Drug adverse event reports (FAERS)

Off label use

Drugs: TREMFYA

Not seriousReport 27325185
Safetyreportversion
1
Safetyreportid
27325185
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-JNJFOC-20260936839
Primarysource
Reportercountry
US
Qualification
3
Sender
Sendertype
6
Senderorganization
JOHNSON AND JOHNSON
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Off label use
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    TREMFYA
    Drugauthorizationnumb
    761061
    Drugseparatedosagenumb
    1
    Drugdosageform
    Unknown
    Drugindication
    Pyoderma gangrenosum
    Actiondrug
    5
    Drugrecurreadministration
    3
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    GUSELKUMAB
  2. Drugcharacterization
    1
    Medicinalproduct
    TREMFYA
    Drugauthorizationnumb
    761061
    Actiondrug
    5
    Drugrecurreadministration
    3
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    GUSELKUMAB
  3. Drugcharacterization
    1
    Medicinalproduct
    TREMFYA
    Drugauthorizationnumb
    761061
    Actiondrug
    5
    Drugrecurreadministration
    3
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    GUSELKUMAB
  4. Drugcharacterization
    1
    Medicinalproduct
    TREMFYA
    Drugauthorizationnumb
    761061
    Actiondrug
    5
    Drugrecurreadministration
    3
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    GUSELKUMAB
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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.