FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25961820 Type 1
Non-Serious
POMALYST
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-BRISTOL-MYERS SQUIBB COMPANY-2025-145411
Authority Number
--
Sender Organization
BRISTOL-MYERS SQUIBB COMPANY
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
61.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

White blood cell count decreased (v28.1) Unknown

Drugs (1)

POMALYST (POMALIDOMIDE) Suspect
Route: 048 | Dosage: -- | Form: Capsule | Indication: Plasma cell myeloma | Action: Withdrawn
Auth#: 204026 | Batch#: C2694A | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.33 day | Cumulative: -- (unit: --)
Start: 09/01/2023 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b53b3830196fa57b52", "safetyreportid": "25961820", "authoritynumb": null, "companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-2025-145411", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 61.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "White blood cell count decreased", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "POMALYST", "drugauthorizationnumb": "204026", "drugbatchnumb": "C2694A", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.33, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Capsule", "drugadministrationroute": "048", "drugindication": "Plasma cell myeloma", "drugstartdateformat": "610", "drugstartdate": "2023-09-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "POMALIDOMIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "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": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BRISTOL-MYERS SQUIBB COMPANY" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25961819 Type 1
Serious
REBLOZYL
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
Pharmacist
Literature Reference
--
Company Number
JP-BRISTOL-MYERS SQUIBB COMPANY-2025-134677
Authority Number
--
Sender Organization
BRISTOL-MYERS SQUIBB COMPANY
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 (1)

Gastroenteritis (v28.1) Unknown

Drugs (1)

REBLOZYL (LUSPATERCEPT-AAMT) Suspect
Route: 058 | Dosage: -- | Form: Injection | Indication: Anaemia of malignant disease | Action: Dose Not Changed
Auth#: 761136 | Batch#: -- | Structured Dosage: 1.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b53b3830196fa57b51", "safetyreportid": "25961819", "authoritynumb": null, "companynumb": "JP-BRISTOL-MYERS SQUIBB COMPANY-2025-134677", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "JP", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gastroenteritis", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "REBLOZYL", "drugauthorizationnumb": "761136", "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "007", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Injection", "drugadministrationroute": "058", "drugindication": "Anaemia of malignant disease", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LUSPATERCEPT-AAMT" }, "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": "BRISTOL-MYERS SQUIBB COMPANY" }, "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" }
25961814 Type 1
Serious
CIPROFLOXACIN
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
Consumer
Literature Reference
--
Company Number
EU-AFSSAPS-BS2025000720
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
--
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (14)

Tendonitis (v28.1) Recovering
Muscle contractions involuntary (v28.1) Not Recovered
Paraesthesia (v28.1) Not Recovered
Bone pain (v28.1) Not Recovered
Arthralgia (v28.1) Not Recovered
Vision blurred (v28.1) Recovering
Brain fog (v28.1) Recovered
Muscular weakness (v28.1) Recovering
Palpitations (v28.1) Recovered
Alopecia (v28.1) Recovered
Papule (v28.1) Recovered
Joint noise (v28.1) Not Recovered
Mouth haemorrhage (v28.1) Not Recovered
Neuralgia (v28.1) Not Recovered

Drugs (1)

CIPROFLOXACIN (CIPROFLOXACIN) Suspect
Route: 048 | Dosage: 500 MILLIGRAM, TWO TIMES A DAY | Form: Unknown | Indication: Urinary tract infection | Action: Withdrawn
Auth#: 77859 | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 2.0 | Interval: 1.0 day | Cumulative: 2000.0 (unit: 003)
Start: 08/20/2019 | End: 08/21/2019 | Duration: 2.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20190101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b53b3830196fa57b4f", "safetyreportid": "25961814", "authoritynumb": null, "companynumb": "EU-AFSSAPS-BS2025000720", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Tendonitis", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Muscle contractions involuntary", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Paraesthesia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Bone pain", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Arthralgia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vision blurred", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Brain fog", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Muscular weakness", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Palpitations", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Alopecia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Papule", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Joint noise", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Mouth haemorrhage", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neuralgia", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CIPROFLOXACIN", "drugauthorizationnumb": "77859", "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 2.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 2000.0, "drugcumulativedosageunit": "003", "drugdosagetext": "500 MILLIGRAM, TWO TIMES A DAY", "drugdosageform": "Unknown", "drugadministrationroute": "048", "drugindication": "Urinary tract infection", "drugstartdateformat": "102", "drugstartdate": "2019-08-20T00:00:00", "drugenddateformat": "102", "drugenddate": "2019-08-21T00:00:00", "drugtreatmentduration": 2.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "CIPROFLOXACIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20190101" }, "primarysource": { "reportercountry": "EU", "qualification": 5, "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": "AUROBINDO" }, "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" }
25961812 Type 1
Serious
EFFEXOR XR EXTENDED-RELEASE, EFFEXOR XR EXTENDED-RELEASE, EFFEXOR XR EXTENDED-RELEASE (+25 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
Physician
Literature Reference
--
Company Number
US-MYLANLABS-2025M1084891
Authority Number
--
Sender Organization
MYLAN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
45.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
111.6 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (10)

Back pain (v28.1) Unknown
Arthralgia (v28.1) Unknown
Lumbar spinal stenosis (v28.1) Unknown
Intervertebral disc protrusion (v28.1) Unknown
Anaesthesia (v28.1) Unknown
Memory impairment (v28.1) Unknown
Self-injurious ideation (v28.1) Unknown
Anxiety (v28.1) Unknown
Disturbance in attention (v28.1) Unknown
Stress (v28.1) Unknown

Drugs (28)

EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: 75 MILLIGRAM, QD (ONCE DAILY) | Form: -- | Indication: Anxiety | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/19/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 75 MILLIGRAM, QD (ONCE DAILY) | Form: -- | Indication: Depression | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/19/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 75 MILLIGRAM, QD (ONCE DAILY) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/19/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: 75 MILLIGRAM, QD (ONCE DAILY) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/19/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 75 MILLIGRAM, QD (ONCE DAILY) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/19/2016 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 75 MILLIGRAM, QD (ONCE DAILY) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/19/2016 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: 75 MILLIGRAM, QD (ONCE DAILY) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/19/2016 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: 75 MILLIGRAM, QD (ONCE DAILY) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/19/2016 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: 75 MILLIGRAM, BID (1 EVERY MORNING AND EVENTING) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/08/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 75 MILLIGRAM, BID (1 EVERY MORNING AND EVENTING) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/08/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 75 MILLIGRAM, BID (1 EVERY MORNING AND EVENTING) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/08/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: 75 MILLIGRAM, BID (1 EVERY MORNING AND EVENTING) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/08/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 112.5 MILLIGRAM, QD (TAKE 3 CAPSULES BY MOUTH ONCE DAILY WITH A MEAL) | Form: -- | Indication: Anxiety | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 112.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/12/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 112.5 MILLIGRAM, QD (TAKE 3 CAPSULES BY MOUTH ONCE DAILY WITH A MEAL) | Form: -- | Indication: Depression | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 112.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/12/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: 112.5 MILLIGRAM, QD (TAKE 3 CAPSULES BY MOUTH ONCE DAILY WITH A MEAL) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 112.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/12/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: 112.5 MILLIGRAM, QD (TAKE 3 CAPSULES BY MOUTH ONCE DAILY WITH A MEAL) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 112.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/12/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: 112.5 MILLIGRAM, QD (TAKE 3 CAPSULES BY MOUTH ONCE DAILY WITH A MEAL) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 112.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/10/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: 112.5 MILLIGRAM, QD (TAKE 3 CAPSULES BY MOUTH ONCE DAILY WITH A MEAL) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 112.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/10/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 112.5 MILLIGRAM, QD (TAKE 3 CAPSULES BY MOUTH ONCE DAILY WITH A MEAL) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 112.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/10/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 112.5 MILLIGRAM, QD (TAKE 3 CAPSULES BY MOUTH ONCE DAILY WITH A MEAL) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 112.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/10/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: 37.5 MILLIGRAM, QD (ONCE DAILY) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 37.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/23/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: 37.5 MILLIGRAM, QD (ONCE DAILY) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 37.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/23/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 37.5 MILLIGRAM, QD (ONCE DAILY) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 37.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/23/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 37.5 MILLIGRAM, QD (ONCE DAILY) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 37.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/23/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 112.5 MILLIGRAM, QD (TAKE 3 CAPSULES BY MOUTH ONCE DAILY WITH A MEAL) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 112.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/23/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 112.5 MILLIGRAM, QD (TAKE 3 CAPSULES BY MOUTH ONCE DAILY WITH A MEAL) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 112.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/23/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: 112.5 MILLIGRAM, QD (TAKE 3 CAPSULES BY MOUTH ONCE DAILY WITH A MEAL) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 112.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/23/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: 112.5 MILLIGRAM, QD (TAKE 3 CAPSULES BY MOUTH ONCE DAILY WITH A MEAL) | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020699 | Batch#: -- | Structured Dosage: 112.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/23/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20160628

Report Duplicates (0)

--

Raw JSON (click to expand)

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"102", "drugstartdate": "2015-04-10T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "VENLAFAXINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "EFFEXOR XR EXTENDED-RELEASE", "drugauthorizationnumb": "020699", "drugbatchnumb": null, "drugstructuredosagenumb": 112.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "112.5 MILLIGRAM, QD (TAKE 3 CAPSULES BY MOUTH ONCE DAILY WITH A MEAL)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2015-04-10T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "VENLAFAXINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "EFFEXOR XR EXTENDED-RELEASE", "drugauthorizationnumb": "020699", "drugbatchnumb": null, "drugstructuredosagenumb": 37.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "37.5 MILLIGRAM, QD (ONCE DAILY)", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2015-10-23T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "VENLAFAXINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "EFFEXOR XR EXTENDED-RELEASE", "drugauthorizationnumb": "020699", "drugbatchnumb": null, "drugstructuredosagenumb": 37.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "37.5 MILLIGRAM, QD (ONCE DAILY)", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2015-10-23T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "VENLAFAXINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "EFFEXOR XR EXTENDED-RELEASE", "drugauthorizationnumb": "020699", "drugbatchnumb": null, "drugstructuredosagenumb": 37.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "37.5 MILLIGRAM, QD (ONCE DAILY)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2015-10-23T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "VENLAFAXINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "EFFEXOR XR EXTENDED-RELEASE", "drugauthorizationnumb": "020699", "drugbatchnumb": null, "drugstructuredosagenumb": 37.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "37.5 MILLIGRAM, QD (ONCE DAILY)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2015-10-23T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "VENLAFAXINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "EFFEXOR XR EXTENDED-RELEASE", "drugauthorizationnumb": "020699", "drugbatchnumb": null, "drugstructuredosagenumb": 112.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "112.5 MILLIGRAM, QD (TAKE 3 CAPSULES BY MOUTH ONCE DAILY WITH A MEAL)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2015-10-23T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "VENLAFAXINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "EFFEXOR XR EXTENDED-RELEASE", "drugauthorizationnumb": "020699", "drugbatchnumb": null, "drugstructuredosagenumb": 112.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "112.5 MILLIGRAM, QD (TAKE 3 CAPSULES BY MOUTH ONCE DAILY WITH A MEAL)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2015-10-23T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "VENLAFAXINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "EFFEXOR XR EXTENDED-RELEASE", "drugauthorizationnumb": "020699", "drugbatchnumb": null, "drugstructuredosagenumb": 112.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "112.5 MILLIGRAM, QD (TAKE 3 CAPSULES BY MOUTH ONCE DAILY WITH A MEAL)", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2015-10-23T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "VENLAFAXINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "EFFEXOR XR EXTENDED-RELEASE", "drugauthorizationnumb": "020699", "drugbatchnumb": null, "drugstructuredosagenumb": 112.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "112.5 MILLIGRAM, QD (TAKE 3 CAPSULES BY MOUTH ONCE DAILY WITH A MEAL)", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2015-10-23T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "VENLAFAXINE HYDROCHLORIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20160628" }, "primarysource": { "reportercountry": "US", "qualification": 1, "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": 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" }
25961817 Type 1
Serious
ATORVASTATIN, VIBEGRON
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
Consumer
Literature Reference
--
Company Number
--
Authority Number
GB-MHRA-MED-202510151741507550-DYFBL
Sender Organization
ACCORD
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
Elderly
Patient Sex
Male
Patient Weight
89.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Rash (v28.1) Not Recovered
Muscular weakness (v28.1) Not Recovered
Gait disturbance (v28.1) Not Recovered
Pain in extremity (v28.1) Not Recovered
Fatigue (v28.1) Not Recovered

Drugs (2)

ATORVASTATIN (ATORVASTATIN) Suspect
Route: -- | Dosage: 20 MG ONCE A DAY AT NIGHT | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 207687 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2024 | End: 10/13/2025 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
VIBEGRON (VIBEGRON) Concomitant
Route: -- | Dosage: STRENGTH: 75MG ONCE A DAY AT NIGHT | Form: -- | Indication: Adverse drug reaction | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b53b3830196fa57b4d", "safetyreportid": "25961817", "authoritynumb": "GB-MHRA-MED-202510151741507550-DYFBL", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": 79.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 89.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rash", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Muscular weakness", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gait disturbance", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pain in extremity", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ATORVASTATIN", "drugauthorizationnumb": "207687", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20 MG ONCE A DAY AT NIGHT", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": "602", "drugstartdate": "2024-01-01T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-13T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ATORVASTATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VIBEGRON", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "STRENGTH: 75MG ONCE A DAY AT NIGHT", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Adverse drug reaction", "drugstartdateformat": "602", "drugstartdate": "2024-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "VIBEGRON" }, "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": "ACCORD" }, "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" }
25961816 Type 1
Serious
CONCERTA
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/18/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Physician
Literature Reference
--
Company Number
CA-JNJFOC-20251029399
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
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Keratoconus (v28.1) Unknown

Drugs (1)

CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: -- | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown
Auth#: 021121 | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b53b3830196fa57b4c", "safetyreportid": "25961816", "authoritynumb": null, "companynumb": "CA-JNJFOC-20251029399", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Keratoconus", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CONCERTA", "drugauthorizationnumb": "021121", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Unknown", "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "METHYLPHENIDATE HYDROCHLORIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "CA", "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": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25961815 Type 2
Serious
CAPIVASERTIB
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-AstraZeneca-CH-00978392A
Authority Number
--
Sender Organization
ALEXION 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 (1)

Death (v28.1) Fatal

Drugs (1)

CAPIVASERTIB (CAPIVASERTIB) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 218197 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250919

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b53b3830196fa57b4b", "safetyreportid": "25961815", "authoritynumb": null, "companynumb": "US-AstraZeneca-CH-00978392A", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CAPIVASERTIB", "drugauthorizationnumb": "218197", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "CAPIVASERTIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250919" }, "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": "ALEXION PHARMACEUTICALS" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25961813 Type 2
Serious
FRUQUINTINIB
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-TAKEDA-2025TUS093768
Authority Number
--
Sender Organization
TAKEDA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
62.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (1)

FRUQUINTINIB (FRUQUINTINIB) Suspect
Route: -- | Dosage: 5 MILLIGRAM | Form: Capsule | Indication: Colon cancer | Action: Unknown
Auth#: 217564 | Batch#: 2093713 | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b53b3830196fa57b4a", "safetyreportid": "25961813", "authoritynumb": null, "companynumb": "US-TAKEDA-2025TUS093768", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 62.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "FRUQUINTINIB", "drugauthorizationnumb": "217564", "drugbatchnumb": "2093713", "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MILLIGRAM", "drugdosageform": "Capsule", "drugadministrationroute": null, "drugindication": "Colon cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FRUQUINTINIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "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": "TAKEDA" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25961811 Type 1
Serious
ENHERTU
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/18/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CN-DSJP-DS-2025-171264-CN
Authority Number
--
Sender Organization
DAIICHI
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
57.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
74.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Myelosuppression (v28.1) Recovering

Drugs (1)

ENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) Suspect
Route: 041 | Dosage: 400 MG, QD | Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | Indication: Targeted cancer therapy | Action: Unknown
Auth#: 761139 | Batch#: 422854 | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 400.0 (unit: 003)
Start: 10/09/2025 | End: 10/09/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251016

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b53b3830196fa57b49", "safetyreportid": "25961811", "authoritynumb": null, "companynumb": "CN-DSJP-DS-2025-171264-CN", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 57.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 74.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Myelosuppression", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ENHERTU", "drugauthorizationnumb": "761139", "drugbatchnumb": "422854", "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 400.0, "drugcumulativedosageunit": "003", "drugdosagetext": "400 MG, QD", "drugdosageform": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "drugadministrationroute": "041", "drugindication": "Targeted cancer therapy", "drugstartdateformat": "102", "drugstartdate": "2025-10-09T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-09T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FAM-TRASTUZUMAB DERUXTECAN-NXKI" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251016" }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CN", "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": "DAIICHI" }, "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" }
25961809 Type 1
Serious
ALOE, ALOE, ALOE (+4 more)
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-DERMARITE INDUSTRIES, LLC.-2025-DER-US000075
Authority Number
--
Sender Organization
DERMARITE INDUSTRIES
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
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Seizure (v28.1) Recovered

Drugs (7)

ALOE (ALOE) Suspect
Route: 061 | Dosage: UNK | Form: Unknown | Indication: Therapeutic skin care topical | Action: Unknown
Auth#: -- | Batch#: 40293.1 | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ALOE (ALOE) Suspect
Route: 061 | Dosage: UNK | Form: Unknown | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 40672.1 | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ALOE (ALOE) Suspect
Route: 061 | Dosage: UNK | Form: Unknown | Indication: Therapeutic skin care topical | Action: Withdrawn
Auth#: -- | Batch#: 40469A | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
ALOE (ALOE) Suspect
Route: 061 | Dosage: UNK | Form: Unknown | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: 40495A | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
COSMETICS (COSMETICS) Suspect
Route: 061 | Dosage: UNK | Form: Unknown | Indication: Product used for unknown indication | Action: Withdrawn
Auth#: -- | Batch#: 41062.1 | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
UTRASURE (ALUMINUM SESQUICHLOROHYDRATE) Suspect
Route: 061 | Dosage: UNK | Form: Anti-Perspirant and Deodorant | Indication: Therapeutic skin care topical | Action: Withdrawn
Auth#: 61924266 | Batch#: 40598.T | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
UTRASURE (ALUMINUM SESQUICHLOROHYDRATE) Suspect
Route: 061 | Dosage: UNK | Form: Anti-Perspirant and Deodorant | Indication: -- | Action: Withdrawn
Auth#: 61924266 | Batch#: 40399.T | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230701

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b53b3830196fa57b48", "safetyreportid": "25961809", "authoritynumb": null, "companynumb": "US-DERMARITE INDUSTRIES, LLC.-2025-DER-US000075", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Seizure", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ALOE", "drugauthorizationnumb": null, "drugbatchnumb": "40293.1", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "drugadministrationroute": "061", "drugindication": "Therapeutic skin care topical", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ALOE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ALOE", "drugauthorizationnumb": null, "drugbatchnumb": "40672.1", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "drugadministrationroute": "061", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ALOE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ALOE", "drugauthorizationnumb": null, "drugbatchnumb": "40469A", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "drugadministrationroute": "061", "drugindication": "Therapeutic skin care topical", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "ALOE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ALOE", "drugauthorizationnumb": null, "drugbatchnumb": "40495A", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "drugadministrationroute": "061", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "ALOE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "COSMETICS", "drugauthorizationnumb": null, "drugbatchnumb": "41062.1", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "drugadministrationroute": "061", "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": "COSMETICS" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "UTRASURE", "drugauthorizationnumb": "61924266", "drugbatchnumb": "40598.T", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Anti-Perspirant and Deodorant", "drugadministrationroute": "061", "drugindication": "Therapeutic skin care topical", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "ALUMINUM SESQUICHLOROHYDRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "UTRASURE", "drugauthorizationnumb": "61924266", "drugbatchnumb": "40399.T", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Anti-Perspirant and Deodorant", "drugadministrationroute": "061", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "ALUMINUM SESQUICHLOROHYDRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230701" }, "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": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "DERMARITE INDUSTRIES" }, "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" }