FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25936537 Type 1
Serious
ADALIMUMAB, ADALIMUMAB, ADALIMUMAB (+16 more)
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/19/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-002147023-PHHY2016US038118
Authority Number
--
Sender Organization
SANDOZ
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
27.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (10)

Mycobacterium marinum infection (v28.1) Recovered
Erythema (v28.1) Recovering
Skin ulcer (v28.1) Recovering
Face oedema (v28.1) Recovering
Pyrexia (v28.1) Recovering
Nodule (v28.1) Recovering
Swelling (v28.1) Recovering
Erythema induratum (v28.1) Recovering
Drug ineffective (v28.1) Unknown
Product use in unapproved indication (v28.1) Unknown

Drugs (19)

ADALIMUMAB (ADALIMUMAB) Suspect
Route: 065 | Dosage: 1 MG, QW | Form: Unknown | Indication: Product used for unknown indication | Action: Dose Increased
Auth#: 761071 | Batch#: -- | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ADALIMUMAB (ADALIMUMAB) Suspect
Route: 058 | Dosage: 40 MG, QW | Form: Unknown | Indication: -- | Action: Dose Increased
Auth#: 761071 | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ADALIMUMAB (ADALIMUMAB) Suspect
Route: 065 | Dosage: UNK | Form: Unknown | Indication: -- | Action: Dose Increased
Auth#: 761071 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CYCLOSPORINE (CYCLOSPORINE) Suspect
Route: 065 | Dosage: 100 MG IN THE MORNING | Form: Unknown | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
CYCLOSPORINE (CYCLOSPORINE) Suspect
Route: 065 | Dosage: 125 MG IN THE EVENING | Form: Unknown | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 125.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
CYCLOSPORINE (CYCLOSPORINE) Suspect
Route: 065 | Dosage: 225 MG (100 MG IN THE MORNING AND 125 MG IN THE EVENING) | Form: Unknown | Indication: Immunosuppression | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 225.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
CYCLOSPORINE (CYCLOSPORINE) Suspect
Route: 065 | Dosage: UNK | Form: Unknown | Indication: Crohn^s disease | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
CERTOLIZUMAB PEGOL (CERTOLIZUMAB PEGOL) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 10 MG/KG, QMO | Form: Powder for concentrate for solution for infusion | Indication: Immunosuppression | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 065 | Dosage: 10 MG/KG, EVERY 4 WEEKS | Form: Powder for concentrate for solution for infusion | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: 4.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 10 MG/KG, EVERY 6 WEEKS | Form: Powder for concentrate for solution for infusion | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 065 | Dosage: 15 MG/KG | Form: Powder for concentrate for solution for infusion | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 15.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: UNK | Form: Powder for concentrate for solution for infusion | Indication: Crohn^s disease | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
METHOTREXATE (METHOTREXATE) Suspect
Route: 065 | Dosage: UNK | Form: Unknown | Indication: Crohn^s disease | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
TACROLIMUS (TACROLIMUS) Suspect
Route: 061 | Dosage: UNK | Form: Unknown | Indication: Crohn^s disease | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
DAPSONE (DAPSONE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | 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: --
METHYLPREDNISOLONE (METHYLPREDNISOLONE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Oropharyngeal pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREDNISONE (PREDNISONE) Concomitant
Route: 065 | Dosage: 10 MG | Form: -- | Indication: Crohn^s disease | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20140501

Report Duplicates (7)

MLMSERVICE: US-MLMSERVICE-20161122-0510706-1
EMA: US-EMA-DD-20181022-aksevhumanp-101209
MLMSERVICE: US-MLMSERVICE-20161122-0510706-1
NOVPHSZ: US-NOVPHSZ-PHHY2016US038118
MLMSERVICE: US-MLMSERVICE-20161122-0510706-1
TEVA: US-TEVA-650060USA
MLMSERVICE: US-MLMSERVICE-20160601-0302724-1

Raw JSON (click to expand)

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"drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "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": "DAPSONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METHYLPREDNISOLONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Oropharyngeal pain", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "METHYLPREDNISOLONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PREDNISONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MG", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Crohn^s disease", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "PREDNISONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SULFAMETHOXAZOLE\\TRIMETHOPRIM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20140501" }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MLMSERVICE", "duplicatenumb": "US-MLMSERVICE-20161122-0510706-1" }, { "duplicatesource": "EMA", "duplicatenumb": "US-EMA-DD-20181022-aksevhumanp-101209" }, { "duplicatesource": "MLMSERVICE", "duplicatenumb": "US-MLMSERVICE-20161122-0510706-1" }, { "duplicatesource": "NOVPHSZ", "duplicatenumb": "US-NOVPHSZ-PHHY2016US038118" }, { "duplicatesource": "MLMSERVICE", "duplicatenumb": "US-MLMSERVICE-20161122-0510706-1" }, { "duplicatesource": "TEVA", "duplicatenumb": "US-TEVA-650060USA" }, { "duplicatesource": "MLMSERVICE", "duplicatenumb": "US-MLMSERVICE-20160601-0302724-1" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANDOZ" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-19T00:00:00", "transmissiondateformat": "102" }
25936535 Type 1
Serious
TAMSULOSIN
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/17/2026
Primary Source Country
GB
Occurrence Country
GB
Reporter Country
GB
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
--
Authority Number
GB-MHRA-MED-202510151336426470-LPJQZ
Sender Organization
SANDOZ
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
60.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Erectile dysfunction (v28.1) Recovered

Drugs (1)

TAMSULOSIN (TAMSULOSIN) Suspect
Route: 065 | Dosage: UNK | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown
Auth#: 78015 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250516

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435343b3830196fa5101d", "safetyreportid": "25936535", "authoritynumb": "GB-MHRA-MED-202510151336426470-LPJQZ", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": 60.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Erectile dysfunction", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TAMSULOSIN", "drugauthorizationnumb": "78015", "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": "TAMSULOSIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250516" }, "primarysource": { "reportercountry": "GB", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANDOZ" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25936533 Type 1
Non-Serious
ELIQUIS
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-BRISTOL-MYERS SQUIBB COMPANY-2025-142402
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
82.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Nasal obstruction (v28.1) Unknown

Drugs (1)

ELIQUIS (APIXABAN) Suspect
Route: -- | Dosage: -- | Form: Film-coated tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: 202155 | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.5 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251015

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435343b3830196fa5101c", "safetyreportid": "25936533", "authoritynumb": null, "companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-2025-142402", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 82.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nasal obstruction", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ELIQUIS", "drugauthorizationnumb": "202155", "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.5, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Film-coated tablet", "drugadministrationroute": null, "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": "APIXABAN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251015" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BRISTOL-MYERS SQUIBB COMPANY" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25936532 Type 1
Non-Serious
PREGABALIN, Avostatin, HZTZ (+6 more)
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
--
Authority Number
782210
Sender Organization
FDA-CTU
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
3
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
76.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
89145.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Middle insomnia (v28.1) --
Feeling drunk (v28.1) --
Balance disorder (v28.1) --
Visual impairment (v28.1) --
Hangover (v28.1) --
Gait disturbance (v28.1) --

Drugs (9)

PREGABALIN (PREGABALIN) Suspect
Route: 048 | Dosage: OTHER QUANTITY : 90 CAPSULE(S);?FREQUENCY : EVERY 8 HOURS;? | Form: Capsule | Indication: Pain | Action: --
Auth#: -- | Batch#: 257998769273 | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 8.0 hr | Cumulative: -- (unit: --)
Start: 10/17/2025 | End: 10/17/2025 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
Avostatin (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
HZTZ (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VITAMINS (VITAMINS) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
poly glycerin (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LOW-DOSE ASPIRIN (ASPIRIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
COENZYME Q10 (DIETARY SUPPLEMENT\UBIDECARENONE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
B12 (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MAGNESIUM CITRATE (MAGNESIUM CITRATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251017

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435343b3830196fa5101b", "safetyreportid": "25936532", "authoritynumb": "782210", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 76.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 89145.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Middle insomnia", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Feeling drunk", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Balance disorder", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Visual impairment", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hangover", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gait disturbance", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PREGABALIN", "drugauthorizationnumb": null, "drugbatchnumb": "257998769273", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 8.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "OTHER QUANTITY : 90 CAPSULE(S);?FREQUENCY : EVERY 8 HOURS;?", "drugdosageform": "Capsule", "drugadministrationroute": "048", "drugindication": "Pain", "drugstartdateformat": "102", "drugstartdate": "2025-10-17T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-17T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": null, "activesubstance": { "activesubstancename": "PREGABALIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Avostatin", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "HZTZ", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VITAMINS", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "VITAMINS" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "poly glycerin", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LOW-DOSE ASPIRIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ASPIRIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "COENZYME Q10", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DIETARY SUPPLEMENT\\UBIDECARENONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "B12", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MAGNESIUM CITRATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "MAGNESIUM CITRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251017" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "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" }
25936530 Type 1
Serious
DUPIXENT
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/19/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
--
Authority Number
FDA-CDER-CTU-2025-70573
Sender Organization
FDA-CTU
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
3
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
77.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
76.7 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Weight increased (v28.1) --

Drugs (1)

DUPIXENT (DUPILUMAB) Suspect
Route: 058 | Dosage: OTHER FREQUENCY : EVERY 14 DAYS;? | Form: -- | Indication: Chronic obstructive pulmonary disease | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/23/2024 | End: 10/07/2025 | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251007

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435343b3830196fa5101a", "safetyreportid": "25936530", "authoritynumb": "FDA-CDER-CTU-2025-70573", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 77.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 76.7, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Weight increased", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "OTHER FREQUENCY : EVERY 14 DAYS;?", "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Chronic obstructive pulmonary disease", "drugstartdateformat": "102", "drugstartdate": "2024-03-23T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-07T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251007" }, "primarysource": { "reportercountry": "US", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-19T00:00:00", "transmissiondateformat": "102" }
25936529 Type 1
Serious
DOXYCYCLINE
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
--
Literature Reference
--
Company Number
--
Authority Number
FDA-CDER-CTU-2025-70572
Sender Organization
FDA-CTU
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
3
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
46.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
77.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Anxiety (v28.1) --

Drugs (1)

DOXYCYCLINE (DOXYCYCLINE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250716

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435343b3830196fa51019", "safetyreportid": "25936529", "authoritynumb": "FDA-CDER-CTU-2025-70572", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 46.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 77.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anxiety", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DOXYCYCLINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DOXYCYCLINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250716" }, "primarysource": { "reportercountry": "US", "qualification": null, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25936528 Type 1
Serious
KEVZARA, AMLODIPINE, ASPIRIN (+3 more)
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
--
Authority Number
FDA-CDER-CTU-2025-70571
Sender Organization
FDA-CTU
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
3
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
63.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
81.33 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Pneumonia (v28.1) --

Drugs (6)

KEVZARA (SARILUMAB) Suspect
Route: 058 | Dosage: OTHER FREQUENCY : EVERY 14 DAYS;? | Form: -- | Indication: Rheumatoid arthritis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/06/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
AMLODIPINE (AMLODIPINE BESYLATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ASPIRIN (ASPIRIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LOSARTAN (LOSARTAN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
HYDROXYCHLOROQUINE (HYDROXYCHLOROQUINE) 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

CASE EVENT DATE: 20251015

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435343b3830196fa51018", "safetyreportid": "25936528", "authoritynumb": "FDA-CDER-CTU-2025-70571", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 63.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 81.33, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pneumonia", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "KEVZARA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "OTHER FREQUENCY : EVERY 14 DAYS;?", "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Rheumatoid arthritis", "drugstartdateformat": "102", "drugstartdate": "2025-05-06T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": null, "activesubstance": { "activesubstancename": "SARILUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AMLODIPINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ASPIRIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ASPIRIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LOSARTAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LOSARTAN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "HYDROXYCHLOROQUINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "HYDROXYCHLOROQUINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PREDNISONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PREDNISONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251015" }, "primarysource": { "reportercountry": "US", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25936524 Type 1
Serious
ORIAHNN
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/19/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
--
Authority Number
782204
Sender Organization
FDA-CTU
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
3
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
50.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Blood pressure increased (v28.1) --
Therapy cessation (v28.1) --

Drugs (1)

ORIAHNN (ELAGOLIX SODIUM\ESTRADIOL\NORETHINDRONE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Uterine leiomyoma | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/13/2025 | End: 10/17/2025 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251017

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435343b3830196fa51017", "safetyreportid": "25936524", "authoritynumb": "782204", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 50.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood pressure increased", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Therapy cessation", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ORIAHNN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Uterine leiomyoma", "drugstartdateformat": "102", "drugstartdate": "2025-08-13T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-17T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": null, "activesubstance": { "activesubstancename": "ELAGOLIX SODIUM\\ESTRADIOL\\NORETHINDRONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251017" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-19T00:00:00", "transmissiondateformat": "102" }
25936523 Type 1
Non-Serious
ZEPBOUND
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
--
Authority Number
782207
Sender Organization
FDA-CTU
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
3
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Therapeutic response changed (v28.1) --

Drugs (1)

ZEPBOUND (TIRZEPATIDE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251016

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435343b3830196fa51016", "safetyreportid": "25936523", "authoritynumb": "782207", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Therapeutic response changed", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": null, "drugbatchnumb": "unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251016" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "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" }
25936522 Type 1
Non-Serious
OLMESARTAN, KEPPRA, Ingeva
Report Version
1
Receive Date
10/17/2025
Receipt Date
10/17/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
--
Authority Number
782201
Sender Organization
FDA-CTU
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
3
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
73.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
67.5 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Muscular weakness (v28.1) --
Gait inability (v28.1) --

Drugs (3)

OLMESARTAN (OLMESARTAN) Suspect
Route: 048 | Dosage: OTHER QUANTITY : 1 TABLET(S);?FREQUENCY : DAILY;? | Form: -- | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 6.0 min | Rechallenge: -- | Additional: --
Recurrences: --
KEPPRA (LEVETIRACETAM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
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Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Ingeva (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250417

Report Duplicates (0)

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Raw JSON (click to expand)

{ "_id": "69d435343b3830196fa51015", "safetyreportid": "25936522", "authoritynumb": "782201", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 73.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 67.5, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Muscular weakness", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gait inability", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "OLMESARTAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "OTHER QUANTITY : 1 TABLET(S);?FREQUENCY : DAILY;?", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Hypertension", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 6.0, "drugtreatmentdurationunit": 806, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "OLMESARTAN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "KEPPRA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LEVETIRACETAM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Ingeva", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250417" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "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" }