FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25952021 Type 1
Serious
PARAGARD T 380A
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-COOPERSURGICAL, INC.-2025CPS004118
Authority Number
--
Sender Organization
COOPERSURGICAL
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
33.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
76.644 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (13)

Surgery (v28.1) Recovered
Device breakage (v28.1) Recovered
Foreign body in reproductive tract (v28.1) Recovered
Complication of device removal (v28.1) Recovered
Embedded device (v28.1) Recovered
Emotional distress (v28.1) Unknown
Infection (v28.1) Recovered
Pelvic pain (v28.1) Recovered
Abnormal uterine bleeding (v28.1) Recovered
Device dislocation (v28.1) Recovered
Vaginal infection (v28.1) Unknown
Back pain (v28.1) Unknown
Vaginal discharge (v28.1) Unknown

Drugs (1)

PARAGARD T 380A (COPPER) Suspect
Route: 015 | Dosage: UNK | Form: Intrauterine | Indication: -- | Action: Withdrawn
Auth#: 018680 | Batch#: 514002 | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/26/2015 | End: 03/11/2022 | Duration: 2543.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20220111

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435833b3830196fa54f49", "safetyreportid": "25952021", "authoritynumb": null, "companynumb": "US-COOPERSURGICAL, INC.-2025CPS004118", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 33.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 76.644, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Surgery", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device breakage", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Foreign body in reproductive tract", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Complication of device removal", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Embedded device", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Emotional distress", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Infection", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pelvic pain", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abnormal uterine bleeding", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device dislocation", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vaginal infection", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Back pain", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vaginal discharge", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PARAGARD T 380A", "drugauthorizationnumb": "018680", "drugbatchnumb": "514002", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Intrauterine", "drugadministrationroute": "015", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2015-03-26T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-03-11T00:00:00", "drugtreatmentduration": 2543.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "COPPER" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20220111" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "COOPERSURGICAL" }, "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" }
25952019 Type 1
Serious
DUPIXENT
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
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-SA-2025SA314503
Authority Number
--
Sender Organization
SANOFI AVENTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
19.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Polycystic ovarian syndrome (v28.1) Unknown
Alopecia (v28.1) Unknown

Drugs (1)

DUPIXENT (DUPILUMAB) Suspect
Route: 058 | Dosage: 300 MG, QOW | Form: Solution for injection | Indication: Dermatitis atopic | Action: Unknown
Auth#: 761055 | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435833b3830196fa54f48", "safetyreportid": "25952019", "authoritynumb": null, "companynumb": "US-SA-2025SA314503", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 19.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Polycystic ovarian syndrome", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Alopecia", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": "761055", "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "300 MG, QOW", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": "Dermatitis atopic", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANOFI AVENTIS" }, "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" }
25952012 Type 1
Serious
ALBUTEROL SULFATE, BUDESONIDE, BREO ELLIPTA (+35 more)
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
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-TEVA-VS-3384289
Authority Number
--
Sender Organization
TEVA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
52.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (25)

Hepatotoxicity (v28.1) Recovered
Gastrooesophageal reflux disease (v28.1) Recovered
Jaundice cholestatic (v28.1) Recovered
Nausea (v28.1) Recovered
Schizophrenia (v28.1) Recovered
Psychotic disorder (v28.1) Recovered
Cardiac murmur (v28.1) Recovered
Condition aggravated (v28.1) Recovered
Vomiting (v28.1) Recovered
Lung neoplasm malignant (v28.1) Recovered
Blood bilirubin increased (v28.1) Recovered
Pneumonia (v28.1) Recovered
Bronchiectasis (v28.1) Recovered
Chronic obstructive pulmonary disease (v28.1) Recovered
Hypomania (v28.1) Recovered
Total lung capacity increased (v28.1) Recovered
Sarcoidosis (v28.1) Recovered
Hepatic enzyme increased (v28.1) Recovered
Wheezing (v28.1) Recovered
Asthma-chronic obstructive pulmonary disease overlap syndrome (v28.1) Recovered
Cholelithiasis (v28.1) Recovered
Oedema peripheral (v28.1) Recovered
Off label use (v28.1) Recovered
Rhinitis allergic (v28.1) Recovered
Nasal polyps (v28.1) Recovered

Drugs (38)

ALBUTEROL SULFATE (ALBUTEROL SULFATE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 072316 | Batch#: UNKNOWN | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
BUDESONIDE (BUDESONIDE) Suspect
Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 077519 | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
BREO ELLIPTA (FLUTICASONE FUROATE\VILANTEROL TRIFENATATE) Suspect
Route: 065 | Dosage: DOSE FORM: INHALATION | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 076089 | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
AZITHROMYCIN (AZITHROMYCIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 065150 | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACLIDINIUM BROMIDE (ACLIDINIUM BROMIDE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Chronic obstructive pulmonary disease | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACLIDINIUM BROMIDE (ACLIDINIUM BROMIDE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Chronic obstructive pulmonary disease | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DIVALPROEX SODIUM (DIVALPROEX SODIUM) Suspect
Route: 065 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 2750.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DIVALPROEX SODIUM (DIVALPROEX SODIUM) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 1500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DIVALPROEX SODIUM (DIVALPROEX SODIUM) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
AMMONIUM CHLORIDE\DIPHENHYDRAMINE HYDROCHLORIDE\SODIUM CITRATE (AMMONIUM CHLORIDE\DIPHENHYDRAMINE HYDROCHLORIDE\SODIUM CITRATE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
GLYCOPYRROLATE (GLYCOPYRROLATE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACLIDINIUM BROMIDE\FORMOTEROL FUMARATE (ACLIDINIUM BROMIDE\FORMOTEROL FUMARATE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ATROVENT (IPRATROPIUM BROMIDE) Suspect
Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
FORMOTEROL FUMARATE (FORMOTEROL FUMARATE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
OLODATEROL HYDROCHLORIDE\TIOTROPIUM BROMIDE MONOHYDRATE (OLODATEROL HYDROCHLORIDE\TIOTROPIUM BROMIDE MONOHYDRATE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
OLODATEROL HYDROCHLORIDE\TIOTROPIUM BROMIDE MONOHYDRATE (OLODATEROL HYDROCHLORIDE\TIOTROPIUM BROMIDE MONOHYDRATE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
NASONEX (MOMETASONE FUROATE) Suspect
Route: 065 | Dosage: DOSE FORM: SPRAY, METERED DOSE | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
MOXIFLOXACIN HYDROCHLORIDE (MOXIFLOXACIN HYDROCHLORIDE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 077437 | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
MOXIFLOXACIN HYDROCHLORIDE (MOXIFLOXACIN HYDROCHLORIDE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 077437 | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
OMNARIS (CICLESONIDE) Suspect
Route: 065 | Dosage: DOSE FORM: SPRAY, METERED DOSE | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Suspect
Route: 048 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Pain in extremity | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 650.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
APTIVUS (TIPRANAVIR) Suspect
Route: 048 | Dosage: -- | Form: Capsule | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
APTIVUS (TIPRANAVIR) Suspect
Route: 048 | Dosage: -- | Form: Capsule | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 650.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
UMECLIDINIUM BROMIDE\VILANTEROL TRIFENATATE (UMECLIDINIUM BROMIDE\VILANTEROL TRIFENATATE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
OLANZAPINE (OLANZAPINE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Musculoskeletal stiffness | Action: Unknown
Auth#: 076000 | Batch#: UNKNOWN | Structured Dosage: 12.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
OLANZAPINE (OLANZAPINE) Suspect
Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Musculoskeletal stiffness | Action: Unknown
Auth#: 076000 | Batch#: UNKNOWN | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ZENHALE (FORMOTEROL FUMARATE\MOMETASONE FUROATE) Suspect
Route: 065 | Dosage: DOSE FORM: AEROSOL, METERED DOSE | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ZENHALE (FORMOTEROL FUMARATE\MOMETASONE FUROATE) Suspect
Route: 065 | Dosage: DOSE FORM: AEROSOL, METERED DOSE | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
NUCALA (MEPOLIZUMAB) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CLONAZEPAM (CLONAZEPAM) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 30.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CLONAZEPAM (CLONAZEPAM) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 3.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
AZITHROMYCIN ANHYDROUS (AZITHROMYCIN ANHYDROUS) Suspect
Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DIAZEPAM (DIAZEPAM) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 250.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DIAZEPAM (DIAZEPAM) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 250.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DIAZEPAM (DIAZEPAM) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DIAZEPAM (DIAZEPAM) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 1500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DIAZEPAM (DIAZEPAM) Suspect
Route: 048 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 2750.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (2)

Health Canada: E2B_08148277
Market Authorization Holder AER Number: CA2025AMR007177

Raw JSON (click to expand)

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"reactionmeddrapt": "Cardiac murmur", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Condition aggravated", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lung neoplasm malignant", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood bilirubin increased", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pneumonia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Bronchiectasis", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Chronic obstructive pulmonary disease", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypomania", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Total lung capacity increased", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Sarcoidosis", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatic enzyme increased", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Wheezing", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Asthma-chronic obstructive pulmonary disease overlap syndrome", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cholelithiasis", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Oedema peripheral", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rhinitis allergic", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nasal polyps", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, 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"drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CICLESONIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ACETAMINOPHEN", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 650.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE FORM: NOT SPECIFIED", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Pain in extremity", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "APTIVUS", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Capsule", "drugadministrationroute": "048", "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": "TIPRANAVIR" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "APTIVUS", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 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{ "duplicatesource": "Market Authorization Holder AER Number", "duplicatenumb": "CA2025AMR007177" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TEVA" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25952010 Type 1
Serious
ATORVASTATIN, SILDENAFIL, EZETIMIBE (+9 more)
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/18/2026
Primary Source Country
GB
Occurrence Country
GB
Reporter Country
GB
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
GB-MHRA-TPP943559C9558410YC1759742349137
Authority Number
--
Sender Organization
RANBAXY
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
71.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
82.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Erectile dysfunction (v28.1) Recovered

Drugs (12)

ATORVASTATIN (ATORVASTATIN) Suspect
Route: 065 | Dosage: 20 MILLIGRAM, DAILY | Form: Unknown | Indication: Ill-defined disorder | Action: Unknown
Auth#: 076477 | Batch#: UNK | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: -- | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 03/17/2025 | End: 10/06/2025 | Duration: 204.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
SILDENAFIL (SILDENAFIL) Concomitant
Route: 065 | Dosage: TAKE ONE TABLET, ONE HOUR BEFORE DESIRED EFFECT. | Form: -- | Indication: Ill-defined disorder | Action: Unknown
Auth#: -- | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/28/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
EZETIMIBE (EZETIMIBE) Concomitant
Route: 065 | Dosage: TAKE ONE TABLET ONCE A DAY TO LOWER CHOLESTEROL... | Form: -- | Indication: Ill-defined disorder | Action: Unknown
Auth#: -- | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/06/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) Concomitant
Route: 065 | Dosage: ONE DROPE TICE DAILY | Form: -- | Indication: Ill-defined disorder | Action: Unknown
Auth#: -- | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/17/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
BRINZOLAMIDE (BRINZOLAMIDE) Concomitant
Route: 065 | Dosage: ONE DROP TWICE DAILY | Form: -- | Indication: Ill-defined disorder | Action: Unknown
Auth#: -- | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/17/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DAPAGLIFLOZIN (DAPAGLIFLOZIN) Concomitant
Route: 065 | Dosage: TAKE ONE DAILY | Form: -- | Indication: Ill-defined disorder | Action: Unknown
Auth#: -- | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/17/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LANSOPRAZOLE (LANSOPRAZOLE) Concomitant
Route: 065 | Dosage: ONE CAPSULE DAILY HALF AN HR BEFORE BREAKFAST | Form: -- | Indication: Ill-defined disorder | Action: Unknown
Auth#: -- | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/17/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TIMOLOL (TIMOLOL) Concomitant
Route: 065 | Dosage: ONE DROP ONCE DAILY | Form: -- | Indication: Ill-defined disorder | Action: Unknown
Auth#: -- | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/17/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RAMIPRIL (RAMIPRIL) Concomitant
Route: 065 | Dosage: TAKE ONE CAPSULE ONCE DAILY | Form: -- | Indication: Ill-defined disorder | Action: Unknown
Auth#: -- | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/17/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RYBELSUS (SEMAGLUTIDE) Concomitant
Route: 065 | Dosage: TAKE ONE DAILY WITH SMALL SIP OF WATER, 30MINS ... | Form: -- | Indication: Ill-defined disorder | Action: Unknown
Auth#: -- | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/17/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
Sukkarto sr (--) Concomitant
Route: 065 | Dosage: TAKE ONE TWICE DAILY | Form: -- | Indication: Ill-defined disorder | Action: Unknown
Auth#: -- | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/17/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TADALAFIL (TADALAFIL) Concomitant
Route: 065 | Dosage: TAKE 1 TABLET AS DIRECTED | Form: -- | Indication: Ill-defined disorder | Action: Unknown
Auth#: -- | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/17/2025 | End: 07/14/2025 | Duration: 120.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251006

Report Duplicates (1)

MHRA: GB-MHRA-TPP943559C9558410YC1759742349137

Raw JSON (click to expand)

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"actiondrug": 5, "activesubstance": { "activesubstancename": "EZETIMIBE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BRIMONIDINE TARTRATE", "drugauthorizationnumb": null, "drugbatchnumb": "UNK", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "ONE DROPE TICE DAILY", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2025-03-17T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "BRIMONIDINE TARTRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BRINZOLAMIDE", "drugauthorizationnumb": null, "drugbatchnumb": "UNK", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "ONE DROP TWICE DAILY", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2025-03-17T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "BRINZOLAMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DAPAGLIFLOZIN", "drugauthorizationnumb": null, "drugbatchnumb": "UNK", "drugstructuredosagenumb": null, "drugstructuredosageunit": 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"drugcumulativedosageunit": null, "drugdosagetext": "ONE CAPSULE DAILY HALF AN HR BEFORE BREAKFAST", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2025-03-17T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LANSOPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TIMOLOL", "drugauthorizationnumb": null, "drugbatchnumb": "UNK", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "ONE DROP ONCE DAILY", "drugdosageform": null, "drugadministrationroute": "065", 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null, "drugbatchnumb": "UNK", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TAKE 1 TABLET AS DIRECTED", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2025-03-17T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-07-14T00:00:00", "drugtreatmentduration": 120.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TADALAFIL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251006" }, "primarysource": { "reportercountry": "GB", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MHRA", "duplicatenumb": "GB-MHRA-TPP943559C9558410YC1759742349137" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "RANBAXY" }, "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" }
25952008 Type 1
Serious
SERTRALINE, VENLAFAXINE, BENSERAZIDE HYDROCHLORIDE\LEVODOPA (+7 more)
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Other Health Professional
Literature Reference
Schorr B, Hantz A, Gueremy A, Boulard JC, Lardin A, Blanc F. Catatonia and dementia a case series. Geriatr Psychol Neuropsych Vieilliss. 2025;23 (2):186-198
Company Number
EU-SUN PHARMACEUTICAL INDUSTRIES LTD-2025RR-532919
Authority Number
--
Sender Organization
RANBAXY
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
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 (2)

Catatonia (v28.1) Recovering
Condition aggravated (v28.1) Recovering

Drugs (10)

SERTRALINE (SERTRALINE HYDROCHLORIDE) Suspect
Route: 065 | Dosage: 50 MILLIGRAM, DAILY | Form: Unknown | Indication: Depression | Action: Withdrawn
Auth#: 077977 | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 065 | Dosage: UNK | Form: Unknown | Indication: Depression | Action: Unknown
Auth#: 91272 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
BENSERAZIDE HYDROCHLORIDE\LEVODOPA (BENSERAZIDE HYDROCHLORIDE\LEVODOPA) Concomitant
Route: 065 | Dosage: 125 MILLIGRAM IN THE MORNING | Form: -- | Indication: Depression | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 125.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
BENSERAZIDE HYDROCHLORIDE\LEVODOPA (BENSERAZIDE HYDROCHLORIDE\LEVODOPA) Concomitant
Route: 065 | Dosage: 50 MILLIGRAM IN THE MIDDAY | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TERALITHE (LITHIUM CARBONATE) Concomitant
Route: 065 | Dosage: 1.5 GRAM, DAILY | Form: -- | Indication: Depression | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.5 (unit: 002) | Separate Dosage#: -- | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
OXAZEPAM (OXAZEPAM) Concomitant
Route: 065 | Dosage: 0.5 DOSAGE FORM, TID (3 HALF-TABLETS OF 50MG PER DAY) | Form: -- | Indication: Depression | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 0.5 (unit: 032) | Separate Dosage#: 1.0 | Interval: 8.0 hr | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RIVASTIGMINE (RIVASTIGMINE) Concomitant
Route: 065 | Dosage: 1 DOSAGE FORM, DAILY (9.5MG/24H 1 PATCH PER DAY) | Form: -- | Indication: Depression | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ASPIRIN (ASPIRIN) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Cardiac disorder | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LERCANIDIPINE (LERCANIDIPINE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Hypertension | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
NEBIVOLOL (NEBIVOLOL) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Hypertension | Action: Unknown
Auth#: -- | Batch#: -- | 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)

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"drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LERCANIDIPINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NEBIVOLOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Hypertension", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "NEBIVOLOL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "EU", "qualification": 3, "literaturereference": "Schorr B, Hantz A, Gueremy A, Boulard JC, Lardin A, Blanc F. Catatonia and dementia a case series. Geriatr Psychol Neuropsych Vieilliss. 2025;23 (2):186-198" }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "RANBAXY" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25952001 Type 1
Serious
RISPERIDONE, POLYETHYLENE GLYCOL, DEXLANSOPRAZOLE (+6 more)
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/18/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CA-TEVA-VS-3383925
Authority Number
--
Sender Organization
TEVA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
17.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
70.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (9)

Neuroleptic malignant syndrome (v28.1) Unknown
Orthostatic hypertension (v28.1) Unknown
Tremor (v28.1) Unknown
Hyperhidrosis (v28.1) Unknown
Mydriasis (v28.1) Unknown
Extrapyramidal disorder (v28.1) Unknown
Hypotonia (v28.1) Unknown
Speech disorder (v28.1) Unknown
Tachycardia (v28.1) Unknown

Drugs (9)

RISPERIDONE (RISPERIDONE) Suspect
Route: 048 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Schizophrenia | Action: Unknown
Auth#: 077860 | Batch#: UNKNOWN | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
POLYETHYLENE GLYCOL (POLYETHYLENE GLYCOL) Concomitant
Route: -- | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DEXLANSOPRAZOLE (DEXLANSOPRAZOLE) Concomitant
Route: -- | Dosage: DOSE FORM: CAPSULE, DELAYED RELEASE | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
GLYCOPYRROLATE (GLYCOPYRROLATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OLANZAPINE (OLANZAPINE) Suspect
Route: 048 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Schizophrenia | Action: Unknown
Auth#: 076000 | Batch#: UNKNOWN | Structured Dosage: 30.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
VRAYLAR (CARIPRAZINE) Suspect
Route: 048 | Dosage: -- | Form: Capsule | Indication: Schizophrenia | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 1.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
FAMOTIDINE (FAMOTIDINE) Concomitant
Route: -- | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CLOZAPINE (CLOZAPINE) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Schizophrenia | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.5 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CLOZAPINE (CLOZAPINE) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Schizophrenia | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

Health Canada: 001154086

Raw JSON (click to expand)

{ "_id": "69d435833b3830196fa54f3d", "safetyreportid": "25952001", "authoritynumb": null, "companynumb": "CA-TEVA-VS-3383925", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": 17.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 70.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neuroleptic malignant syndrome", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Orthostatic hypertension", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Tremor", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hyperhidrosis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Mydriasis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Extrapyramidal disorder", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypotonia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Speech disorder", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Tachycardia", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "RISPERIDONE", "drugauthorizationnumb": "077860", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE FORM: NOT SPECIFIED", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Schizophrenia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RISPERIDONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "POLYETHYLENE GLYCOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE FORM: NOT SPECIFIED", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "POLYETHYLENE GLYCOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DEXLANSOPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE FORM: CAPSULE, DELAYED RELEASE", "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": "DEXLANSOPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "GLYCOPYRROLATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "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": "GLYCOPYRROLATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OLANZAPINE", "drugauthorizationnumb": "076000", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 30.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE FORM: NOT SPECIFIED", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Schizophrenia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "OLANZAPINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VRAYLAR", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 1.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Capsule", "drugadministrationroute": "048", "drugindication": "Schizophrenia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CARIPRAZINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FAMOTIDINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE FORM: NOT SPECIFIED", "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": "FAMOTIDINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CLOZAPINE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.5, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Schizophrenia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CLOZAPINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CLOZAPINE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Schizophrenia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CLOZAPINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Health Canada", "duplicatenumb": "001154086" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TEVA" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25952011 Type 1
Serious
ATEZOLIZUMAB, CARBOPLATIN, PACLITAXEL
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/17/2026
Primary Source Country
BR
Occurrence Country
BR
Reporter Country
BR
Reporter Qualification
Physician
Literature Reference
--
Company Number
BR-ROCHE-10000415486
Authority Number
--
Sender Organization
ROCHE
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
Elderly
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Lung disorder (v28.1) Unknown
Bone disorder (v28.1) Unknown
Adrenal disorder (v28.1) Unknown
Death (v28.1) Fatal

Drugs (3)

ATEZOLIZUMAB (ATEZOLIZUMAB) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Lung adenocarcinoma | Action: Not Applicable
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2018 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
CARBOPLATIN (CARBOPLATIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Lung adenocarcinoma | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/01/2018 | End: 06/01/2018 | Duration: 32.0 day | Rechallenge: -- | Additional: --
Recurrences: --
PACLITAXEL (PACLITAXEL) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Lung adenocarcinoma | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/01/2018 | End: 06/01/2018 | Duration: 32.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20180501

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435833b3830196fa54f3c", "safetyreportid": "25952011", "authoritynumb": null, "companynumb": "BR-ROCHE-10000415486", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "BR", "patient": { "patientonsetage": 77.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lung disorder", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Bone disorder", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Adrenal disorder", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ATEZOLIZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Lung adenocarcinoma", "drugstartdateformat": "610", "drugstartdate": "2018-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ATEZOLIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CARBOPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Lung adenocarcinoma", "drugstartdateformat": "610", "drugstartdate": "2018-05-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2018-06-01T00:00:00", "drugtreatmentduration": 32.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CARBOPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PACLITAXEL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Lung adenocarcinoma", "drugstartdateformat": "610", "drugstartdate": "2018-05-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2018-06-01T00:00:00", "drugtreatmentduration": 32.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PACLITAXEL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20180501" }, "primarysource": { "reportercountry": "BR", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "BR", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ROCHE" }, "serious": 1, "seriousnesscongenitalanomali": null, "seriousnessdeath": 1, "seriousnessdisabling": null, "seriousnesshospitalization": null, "seriousnesslifethreatening": null, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25952007 Type 1
Non-Serious
GABAPENTIN, GABAPENTIN, NURTEC ODT
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-MYLANLABS-2025M1086661
Authority Number
--
Sender Organization
MYLAN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
90.72 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Disorientation (v28.1) Unknown
Off label use (v28.1) Unknown

Drugs (3)

GABAPENTIN (GABAPENTIN) Suspect
Route: -- | Dosage: UNK, PRN (AS NEEDED) | Form: -- | Indication: Neuralgia | Action: Dose Not Changed
Auth#: 020235 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
GABAPENTIN (GABAPENTIN) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Migraine prophylaxis | Action: Dose Not Changed
Auth#: 020235 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
NURTEC ODT (RIMEGEPANT SULFATE) Suspect
Route: -- | Dosage: 75 MILLIGRAM, PRN (TAKES WHEN NEEDED, PUTS IN MOUTH LETS DISSOLVE) | Form: -- | Indication: Migraine | Action: Unknown
Auth#: -- | Batch#: 5637608 | Structured Dosage: 75.0 (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": "69d435833b3830196fa54f3a", "safetyreportid": "25952007", "authoritynumb": null, "companynumb": "US-MYLANLABS-2025M1086661", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": 90.72, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Disorientation", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "GABAPENTIN", "drugauthorizationnumb": "020235", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, PRN (AS NEEDED)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Neuralgia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "GABAPENTIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "GABAPENTIN", "drugauthorizationnumb": "020235", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Migraine prophylaxis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "GABAPENTIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "NURTEC ODT", "drugauthorizationnumb": null, "drugbatchnumb": "5637608", "drugstructuredosagenumb": 75.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "75 MILLIGRAM, PRN (TAKES WHEN NEEDED, PUTS IN MOUTH LETS DISSOLVE)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Migraine", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RIMEGEPANT SULFATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MYLAN" }, "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" }
25952006 Type 1
Serious
ATORVASTATIN, RAMIPRIL, DAPAGLIFLOZIN (+1 more)
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/18/2026
Primary Source Country
GB
Occurrence Country
GB
Reporter Country
GB
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
GB-MHRA-MED-202508291609569350-NPWBH
Authority Number
--
Sender Organization
AUROBINDO
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
70.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
96.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (8)

Muscular weakness (v28.1) Fatal
Myositis (v28.1) Fatal
Blood creatinine increased (v28.1) Not Recovered
Renal impairment (v28.1) Not Recovered
Blood potassium increased (v28.1) Not Recovered
Bulbar palsy (v28.1) Not Recovered
Abdominal pain (v28.1) Not Recovered
Myalgia (v28.1) Not Recovered

Drugs (4)

ATORVASTATIN (ATORVASTATIN) Suspect
Route: 065 | Dosage: 20 MILLIGRAM, ONCE A DAY (AT NIGHT) | Form: Unknown | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 217118 | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/01/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
RAMIPRIL (RAMIPRIL) Concomitant
Route: 065 | Dosage: UNK | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DAPAGLIFLOZIN (DAPAGLIFLOZIN) Concomitant
Route: 065 | Dosage: UNK | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
COCODAMOL (ACETAMINOPHEN\CODEINE PHOSPHATE) Concomitant
Route: 065 | Dosage: UNK | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435833b3830196fa54f39", "safetyreportid": "25952006", "authoritynumb": null, "companynumb": "GB-MHRA-MED-202508291609569350-NPWBH", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": 70.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 96.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Muscular weakness", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Myositis", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood creatinine increased", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Renal impairment", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood potassium increased", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Bulbar palsy", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Myalgia", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ATORVASTATIN", "drugauthorizationnumb": "217118", "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20 MILLIGRAM, ONCE A DAY (AT NIGHT)", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-08-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ATORVASTATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "RAMIPRIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RAMIPRIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DAPAGLIFLOZIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DAPAGLIFLOZIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "COCODAMOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ACETAMINOPHEN\\CODEINE PHOSPHATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "GB", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "AUROBINDO" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25952000 Type 2
Serious
HUMIRA, LEFLUNOMIDE
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/18/2026
Primary Source Country
ZA
Occurrence Country
ZA
Reporter Country
ZA
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
ZA-ABBVIE-6509932
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
46.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (15)

Encephalitis autoimmune (v28.1) Unknown
Constipation (v28.1) Unknown
Gastrointestinal inflammation (v28.1) Unknown
Hyperreflexia (v28.1) Unknown
Hypoaesthesia (v28.1) Unknown
Hemiparesis (v28.1) Unknown
Abdominal pain (v28.1) Unknown
Facial asymmetry (v28.1) Unknown
Photophobia (v28.1) Unknown
Headache (v28.1) Unknown
Gait disturbance (v28.1) Unknown
Drug specific antibody present (v28.1) Unknown
Magnetic resonance imaging abnormal (v28.1) Unknown
CSF protein increased (v28.1) Unknown
Paraesthesia (v28.1) Unknown

Drugs (2)

HUMIRA (ADALIMUMAB) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Psoriatic arthropathy | Action: Withdrawn
Auth#: 125057 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/21/2025 | End: 10/01/2025 | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LEFLUNOMIDE (LEFLUNOMIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/21/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435833b3830196fa54f37", "safetyreportid": "25952000", "authoritynumb": null, "companynumb": "ZA-ABBVIE-6509932", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "ZA", "patient": { "patientonsetage": 46.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Encephalitis autoimmune", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Constipation", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gastrointestinal inflammation", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hyperreflexia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypoaesthesia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hemiparesis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Facial asymmetry", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Photophobia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Headache", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gait disturbance", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug specific antibody present", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Magnetic resonance imaging abnormal", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "CSF protein increased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Paraesthesia", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "HUMIRA", "drugauthorizationnumb": "125057", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Psoriatic arthropathy", "drugstartdateformat": "102", "drugstartdate": "2025-02-21T00:00:00", "drugenddateformat": "610", "drugenddate": "2025-10-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "ADALIMUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LEFLUNOMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-02-21T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LEFLUNOMIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "ZA", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "ZA", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ABBVIE" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }