FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25962328 Type 1
Serious
ACETAMINOPHEN, ACETAMINOPHEN, ACETAMINOPHEN (+1 more)
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
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-LL2025001758
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
40.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Accidental overdose (v28.1) Not Recovered

Drugs (4)

ACETAMINOPHEN (ACETAMINOPHEN) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Tooth abscess | Action: Not Applicable
Auth#: 213255 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Suspect
Route: 048 | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 213255 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Suspect
Route: 048 | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 213255 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 213255 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250829

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b93b3830196fa57d60", "safetyreportid": "25962328", "authoritynumb": "EU-AFSSAPS-LL2025001758", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 40.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Accidental overdose", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ACETAMINOPHEN", "drugauthorizationnumb": "213255", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Tooth abscess", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ACETAMINOPHEN", "drugauthorizationnumb": "213255", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ACETAMINOPHEN", "drugauthorizationnumb": "213255", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ACETAMINOPHEN", "drugauthorizationnumb": "213255", "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": "ACETAMINOPHEN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250829" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "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": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25962325 Type 1
Serious
VENLAFAXINE, VENLAFAXINE, VENLAFAXINE (+5 more)
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
--
Authority Number
EU-AFSSAPS-GR2025001579
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
74.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
61.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Hypoglycaemia (v28.1) Not Recovered

Drugs (8)

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: Depression | Action: Dose Not Changed
Auth#: 020699 | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/15/2025 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 020699 | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/15/2025 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 020699 | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/15/2025 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 020699 | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/15/2025 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
BACTRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: -- | Dosage: 2 DOSAGE FORM, QD | Form: -- | Indication: Product used for unknown indication | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 24.0 (unit: 032)
Start: 08/05/2025 | End: 08/18/2025 | Duration: 14.0 day | Rechallenge: -- | Additional: No
Recurrences: --
BACTRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 048 | Dosage: 2 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 24.0 (unit: 032)
Start: 08/05/2025 | End: 08/18/2025 | Duration: 14.0 day | Rechallenge: -- | Additional: No
Recurrences: --
BACTRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 048 | Dosage: 2 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 24.0 (unit: 032)
Start: 08/05/2025 | End: 08/18/2025 | Duration: 14.0 day | Rechallenge: -- | Additional: No
Recurrences: --
BACTRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: -- | Dosage: 2 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 24.0 (unit: 032)
Start: 08/05/2025 | End: 08/18/2025 | Duration: 14.0 day | Rechallenge: -- | Additional: No
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250816

Report Duplicates (1)

AFSSAPS: EU-AFSSAPS-2025092985

Raw JSON (click to expand)

{ "_id": "69d435b93b3830196fa57d5b", "safetyreportid": "25962325", "authoritynumb": "EU-AFSSAPS-GR2025001579", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 74.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 61.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypoglycaemia", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "VENLAFAXINE", "drugauthorizationnumb": "020699", "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": "Depression", "drugstartdateformat": "102", "drugstartdate": "2025-08-15T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "VENLAFAXINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VENLAFAXINE", "drugauthorizationnumb": "020699", "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": "2025-08-15T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "VENLAFAXINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VENLAFAXINE", "drugauthorizationnumb": "020699", "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": "2025-08-15T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "VENLAFAXINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VENLAFAXINE", "drugauthorizationnumb": "020699", "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": "2025-08-15T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "VENLAFAXINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BACTRIM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 24.0, "drugcumulativedosageunit": "032", "drugdosagetext": "2 DOSAGE FORM, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-08-05T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-18T00:00:00", "drugtreatmentduration": 14.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 2, "actiondrug": 1, "activesubstance": { "activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BACTRIM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 24.0, "drugcumulativedosageunit": "032", "drugdosagetext": "2 DOSAGE FORM, QD", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-08-05T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-18T00:00:00", "drugtreatmentduration": 14.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 2, "actiondrug": 1, "activesubstance": { "activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BACTRIM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 24.0, "drugcumulativedosageunit": "032", "drugdosagetext": "2 DOSAGE FORM, QD", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-08-05T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-18T00:00:00", "drugtreatmentduration": 14.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 2, "actiondrug": 1, "activesubstance": { "activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BACTRIM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 24.0, "drugcumulativedosageunit": "032", "drugdosagetext": "2 DOSAGE FORM, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-08-05T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-18T00:00:00", "drugtreatmentduration": 14.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 2, "actiondrug": 1, "activesubstance": { "activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250816" }, "primarysource": { "reportercountry": "EU", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "AFSSAPS", "duplicatenumb": "EU-AFSSAPS-2025092985" } ], "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": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25962324 Type 1
Serious
PRAMIPEXOLE
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/17/2026
Primary Source Country
GB
Occurrence Country
GB
Reporter Country
GB
Reporter Qualification
Consumer
Literature Reference
--
Company Number
--
Authority Number
GB-MHRA-MED-202510241708292810-GZDRK
Sender Organization
BOEHRINGER INGELHEIM
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
46.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
90.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Medication error (v28.1) Unknown
Gambling (v28.1) Recovered
Sexually active (v28.1) Recovered
Sleep disorder (v28.1) Recovered

Drugs (1)

PRAMIPEXOLE (PRAMIPEXOLE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Restless legs syndrome | Action: Dose Increased
Auth#: 22421 | Batch#: -- | Structured Dosage: 0.8 (unit: 003) | Separate Dosage#: 1.0 | Interval: 6.0 hr | Cumulative: -- (unit: --)
Start: 06/05/2024 | End: 02/07/2025 | Duration: 248.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b93b3830196fa57d5a", "safetyreportid": "25962324", "authoritynumb": "GB-MHRA-MED-202510241708292810-GZDRK", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": 46.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 90.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Medication error", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gambling", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Sexually active", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Sleep disorder", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PRAMIPEXOLE", "drugauthorizationnumb": "22421", "drugbatchnumb": null, "drugstructuredosagenumb": 0.8, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 6.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Restless legs syndrome", "drugstartdateformat": "102", "drugstartdate": "2024-06-05T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-02-07T00:00:00", "drugtreatmentduration": 248.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 3, "activesubstance": { "activesubstancename": "PRAMIPEXOLE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "GB", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BOEHRINGER INGELHEIM" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 1, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25962318 Type 2
Serious
LISINOPRIL, ORGOVYX, ORGOVYX (+11 more)
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-AZURITY PHARMACEUTICALS, INC.-AZR202510-003217
Authority Number
--
Sender Organization
AZURITY PHARMACEUTICALS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Pulmonary embolism (v28.1) Unknown
Blister (v28.1) Unknown
Mood swings (v28.1) Unknown
Fatigue (v28.1) Unknown
Rash pruritic (v28.1) Recovering
Cough (v28.1) Recovered

Drugs (14)

LISINOPRIL (LISINOPRIL) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: Withdrawn
Auth#: 208401 | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
ORGOVYX (RELUGOLIX) Suspect
Route: 048 | Dosage: 360 MILLIGRAM, SINGLE | Form: Tablet | Indication: Prostate cancer | Action: Unknown
Auth#: -- | Batch#: CSWKDA | Structured Dosage: 360.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: 01/01/2023 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ORGOVYX (RELUGOLIX) Suspect
Route: 048 | Dosage: REDUCED TO 120 MILLIGRAM, QD | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: CSWKDA | Structured Dosage: 120.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ABIRATERONE ACETATE (ABIRATERONE ACETATE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ASPIRIN (ASPIRIN) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ATORVASTATIN (ATORVASTATIN) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CALCIUM (CALCIUM) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
GLUCOSAMINE (GLUCOSAMINE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Jaka? (--) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OMEPRAZOLE (OMEPRAZOLE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIUM (POTASSIUM) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SILDENAFIL (SILDENAFIL) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VALSARTAN (VALSARTAN) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
XARELTO (RIVAROXABAN) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b93b3830196fa57d58", "safetyreportid": "25962318", "authoritynumb": null, "companynumb": "US-AZURITY PHARMACEUTICALS, INC.-AZR202510-003217", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pulmonary embolism", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blister", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Mood swings", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rash pruritic", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cough", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "LISINOPRIL", "drugauthorizationnumb": "208401", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LISINOPRIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ORGOVYX", "drugauthorizationnumb": null, "drugbatchnumb": "CSWKDA", "drugstructuredosagenumb": 360.0, "drugstructuredosageunit": "003", 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"drugcumulativedosageunit": null, "drugdosagetext": "REDUCED TO 120 MILLIGRAM, QD", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "602", "drugstartdate": "2023-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RELUGOLIX" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ABIRATERONE ACETATE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ABIRATERONE ACETATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ASPIRIN", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ASPIRIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ATORVASTATIN", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ATORVASTATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CALCIUM", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "GLUCOSAMINE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "GLUCOSAMINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Jaka?", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OMEPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "OMEPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "POTASSIUM", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "POTASSIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SILDENAFIL", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SILDENAFIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VALSARTAN", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "VALSARTAN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "XARELTO", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "RIVAROXABAN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "AZURITY PHARMACEUTICALS" }, "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" }
25962321 Type 1
Serious
TACROLIMUS, PREDNISOLONE, PREDNISOLONE (+2 more)
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/18/2026
Primary Source Country
JP
Occurrence Country
JP
Reporter Country
JP
Reporter Qualification
Other Health Professional
Literature Reference
Fujimoto K, Hosomi S, Kobayashi Y, Nakata R, Nishida Y, Tanaka F, et al. Severe Gastroduodenitis Associated With Ulcerative Colitis After Total Colectomy Successfully Treated With Endoscopic Hemostasis and Oral Tacrolimus. DEN Open. 2025 Oct 6;6(1):e70217. doi: 10.1002/deo2.70217.
Company Number
JP-PBT-010931
Authority Number
--
Sender Organization
PANACEA BIOTEC PHARMA LIMITED
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
42.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Therapeutic product effect incomplete (v28.1) Unknown
Product use in unapproved indication (v28.1) Unknown

Drugs (5)

TACROLIMUS (TACROLIMUS) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Proctitis ulcerative | Action: Unknown
Auth#: 090802 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREDNISOLONE (PREDNISOLONE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Colitis ulcerative | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PREDNISOLONE (PREDNISOLONE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Pouchitis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 60.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TACROLIMUS (TACROLIMUS) Suspect
Route: 048 | Dosage: ON DAY 29 | Form: -- | Indication: Gastroduodenal ulcer | Action: Unknown
Auth#: 090802 | Batch#: -- | Structured Dosage: 6.0 (unit: 003) | Separate Dosage#: -- | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TACROLIMUS (TACROLIMUS) Suspect
Route: 048 | Dosage: ON DAY 29 | Form: -- | Indication: Pouchitis | Action: Unknown
Auth#: 090802 | Batch#: -- | Structured Dosage: 6.0 (unit: 003) | Separate Dosage#: -- | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b93b3830196fa57d57", "safetyreportid": "25962321", "authoritynumb": null, "companynumb": "JP-PBT-010931", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "JP", "patient": { "patientonsetage": 42.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Therapeutic product effect incomplete", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product use in unapproved indication", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TACROLIMUS", "drugauthorizationnumb": "090802", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Proctitis ulcerative", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TACROLIMUS" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PREDNISOLONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Colitis ulcerative", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PREDNISOLONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PREDNISOLONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Pouchitis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PREDNISOLONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TACROLIMUS", "drugauthorizationnumb": "090802", "drugbatchnumb": null, "drugstructuredosagenumb": 6.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "ON DAY 29", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Gastroduodenal ulcer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TACROLIMUS" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TACROLIMUS", "drugauthorizationnumb": "090802", "drugbatchnumb": null, "drugstructuredosagenumb": 6.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "ON DAY 29", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Pouchitis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TACROLIMUS" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "JP", "qualification": 3, "literaturereference": "Fujimoto K, Hosomi S, Kobayashi Y, Nakata R, Nishida Y, Tanaka F, et al. Severe Gastroduodenitis Associated With Ulcerative Colitis After Total Colectomy Successfully Treated With Endoscopic Hemostasis and Oral Tacrolimus. DEN Open. 2025 Oct 6;6(1):e70217. doi: 10.1002/deo2.70217." }, "primarysourcecountry": "JP", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "PANACEA BIOTEC PHARMA LIMITED" }, "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" }
25962320 Type 1
Serious
INFLIXIMAB, NIVOLUMAB, METHYLPREDNISOLONE (+2 more)
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/18/2026
Primary Source Country
GB
Occurrence Country
GB
Reporter Country
GB
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
--
Authority Number
GB-MHRA-MIDB-550e8b2c-2f53-47d1-bfa9-729f8457693c
Sender Organization
JOHNSON AND JOHNSON
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
49.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Pancreatitis acute (v28.1) Recovered

Drugs (5)

INFLIXIMAB (INFLIXIMAB) Suspect
Route: 041 | Dosage: -- | Form: Solution for infusion | Indication: Product used for unknown indication | Action: Withdrawn
Auth#: 103772 | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
NIVOLUMAB (NIVOLUMAB) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: unk | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
METHYLPREDNISOLONE (METHYLPREDNISOLONE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Withdrawn
Auth#: -- | Batch#: unk | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
PREDNISOLONE (PREDNISOLONE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: unk | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
IPILIMUMAB (IPILIMUMAB) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Withdrawn
Auth#: -- | Batch#: unk | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b93b3830196fa57d56", "safetyreportid": "25962320", "authoritynumb": "GB-MHRA-MIDB-550e8b2c-2f53-47d1-bfa9-729f8457693c", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": 49.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pancreatitis acute", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "INFLIXIMAB", "drugauthorizationnumb": "103772", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for infusion", "drugadministrationroute": "041", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "INFLIXIMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "NIVOLUMAB", "drugauthorizationnumb": null, "drugbatchnumb": "unk", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "NIVOLUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METHYLPREDNISOLONE", "drugauthorizationnumb": null, "drugbatchnumb": "unk", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "METHYLPREDNISOLONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PREDNISOLONE", "drugauthorizationnumb": null, "drugbatchnumb": "unk", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PREDNISOLONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "IPILIMUMAB", "drugauthorizationnumb": null, "drugbatchnumb": "unk", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IPILIMUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "GB", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "JOHNSON AND JOHNSON" }, "serious": 1, "seriousnesscongenitalanomali": null, "seriousnessdeath": null, "seriousnessdisabling": null, "seriousnesshospitalization": null, "seriousnesslifethreatening": null, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25962323 Type 2
Serious
SPRAVATO, SPRAVATO, ADDERALL XR
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-JNJFOC-20251028576
Authority Number
--
Sender Organization
JOHNSON AND JOHNSON
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
36.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Hallucination (v28.1) Unknown
Hypertension (v28.1) Unknown
Dissociation (v28.1) Unknown

Drugs (3)

SPRAVATO (ESKETAMINE) Suspect
Route: 045 | Dosage: ^56 MG, 2 TOTAL DOSES^ | Form: Nasal spray | Indication: Depression | Action: Unknown
Auth#: 211243 | Batch#: Unknown | Structured Dosage: 56.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/13/2025 | End: 10/15/2025 | Duration: 2.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
SPRAVATO (ESKETAMINE) Suspect
Route: 045 | Dosage: ^56 MG, MOST RECENT DOSE ADMINISTERED^ | Form: Nasal spray | Indication: -- | Action: Unknown
Auth#: 211243 | Batch#: 25CG622 | Structured Dosage: 56.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/20/2025 | End: 10/20/2025 | Duration: -- day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
ADDERALL XR (AMPHETAMINE ASPARTATE\AMPHETAMINE SULFATE\DEXTROAMPHETAMINE SACCHARATE\DEXTROAMPHETAMINE SULFATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251020

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b93b3830196fa57d55", "safetyreportid": "25962323", "authoritynumb": null, "companynumb": "US-JNJFOC-20251028576", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 36.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hallucination", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypertension", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dissociation", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SPRAVATO", "drugauthorizationnumb": "211243", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 56.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "^56 MG, 2 TOTAL DOSES^", "drugdosageform": "Nasal spray", "drugadministrationroute": "045", "drugindication": "Depression", "drugstartdateformat": "102", "drugstartdate": "2025-10-13T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-15T00:00:00", "drugtreatmentduration": 2.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ESKETAMINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SPRAVATO", "drugauthorizationnumb": "211243", "drugbatchnumb": "25CG622", "drugstructuredosagenumb": 56.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "^56 MG, MOST RECENT DOSE ADMINISTERED^", "drugdosageform": "Nasal spray", "drugadministrationroute": "045", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-10-20T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-20T00:00:00", "drugtreatmentduration": 0.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ESKETAMINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ADDERALL XR", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 25.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "AMPHETAMINE ASPARTATE\\AMPHETAMINE SULFATE\\DEXTROAMPHETAMINE SACCHARATE\\DEXTROAMPHETAMINE SULFATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251020" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "JOHNSON AND JOHNSON" }, "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" }
25962319 Type 1
Serious
GABAPENTIN ENACARBIL
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/17/2026
Primary Source Country
JP
Occurrence Country
JP
Reporter Country
JP
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
JP-AZURITY PHARMACEUTICALS, INC.-AZR202510-003293
Authority Number
--
Sender Organization
AZURITY PHARMACEUTICALS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Decreased appetite (v28.1) Unknown
Malaise (v28.1) Unknown
Product storage error (v28.1) Unknown

Drugs (1)

GABAPENTIN ENACARBIL (GABAPENTIN ENACARBIL) Suspect
Route: 065 | Dosage: UNK | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: 022399 | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b93b3830196fa57d53", "safetyreportid": "25962319", "authoritynumb": null, "companynumb": "JP-AZURITY PHARMACEUTICALS, INC.-AZR202510-003293", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "JP", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Decreased appetite", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Malaise", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product storage error", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "GABAPENTIN ENACARBIL", "drugauthorizationnumb": "022399", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Tablet", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "GABAPENTIN ENACARBIL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "JP", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "JP", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "AZURITY PHARMACEUTICALS" }, "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" }
25962312 Type 1
Serious
ZOLPIDEM, ALPRAZOLAM, DAFALGAN CODEINE
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
--
Authority Number
EU-FAMHP-DHH-N2025-125661
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
28.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Pharmaceutical nomadism (v28.1) Unknown

Drugs (3)

ZOLPIDEM (ZOLPIDEM TARTRATE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 021997 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
ALPRAZOLAM (ALPRAZOLAM) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 018276 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
DAFALGAN CODEINE (ACETAMINOPHEN\CODEINE PHOSPHATE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Product used for unknown 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

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b93b3830196fa57d52", "safetyreportid": "25962312", "authoritynumb": "EU-FAMHP-DHH-N2025-125661", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 28.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pharmaceutical nomadism", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ZOLPIDEM", "drugauthorizationnumb": "021997", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ZOLPIDEM TARTRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ALPRAZOLAM", "drugauthorizationnumb": "018276", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ALPRAZOLAM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DAFALGAN CODEINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ACETAMINOPHEN\\CODEINE PHOSPHATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "EU", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "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" }
25962315 Type 1
Serious
PAROXETINE, BISOPROLOL FUMARATE
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
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-NC2025001568
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
66.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Nightmare (v28.1) Not Recovered
Condition aggravated (v28.1) Not Recovered

Drugs (2)

PAROXETINE (PAROXETINE) Suspect
Route: -- | Dosage: 20 MILLIGRAM, QD | Form: -- | Indication: Affective disorder | Action: Dose Not Changed
Auth#: 078902 | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 06/01/2024 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
BISOPROLOL FUMARATE (BISOPROLOL FUMARATE) Suspect
Route: -- | Dosage: 2.5 MILLIGRAM, BID (2.5 MG 2X/DAY, 5 MG, 1 DAY) | Form: -- | Indication: Atrial fibrillation | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 09/30/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250623

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b93b3830196fa57d50", "safetyreportid": "25962315", "authoritynumb": "EU-AFSSAPS-NC2025001568", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 66.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nightmare", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Condition aggravated", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PAROXETINE", "drugauthorizationnumb": "078902", "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": "Affective disorder", "drugstartdateformat": "102", "drugstartdate": "2024-06-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "PAROXETINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BISOPROLOL FUMARATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MILLIGRAM, BID (2.5 MG 2X/DAY, 5 MG, 1 DAY)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Atrial fibrillation", "drugstartdateformat": "102", "drugstartdate": "2024-09-30T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "BISOPROLOL FUMARATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250623" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "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" }