Drug adverse event reports (FAERS)

Somnolence, Cardiac disorder

Drugs: THALOMID

SeriousOther seriousReport 26940064
Safetyreportversion
1
Safetyreportid
26940064
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20260709
Reporttype
1
Serious
1
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
1
Receivedateformat
102
Receivedate
20260630
Receiptdateformat
102
Receiptdate
20260630
Fulfillexpeditecriteria
1
Companynumb
US-BRISTOL-MYERS SQUIBB COMPANY-2026-073749
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
BRISTOL-MYERS SQUIBB COMPANY
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
78
Patientonsetageunit
801
Patientagegroup
6
Patientsex
2
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Somnolence
    Reactionoutcome
    6
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Cardiac disorder
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    THALOMID
    Drugauthorizationnumb
    020785
    Drugstructuredosagenumb
    50
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    1
    Drugintervaldosagedefinition
    804
    Drugdosagetext
    QHS
    Drugdosageform
    Capsule
    Drugadministrationroute
    048
    Drugindication
    Arteriovenous fistula
    Actiondrug
    4
    Drugrecurreadministration
    3
    Activesubstance
    Activesubstancename
    THALIDOMIDE
    Harmonized identifiers (openFDA)
    Application number
    NDA020785
    Brand name
    THALOMID
    Generic name
    THALIDOMIDE
    Manufacturer name
    Celgene Corporation
    Product NDC
    59572-205, 59572-210, 59572-215, 59572-220
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    THALIDOMIDE
    RxCUI
    200390, 213360, 360176, 360177, 404449, 404450, 700416, 700418
    SPL ID
    58b287d1-24f5-4dfe-84ca-898a8a5b9302
    SPL set ID
    2eda833b-1357-4ed4-a093-194524fcb061
    Package NDC
    59572-205-14, 59572-205-94, 59572-205-17, 59572-205-97, 59572-210-15, 59572-210-95, 59572-215-13, 59572-215-93, 59572-220-16, 59572-220-96
    Nui
    N0000008663
    Pharm class pe
    Decreased Immunologically Active Molecule Activity [PE]
    UNII
    4Z8R6ORS6L
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How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.