Drug adverse event reports (FAERS)

Off label use

Drugs: ELIQUIS

Not seriousReport 27325190
Safetyreportversion
1
Safetyreportid
27325190
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20261010
Reporttype
1
Serious
2
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
2
Receivedateformat
102
Receivedate
20260930
Receiptdateformat
102
Receiptdate
20260930
Fulfillexpeditecriteria
2
Companynumb
US-BRISTOL-MYERS SQUIBB COMPANY-2026-109851
Primarysource
Reportercountry
US
Qualification
1
Sender
Sendertype
6
Senderorganization
BRISTOL-MYERS SQUIBB COMPANY
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
82
Patientonsetageunit
801
Patientagegroup
6
Patientsex
2
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Off label use
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    ELIQUIS
    Drugauthorizationnumb
    202155
    Drugstructuredosagenumb
    1
    Drugstructuredosageunit
    032
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    0.5
    Drugintervaldosagedefinition
    804
    Drugdosageform
    Film-coated tablet
    Drugadministrationroute
    048
    Drugindication
    Product used for unknown indication
    Actiondrug
    5
    Drugrecurreadministration
    3
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    APIXABAN
  2. Drugcharacterization
    1
    Medicinalproduct
    ELIQUIS
    Drugauthorizationnumb
    202155
    Drugstructuredosagenumb
    5
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    2
    Drugintervaldosagedefinition
    804
    Drugdosageform
    Film-coated tablet
    Drugadministrationroute
    048
    Actiondrug
    5
    Drugrecurreadministration
    3
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    APIXABAN
Summary
Narrativeincludeclinical
CASE EVENT DATE: 20260928
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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.