FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25974292 Type 1
Serious
LEVETIRACETAM, DEXTROSE
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
Mount J, Reynolds J, Stauffer J. Insulinoma Masquerading as Epilepsy in a Pediatric Patient. HPB 2025; 27 (Suppl.) S607-S608.
Company Number
US-MYLANLABS-2025M1091713
Authority Number
--
Sender Organization
MYLAN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
17.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Drug ineffective (v28.1) Unknown

Drugs (2)

LEVETIRACETAM (LEVETIRACETAM) Suspect
Route: -- | Dosage: UNK, DOSE WAS TAPERED OFF | Form: -- | Indication: Generalised tonic-clonic seizure | Action: Withdrawn
Auth#: 076919 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DEXTROSE (DEXTROSE MONOHYDRATE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Hypoglycaemia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

Wipro: IN-Wipro-4095701-427407

Raw JSON (click to expand)

{ "_id": "69d435ea3b3830196fa5ab9d", "safetyreportid": "25974292", "authoritynumb": null, "companynumb": "US-MYLANLABS-2025M1091713", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 17.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "LEVETIRACETAM", "drugauthorizationnumb": "076919", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, DOSE WAS TAPERED OFF", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Generalised tonic-clonic seizure", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEVETIRACETAM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DEXTROSE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Hypoglycaemia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DEXTROSE MONOHYDRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": "Mount J, Reynolds J, Stauffer J. Insulinoma Masquerading as Epilepsy in a Pediatric Patient. HPB 2025; 27 (Suppl.) S607-S608." }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Wipro", "duplicatenumb": "IN-Wipro-4095701-427407" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MYLAN" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25974289 Type 1
Serious
NOXAFIL
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
JP
Occurrence Country
JP
Reporter Country
JP
Reporter Qualification
Physician
Literature Reference
--
Company Number
JP-009507513-2327357
Authority Number
--
Sender Organization
MERCK SHARP & DOHME LLC
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
51.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Fungal infection (v28.1) Fatal
Hypokalaemia (v28.1) Not Recovered

Drugs (1)

NOXAFIL (POSACONAZOLE) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Fungal infection | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/10/2025 | End: 07/14/2025 | Duration: 5.0 day | Rechallenge: Unknown | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (1)

MR: JP-MSD-M2025-37863

Raw JSON (click to expand)

{ "_id": "69d435ea3b3830196fa5ab9a", "safetyreportid": "25974289", "authoritynumb": null, "companynumb": "JP-009507513-2327357", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "JP", "patient": { "patientonsetage": 51.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fungal infection", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypokalaemia", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "NOXAFIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Fungal infection", "drugstartdateformat": "102", "drugstartdate": "2025-07-10T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-07-14T00:00:00", "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "POSACONAZOLE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "JP", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "JP", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MR", "duplicatenumb": "JP-MSD-M2025-37863" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MERCK SHARP & DOHME LLC" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25974293 Type 1
Serious
SILDENAFIL, SILDENAFIL, SILDENAFIL (+17 more)
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
Zhao L, Zhen Z, Yang Y, Lei L, Tu Y, Ma H, et al. Multi-strategic mass spectrometry technological confirmation of poisoning causes in a patient with unexplained multi-organ damage. [Chinese]. China-Trop-Med 2024; 24 (5): 612-617.
Company Number
CN-MYLANLABS-2025M1091555
Authority Number
--
Sender Organization
MYLAN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
46.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (7)

Cerebral infarction (v28.1) Unknown
Multiple organ dysfunction syndrome (v28.1) Unknown
Haemorrhage (v28.1) Unknown
Toxicity to various agents (v28.1) Unknown
Myocardial infarction (v28.1) Unknown
Hepatic function abnormal (v28.1) Unknown
Overdose (v28.1) Unknown

Drugs (20)

SILDENAFIL (SILDENAFIL) Suspect
Route: -- | Dosage: 15.8 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG POWDER WITH THE CONTENT OF 2.0 MG/G WITH DAILY INTAKE OF 15.8 MG | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 020895 | Batch#: -- | Structured Dosage: 15.8 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SILDENAFIL (SILDENAFIL) Suspect
Route: 065 | Dosage: 15.8 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG POWDER WITH THE CONTENT OF 2.0 MG/G WITH DAILY INTAKE OF 15.8 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: 020895 | Batch#: -- | Structured Dosage: 15.8 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SILDENAFIL (SILDENAFIL) Suspect
Route: 065 | Dosage: 15.8 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG POWDER WITH THE CONTENT OF 2.0 MG/G WITH DAILY INTAKE OF 15.8 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: 020895 | Batch#: -- | Structured Dosage: 15.8 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SILDENAFIL (SILDENAFIL) Suspect
Route: -- | Dosage: 15.8 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG POWDER WITH THE CONTENT OF 2.0 MG/G WITH DAILY INTAKE OF 15.8 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: 020895 | Batch#: -- | Structured Dosage: 15.8 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DICLOFENAC (DICLOFENAC) Suspect
Route: -- | Dosage: 45.6 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN PAPER PACKAGE PILL WITH THE CONTENT OF 5.7 MG/G WITH DAILY INTAKE OF 22.8-45.6 MG | Form: -- | Indication: Gout | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 45.6 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DICLOFENAC (DICLOFENAC) Suspect
Route: 065 | Dosage: 45.6 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN PAPER PACKAGE PILL WITH THE CONTENT OF 5.7 MG/G WITH DAILY INTAKE OF 22.8-45.6 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 45.6 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DICLOFENAC (DICLOFENAC) Suspect
Route: 065 | Dosage: 45.6 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN PAPER PACKAGE PILL WITH THE CONTENT OF 5.7 MG/G WITH DAILY INTAKE OF 22.8-45.6 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 45.6 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DICLOFENAC (DICLOFENAC) Suspect
Route: -- | Dosage: 45.6 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN PAPER PACKAGE PILL WITH THE CONTENT OF 5.7 MG/G WITH DAILY INTAKE OF 22.8-45.6 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 45.6 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Suspect
Route: -- | Dosage: 3.2 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG POWDER WITH THE CONTENT OF 0.4 MG/G WITH DAILY INTAKE OF 3.2 MG | Form: -- | Indication: Gout | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 3.2 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Suspect
Route: 065 | Dosage: 3.2 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG POWDER WITH THE CONTENT OF 0.4 MG/G WITH DAILY INTAKE OF 3.2 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 3.2 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Suspect
Route: 065 | Dosage: 3.2 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG POWDER WITH THE CONTENT OF 0.4 MG/G WITH DAILY INTAKE OF 3.2 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 3.2 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Suspect
Route: -- | Dosage: 3.2 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG POWDER WITH THE CONTENT OF 0.4 MG/G WITH DAILY INTAKE OF 3.2 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 3.2 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TADALAFIL (TADALAFIL) Suspect
Route: -- | Dosage: 30.5 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN CAPSULE | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 30.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TADALAFIL (TADALAFIL) Suspect
Route: -- | Dosage: 30.5 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN CAPSULE | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 30.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TADALAFIL (TADALAFIL) Suspect
Route: 065 | Dosage: 30.5 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN CAPSULE | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 30.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TADALAFIL (TADALAFIL) Suspect
Route: 065 | Dosage: 30.5 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN CAPSULE | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 30.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TADALAFIL (TADALAFIL) Suspect
Route: -- | Dosage: FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG PACKAGE POWDER | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 0.05 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TADALAFIL (TADALAFIL) Suspect
Route: -- | Dosage: FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG PACKAGE POWDER | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 0.05 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TADALAFIL (TADALAFIL) Suspect
Route: 065 | Dosage: FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG PACKAGE POWDER | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 0.05 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TADALAFIL (TADALAFIL) Suspect
Route: 065 | Dosage: FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG PACKAGE POWDER | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 0.05 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

Wipro: IN-Wipro-4095678-427336

Raw JSON (click to expand)

{ "_id": "69d435ea3b3830196fa5ab9c", "safetyreportid": "25974293", "authoritynumb": null, "companynumb": "CN-MYLANLABS-2025M1091555", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 46.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cerebral infarction", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Multiple organ dysfunction syndrome", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Haemorrhage", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Toxicity to various agents", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Myocardial infarction", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatic function abnormal", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Overdose", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SILDENAFIL", "drugauthorizationnumb": "020895", "drugbatchnumb": null, "drugstructuredosagenumb": 15.8, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "15.8 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG POWDER WITH THE CONTENT OF 2.0 MG/G WITH DAILY INTAKE OF 15.8 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "SILDENAFIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SILDENAFIL", "drugauthorizationnumb": "020895", "drugbatchnumb": null, "drugstructuredosagenumb": 15.8, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "15.8 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG POWDER WITH THE CONTENT OF 2.0 MG/G WITH DAILY INTAKE OF 15.8 MG", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "SILDENAFIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SILDENAFIL", "drugauthorizationnumb": "020895", "drugbatchnumb": null, "drugstructuredosagenumb": 15.8, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "15.8 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG POWDER WITH THE CONTENT OF 2.0 MG/G WITH DAILY INTAKE OF 15.8 MG", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "SILDENAFIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SILDENAFIL", "drugauthorizationnumb": "020895", "drugbatchnumb": null, "drugstructuredosagenumb": 15.8, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "15.8 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG POWDER WITH THE CONTENT OF 2.0 MG/G WITH DAILY INTAKE OF 15.8 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "SILDENAFIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DICLOFENAC", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 45.6, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "45.6 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN PAPER PACKAGE PILL WITH THE CONTENT OF 5.7 MG/G WITH DAILY INTAKE OF 22.8-45.6 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Gout", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DICLOFENAC" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DICLOFENAC", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 45.6, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "45.6 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN PAPER PACKAGE PILL WITH THE CONTENT OF 5.7 MG/G WITH DAILY INTAKE OF 22.8-45.6 MG", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DICLOFENAC" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DICLOFENAC", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 45.6, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "45.6 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN PAPER PACKAGE PILL WITH THE CONTENT OF 5.7 MG/G WITH DAILY INTAKE OF 22.8-45.6 MG", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DICLOFENAC" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DICLOFENAC", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 45.6, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "45.6 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN PAPER PACKAGE PILL WITH THE CONTENT OF 5.7 MG/G WITH DAILY INTAKE OF 22.8-45.6 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DICLOFENAC" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ACETAMINOPHEN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3.2, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3.2 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG POWDER WITH THE CONTENT OF 0.4 MG/G WITH DAILY INTAKE OF 3.2 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Gout", "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": "ACETAMINOPHEN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3.2, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3.2 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG POWDER WITH THE CONTENT OF 0.4 MG/G WITH DAILY INTAKE OF 3.2 MG", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "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": "ACETAMINOPHEN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3.2, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3.2 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG POWDER WITH THE CONTENT OF 0.4 MG/G WITH DAILY INTAKE OF 3.2 MG", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "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": "ACETAMINOPHEN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3.2, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3.2 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG POWDER WITH THE CONTENT OF 0.4 MG/G WITH DAILY INTAKE OF 3.2 MG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "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": "TADALAFIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 30.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "30.5 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN CAPSULE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TADALAFIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TADALAFIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 30.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "30.5 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN CAPSULE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TADALAFIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TADALAFIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 30.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "30.5 MILLIGRAM, QD, FOUND IN TRADITIONAL CHINESE MEDICINE IN CAPSULE", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TADALAFIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TADALAFIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 30.5, "drugstructuredosageunit": 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"drugcumulativedosageunit": null, "drugdosagetext": "FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG PACKAGE POWDER", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TADALAFIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TADALAFIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 0.05, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG PACKAGE POWDER", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TADALAFIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TADALAFIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 0.05, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG PACKAGE POWDER", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TADALAFIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TADALAFIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 0.05, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FOUND IN TRADITIONAL CHINESE MEDICINE IN BAG PACKAGE POWDER", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TADALAFIL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": "Zhao L, Zhen Z, Yang Y, Lei L, Tu Y, Ma H, et al. Multi-strategic mass spectrometry technological confirmation of poisoning causes in a patient with unexplained multi-organ damage. [Chinese]. China-Trop-Med 2024; 24 (5): 612-617." }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Wipro", "duplicatenumb": "IN-Wipro-4095678-427336" } ], "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" }
25974288 Type 2
Serious
DALFAMPRIDINE
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Consumer
Literature Reference
--
Company Number
EU-ACORDA THERAPEUTICS IRELAND LIMITED-ACO_179515_2025
Authority Number
--
Sender Organization
MERZ
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
71.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Renal impairment (v28.1) Recovering

Drugs (1)

DALFAMPRIDINE (DALFAMPRIDINE) Suspect
Route: 048 | Dosage: 10 MILLIGRAM, BID | Form: Tablet | Indication: Multiple sclerosis | Action: Withdrawn
Auth#: 22250 | Batch#: Unknown | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 2.0 | Interval: 1.0 day | Cumulative: 41900.0 (unit: 003)
Start: 10/27/2019 | End: 07/21/2025 | Duration: 2095.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250721

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435ea3b3830196fa5ab9b", "safetyreportid": "25974288", "authoritynumb": null, "companynumb": "EU-ACORDA THERAPEUTICS IRELAND LIMITED-ACO_179515_2025", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 71.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Renal impairment", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DALFAMPRIDINE", "drugauthorizationnumb": "22250", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 2.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 41900.0, "drugcumulativedosageunit": "003", "drugdosagetext": "10 MILLIGRAM, BID", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Multiple sclerosis", "drugstartdateformat": "102", "drugstartdate": "2019-10-27T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-07-21T00:00:00", "drugtreatmentduration": 2095.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "DALFAMPRIDINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250721" }, "primarysource": { "reportercountry": "EU", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MERZ" }, "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" }
25974286 Type 1
Serious
TISLELIZUMAB, TISLELIZUMAB, TISLELIZUMAB (+7 more)
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
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-BEIGENE-BGN-2025-018288
Authority Number
--
Sender Organization
BEIGENE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
77.0 yr
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Myelosuppression (v28.1) Recovering

Drugs (10)

TISLELIZUMAB (TISLELIZUMAB) Suspect
Route: -- | Dosage: 200 MILLIGRAM | Form: -- | Indication: Lung neoplasm malignant | Action: Unknown
Auth#: 761232 | Batch#: G202502006 | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
TISLELIZUMAB (TISLELIZUMAB) Suspect
Route: 041 | Dosage: 200 MILLIGRAM | Form: -- | Indication: -- | Action: Unknown
Auth#: 761232 | Batch#: G202502006 | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
TISLELIZUMAB (TISLELIZUMAB) Suspect
Route: 041 | Dosage: 200 MILLIGRAM | Form: -- | Indication: -- | Action: Unknown
Auth#: 761232 | Batch#: G202502006 | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
TISLELIZUMAB (TISLELIZUMAB) Suspect
Route: -- | Dosage: 200 MILLIGRAM | Form: -- | Indication: -- | Action: Unknown
Auth#: 761232 | Batch#: G202502006 | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 1.76 GRAM | Form: -- | Indication: Lung neoplasm malignant | Action: Unknown
Auth#: -- | Batch#: 2505211 | Structured Dosage: 1.76 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE) Suspect
Route: 041 | Dosage: 1.76 GRAM | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 2505211 | Structured Dosage: 1.76 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 1.76 GRAM | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 2505211 | Structured Dosage: 1.76 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE) Suspect
Route: 041 | Dosage: 1.76 GRAM | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 2505211 | Structured Dosage: 1.76 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CISPLATIN (CISPLATIN) Suspect
Route: 041 | Dosage: 130 MILLIGRAM | Form: -- | Indication: Lung neoplasm malignant | Action: Unknown
Auth#: -- | Batch#: 5B0168B03 | Structured Dosage: 130.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CISPLATIN (CISPLATIN) Suspect
Route: -- | Dosage: 130 MILLIGRAM | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 5B0168B03 | Structured Dosage: 130.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

NMPACDR: 3101071025740202500373

Raw JSON (click to expand)

{ "_id": "69d435ea3b3830196fa5ab99", "safetyreportid": "25974286", "authoritynumb": null, "companynumb": "CN-BEIGENE-BGN-2025-018288", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 77.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Myelosuppression", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TISLELIZUMAB", "drugauthorizationnumb": "761232", "drugbatchnumb": "G202502006", "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Lung neoplasm malignant", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TISLELIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TISLELIZUMAB", "drugauthorizationnumb": "761232", "drugbatchnumb": "G202502006", "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, 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"drugauthorizationnumb": "761232", "drugbatchnumb": "G202502006", "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TISLELIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "GEMCITABINE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": "2505211", "drugstructuredosagenumb": 1.76, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, 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"drugdosagetext": "1.76 GRAM", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "GEMCITABINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "GEMCITABINE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": "2505211", "drugstructuredosagenumb": 1.76, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1.76 GRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, 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"actiondrug": 5, "activesubstance": { "activesubstancename": "GEMCITABINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CISPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": "5B0168B03", "drugstructuredosagenumb": 130.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "130 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": "Lung neoplasm malignant", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CISPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CISPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": "5B0168B03", "drugstructuredosagenumb": 130.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "130 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CISPLATIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "NMPACDR", "duplicatenumb": "3101071025740202500373" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BEIGENE" }, "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" }
25974287 Type 1
Serious
METHOTREXATE, QUETIAPINE FUMARATE, MYCOPHENOLATE MOFETIL (+76 more)
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
--
Authority Number
CA-MHPD-E2B_07961296
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
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (19)

Sciatica (v28.1) Fatal
Wheezing (v28.1) Fatal
Synovitis (v28.1) Fatal
Wound (v28.1) Fatal
Systemic lupus erythematosus (v28.1) Fatal
Weight decreased (v28.1) Fatal
Rheumatoid factor positive (v28.1) Fatal
Tachycardia (v28.1) Fatal
Vomiting (v28.1) Fatal
Wound infection (v28.1) Fatal
Upper respiratory tract infection (v28.1) Fatal
Visual impairment (v28.1) Fatal
Road traffic accident (v28.1) Fatal
Seronegative arthritis (v28.1) Fatal
Swollen joint count increased (v28.1) Fatal
Urticaria (v28.1) Fatal
Sinusitis (v28.1) Fatal
Type 2 diabetes mellitus (v28.1) Fatal
Weight increased (v28.1) Fatal

Drugs (79)

METHOTREXATE (METHOTREXATE) Suspect
Route: 016 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 040716 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 202152 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL) Suspect
Route: -- | Dosage: -- | Form: Capsule | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 067 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
SULFASALAZINE (SULFASALAZINE) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
THYMOL (THYMOL) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TOCILIZUMAB (TOCILIZUMAB) Suspect
Route: 016 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 728.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TOFACITINIB (TOFACITINIB) Suspect
Route: -- | Dosage: 1 EVERY 1 DAY | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) Suspect
Route: 014 | Dosage: SUSPENSION | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TRICLOSAN (TRICLOSAN) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TYROTHRICIN (TYROTHRICIN) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
USTEKINUMAB (USTEKINUMAB) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 45.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
VITAMIN D3 (CHOLECALCIFEROL) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TOFACITINIB (TOFACITINIB) Suspect
Route: 048 | Dosage: 1 EVERY 1 DAY | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
DICLOFENAC (DICLOFENAC) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM) Suspect
Route: -- | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
MESALAMINE (MESALAMINE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
MORPHINE SULFATE (MORPHINE SULFATE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
NAPROXEN SODIUM (NAPROXEN SODIUM) Suspect
Route: -- | Dosage: 1 EVERY 1 DAY | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 1000.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
NITROFURAZONE (NITROFURAZONE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
ORENCIA (ABATACEPT) Suspect
Route: 058 | Dosage: 1 EVERY 1 WEEK | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 125.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
APREMILAST (APREMILAST) Suspect
Route: 048 | Dosage: 1 EVERY 1 DAY | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 6.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
OXYCODONE (OXYCODONE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
PHTHALYLSULFATHIAZOLE (PHTHALYLSULFATHIAZOLE) Suspect
Route: 048 | Dosage: 1 EVERY 1 DAY | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 1000.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
PREDNISONE (PREDNISONE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: -- | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
ACETAMINOPHEN\CODEINE PHOSPHATE\METHOCARBAMOL (ACETAMINOPHEN\CODEINE PHOSPHATE\METHOCARBAMOL) Suspect
Route: -- | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
DIETARY SUPPLEMENT\HERBALS (DIETARY SUPPLEMENT\HERBALS) Suspect
Route: 048 | Dosage: -- | Form: Oral drops | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
SALICYLIC ACID (SALICYLIC ACID) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
DICLOFENAC SODIUM (DICLOFENAC SODIUM) Suspect
Route: -- | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
ORENCIA (ABATACEPT) Suspect
Route: 053 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
ORENCIA (ABATACEPT) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 365.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
ORENCIA (ABATACEPT) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 120.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
ORENCIA (ABATACEPT) Suspect
Route: -- | Dosage: 1 EVERY 1 DAY | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 17.88 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
ORENCIA (ABATACEPT) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 17.86 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
ORENCIA (ABATACEPT) Suspect
Route: -- | Dosage: 1 EVERY 1 DAY | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 18.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
APREMILAST (APREMILAST) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 3.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
PHTHALYLSULFATHIAZOLE (PHTHALYLSULFATHIAZOLE) Suspect
Route: 048 | Dosage: 1 EVERY 1 DAY | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 2000.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
PHTHALYLSULFATHIAZOLE (PHTHALYLSULFATHIAZOLE) Suspect
Route: 048 | Dosage: 1 EVERY 1 DAY | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
PHTHALYLSULFATHIAZOLE (PHTHALYLSULFATHIAZOLE) Suspect
Route: 058 | Dosage: 1 EVERY 1 DAY | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 2000.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
PHTHALYLSULFATHIAZOLE (PHTHALYLSULFATHIAZOLE) Suspect
Route: 016 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
PHTHALYLSULFATHIAZOLE (PHTHALYLSULFATHIAZOLE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
PREDNISONE (PREDNISONE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
PREDNISONE (PREDNISONE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 7.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
PREDNISONE (PREDNISONE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
PREDNISONE (PREDNISONE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
DICLOFENAC SODIUM (DICLOFENAC SODIUM) Suspect
Route: -- | Dosage: 1 EVERY 1 DAY | Form: Tablet | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
DICLOFENAC SODIUM (DICLOFENAC SODIUM) Suspect
Route: -- | Dosage: -- | Form: Suppository | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
SULFASALAZINE (SULFASALAZINE) Suspect
Route: 048 | Dosage: 1 EVERY 1 DAY | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 2000.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
SULFASALAZINE (SULFASALAZINE) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
SULFASALAZINE (SULFASALAZINE) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
SULFASALAZINE (SULFASALAZINE) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 1000.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
SULFASALAZINE (SULFASALAZINE) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TOCILIZUMAB (TOCILIZUMAB) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 728.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TOCILIZUMAB (TOCILIZUMAB) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 3011.2 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TOCILIZUMAB (TOCILIZUMAB) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TOCILIZUMAB (TOCILIZUMAB) Suspect
Route: 042 | Dosage: 1 EVERY 1 WEEK | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 2912.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TOCILIZUMAB (TOCILIZUMAB) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 3011.2 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TOCILIZUMAB (TOCILIZUMAB) Suspect
Route: -- | Dosage: 1 EVERY 1 WEEK | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 752.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TOCILIZUMAB (TOCILIZUMAB) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 2912.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TOCILIZUMAB (TOCILIZUMAB) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 752.8 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TOCILIZUMAB (TOCILIZUMAB) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 752.8 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TOCILIZUMAB (TOCILIZUMAB) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
VITAMIN D3 (CHOLECALCIFEROL) Suspect
Route: -- | Dosage: -- | Form: Capsule | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TOFACITINIB (TOFACITINIB) Suspect
Route: -- | Dosage: 1 EVERY 1 DAY | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
METHOTREXATE (METHOTREXATE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 040716 | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
METHOTREXATE (METHOTREXATE) Suspect
Route: 013 | Dosage: SOLUTION | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 040716 | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
METHOTREXATE (METHOTREXATE) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 040716 | Batch#: -- | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
METHOTREXATE (METHOTREXATE) Suspect
Route: 058 | Dosage: 1 EVERY 1 DAY | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 040716 | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
METHOTREXATE (METHOTREXATE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 040716 | Batch#: -- | Structured Dosage: 225.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
METHOTREXATE (METHOTREXATE) Suspect
Route: 048 | Dosage: 1 EVERY 1 DAY | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 040716 | Batch#: -- | Structured Dosage: 15.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
METHOTREXATE (METHOTREXATE) Suspect
Route: 013 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 040716 | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
METHOTREXATE (METHOTREXATE) Suspect
Route: 013 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 040716 | Batch#: -- | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
METHOTREXATE (METHOTREXATE) Suspect
Route: 058 | Dosage: 1 EVERY 1 DAY | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 040716 | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
METHOTREXATE (METHOTREXATE) Suspect
Route: 048 | Dosage: 1 EVERY 1 DAY | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 040716 | Batch#: -- | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
METHOTREXATE (METHOTREXATE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 040716 | Batch#: -- | Structured Dosage: 2.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

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Raw JSON (click to expand)

{ "_id": "69d435ea3b3830196fa5ab97", "safetyreportid": "25974287", "authoritynumb": "CA-MHPD-E2B_07961296", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Sciatica", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Wheezing", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Synovitis", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Wound", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Systemic lupus erythematosus", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Weight decreased", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rheumatoid factor positive", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Tachycardia", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Wound infection", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Upper respiratory tract infection", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Visual impairment", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Road traffic accident", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Seronegative arthritis", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Swollen joint count increased", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Urticaria", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Sinusitis", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Type 2 diabetes mellitus", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Weight increased", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "METHOTREXATE", "drugauthorizationnumb": "040716", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "016", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, 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"drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "TOCILIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TOCILIZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 752.8, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "TOCILIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TOCILIZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 752.8, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "TOCILIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TOCILIZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "TOCILIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VITAMIN D3", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, 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"drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "TOFACITINIB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METHOTREXATE", "drugauthorizationnumb": "040716", "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, 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"activesubstancename": "METHOTREXATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METHOTREXATE", "drugauthorizationnumb": "040716", "drugbatchnumb": null, "drugstructuredosagenumb": 25.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METHOTREXATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METHOTREXATE", "drugauthorizationnumb": "040716", 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"reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ACCORD" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25974285 Type 2
Serious
HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-TAKEDA-2025TUS094434
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
--
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Death (v28.1) Fatal
Hepatic cirrhosis (v28.1) Unknown

Drugs (2)

HUMAN IMMUNOGLOBULIN G (HUMAN IMMUNOGLOBULIN G) Suspect
Route: -- | Dosage: 12 GRAM, 1/WEEK | Form: Solution for infusion | Indication: Immunodeficiency common variable | Action: Unknown
Auth#: 125105 | Batch#: -- | Structured Dosage: 12.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
HUMAN IMMUNOGLOBULIN G (HUMAN IMMUNOGLOBULIN G) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Primary immunodeficiency syndrome | Action: Unknown
Auth#: 125105 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250401

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435ea3b3830196fa5ab94", "safetyreportid": "25974285", "authoritynumb": null, "companynumb": "US-TAKEDA-2025TUS094434", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 6, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatic cirrhosis", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "HUMAN IMMUNOGLOBULIN G", "drugauthorizationnumb": "125105", "drugbatchnumb": null, "drugstructuredosagenumb": 12.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "12 GRAM, 1/WEEK", "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Immunodeficiency common variable", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "HUMAN IMMUNOGLOBULIN G" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "HUMAN IMMUNOGLOBULIN G", "drugauthorizationnumb": "125105", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Primary immunodeficiency syndrome", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "HUMAN IMMUNOGLOBULIN G" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250401" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "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" }
25974284 Type 2
Non-Serious
NUPLAZID
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-ACADIA PHARMACEUTICALS INC.-ACA-2025-PIM-011505
Authority Number
--
Sender Organization
ACADIA PHARMACEUTICALS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
87.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Memory impairment (v28.1) Not Recovered
Condition aggravated (v28.1) Not Recovered
Loss of personal independence in daily activities (v28.1) Not Recovered

Drugs (1)

NUPLAZID (PIMAVANSERIN TARTRATE) Suspect
Route: 048 | Dosage: 34 MILLIGRAM, QD | Form: Capsule | Indication: Parkinson^s disease | Action: Dose Not Changed
Auth#: 210793 | Batch#: -- | Structured Dosage: 34.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 11/30/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251021

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435ea3b3830196fa5ab93", "safetyreportid": "25974284", "authoritynumb": null, "companynumb": "US-ACADIA PHARMACEUTICALS INC.-ACA-2025-PIM-011505", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 87.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Memory impairment", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Condition aggravated", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Loss of personal independence in daily activities", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "NUPLAZID", "drugauthorizationnumb": "210793", "drugbatchnumb": null, "drugstructuredosagenumb": 34.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "34 MILLIGRAM, QD", "drugdosageform": "Capsule", "drugadministrationroute": "048", "drugindication": "Parkinson^s disease", "drugstartdateformat": "102", "drugstartdate": "2023-11-30T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "PIMAVANSERIN TARTRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251021" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ACADIA PHARMACEUTICALS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25974281 Type 1
Non-Serious
CHLORAPREP WITH TINT
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-BECTON DICKINSON-US-BD-25-000516
Authority Number
--
Sender Organization
BECTON DICKINSON
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
5
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)

Product contamination physical (v28.1) Unknown

Drugs (1)

CHLORAPREP WITH TINT (CHLORHEXIDINE GLUCONATE\ISOPROPYL ALCOHOL) Suspect
Route: 065 | Dosage: N/A | Form: Solution | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 020832 | Batch#: 5079427 | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251006

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435ea3b3830196fa5ab92", "safetyreportid": "25974281", "authoritynumb": null, "companynumb": "US-BECTON DICKINSON-US-BD-25-000516", "duplicate": null, "fulfillexpeditecriteria": 5, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product contamination physical", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CHLORAPREP WITH TINT", "drugauthorizationnumb": "020832", "drugbatchnumb": "5079427", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "N/A", "drugdosageform": "Solution", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "CHLORHEXIDINE GLUCONATE\\ISOPROPYL ALCOHOL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251006" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BECTON DICKINSON" }, "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" }
25974280 Type 1
Non-Serious
CHLORAPREP WITH TINT
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
CO
Occurrence Country
CO
Reporter Country
CO
Reporter Qualification
Consumer
Literature Reference
--
Company Number
CO-BECTON DICKINSON-CO-BD-25-000524
Authority Number
--
Sender Organization
BECTON DICKINSON
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
5
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)

Device leakage (v28.1) Unknown

Drugs (1)

CHLORAPREP WITH TINT (CHLORHEXIDINE GLUCONATE\ISOPROPYL ALCOHOL) Suspect
Route: 065 | Dosage: N/A | Form: Solution | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 020832 | Batch#: 4324545 | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251006

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435ea3b3830196fa5ab91", "safetyreportid": "25974280", "authoritynumb": null, "companynumb": "CO-BECTON DICKINSON-CO-BD-25-000524", "duplicate": null, "fulfillexpeditecriteria": 5, "occurcountry": "CO", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device leakage", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CHLORAPREP WITH TINT", "drugauthorizationnumb": "020832", "drugbatchnumb": "4324545", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "N/A", "drugdosageform": "Solution", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "CHLORHEXIDINE GLUCONATE\\ISOPROPYL ALCOHOL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251006" }, "primarysource": { "reportercountry": "CO", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "CO", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BECTON DICKINSON" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }