Drug adverse event reports (FAERS)

Product storage issue, Product dose omission issue

Drugs: TREMFYA

Not seriousReport 27325172
Safetyreportversion
1
Safetyreportid
27325172
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20261008
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-20260936136
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
JOHNSON AND JOHNSON
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
45
Patientonsetageunit
801
Patientagegroup
5
Patientsex
2
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Product storage issue
    Reactionoutcome
    6
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Product dose omission issue
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    TREMFYA
    Drugbatchnumb
    RBS2302.A
    Drugauthorizationnumb
    761061
    Drugstructuredosagenumb
    400
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugdosageform
    Solution for injection in pre-filled pen
    Drugindication
    Product used for unknown indication
    Actiondrug
    5
    Drugrecurreadministration
    3
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    GUSELKUMAB
Summary
Narrativeincludeclinical
CASE EVENT DATE: 20260922
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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.