FDA FAERS Adverse Event Reports

110500
Total Reports
60546
Serious Reports
108
Reporter Countries
Clear
25966783 Type 2
Non-Serious
QINLOCK, QINLOCK
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-DECIPHERA PHARMACEUTICALS LLC-2025US001258
Authority Number
--
Sender Organization
DECIPHERA PHARMACEUTICALS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
90.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
78.785 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Arthritis (v28.1) Unknown

Drugs (2)

QINLOCK (RIPRETINIB) Suspect
Route: -- | Dosage: 150 MILLIGRAM, QD | Form: -- | Indication: Malignant connective tissue neoplasm | Action: Unknown
Auth#: 213973 | Batch#: 2057195 | Structured Dosage: 150.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/29/2024 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
QINLOCK (RIPRETINIB) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Soft tissue sarcoma | Action: Unknown
Auth#: 213973 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974faa8e900fe3f48c4d9b", "safetyreportid": "25966783", "authoritynumb": null, "companynumb": "US-DECIPHERA PHARMACEUTICALS LLC-2025US001258", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 90.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 78.785, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Arthritis", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "QINLOCK", "drugauthorizationnumb": "213973", "drugbatchnumb": "2057195", "drugstructuredosagenumb": 150.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "150 MILLIGRAM, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Malignant connective tissue neoplasm", "drugstartdateformat": "102", "drugstartdate": "2024-08-29T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RIPRETINIB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "QINLOCK", "drugauthorizationnumb": "213973", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Soft tissue sarcoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RIPRETINIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "DECIPHERA PHARMACEUTICALS" }, "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" }
25966782 Type 1
Non-Serious
BRUKINSA
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-BEIGENE-BGN-2025-017355
Authority Number
--
Sender Organization
BEIGENE
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)

Haemoglobin decreased (v28.1) Unknown

Drugs (1)

BRUKINSA (ZANUBRUTINIB) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Waldenstrom^s macroglobulinaemia | Action: Unknown
Auth#: 213217 | Batch#: -- | 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": "69974faa8e900fe3f48c4d9a", "safetyreportid": "25966782", "authoritynumb": null, "companynumb": "US-BEIGENE-BGN-2025-017355", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Haemoglobin decreased", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BRUKINSA", "drugauthorizationnumb": "213217", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Waldenstrom^s macroglobulinaemia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ZANUBRUTINIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BEIGENE" }, "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" }
25966774 Type 1
Non-Serious
BIMZELX, ADDERALL, EFFEXOR (+22 more)
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-UCBSA-2025034788
Authority Number
--
Sender Organization
UCB
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
102.95 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Disturbance in attention (v28.1) Unknown

Drugs (25)

BIMZELX (BIMEKIZUMAB-BKZX) Suspect
Route: -- | Dosage: 160 MILLIGRAM, EV 4 WEEKS | Form: Solution for injection in pre-filled pen | Indication: Ankylosing spondylitis | Action: Unknown
Auth#: 761151 | Batch#: 418892 | Structured Dosage: 160.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 4.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ADDERALL (AMPHETAMINE ASPARTATE\AMPHETAMINE SULFATE\DEXTROAMPHETAMINE SACCHARATE\DEXTROAMPHETAMINE SULFATE) Concomitant
Route: -- | Dosage: 20 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR (VENLAFAXINE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 37.5 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 37.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VITAMIN B6 (PYRIDOXINE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 100 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CEQUA (CYCLOSPORINE) Concomitant
Route: -- | Dosage: 0.09 PERCENT DROP PER RATE | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 0.09 (unit: 030) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VITAMIN D2 (ERGOCALCIFEROL) Concomitant
Route: -- | Dosage: 1250 MICROGRAM | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1250.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
GEMTESA (VIBEGRON) Concomitant
Route: -- | Dosage: 75 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CYTOMEL (LIOTHYRONINE SODIUM) Concomitant
Route: -- | Dosage: 25 MICROGRAM | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 25.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DESONIDE (DESONIDE) Concomitant
Route: -- | Dosage: 0.05 PERCENT | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 0.05 (unit: 030) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
GABAPENTIN (GABAPENTIN) Concomitant
Route: -- | Dosage: 100 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LIPITOR (ATORVASTATIN CALCIUM) Concomitant
Route: -- | Dosage: 10 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MELATONIN (MELATONIN) Concomitant
Route: -- | Dosage: 10 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MIRALAX (POLYETHYLENE GLYCOL 3350) Concomitant
Route: -- | Dosage: 17 GRAM POWDER PACK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 17.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OZEMPIC (SEMAGLUTIDE) Concomitant
Route: -- | Dosage: .25 OR 0.5 | Form: Solution for injection in pre-filled pen | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OXYCODONE (OXYCODONE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PREDNISOLONE (PREDNISOLONE) Concomitant
Route: -- | Dosage: 15 MG/5ML SOLUTION | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
QVAR (BECLOMETHASONE DIPROPIONATE) Concomitant
Route: -- | Dosage: 40 MICROGRAM HFA AEROBA | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ROBAXIN (METHOCARBAMOL) Concomitant
Route: -- | Dosage: 100 MG/ML VIAL | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SOOLANTRA (IVERMECTIN) Concomitant
Route: -- | Dosage: 1 PERCENT | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 030) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SINGULAIR (MONTELUKAST SODIUM) Concomitant
Route: -- | Dosage: 10 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SYSTANE ULTRA (POLYETHYLENE GLYCOL 400\PROPYLENE GLYCOL) Concomitant
Route: -- | Dosage: 0.3% TO 0.4% DROPS | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TAZAROTENE (TAZAROTENE) Concomitant
Route: -- | Dosage: 0.1 PERCENT | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 0.1 (unit: 030) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TIROSINT (LEVOTHYROXINE SODIUM) Concomitant
Route: -- | Dosage: 13 MCG/ML SOLUTION | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
XOPENEX (LEVALBUTEROL HYDROCHLORIDE) Concomitant
Route: -- | Dosage: HFA 45 MCG HFA AER AD, | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VITAMIN B12 (CYANOCOBALAMIN) Concomitant
Route: -- | Dosage: 2500 MICROGRAM | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2500.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974faa8e900fe3f48c4d99", "safetyreportid": "25966774", "authoritynumb": null, "companynumb": "US-UCBSA-2025034788", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": null, "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": 102.95, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Disturbance in attention", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BIMZELX", "drugauthorizationnumb": "761151", "drugbatchnumb": "418892", "drugstructuredosagenumb": 160.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 4.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "160 MILLIGRAM, EV 4 WEEKS", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": null, "drugindication": "Ankylosing spondylitis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "BIMEKIZUMAB-BKZX" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ADDERALL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "AMPHETAMINE ASPARTATE\\AMPHETAMINE SULFATE\\DEXTROAMPHETAMINE SACCHARATE\\DEXTROAMPHETAMINE SULFATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "EFFEXOR", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 37.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "37.5 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "VENLAFAXINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VITAMIN B6", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PYRIDOXINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CEQUA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 0.09, "drugstructuredosageunit": "030", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.09 PERCENT DROP PER RATE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CYCLOSPORINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VITAMIN D2", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1250.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1250 MICROGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ERGOCALCIFEROL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "GEMTESA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 75.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "75 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "VIBEGRON" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CYTOMEL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 25.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "25 MICROGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LIOTHYRONINE SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DESONIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 0.05, "drugstructuredosageunit": "030", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.05 PERCENT", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DESONIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "GABAPENTIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "GABAPENTIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LIPITOR", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MELATONIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "MELATONIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MIRALAX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 17.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "17 GRAM POWDER PACK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "POLYETHYLENE GLYCOL 3350" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OZEMPIC", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": ".25 OR 0.5", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SEMAGLUTIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OXYCODONE", "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": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "OXYCODONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PREDNISOLONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "15 MG/5ML SOLUTION", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PREDNISOLONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "QVAR", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MICROGRAM HFA AEROBA", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "BECLOMETHASONE DIPROPIONATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ROBAXIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MG/ML VIAL", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "METHOCARBAMOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SOOLANTRA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "030", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 PERCENT", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "IVERMECTIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SINGULAIR", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "MONTELUKAST SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SYSTANE ULTRA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.3% TO 0.4% DROPS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "POLYETHYLENE GLYCOL 400\\PROPYLENE GLYCOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TAZAROTENE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 0.1, "drugstructuredosageunit": "030", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.1 PERCENT", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TAZAROTENE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TIROSINT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "13 MCG/ML SOLUTION", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LEVOTHYROXINE SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "XOPENEX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "HFA 45 MCG HFA AER AD,", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LEVALBUTEROL HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VITAMIN B12", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2500.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2500 MICROGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CYANOCOBALAMIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "UCB" }, "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" }
25966781 Type 1
Serious
EYLEA
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
CO
Occurrence Country
CO
Reporter Country
CO
Reporter Qualification
Consumer
Literature Reference
--
Company Number
CO-BAYER-2025A140789
Authority Number
--
Sender Organization
REGENERON
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
60.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Cardiac disorder (v28.1) Unknown
Retinal detachment (v28.1) Unknown
Retinal tear (v28.1) Unknown

Drugs (1)

EYLEA (AFLIBERCEPT) Suspect
Route: 031 | Dosage: 40 MG, Q1MON, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, 40 MG/ML | Form: Injection | Indication: Macular degeneration | Action: Unknown
Auth#: 125387 | Batch#: Unknown | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: 09/12/2025 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250901

Report Duplicates (2)

BAYER: CO-BAYER-2025A140789
IMA 2019M-0013274: INVIMA 2019M-0013274-R1

Raw JSON (click to expand)

{ "_id": "69974faa8e900fe3f48c4d98", "safetyreportid": "25966781", "authoritynumb": null, "companynumb": "CO-BAYER-2025A140789", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CO", "patient": { "patientonsetage": 60.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cardiac disorder", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Retinal detachment", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Retinal tear", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "EYLEA", "drugauthorizationnumb": "125387", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 802, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MG, Q1MON, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, 40 MG/ML", "drugdosageform": "Injection", "drugadministrationroute": "031", "drugindication": "Macular degeneration", "drugstartdateformat": "102", "drugstartdate": "2025-09-12T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "AFLIBERCEPT" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250901" }, "primarysource": { "reportercountry": "CO", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "CO", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "BAYER", "duplicatenumb": "CO-BAYER-2025A140789" }, { "duplicatesource": "IMA 2019M-0013274", "duplicatenumb": "INVIMA 2019M-0013274-R1" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "REGENERON" }, "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" }
25966779 Type 1
Non-Serious
BIMZELX
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-UCBSA-2025034598
Authority Number
--
Sender Organization
UCB
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
29.0 yr
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Product dose omission issue (v28.1) Unknown
Inappropriate schedule of product administration (v28.1) Unknown

Drugs (1)

BIMZELX (BIMEKIZUMAB-BKZX) Suspect
Route: -- | Dosage: 320 MILLIGRAM, EV 2 WEEKS(QOW) | Form: Solution for injection in pre-filled pen | Indication: Hidradenitis | Action: Not Applicable
Auth#: 761151 | Batch#: -- | Structured Dosage: 320.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: 4
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974faa8e900fe3f48c4d97", "safetyreportid": "25966779", "authoritynumb": null, "companynumb": "US-UCBSA-2025034598", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": null, "patient": { "patientonsetage": 29.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product dose omission issue", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Inappropriate schedule of product administration", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BIMZELX", "drugauthorizationnumb": "761151", "drugbatchnumb": null, "drugstructuredosagenumb": 320.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "320 MILLIGRAM, EV 2 WEEKS(QOW)", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": null, "drugindication": "Hidradenitis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "BIMEKIZUMAB-BKZX" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "UCB" }, "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" }
25966778 Type 1
Non-Serious
BIMZELX
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-UCBSA-2025034595
Authority Number
--
Sender Organization
UCB
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
77.04 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Pain (v28.1) Unknown
Swelling (v28.1) Unknown

Drugs (1)

BIMZELX (BIMEKIZUMAB-BKZX) Suspect
Route: -- | Dosage: 160 MILLIGRAM, EV 4 WEEKS | Form: Solution for injection in pre-filled syringe | Indication: Psoriatic arthropathy | Action: Unknown
Auth#: 761151 | Batch#: 412019 | Structured Dosage: 160.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 4.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974faa8e900fe3f48c4d96", "safetyreportid": "25966778", "authoritynumb": null, "companynumb": "US-UCBSA-2025034595", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": null, "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": 77.04, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pain", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Swelling", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BIMZELX", "drugauthorizationnumb": "761151", "drugbatchnumb": "412019", "drugstructuredosagenumb": 160.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 4.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "160 MILLIGRAM, EV 4 WEEKS", "drugdosageform": "Solution for injection in pre-filled syringe", "drugadministrationroute": null, "drugindication": "Psoriatic arthropathy", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "BIMEKIZUMAB-BKZX" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "UCB" }, "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" }
25966777 Type 1
Non-Serious
BIMZELX
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-UCBSA-2025034583
Authority Number
--
Sender Organization
UCB
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
61.0 yr
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Device leakage (v28.1) Unknown
Product dose omission issue (v28.1) Unknown

Drugs (1)

BIMZELX (BIMEKIZUMAB-BKZX) Suspect
Route: -- | Dosage: 320 MILLIGRAM, EV 2 WEEKS(QOW) | Form: Solution for injection in pre-filled pen | Indication: Hidradenitis | Action: Not Applicable
Auth#: 761151 | Batch#: 412199 | Structured Dosage: 320.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: 4
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974faa8e900fe3f48c4d95", "safetyreportid": "25966777", "authoritynumb": null, "companynumb": "US-UCBSA-2025034583", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": null, "patient": { "patientonsetage": 61.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device leakage", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product dose omission issue", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BIMZELX", "drugauthorizationnumb": "761151", "drugbatchnumb": "412199", "drugstructuredosagenumb": 320.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "320 MILLIGRAM, EV 2 WEEKS(QOW)", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": null, "drugindication": "Hidradenitis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "BIMEKIZUMAB-BKZX" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "UCB" }, "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" }
25966776 Type 1
Non-Serious
BIMZELX
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-UCBSA-2025034562
Authority Number
--
Sender Organization
UCB
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
54.0 yr
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Injection site pain (v28.1) Recovered
Fatigue (v28.1) Unknown
Hidradenitis (v28.1) Recovered
Oropharyngeal pain (v28.1) Recovered

Drugs (1)

BIMZELX (BIMEKIZUMAB-BKZX) Suspect
Route: -- | Dosage: 320 MILLIGRAM, EV 2 WEEKS(QOW) | Form: Solution for injection in pre-filled pen | Indication: Hidradenitis | Action: Dose Not Changed
Auth#: 761151 | Batch#: -- | Structured Dosage: 320.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974faa8e900fe3f48c4d94", "safetyreportid": "25966776", "authoritynumb": null, "companynumb": "US-UCBSA-2025034562", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": null, "patient": { "patientonsetage": 54.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Injection site pain", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hidradenitis", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Oropharyngeal pain", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BIMZELX", "drugauthorizationnumb": "761151", "drugbatchnumb": null, "drugstructuredosagenumb": 320.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "320 MILLIGRAM, EV 2 WEEKS(QOW)", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": null, "drugindication": "Hidradenitis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "BIMEKIZUMAB-BKZX" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "UCB" }, "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" }
25966775 Type 1
Non-Serious
BIMZELX
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-UCBSA-2025034561
Authority Number
--
Sender Organization
UCB
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
67.0 yr
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Rash erythematous (v28.1) Not Recovered
Pruritus (v28.1) Not Recovered
Rhinorrhoea (v28.1) Not Recovered
Cough (v28.1) Not Recovered
Ear pain (v28.1) Not Recovered

Drugs (1)

BIMZELX (BIMEKIZUMAB-BKZX) Suspect
Route: -- | Dosage: 160 MILLIGRAM, EV 4 WEEKS | Form: Solution for injection in pre-filled syringe | Indication: Psoriatic arthropathy | Action: Dose Not Changed
Auth#: 761151 | Batch#: -- | Structured Dosage: 160.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 4.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974faa8e900fe3f48c4d93", "safetyreportid": "25966775", "authoritynumb": null, "companynumb": "US-UCBSA-2025034561", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": null, "patient": { "patientonsetage": 67.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rash erythematous", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pruritus", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rhinorrhoea", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cough", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Ear pain", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BIMZELX", "drugauthorizationnumb": "761151", "drugbatchnumb": null, "drugstructuredosagenumb": 160.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 4.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "160 MILLIGRAM, EV 4 WEEKS", "drugdosageform": "Solution for injection in pre-filled syringe", "drugadministrationroute": null, "drugindication": "Psoriatic arthropathy", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "BIMEKIZUMAB-BKZX" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "UCB" }, "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" }
25966773 Type 1
Non-Serious
BIMZELX
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-UCBSA-2025034556
Authority Number
--
Sender Organization
UCB
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
61.0 yr
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Pharyngeal disorder (v28.1) Unknown
Gastrointestinal pain (v28.1) Unknown

Drugs (1)

BIMZELX (BIMEKIZUMAB-BKZX) Suspect
Route: -- | Dosage: 320 MILLIGRAM, EV 2 WEEKS(QOW) | Form: Solution for injection in pre-filled pen | Indication: Hidradenitis | Action: Withdrawn
Auth#: 761151 | Batch#: -- | Structured Dosage: 320.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974faa8e900fe3f48c4d92", "safetyreportid": "25966773", "authoritynumb": null, "companynumb": "US-UCBSA-2025034556", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": null, "patient": { "patientonsetage": 61.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pharyngeal disorder", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gastrointestinal pain", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BIMZELX", "drugauthorizationnumb": "761151", "drugbatchnumb": null, "drugstructuredosagenumb": 320.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "320 MILLIGRAM, EV 2 WEEKS(QOW)", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": null, "drugindication": "Hidradenitis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "BIMEKIZUMAB-BKZX" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "UCB" }, "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" }