FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25942813 Type 1
Serious
PERINDOPRIL, INDAPAMIDE, APIDRA (+11 more)
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-AFSSAPS-RE2025000845
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
61.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
110.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Angioedema (v28.1) Recovered

Drugs (14)

PERINDOPRIL (PERINDOPRIL) Suspect
Route: 048 | Dosage: 2 DOSAGE FORM, ONCE A DAY | Form: Unknown | Indication: Hypertension | Action: Withdrawn
Auth#: 79070 | Batch#: -- | Structured Dosage: 2.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: 07/15/2025 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
INDAPAMIDE (INDAPAMIDE) Suspect
Route: 048 | Dosage: 2 DOSAGE FORM, ONCE A DAY | Form: Unknown | Indication: Hypertension | Action: Withdrawn
Auth#: 075105 | Batch#: -- | Structured Dosage: 2.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: 07/15/2025 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
APIDRA (INSULIN GLULISINE) Concomitant
Route: 065 | Dosage: UNK | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ATENOLOL (ATENOLOL) Concomitant
Route: 065 | Dosage: UNK | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
KARDEGIC (ASPIRIN DL-LYSINE) Concomitant
Route: 065 | Dosage: UNK (POWDER FOR ORAL SOLUTION IN SACHET) | Form: Powder for oral solution in sachet | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LANTUS (INSULIN GLARGINE) Concomitant
Route: 065 | Dosage: UNK | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
GABAPENTIN (GABAPENTIN) Concomitant
Route: 065 | Dosage: UNK | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SIMVASTATIN (SIMVASTATIN) Concomitant
Route: 065 | Dosage: UNK | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: UNK | Form: Prolonged released Capsule | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PANTOPRAZOLE (PANTOPRAZOLE) Concomitant
Route: 065 | Dosage: UNK | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SERETIDE (FLUTICASONE PROPIONATE\SALMETEROL XINAFOATE) Concomitant
Route: 065 | Dosage: UNK | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CLOBAZAM (CLOBAZAM) Concomitant
Route: 065 | Dosage: UNK | Form: Scored Tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ALBUTEROL (ALBUTEROL) Concomitant
Route: 065 | Dosage: UNK | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ZOPICLONE (ZOPICLONE) Concomitant
Route: 065 | Dosage: UNK | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250714

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52a38", "safetyreportid": "25942813", "authoritynumb": null, "companynumb": "EU-AFSSAPS-RE2025000845", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 61.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 110.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Angioedema", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PERINDOPRIL", "drugauthorizationnumb": "79070", "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2 DOSAGE FORM, ONCE A DAY", "drugdosageform": "Unknown", "drugadministrationroute": "048", "drugindication": "Hypertension", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "102", "drugenddate": "2025-07-15T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "PERINDOPRIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INDAPAMIDE", "drugauthorizationnumb": "075105", "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2 DOSAGE FORM, ONCE A DAY", "drugdosageform": "Unknown", "drugadministrationroute": "048", "drugindication": "Hypertension", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "102", "drugenddate": "2025-07-15T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "INDAPAMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "APIDRA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "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": "INSULIN GLULISINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ATENOLOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "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": "ATENOLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "KARDEGIC", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK (POWDER FOR ORAL SOLUTION IN SACHET)", "drugdosageform": "Powder for oral solution in sachet", "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": "ASPIRIN DL-LYSINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LANTUS", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "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": "INSULIN GLARGINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "GABAPENTIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "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": "GABAPENTIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SIMVASTATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "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": "SIMVASTATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NICARDIPINE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Prolonged released 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": "NICARDIPINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PANTOPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "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": "PANTOPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SERETIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "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": "FLUTICASONE PROPIONATE\\SALMETEROL XINAFOATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CLOBAZAM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Scored Tablet", "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": "CLOBAZAM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ALBUTEROL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "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": "ALBUTEROL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ZOPICLONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "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": "ZOPICLONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250714" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "AUROBINDO" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25942811 Type 1
Non-Serious
BREZTRI
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-AstraZeneca-CH-00973365A
Authority Number
--
Sender Organization
ALEXION 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
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Chronic obstructive pulmonary disease (v28.1) Unknown

Drugs (1)

BREZTRI (BUDESONIDE\FORMOTEROL\GLYCOPYRROLATE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: 212122 | Batch#: Unknown | Structured Dosage: -- (unit: --) | 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": "69d435593b3830196fa52a33", "safetyreportid": "25942811", "authoritynumb": null, "companynumb": "US-AstraZeneca-CH-00973365A", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Chronic obstructive pulmonary disease", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BREZTRI", "drugauthorizationnumb": "212122", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "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": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "BUDESONIDE\\FORMOTEROL\\GLYCOPYRROLATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ALEXION 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" }
25942805 Type 1
Non-Serious
POMALYST
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-BRISTOL-MYERS SQUIBB COMPANY-2025-143262
Authority Number
--
Sender Organization
BRISTOL-MYERS SQUIBB COMPANY
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
84.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Product dose omission issue (v28.1) Unknown

Drugs (1)

POMALYST (POMALIDOMIDE) Suspect
Route: -- | Dosage: DAILY FOR 21 DAYS THEN 7 DAYS OFF | Form: Capsule | Indication: Plasma cell myeloma | Action: Dose Not Changed
Auth#: 204026 | Batch#: -- | Structured Dosage: 2.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.33 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52a31", "safetyreportid": "25942805", "authoritynumb": null, "companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-2025-143262", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 84.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product dose omission issue", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "POMALYST", "drugauthorizationnumb": "204026", "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.33, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DAILY FOR 21 DAYS THEN 7 DAYS OFF", "drugdosageform": "Capsule", "drugadministrationroute": null, "drugindication": "Plasma cell myeloma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "POMALIDOMIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BRISTOL-MYERS SQUIBB COMPANY" }, "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" }
25942800 Type 1
Non-Serious
NEMLUVIO
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-GALDERMA-US2025019281
Authority Number
--
Sender Organization
GALDERMA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
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 (5)

Taste disorder (v28.1) Unknown
Hyposmia (v28.1) Unknown
Dry skin (v28.1) Not Recovered
Skin exfoliation (v28.1) Not Recovered
Scab (v28.1) Not Recovered

Drugs (1)

NEMLUVIO (NEMOLIZUMAB-ILTO) Suspect
Route: 058 | Dosage: UNK | Form: Injection | Indication: Dermatitis atopic | Action: Unknown
Auth#: 761390 | Batch#: B000427746 | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/01/2025 | End: 08/01/2025 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (1)

093025: GL-093025-38552

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52a2c", "safetyreportid": "25942800", "authoritynumb": null, "companynumb": "US-GALDERMA-US2025019281", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Taste disorder", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hyposmia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dry skin", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Skin exfoliation", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Scab", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "NEMLUVIO", "drugauthorizationnumb": "761390", "drugbatchnumb": "B000427746", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Injection", "drugadministrationroute": "058", "drugindication": "Dermatitis atopic", "drugstartdateformat": "610", "drugstartdate": "2025-08-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2025-08-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "NEMOLIZUMAB-ILTO" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "093025", "duplicatenumb": "GL-093025-38552" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "GALDERMA" }, "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" }
25942815 Type 2
Serious
VEDOLIZUMAB, TOFACITINIB
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/19/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CA-TAKEDA-2025TUS092161
Authority Number
--
Sender Organization
TAKEDA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
72.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (2)

VEDOLIZUMAB (VEDOLIZUMAB) Suspect
Route: -- | Dosage: 300 MILLIGRAM | Form: Powder for solution for infusion | Indication: Colitis ulcerative | Action: Withdrawn
Auth#: 125476 | Batch#: 12759940 | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/24/2024 | End: 09/17/2025 | Duration: 359.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
TOFACITINIB (TOFACITINIB) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52a37", "safetyreportid": "25942815", "authoritynumb": null, "companynumb": "CA-TAKEDA-2025TUS092161", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": 72.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "VEDOLIZUMAB", "drugauthorizationnumb": "125476", "drugbatchnumb": "12759940", "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "300 MILLIGRAM", "drugdosageform": "Powder for solution for infusion", "drugadministrationroute": null, "drugindication": "Colitis ulcerative", "drugstartdateformat": "102", "drugstartdate": "2024-09-24T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-17T00:00:00", "drugtreatmentduration": 359.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TOFACITINIB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TOFACITINIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TAKEDA" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-19T00:00:00", "transmissiondateformat": "102" }
25942820 Type 1
Serious
METHOTREXATE, ACTEMRA, ACTEMRA (+26 more)
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/18/2026
Primary Source Country
CA
Occurrence Country
--
Reporter Country
CA
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CA-Orion Corporation ORION PHARMA-TREX2025-0161
Authority Number
--
Sender Organization
ORION
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
31.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
46.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (13)

Abdominal pain upper (v28.1) Not Recovered
Weight decreased (v28.1) Not Recovered
Poor venous access (v28.1) Not Recovered
Weight increased (v28.1) Not Recovered
Angiopathy (v28.1) Not Recovered
Blood pressure diastolic abnormal (v28.1) Not Recovered
Abdominal pain (v28.1) Not Recovered
Heart rate decreased (v28.1) Not Recovered
Blood pressure diastolic decreased (v28.1) Not Recovered
Abdominal discomfort (v28.1) Not Recovered
Cough (v28.1) Not Recovered
Ear infection (v28.1) Not Recovered
Nasopharyngitis (v28.1) Not Recovered

Drugs (29)

METHOTREXATE (METHOTREXATE) Suspect
Route: -- | Dosage: -- | Form: Tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 448.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 448.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 480.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 448.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 384.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 384.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 389.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 450.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 454.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACTEMRA (TOCILIZUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 23.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ESOMEPRAZOLE MAGNESIUM\NAPROXEN (ESOMEPRAZOLE MAGNESIUM\NAPROXEN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PREDNISONE (PREDNISONE) Concomitant
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 (2)

Apotex: 2025AP031210
Health Canada: E2B_03075873

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52a39", "safetyreportid": "25942820", "authoritynumb": null, "companynumb": "CA-Orion Corporation ORION PHARMA-TREX2025-0161", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": null, "patient": { "patientonsetage": 31.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 46.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain upper", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Weight decreased", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Poor venous access", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Weight increased", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Angiopathy", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood pressure diastolic abnormal", "reactionoutcome": 3 }, { 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"seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25942806 Type 1
Non-Serious
DUPIXENT
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
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-SA-2025SA311172
Authority Number
--
Sender Organization
SANOFI AVENTIS
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
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Maternal exposure during pregnancy (v28.1) Unknown

Drugs (1)

DUPIXENT (DUPILUMAB) Suspect
Route: 058 | Dosage: 300 MG, QW | Form: Solution for injection | Indication: Eosinophilic oesophagitis | Action: Withdrawn
Auth#: 761055 | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52a32", "safetyreportid": "25942806", "authoritynumb": null, "companynumb": "US-SA-2025SA311172", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Maternal exposure during pregnancy", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": "761055", "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "300 MG, QW", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": "Eosinophilic oesophagitis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANOFI AVENTIS" }, "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" }
25942823 Type 1
Non-Serious
INFLECTRA
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-CELLTRION INC.-2024US020809
Authority Number
--
Sender Organization
CELLTRION
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
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Off label use (v28.1) Unknown

Drugs (1)

INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 065 | Dosage: -- | Form: Powder for injection | Indication: Pulmonary sarcoidosis | Action: Unknown
Auth#: 125544 | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52a3e", "safetyreportid": "25942823", "authoritynumb": null, "companynumb": "US-CELLTRION INC.-2024US020809", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "INFLECTRA", "drugauthorizationnumb": "125544", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Powder for injection", "drugadministrationroute": "065", "drugindication": "Pulmonary sarcoidosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "CELLTRION" }, "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" }
25942804 Type 1
Serious
XGEVA, CARBOPLATIN, PEMETREXED DISODIUM (+1 more)
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
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-AMGEN-CHNSP2025204711
Authority Number
--
Sender Organization
AMGEN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
73.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
70.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Granulocyte count decreased (v28.1) Unknown

Drugs (4)

XGEVA (DENOSUMAB) Suspect
Route: 040 | Dosage: 120 MILLIGRAM, QD | Form: Solution for injection | Indication: Lung neoplasm malignant | Action: Withdrawn
Auth#: 125320 | Batch#: 1173500 | Structured Dosage: 120.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/19/2025 | End: 08/19/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
CARBOPLATIN (CARBOPLATIN) Suspect
Route: 040 | Dosage: 550 MILLIGRAM, QD | Form: Injection | Indication: Lung neoplasm malignant | Action: --
Auth#: -- | Batch#: AB1J4031 | Structured Dosage: 550.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/19/2025 | End: 08/19/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
PEMETREXED DISODIUM (PEMETREXED DISODIUM) Suspect
Route: 040 | Dosage: 800 MILLIGRAM, QD | Form: INJECTION, POWDER, FOR SOLUTION | Indication: Lung neoplasm malignant | Action: --
Auth#: -- | Batch#: 4H0015B34 | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/19/2025 | End: 08/19/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
BEVACIZUMAB (BEVACIZUMAB) Suspect
Route: 040 | Dosage: 500 MILLIGRAM, QD | Form: Injection | Indication: Lung neoplasm malignant | Action: --
Auth#: -- | Batch#: H0402B03 | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/19/2025 | End: 08/19/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

NMPACDR: 2101021025837202501554

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52a30", "safetyreportid": "25942804", "authoritynumb": null, "companynumb": "CN-AMGEN-CHNSP2025204711", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 73.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 70.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Granulocyte count decreased", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "XGEVA", "drugauthorizationnumb": "125320", "drugbatchnumb": "1173500", "drugstructuredosagenumb": 120.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "120 MILLIGRAM, QD", "drugdosageform": "Solution for injection", "drugadministrationroute": "040", "drugindication": "Lung neoplasm malignant", "drugstartdateformat": "102", "drugstartdate": "2025-08-19T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-19T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "DENOSUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CARBOPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": "AB1J4031", "drugstructuredosagenumb": 550.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "550 MILLIGRAM, QD", "drugdosageform": "Injection", "drugadministrationroute": "040", "drugindication": "Lung neoplasm malignant", "drugstartdateformat": "102", "drugstartdate": "2025-08-19T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-19T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CARBOPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PEMETREXED DISODIUM", "drugauthorizationnumb": null, "drugbatchnumb": "4H0015B34", "drugstructuredosagenumb": 800.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "800 MILLIGRAM, QD", "drugdosageform": "INJECTION, POWDER, FOR SOLUTION", "drugadministrationroute": "040", "drugindication": "Lung neoplasm malignant", "drugstartdateformat": "102", "drugstartdate": "2025-08-19T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-19T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PEMETREXED DISODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BEVACIZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": "H0402B03", "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MILLIGRAM, QD", "drugdosageform": "Injection", "drugadministrationroute": "040", "drugindication": "Lung neoplasm malignant", "drugstartdateformat": "102", "drugstartdate": "2025-08-19T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-19T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "BEVACIZUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "NMPACDR", "duplicatenumb": "2101021025837202501554" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "AMGEN" }, "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" }
25942802 Type 2
Serious
RINVOQ
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/18/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Consumer
Literature Reference
--
Company Number
CA-ABBVIE-6510907
Authority Number
--
Sender Organization
ABBVIE
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
Elderly
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (1)

RINVOQ (UPADACITINIB) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Rheumatoid arthritis | Action: Not Applicable
Auth#: 211675 | Batch#: 1262601 | Structured Dosage: 15.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52a2e", "safetyreportid": "25942802", "authoritynumb": null, "companynumb": "CA-ABBVIE-6510907", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 6, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "RINVOQ", "drugauthorizationnumb": "211675", "drugbatchnumb": "1262601", "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Rheumatoid arthritis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "UPADACITINIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ABBVIE" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }