Drug adverse event reports (FAERS)

Device deployment issue, Product dose omission issue

Drugs: SIMPONI

Not seriousReport 26940079
Safetyreportversion
1
Safetyreportid
26940079
Primarysourcecountry
AU
Occurcountry
AU
Transmissiondateformat
102
Transmissiondate
20260709
Reporttype
1
Serious
2
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
2
Receivedateformat
102
Receivedate
20260630
Receiptdateformat
102
Receiptdate
20260630
Fulfillexpeditecriteria
5
Companynumb
AU-JNJFOC-20260618680
Primarysource
Reportercountry
AU
Qualification
3
Sender
Sendertype
6
Senderorganization
JOHNSON AND JOHNSON
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Device deployment issue
    Reactionoutcome
    6
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Product dose omission issue
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    SIMPONI
    Drugauthorizationnumb
    125289
    Drugstructuredosagenumb
    50
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugdosagetext
    STRENGTH- 50.00 MG / 0.50 ML
    Drugdosageform
    Solution for injection in pre-filled pen
    Drugadministrationroute
    058
    Drugindication
    Product used for unknown indication
    Actiondrug
    5
    Drugrecurreadministration
    3
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    GOLIMUMAB
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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.