 15.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SINTILIMAB (SINTILIMAB) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Hepatocellular carcinoma | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Suspect
Route: 065 | Dosage: -- | Form: Infusion | Indication: Hepatocellular carcinoma | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 85.0 (unit: 009) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Hepatocellular carcinoma | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 400.0 (unit: 009) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: 065 | Dosage: -- | Form: Infusion | Indication: Hepatocellular carcinoma | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 2400.0 (unit: 009) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: 065 | Dosage: -- | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 400.0 (unit: 009) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4352f3b3830196fa50d63", "safetyreportid": "25935916", "authoritynumb": null, "companynumb": "CN-ROCHE-10000411649", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pneumonia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Palmar-plantar erythrodysaesthesia syndrome", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neutrophil count decreased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Platelet count decreased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Aspartate aminotransferase increased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Alanine aminotransferase increased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood bilirubin increased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood albumin decreased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal discomfort", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pyrexia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Haemorrhage", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Oesophageal varices haemorrhage", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gastric varices haemorrhage", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypertension", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Proteinuria", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypothyroidism", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hyperthyroidism", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rash", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pruritus", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "White blood cell count decreased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Decreased appetite", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gastroduodenal haemorrhage", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gingival bleeding", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Epistaxis", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BEVACIZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 7.5, "drugstructuredosageunit": "007", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Hepatocellular carcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "BEVACIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BEVACIZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "007", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "BEVACIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SINTILIMAB", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Hepatocellular carcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "SINTILIMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OXALIPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 85.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Infusion", "drugadministrationroute": "065", "drugindication": "Hepatocellular carcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN CALCIUM", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Hepatocellular carcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 2400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Infusion", "drugadministrationroute": "065", "drugindication": "Hepatocellular carcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Infusion", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": "Xu L, Efficacy and safety analysis of transvascular intervention combined with sintilimab and bevacizumab in first-line treatment of unresectable hepatocellular carcinoma. 2025;5 (30):1-67." }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ROCHE" }, "serious": 1, "seriousnesscongenitalanomali": null, "seriousnessdeath": 1, "seriousnessdisabling": null, "seriousnesshospitalization": null, "seriousnesslifethreatening": null, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25935915 Type 1
Serious
TORIPALIMAB, TORIPALIMAB, CARBOPLATIN (+9 more)
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/18/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CN-SHANGHAI JUNSHI BIOSCIENCES CO., LTD.-CN2025016055
Authority Number
--
Sender Organization
COHERUS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Myelosuppression (v28.1) Recovering

Drugs (12)

TORIPALIMAB (TORIPALIMAB) Suspect
Route: 041 | Dosage: 240 MG, SINGLE | Form: Solution for infusion | Indication: Transitional cell cancer of the renal pelvis and ureter | Action: Dose Not Changed
Auth#: 761240 | Batch#: 202502005 | Structured Dosage: 240.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 240.0 (unit: 003)
Start: 09/12/2025 | End: 09/12/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
TORIPALIMAB (TORIPALIMAB) Suspect
Route: 041 | Dosage: 240 MG, SINGLE | Form: Solution for infusion | Indication: -- | Action: Dose Not Changed
Auth#: 761240 | Batch#: 202502005 | Structured Dosage: 240.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 240.0 (unit: 003)
Start: 10/04/2025 | End: 10/04/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
CARBOPLATIN (CARBOPLATIN) Suspect
Route: 041 | Dosage: 400 MG, SINGLE | Form: -- | Indication: Transitional cell cancer of the renal pelvis and ureter | Action: Dose Not Changed
Auth#: -- | Batch#: 5E036CA4 | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 8400.0 (unit: 003)
Start: 09/12/2025 | End: 09/12/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
CARBOPLATIN (CARBOPLATIN) Suspect
Route: 041 | Dosage: 400 MG, SINGLE | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: -- | Batch#: 5E036CA4 | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 8400.0 (unit: 003)
Start: 10/04/2025 | End: 10/04/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 1.6 G, SINGLE | Form: Solution for infusion | Indication: Transitional cell cancer of the renal pelvis and ureter | Action: Dose Not Changed
Auth#: -- | Batch#: FA3D5011B | Structured Dosage: 1.6 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 1.6 (unit: 002)
Start: 09/12/2025 | End: 09/12/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE) Suspect
Route: 041 | Dosage: 1.6 G, SINGLE | Form: Solution for infusion | Indication: -- | Action: Dose Not Changed
Auth#: -- | Batch#: FA3D5011B | Structured Dosage: 1.6 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 1.6 (unit: 002)
Start: 10/04/2025 | End: 10/04/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant
Route: 041 | Dosage: 100 ML, SINGLE, SOLVENT OF GEMCITABINE HYDROCHLORIDE | Form: Solution for infusion | Indication: Medication dilution | Action: --
Auth#: -- | Batch#: E225040303 | Structured Dosage: 100.0 (unit: 012) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 2100.0 (unit: 012)
Start: 09/12/2025 | End: 09/12/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant
Route: 041 | Dosage: 100 ML, SINGLE, SOLVENT OF TUO YI | Form: Solution for infusion | Indication: -- | Action: --
Auth#: -- | Batch#: E225040303 | Structured Dosage: 100.0 (unit: 012) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 2100.0 (unit: 012)
Start: 09/12/2025 | End: 09/12/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant
Route: 041 | Dosage: 100 ML, SINGLE, SOLVENT OF GEMCITABINE HYDROCHLORIDE | Form: Solution for infusion | Indication: -- | Action: --
Auth#: -- | Batch#: E225040303 | Structured Dosage: 100.0 (unit: 012) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 2100.0 (unit: 012)
Start: 09/12/2025 | End: 09/12/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant
Route: 041 | Dosage: 100 ML, SINGLE, SOLVENT OF TUO YI | Form: Solution for infusion | Indication: -- | Action: --
Auth#: -- | Batch#: E225040303 | Structured Dosage: 100.0 (unit: 012) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 2100.0 (unit: 012)
Start: 10/04/2025 | End: 10/04/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DEXTROSE (DEXTROSE MONOHYDRATE) Concomitant
Route: 041 | Dosage: 500 ML, SINGLE, SOLVENT OF CARBOPLATIN | Form: Solution for infusion | Indication: Medication dilution | Action: --
Auth#: -- | Batch#: D25011502 | Structured Dosage: 500.0 (unit: 012) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 500.0 (unit: 012)
Start: 09/12/2025 | End: 09/12/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DEXTROSE (DEXTROSE MONOHYDRATE) Concomitant
Route: 041 | Dosage: 500 ML, SINGLE, SOLVENT OF CARBOPLATIN | Form: Solution for infusion | Indication: -- | Action: --
Auth#: -- | Batch#: D25011502 | Structured Dosage: 500.0 (unit: 012) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 500.0 (unit: 012)
Start: 10/04/2025 | End: 10/04/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251002

Report Duplicates (1)

SHANGHAI JUNSHI BIOSCIENCES CO., LTD.: CN-SHANGHAI JUNSHI BIOSCIENCES CO., LTD.-CN2025016055

Raw JSON (click to expand)

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"drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "CARBOPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CARBOPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": "5E036CA4", "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 8400.0, "drugcumulativedosageunit": "003", "drugdosagetext": "400 MG, SINGLE", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-10-04T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-04T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "CARBOPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "GEMCITABINE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": "FA3D5011B", "drugstructuredosagenumb": 1.6, "drugstructuredosageunit": "002", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 1.6, "drugcumulativedosageunit": "002", "drugdosagetext": "1.6 G, SINGLE", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Transitional cell cancer of the renal pelvis and ureter", "drugstartdateformat": "102", "drugstartdate": "2025-09-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-12T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "GEMCITABINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "GEMCITABINE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": "FA3D5011B", "drugstructuredosagenumb": 1.6, "drugstructuredosageunit": "002", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 1.6, "drugcumulativedosageunit": "002", "drugdosagetext": "1.6 G, SINGLE", "drugdosageform": "Solution for infusion", "drugadministrationroute": "041", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-10-04T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-04T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "GEMCITABINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SODIUM CHLORIDE", "drugauthorizationnumb": null, 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"drugstructuredosageunit": "012", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 2100.0, "drugcumulativedosageunit": "012", "drugdosagetext": "100 ML, SINGLE, SOLVENT OF TUO YI", "drugdosageform": "Solution for infusion", "drugadministrationroute": "041", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-09-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-12T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SODIUM CHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SODIUM CHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": "E225040303", "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "012", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, 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"drugdosageform": "Solution for infusion", "drugadministrationroute": "041", "drugindication": "Medication dilution", "drugstartdateformat": "102", "drugstartdate": "2025-09-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-12T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DEXTROSE MONOHYDRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DEXTROSE", "drugauthorizationnumb": null, "drugbatchnumb": "D25011502", "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "012", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 500.0, "drugcumulativedosageunit": "012", "drugdosagetext": "500 ML, SINGLE, SOLVENT OF CARBOPLATIN", "drugdosageform": "Solution for infusion", "drugadministrationroute": "041", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-10-04T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-04T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DEXTROSE MONOHYDRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251002" }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "SHANGHAI JUNSHI BIOSCIENCES CO., LTD.", "duplicatenumb": "CN-SHANGHAI JUNSHI BIOSCIENCES CO., LTD.-CN2025016055" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "COHERUS" }, "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" }
25935913 Type 1
Non-Serious
COMBIPATCH, COMBIPATCH, TIROSINT
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-SANDOZ-SDZ2025US076534
Authority Number
--
Sender Organization
SANDOZ
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
52.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (9)

Intermenstrual bleeding (v28.1) Not Recovered
Mood altered (v28.1) Recovered
Emotional disorder (v28.1) Recovered
Pain in extremity (v28.1) Recovered
Fatigue (v28.1) Recovered
Nausea (v28.1) Recovered
Headache (v28.1) Recovered
Therapeutic response unexpected (v28.1) Recovered
Product storage error (v28.1) Recovered

Drugs (3)

COMBIPATCH (ESTRADIOL\NORETHINDRONE ACETATE) Suspect
Route: 062 | Dosage: 0.05/0.14 MG, ON WEDNESDAYS AND SATURDAYS | Form: Transdermal patch | Indication: Menopausal symptoms | Action: Withdrawn
Auth#: 20323 | Batch#: 16193 | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
COMBIPATCH (ESTRADIOL\NORETHINDRONE ACETATE) Suspect
Route: -- | Dosage: -- | Form: Transdermal patch | Indication: Hot flush | Action: Withdrawn
Auth#: 20323 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
TIROSINT (LEVOTHYROXINE SODIUM) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Thyroid disorder | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251011

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4352f3b3830196fa50d61", "safetyreportid": "25935913", "authoritynumb": null, "companynumb": "US-SANDOZ-SDZ2025US076534", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 52.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Intermenstrual bleeding", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Mood altered", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Emotional disorder", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pain in extremity", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Headache", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Therapeutic response unexpected", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product storage error", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "COMBIPATCH", "drugauthorizationnumb": "20323", "drugbatchnumb": "16193", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.05/0.14 MG, ON WEDNESDAYS AND SATURDAYS", "drugdosageform": "Transdermal patch", "drugadministrationroute": "062", "drugindication": "Menopausal symptoms", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "ESTRADIOL\\NORETHINDRONE ACETATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "COMBIPATCH", "drugauthorizationnumb": "20323", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Transdermal patch", "drugadministrationroute": null, "drugindication": "Hot flush", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "ESTRADIOL\\NORETHINDRONE ACETATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TIROSINT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Thyroid disorder", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LEVOTHYROXINE SODIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251011" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANDOZ" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25935914 Type 1
Serious
FLUOROURACIL, OXALIPLATIN, LEUCOVORIN
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
Majmudar UV, Dhamija K, Khan E, Caudill A, Ramanan S, Singh J, et al. Rechallenging Patients With Fluoropyridine-Induced Coronary Vasospasm: 5 Success Stories. JACC-Case-Rep 2025; 30 (23):.; Majmudar UV, Dhamija K, Khan E, Caudill A, Ramanan S, Singh J, et al. Rechallenging Patients With Fluoropyridine-Induced Coronary Vasospasm: 5 Success Stories. JACC-Case-Rep 2025; 30 (23):.
Company Number
US-TEVA-VS-3382015
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
57.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Arteriospasm coronary (v28.1) Recovered
Electrocardiogram ST segment elevation (v28.1) Unknown
Ischaemia (v28.1) Unknown
Ejection fraction decreased (v28.1) Unknown

Drugs (3)

FLUOROURACIL (FLUOROURACIL) Suspect
Route: 065 | Dosage: 5-FU FOLFOX REGIMEN; BOLUS | Form: -- | Indication: Rectal adenocarcinoma | Action: Withdrawn
Auth#: 040333 | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Yes
Recurrences: --
OXALIPLATIN (OXALIPLATIN) Concomitant
Route: 065 | Dosage: FOLFOX REGIMEN | Form: -- | Indication: Adenocarcinoma of colon | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Concomitant
Route: 065 | Dosage: FOLFOX REGIMEN | Form: -- | Indication: Rectal adenocarcinoma | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (2)

Wipro: IN-Wipro-4090756-425749
MLM_Duplicate: US-MLMSERVICE-20250818-PI616558-00152

Raw JSON (click to expand)

{ "_id": "69d4352f3b3830196fa50d60", "safetyreportid": "25935914", "authoritynumb": null, "companynumb": "US-TEVA-VS-3382015", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 57.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Arteriospasm coronary", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Electrocardiogram ST segment elevation", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Ischaemia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Ejection fraction decreased", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": "040333", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5-FU FOLFOX REGIMEN; BOLUS", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Rectal adenocarcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 2, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OXALIPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FOLFOX REGIMEN", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Adenocarcinoma of colon", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FOLFOX REGIMEN", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Rectal adenocarcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": "Majmudar UV, Dhamija K, Khan E, Caudill A, Ramanan S, Singh J, et al. Rechallenging Patients With Fluoropyridine-Induced Coronary Vasospasm: 5 Success Stories. JACC-Case-Rep 2025; 30 (23):.; Majmudar UV, Dhamija K, Khan E, Caudill A, Ramanan S, Singh J, et al. Rechallenging Patients With Fluoropyridine-Induced Coronary Vasospasm: 5 Success Stories. JACC-Case-Rep 2025; 30 (23):." }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Wipro", "duplicatenumb": "IN-Wipro-4090756-425749" }, { "duplicatesource": "MLM_Duplicate", "duplicatenumb": "US-MLMSERVICE-20250818-PI616558-00152" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TEVA" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 1, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25935911 Type 1
Serious
TORIPALIMAB, CARBOPLATIN, PACLITAXEL (+3 more)
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/18/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CN-SHANGHAI JUNSHI BIOSCIENCES CO., LTD.-CN2025016064
Authority Number
--
Sender Organization
COHERUS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Myelosuppression (v28.1) Recovering

Drugs (6)

TORIPALIMAB (TORIPALIMAB) Suspect
Route: 041 | Dosage: 240 MG, SINGLE | Form: Solution for infusion | Indication: Nonkeratinising carcinoma of nasopharynx | Action: Unknown
Auth#: 761240 | Batch#: 2025060325A | Structured Dosage: 240.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 240.0 (unit: 003)
Start: 09/17/2025 | End: 09/17/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
CARBOPLATIN (CARBOPLATIN) Suspect
Route: 041 | Dosage: 550 MG, SINGLE | Form: Solution for infusion | Indication: Nonkeratinising carcinoma of nasopharynx | Action: Unknown
Auth#: -- | Batch#: 5F066CA4 | Structured Dosage: 550.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 550.0 (unit: 003)
Start: 09/18/2025 | End: 09/18/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PACLITAXEL (PACLITAXEL) Suspect
Route: 041 | Dosage: 300 MG, SINGLE | Form: -- | Indication: Nonkeratinising carcinoma of nasopharynx | Action: Unknown
Auth#: -- | Batch#: 25070411 | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 300.0 (unit: 003)
Start: 09/18/2025 | End: 09/18/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant
Route: 041 | Dosage: 100 ML, SINGLE | Form: Solution for infusion | Indication: Medication dilution | Action: --
Auth#: -- | Batch#: E224102002 | Structured Dosage: 100.0 (unit: 012) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 100.0 (unit: 012)
Start: 09/17/2025 | End: 09/17/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant
Route: 041 | Dosage: 400 ML, SINGLE | Form: Solution for infusion | Indication: Medication dilution | Action: --
Auth#: -- | Batch#: D25040102 | Structured Dosage: 400.0 (unit: 012) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 400.0 (unit: 012)
Start: 09/18/2025 | End: 09/18/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DEXTROSE (DEXTROSE MONOHYDRATE) Concomitant
Route: 041 | Dosage: 500 ML, SINGLE | Form: Solution for infusion | Indication: Medication dilution | Action: --
Auth#: -- | Batch#: D25011006 | Structured Dosage: 500.0 (unit: 012) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 500.0 (unit: 012)
Start: 09/18/2025 | End: 09/18/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250929

Report Duplicates (1)

SHANGHAI JUNSHI BIOSCIENCES CO., LTD.: CN-SHANGHAI JUNSHI BIOSCIENCES CO., LTD.-CN2025016064

Raw JSON (click to expand)

{ "_id": "69d4352f3b3830196fa50d5e", "safetyreportid": "25935911", "authoritynumb": null, "companynumb": "CN-SHANGHAI JUNSHI BIOSCIENCES CO., LTD.-CN2025016064", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Myelosuppression", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TORIPALIMAB", "drugauthorizationnumb": "761240", "drugbatchnumb": "2025060325A", "drugstructuredosagenumb": 240.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 240.0, "drugcumulativedosageunit": "003", "drugdosagetext": "240 MG, SINGLE", "drugdosageform": "Solution for infusion", "drugadministrationroute": "041", "drugindication": "Nonkeratinising carcinoma of nasopharynx", "drugstartdateformat": "102", "drugstartdate": "2025-09-17T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-17T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TORIPALIMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CARBOPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": "5F066CA4", "drugstructuredosagenumb": 550.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 550.0, "drugcumulativedosageunit": "003", "drugdosagetext": "550 MG, SINGLE", "drugdosageform": "Solution for infusion", "drugadministrationroute": "041", "drugindication": "Nonkeratinising carcinoma of nasopharynx", "drugstartdateformat": "102", "drugstartdate": "2025-09-18T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-18T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CARBOPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PACLITAXEL", "drugauthorizationnumb": null, "drugbatchnumb": "25070411", "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 300.0, "drugcumulativedosageunit": "003", "drugdosagetext": "300 MG, SINGLE", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": "Nonkeratinising carcinoma of nasopharynx", "drugstartdateformat": "102", "drugstartdate": "2025-09-18T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-18T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PACLITAXEL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SODIUM CHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": "E224102002", "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "012", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 100.0, "drugcumulativedosageunit": "012", "drugdosagetext": "100 ML, SINGLE", "drugdosageform": "Solution for infusion", "drugadministrationroute": "041", "drugindication": "Medication dilution", "drugstartdateformat": "102", "drugstartdate": "2025-09-17T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-17T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SODIUM CHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SODIUM CHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": "D25040102", "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "012", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 400.0, "drugcumulativedosageunit": "012", "drugdosagetext": "400 ML, SINGLE", "drugdosageform": "Solution for infusion", "drugadministrationroute": "041", "drugindication": "Medication dilution", "drugstartdateformat": "102", "drugstartdate": "2025-09-18T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-18T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SODIUM CHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DEXTROSE", "drugauthorizationnumb": null, "drugbatchnumb": "D25011006", "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "012", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 500.0, "drugcumulativedosageunit": "012", "drugdosagetext": "500 ML, SINGLE", "drugdosageform": "Solution for infusion", "drugadministrationroute": "041", "drugindication": "Medication dilution", "drugstartdateformat": "102", "drugstartdate": "2025-09-18T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-18T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DEXTROSE MONOHYDRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250929" }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "SHANGHAI JUNSHI BIOSCIENCES CO., LTD.", "duplicatenumb": "CN-SHANGHAI JUNSHI BIOSCIENCES CO., LTD.-CN2025016064" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "COHERUS" }, "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" }