FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25940850 Type 1
Non-Serious
LANTUS SOLOSTAR
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-SANOFI-02692985
Authority Number
--
Sender Organization
SANOFI AVENTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Product dispensing error (v28.1) Unknown

Drugs (1)

LANTUS SOLOSTAR (INSULIN GLARGINE) Suspect
Route: -- | Dosage: UNK | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: 021081 | Batch#: 4F9842A | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

SANOFI: US-SANOFI-02692985

Raw JSON (click to expand)

{ "_id": "69d4354e3b3830196fa521db", "safetyreportid": "25940850", "authoritynumb": null, "companynumb": "US-SANOFI-02692985", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product dispensing error", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "LANTUS SOLOSTAR", "drugauthorizationnumb": "021081", "drugbatchnumb": "4F9842A", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Solution for injection", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "INSULIN GLARGINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "SANOFI", "duplicatenumb": "US-SANOFI-02692985" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANOFI AVENTIS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25940846 Type 1
Serious
MIRTAZAPINE, MEMANTINE, ALENDRONIC ACID (+3 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
GB
Occurrence Country
--
Reporter Country
GB
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
--
Authority Number
GB-MHRA-MED-202510141607062430-NTZQJ
Sender Organization
ORGANON
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
77.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Pancytopenia (v28.1) Not Recovered
Myelodysplastic syndrome (v28.1) Not Recovered

Drugs (6)

MIRTAZAPINE (MIRTAZAPINE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: 20415 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
MEMANTINE (MEMANTINE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ALENDRONIC ACID (ALENDRONIC ACID) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
APIXABAN (APIXABAN) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ENOXAPARIN SODIUM (ENOXAPARIN SODIUM) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FOLIC ACID (FOLIC ACID) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4354e3b3830196fa521d8", "safetyreportid": "25940846", "authoritynumb": "GB-MHRA-MED-202510141607062430-NTZQJ", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": null, "patient": { "patientonsetage": 77.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pancytopenia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Myelodysplastic syndrome", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MIRTAZAPINE", "drugauthorizationnumb": "20415", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "MIRTAZAPINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MEMANTINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "MEMANTINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ALENDRONIC ACID", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ALENDRONIC ACID" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "APIXABAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "APIXABAN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ENOXAPARIN SODIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ENOXAPARIN SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FOLIC ACID", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FOLIC ACID" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "GB", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ORGANON" }, "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" }
25940845 Type 1
Serious
CANDESARTAN, DESYREL, DIHYDROERGOTAMINE (+31 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CA-AstraZeneca-2020SF02720
Authority Number
--
Sender Organization
ANI
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
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (18)

Diarrhoea (v28.1) Unknown
Neovascularisation (v28.1) Unknown
Paradoxical drug reaction (v28.1) Unknown
Weight decreased (v28.1) Unknown
Drug ineffective (v28.1) Unknown
Treatment failure (v28.1) Unknown
Drug ineffective for unapproved indication (v28.1) Unknown
Product use in unapproved indication (v28.1) Unknown
Off label use (v28.1) Unknown
Product use issue (v28.1) Unknown
Dyspepsia (v28.1) Unknown
Dyspnoea (v28.1) Unknown
Nausea (v28.1) Unknown
Anuria (v28.1) Unknown
Cough (v28.1) Unknown
Abdominal pain (v28.1) Unknown
Extrapyramidal disorder (v28.1) Unknown
Migraine (v28.1) Unknown

Drugs (34)

CANDESARTAN (CANDESARTAN) Suspect
Route: 048 | Dosage: 16 MG QD; 16 MILLIGRAM, UNK | Form: Tablet | Indication: Migraine | Action: Unknown
Auth#: 020838 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
DESYREL (TRAZODONE HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
DIHYDROERGOTAMINE (DIHYDROERGOTAMINE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
GABAPENTIN (GABAPENTIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
LAMICTAL (LAMOTRIGINE) Suspect
Route: 065 | Dosage: -- | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
MAXALT (RIZATRIPTAN BENZOATE) Suspect
Route: 065 | Dosage: -- | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
METOCLOPRAMIDE HYDROCHLORIDE (METOCLOPRAMIDE HYDROCHLORIDE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
NAPROXEN (NAPROXEN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
NARATRIPTAN HYDROCHLORIDE (NARATRIPTAN HYDROCHLORIDE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
NIFEDIPINE (NIFEDIPINE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
NORTRIPTYLINE (NORTRIPTYLINE) Suspect
Route: 065 | Dosage: -- | Form: Capsule | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
ATENOLOL (ATENOLOL) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
PIZOTYLINE (PIZOTYLINE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
PREDNISONE (PREDNISONE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
PROCHLORPERAZINE (PROCHLORPERAZINE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
TOPIRAMATE (TOPIRAMATE) Suspect
Route: 065 | Dosage: 75 MG UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
DIVALPROEX SODIUM (DIVALPROEX SODIUM) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
VERAPAMIL (VERAPAMIL HYDROCHLORIDE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
ZOPICLONE (ZOPICLONE) Suspect
Route: 065 | Dosage: -- | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
FROVATRIPTAN SUCCINATE MONOHYDRATE (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
GRAVOL (DIMENHYDRINATE) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
BOTULINUM TOXIN TYPE A (BOTULINUM TOXIN TYPE A) Concomitant
Route: 065 | Dosage: 20 MG UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
VALPROATE SODIUM (VALPROATE SODIUM) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
TENORMIN (ATENOLOL) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
TYLENOL (ACETAMINOPHEN) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
ALLOPURINOL (ALLOPURINOL) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
PROPRANOLOL (PROPRANOLOL HYDROCHLORIDE) Suspect
Route: 065 | Dosage: 80 MG DAILY / UNK / 40 MG BID / 40 MG DAILY / 40 MG Q12H | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
ELAVIL (AMITRIPTYLINE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: 20 MG UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE) Suspect
Route: 065 | Dosage: 80 MG DAILY / UNK / 40 MG BID / 40 MG DAILY / 40 MG Q12H | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
AIMOVIG (ERENUMAB-AOOE) Suspect
Route: 065 | Dosage: UNKNOWN DOSE AND FREQUENCY/ ERENUMAB GENERIC | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
AMLODIPINE (AMLODIPINE BESYLATE) Suspect
Route: 065 | Dosage: -- | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
CLONIDINE (CLONIDINE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --
CORGARD (NADOLOL) Suspect
Route: 065 | Dosage: -- | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Unknown
Recurrences: --

Clinical Narrative

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Report Duplicates (0)

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Raw JSON (click to expand)

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"reactionmeddrapt": "Drug ineffective for unapproved indication", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product use in unapproved indication", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product use issue", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dyspepsia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anuria", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cough", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Extrapyramidal disorder", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Migraine", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CANDESARTAN", "drugauthorizationnumb": "020838", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "16 MG QD; 16 MILLIGRAM, UNK", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Migraine", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 2, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CANDESARTAN" }, 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"sendertype": 6, "senderorganization": "ANI" }, "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" }
25940842 Type 1
Serious
ROCURONIUM, ROCURONIUM, ROCURONIUM (+13 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
EU-AFSSAPS-PV2025000747
Sender Organization
MYLAN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
45.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
60.5 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Drug ineffective (v28.1) Recovered

Drugs (16)

ROCURONIUM (ROCURONIUM BROMIDE) Suspect
Route: -- | Dosage: 40 MILLIGRAM | Form: -- | Indication: Neuromuscular blocking therapy | Action: Not Applicable
Auth#: 079199 | Batch#: 7609580 | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/22/2025 | End: 09/22/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
ROCURONIUM (ROCURONIUM BROMIDE) Suspect
Route: -- | Dosage: 40 MILLIGRAM | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 079199 | Batch#: 7609580 | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/22/2025 | End: 09/22/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
ROCURONIUM (ROCURONIUM BROMIDE) Suspect
Route: 042 | Dosage: 40 MILLIGRAM | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 079199 | Batch#: 7609580 | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/22/2025 | End: 09/22/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
ROCURONIUM (ROCURONIUM BROMIDE) Suspect
Route: 042 | Dosage: 40 MILLIGRAM | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 079199 | Batch#: 7609580 | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/22/2025 | End: 09/22/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
ROCURONIUM (ROCURONIUM BROMIDE) Suspect
Route: -- | Dosage: 30 MILLIGRAM | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 079199 | Batch#: 7609580 | Structured Dosage: 30.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/22/2025 | End: 09/22/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
ROCURONIUM (ROCURONIUM BROMIDE) Suspect
Route: -- | Dosage: 30 MILLIGRAM | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 079199 | Batch#: 7609580 | Structured Dosage: 30.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/22/2025 | End: 09/22/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
ROCURONIUM (ROCURONIUM BROMIDE) Suspect
Route: 042 | Dosage: 30 MILLIGRAM | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 079199 | Batch#: 7609580 | Structured Dosage: 30.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/22/2025 | End: 09/22/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
ROCURONIUM (ROCURONIUM BROMIDE) Suspect
Route: 042 | Dosage: 30 MILLIGRAM | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 079199 | Batch#: 7609580 | Structured Dosage: 30.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/22/2025 | End: 09/22/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
ROCURONIUM (ROCURONIUM BROMIDE) Suspect
Route: -- | Dosage: 40 MILLIGRAM | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 079199 | Batch#: 7609499 | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/22/2025 | End: 09/22/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
ROCURONIUM (ROCURONIUM BROMIDE) Suspect
Route: 042 | Dosage: 40 MILLIGRAM | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 079199 | Batch#: 7609499 | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/22/2025 | End: 09/22/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
ROCURONIUM (ROCURONIUM BROMIDE) Suspect
Route: -- | Dosage: 40 MILLIGRAM | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 079199 | Batch#: 7609499 | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/22/2025 | End: 09/22/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
ROCURONIUM (ROCURONIUM BROMIDE) Suspect
Route: 042 | Dosage: 40 MILLIGRAM | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 079199 | Batch#: 7609499 | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/22/2025 | End: 09/22/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
PROPOFOL (PROPOFOL) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
PROPOFOL (PROPOFOL) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
PROPOFOL (PROPOFOL) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
PROPOFOL (PROPOFOL) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250922

Report Duplicates (0)

--

Raw JSON (click to expand)

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"drugdosagetext": "30 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-09-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-22T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ROCURONIUM BROMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ROCURONIUM", "drugauthorizationnumb": "079199", "drugbatchnumb": "7609580", "drugstructuredosagenumb": 30.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "30 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-09-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-22T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ROCURONIUM BROMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ROCURONIUM", "drugauthorizationnumb": "079199", "drugbatchnumb": "7609499", "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-09-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-22T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ROCURONIUM BROMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ROCURONIUM", "drugauthorizationnumb": "079199", "drugbatchnumb": "7609499", "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-09-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-22T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ROCURONIUM BROMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ROCURONIUM", "drugauthorizationnumb": "079199", "drugbatchnumb": "7609499", "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-09-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-22T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ROCURONIUM BROMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ROCURONIUM", "drugauthorizationnumb": "079199", "drugbatchnumb": "7609499", "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-09-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-22T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ROCURONIUM BROMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PROPOFOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "PROPOFOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PROPOFOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "PROPOFOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PROPOFOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "PROPOFOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PROPOFOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "PROPOFOL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250922" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MYLAN" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25940841 Type 1
Serious
UPADACITINIB
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-ABBVIE-6509308
Authority Number
--
Sender Organization
ABBVIE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
55.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Acute myocardial infarction (v28.1) Recovering
Cardiac arrest (v28.1) Recovering

Drugs (1)

UPADACITINIB (UPADACITINIB) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Colitis ulcerative | Action: Unknown
Auth#: 211675 | Batch#: Not Available | Structured Dosage: 45.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4354e3b3830196fa521d3", "safetyreportid": "25940841", "authoritynumb": null, "companynumb": "EU-ABBVIE-6509308", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 55.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Acute myocardial infarction", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cardiac arrest", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "UPADACITINIB", "drugauthorizationnumb": "211675", "drugbatchnumb": "Not Available", "drugstructuredosagenumb": 45.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Colitis ulcerative", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "UPADACITINIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ABBVIE" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25940837 Type 2
Serious
LYRICA, LYRICA, LYRICA (+29 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/18/2026
Primary Source Country
KR
Occurrence Country
KR
Reporter Country
KR
Reporter Qualification
Physician
Literature Reference
--
Company Number
KR-MYLANLABS-2025M1087064
Authority Number
--
Sender Organization
MYLAN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
64.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Cholangitis (v28.1) Recovered

Drugs (32)

LYRICA (PREGABALIN) Suspect
Route: 048 | Dosage: 1 DOSAGE FORM, BID | Form: -- | Indication: Diabetic neuropathy | Action: Dose Not Changed
Auth#: 021446 | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 06/24/2021 | End: 08/03/2021 | Duration: 41.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
LYRICA (PREGABALIN) Suspect
Route: -- | Dosage: 1 DOSAGE FORM, BID | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 021446 | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 06/24/2021 | End: 08/03/2021 | Duration: 41.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
LYRICA (PREGABALIN) Suspect
Route: -- | Dosage: 1 DOSAGE FORM, BID | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 021446 | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 06/24/2021 | End: 08/03/2021 | Duration: 41.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
LYRICA (PREGABALIN) Suspect
Route: 048 | Dosage: 1 DOSAGE FORM, BID | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 021446 | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 06/24/2021 | End: 08/03/2021 | Duration: 41.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
LYRICA (PREGABALIN) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 021446 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
LYRICA (PREGABALIN) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 021446 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
LYRICA (PREGABALIN) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 021446 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
LYRICA (PREGABALIN) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 021446 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: -- | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: Diabetic neuropathy | Action: Dose Not Changed
Auth#: 021446 | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 16.0 (unit: 032)
Start: 08/04/2021 | End: 09/07/2021 | Duration: 35.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: -- | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 021446 | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 16.0 (unit: 032)
Start: 08/04/2021 | End: 09/07/2021 | Duration: 35.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 021446 | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 16.0 (unit: 032)
Start: 08/04/2021 | End: 09/07/2021 | Duration: 35.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 021446 | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 16.0 (unit: 032)
Start: 08/04/2021 | End: 09/07/2021 | Duration: 35.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 021446 | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: 16.0 (unit: 032)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 021446 | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: 16.0 (unit: 032)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 021446 | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: 16.0 (unit: 032)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 021446 | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: 16.0 (unit: 032)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
EZETIMIBE\ROSUVASTATIN CALCIUM (EZETIMIBE\ROSUVASTATIN CALCIUM) Concomitant
Route: -- | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: Dyslipidaemia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/22/2018 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EZETIMIBE\ROSUVASTATIN CALCIUM (EZETIMIBE\ROSUVASTATIN CALCIUM) Concomitant
Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/22/2018 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EZETIMIBE\ROSUVASTATIN CALCIUM (EZETIMIBE\ROSUVASTATIN CALCIUM) Concomitant
Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/22/2018 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EZETIMIBE\ROSUVASTATIN CALCIUM (EZETIMIBE\ROSUVASTATIN CALCIUM) Concomitant
Route: -- | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/22/2018 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LAFUTIDINE (LAFUTIDINE) Concomitant
Route: -- | Dosage: 1 DOSAGE FORM, BID | Form: -- | Indication: Epigastric discomfort | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/27/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LAFUTIDINE (LAFUTIDINE) Concomitant
Route: 048 | Dosage: 1 DOSAGE FORM, BID | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/27/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LAFUTIDINE (LAFUTIDINE) Concomitant
Route: 048 | Dosage: 1 DOSAGE FORM, BID | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/27/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LAFUTIDINE (LAFUTIDINE) Concomitant
Route: -- | Dosage: 1 DOSAGE FORM, BID | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/27/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
THIOCTIC ACID TROMETHAMINE (THIOCTIC ACID TROMETHAMINE) Concomitant
Route: -- | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/18/2018 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
THIOCTIC ACID TROMETHAMINE (THIOCTIC ACID TROMETHAMINE) Concomitant
Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/18/2018 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
THIOCTIC ACID TROMETHAMINE (THIOCTIC ACID TROMETHAMINE) Concomitant
Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/18/2018 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
THIOCTIC ACID TROMETHAMINE (THIOCTIC ACID TROMETHAMINE) Concomitant
Route: -- | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/18/2018 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PREGABALIN (PREGABALIN) Concomitant
Route: -- | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 392.0 (unit: 032)
Start: 05/28/2020 | End: 06/23/2021 | Duration: 392.0 day | Rechallenge: -- | Additional: --
Recurrences: --
PREGABALIN (PREGABALIN) Concomitant
Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 392.0 (unit: 032)
Start: 05/28/2020 | End: 06/23/2021 | Duration: 392.0 day | Rechallenge: -- | Additional: --
Recurrences: --
PREGABALIN (PREGABALIN) Concomitant
Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 392.0 (unit: 032)
Start: 05/28/2020 | End: 06/23/2021 | Duration: 392.0 day | Rechallenge: -- | Additional: --
Recurrences: --
PREGABALIN (PREGABALIN) Concomitant
Route: -- | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 392.0 (unit: 032)
Start: 05/28/2020 | End: 06/23/2021 | Duration: 392.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20210819

Report Duplicates (1)

HA reference number: 2022001657943

Raw JSON (click to expand)

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"drugdosagetext": "1 DOSAGE FORM, BID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2020-02-27T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LAFUTIDINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "THIOCTIC ACID TROMETHAMINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DOSAGE FORM, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2018-04-18T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "THIOCTIC ACID TROMETHAMINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "THIOCTIC ACID TROMETHAMINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DOSAGE FORM, QD", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2018-04-18T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "THIOCTIC ACID TROMETHAMINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "THIOCTIC ACID TROMETHAMINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DOSAGE FORM, QD", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2018-04-18T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "THIOCTIC ACID TROMETHAMINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "THIOCTIC ACID TROMETHAMINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DOSAGE FORM, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2018-04-18T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "THIOCTIC ACID TROMETHAMINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PREGABALIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 392.0, "drugcumulativedosageunit": "032", "drugdosagetext": "1 DOSAGE FORM, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2020-05-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-06-23T00:00:00", "drugtreatmentduration": 392.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PREGABALIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PREGABALIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 392.0, "drugcumulativedosageunit": "032", "drugdosagetext": "1 DOSAGE FORM, QD", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2020-05-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-06-23T00:00:00", "drugtreatmentduration": 392.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PREGABALIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PREGABALIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 392.0, "drugcumulativedosageunit": "032", "drugdosagetext": "1 DOSAGE FORM, QD", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2020-05-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-06-23T00:00:00", "drugtreatmentduration": 392.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PREGABALIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PREGABALIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 392.0, "drugcumulativedosageunit": "032", "drugdosagetext": "1 DOSAGE FORM, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2020-05-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2021-06-23T00:00:00", "drugtreatmentduration": 392.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PREGABALIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20210819" }, "primarysource": { "reportercountry": "KR", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "KR", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "HA reference number", "duplicatenumb": "2022001657943" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MYLAN" }, "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" }
25940836 Type 1
Serious
LANSOPRAZOLE, LANSOPRAZOLE, LANSOPRAZOLE (+1 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
EU-AFSSAPS-PP2025001097
Sender Organization
MYLAN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
89.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
50.5 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Colitis microscopic (v28.1) Recovered

Drugs (4)

LANSOPRAZOLE (LANSOPRAZOLE) Suspect
Route: -- | Dosage: 15 MILLIGRAM,QD,(15 MG/DAY) | Form: -- | Indication: Prophylaxis against gastrointestinal ulcer | Action: Withdrawn
Auth#: 090763 | Batch#: -- | Structured Dosage: 15.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 495.0 (unit: 003)
Start: 07/12/2025 | End: 08/15/2025 | Duration: 35.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LANSOPRAZOLE (LANSOPRAZOLE) Suspect
Route: 048 | Dosage: 15 MILLIGRAM,QD,(15 MG/DAY) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 090763 | Batch#: -- | Structured Dosage: 15.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 495.0 (unit: 003)
Start: 07/12/2025 | End: 08/15/2025 | Duration: 35.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LANSOPRAZOLE (LANSOPRAZOLE) Suspect
Route: 048 | Dosage: 15 MILLIGRAM,QD,(15 MG/DAY) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 090763 | Batch#: -- | Structured Dosage: 15.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 495.0 (unit: 003)
Start: 07/12/2025 | End: 08/15/2025 | Duration: 35.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LANSOPRAZOLE (LANSOPRAZOLE) Suspect
Route: -- | Dosage: 15 MILLIGRAM,QD,(15 MG/DAY) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 090763 | Batch#: -- | Structured Dosage: 15.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 495.0 (unit: 003)
Start: 07/12/2025 | End: 08/15/2025 | Duration: 35.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250813

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4354e3b3830196fa521cf", "safetyreportid": "25940836", "authoritynumb": "EU-AFSSAPS-PP2025001097", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 89.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 50.5, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Colitis microscopic", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "LANSOPRAZOLE", "drugauthorizationnumb": "090763", "drugbatchnumb": null, "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 495.0, "drugcumulativedosageunit": "003", "drugdosagetext": "15 MILLIGRAM,QD,(15 MG/DAY)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Prophylaxis against gastrointestinal ulcer", "drugstartdateformat": "102", "drugstartdate": "2025-07-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-15T00:00:00", "drugtreatmentduration": 35.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LANSOPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LANSOPRAZOLE", "drugauthorizationnumb": "090763", "drugbatchnumb": null, "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 495.0, "drugcumulativedosageunit": "003", "drugdosagetext": "15 MILLIGRAM,QD,(15 MG/DAY)", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-07-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-15T00:00:00", "drugtreatmentduration": 35.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LANSOPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LANSOPRAZOLE", "drugauthorizationnumb": "090763", "drugbatchnumb": null, "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 495.0, "drugcumulativedosageunit": "003", "drugdosagetext": "15 MILLIGRAM,QD,(15 MG/DAY)", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-07-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-15T00:00:00", "drugtreatmentduration": 35.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LANSOPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LANSOPRAZOLE", "drugauthorizationnumb": "090763", "drugbatchnumb": null, "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 495.0, "drugcumulativedosageunit": "003", "drugdosagetext": "15 MILLIGRAM,QD,(15 MG/DAY)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-07-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-15T00:00:00", "drugtreatmentduration": 35.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LANSOPRAZOLE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250813" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MYLAN" }, "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" }
25940838 Type 1
Serious
ROCURONIUM
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
EU-AFSSAPS-PV2025000765
Sender Organization
MYLAN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
85.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
62.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Drug ineffective (v28.1) Recovered

Drugs (1)

ROCURONIUM (ROCURONIUM BROMIDE) Suspect
Route: -- | Dosage: 170 MILLIGRAM | Form: -- | Indication: Neuromuscular blocking therapy | Action: Not Applicable
Auth#: 079199 | Batch#: 7609580 | Structured Dosage: 170.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/02/2025 | End: 10/02/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251002

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4354e3b3830196fa521d2", "safetyreportid": "25940838", "authoritynumb": "EU-AFSSAPS-PV2025000765", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 85.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 62.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ROCURONIUM", "drugauthorizationnumb": "079199", "drugbatchnumb": "7609580", "drugstructuredosagenumb": 170.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "170 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Neuromuscular blocking therapy", "drugstartdateformat": "102", "drugstartdate": "2025-10-02T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-02T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ROCURONIUM BROMIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251002" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MYLAN" }, "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" }
25940832 Type 1
Serious
AMLODIPINE, PERINDOPRIL, LOPERAMIDE (+7 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
EU-AFSSAPS-AN2025001260
Sender Organization
MYLAN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
57.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
75.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Ischaemic stroke (v28.1) Recovering

Drugs (10)

AMLODIPINE (AMLODIPINE BESYLATE) Suspect
Route: -- | Dosage: 5 MILLIGRAM, QD | Form: -- | Indication: Hypertension | Action: Dose Increased
Auth#: 019787 | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
PERINDOPRIL (PERINDOPRIL) Suspect
Route: -- | Dosage: 4 MILLIGRAM, QD | Form: -- | Indication: Hypertension | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
LOPERAMIDE (LOPERAMIDE) Suspect
Route: -- | Dosage: 12 MILLIGRAM, QD | Form: -- | Indication: Diarrhoea | Action: Dose Not Changed
Auth#: 072741 | Batch#: -- | Structured Dosage: 12.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
SITAGLIPTIN (SITAGLIPTIN) Suspect
Route: -- | Dosage: 50 MILLIGRAM, QD | Form: -- | Indication: Type 2 diabetes mellitus | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
TERBINAFINE (TERBINAFINE) Suspect
Route: -- | Dosage: 250 MILLIGRAM, QD | Form: -- | Indication: Product used for unknown indication | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 250.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
ESOMEPRAZOLE (ESOMEPRAZOLE) Suspect
Route: -- | Dosage: 20 MILLIGRAM, QD | Form: -- | Indication: Prophylaxis against gastrointestinal ulcer | Action: Dose Not Changed
Auth#: 078936 | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 2000 MILLIGRAM, QD | Form: -- | Indication: Type 2 diabetes mellitus | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 2000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: -- | Dosage: 360 MILLIGRAM | Form: -- | Indication: Crohn^s disease | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 360.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DAPAGLIFLOZIN (DAPAGLIFLOZIN) Suspect
Route: -- | Dosage: 10 MILLIGRAM, QD | Form: -- | Indication: Type 2 diabetes mellitus | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ELIQUIS (APIXABAN) Concomitant
Route: -- | Dosage: 2 DOSAGE FORM, QD | Form: -- | Indication: Cardiovascular event prophylaxis | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250823

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4354e3b3830196fa521cc", "safetyreportid": "25940832", "authoritynumb": "EU-AFSSAPS-AN2025001260", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 57.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 75.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Ischaemic stroke", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "AMLODIPINE", "drugauthorizationnumb": "019787", "drugbatchnumb": null, "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MILLIGRAM, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Hypertension", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 3, "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PERINDOPRIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4 MILLIGRAM, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Hypertension", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "PERINDOPRIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LOPERAMIDE", "drugauthorizationnumb": "072741", "drugbatchnumb": null, "drugstructuredosagenumb": 12.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "12 MILLIGRAM, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Diarrhoea", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LOPERAMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SITAGLIPTIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "50 MILLIGRAM, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Type 2 diabetes mellitus", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "SITAGLIPTIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TERBINAFINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 250.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "250 MILLIGRAM, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "TERBINAFINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ESOMEPRAZOLE", "drugauthorizationnumb": "078936", "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20 MILLIGRAM, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Prophylaxis against gastrointestinal ulcer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "ESOMEPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METFORMIN HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2000.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2000 MILLIGRAM, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Type 2 diabetes mellitus", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "METFORMIN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLIXIMAB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 360.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "360 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Crohn^s disease", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DAPAGLIFLOZIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MILLIGRAM, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Type 2 diabetes mellitus", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "DAPAGLIFLOZIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ELIQUIS", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2 DOSAGE FORM, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Cardiovascular event prophylaxis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "APIXABAN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250823" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MYLAN" }, "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" }
25940835 Type 1
Serious
LYRICA, LYRICA, LYRICA (+1 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/18/2026
Primary Source Country
KR
Occurrence Country
KR
Reporter Country
KR
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
KR-MYLANLABS-2025M1087009
Authority Number
--
Sender Organization
MYLAN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
79.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Helplessness (v28.1) Unknown
Dizziness (v28.1) Unknown
Off label use (v28.1) Unknown

Drugs (4)

LYRICA (PREGABALIN) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Helplessness | Action: Unknown
Auth#: 021446 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
LYRICA (PREGABALIN) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: Dizziness | Action: Unknown
Auth#: 021446 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
LYRICA (PREGABALIN) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: 021446 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
LYRICA (PREGABALIN) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: 021446 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20220819

Report Duplicates (1)

HA reference number: 2022001331233

Raw JSON (click to expand)

{ "_id": "69d4354e3b3830196fa521cd", "safetyreportid": "25940835", "authoritynumb": null, "companynumb": "KR-MYLANLABS-2025M1087009", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "KR", "patient": { "patientonsetage": 79.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Helplessness", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dizziness", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "LYRICA", "drugauthorizationnumb": "021446", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Helplessness", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PREGABALIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LYRICA", "drugauthorizationnumb": "021446", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Dizziness", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PREGABALIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LYRICA", "drugauthorizationnumb": "021446", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PREGABALIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LYRICA", "drugauthorizationnumb": "021446", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PREGABALIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20220819" }, "primarysource": { "reportercountry": "KR", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "KR", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "HA reference number", "duplicatenumb": "2022001331233" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MYLAN" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }