Drug adverse event reports (FAERS)

Needle issue, Accidental exposure to product, Device leakage +2

Drugs: TREMFYA

Not seriousReport 26940092
Safetyreportversion
1
Safetyreportid
26940092
Primarysourcecountry
US
Occurcountry
US
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
2
Companynumb
US-JNJFOC-20260628006
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
JOHNSON AND JOHNSON
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
75
Patientonsetageunit
801
Patientagegroup
6
Patientsex
2
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Needle issue
    Reactionoutcome
    6
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Accidental exposure to product
    Reactionoutcome
    6
  3. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Device leakage
    Reactionoutcome
    6
  4. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Feeling abnormal
    Reactionoutcome
    6
  5. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Product dose omission issue
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    TREMFYA
    Drugbatchnumb
    QIS5H01
    Drugauthorizationnumb
    761061
    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
    Harmonized identifiers (openFDA)
    Application number
    BLA761061
    Brand name
    TREMFYA
    Generic name
    GUSELKUMAB
    Manufacturer name
    Janssen Biotech, Inc.
    Product NDC
    57894-640, 57894-650, 57894-651
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    SUBCUTANEOUS, INTRAVENOUS
    Substance name
    GUSELKUMAB
    RxCUI
    1928686, 1928689, 2118739, 2118741, 2693088, 2693092, 2693094, 2693095, 2693096, 2693097, 2711637, 2711638
    SPL ID
    01b4ab20-c027-482f-b358-b9beae545cb3
    SPL set ID
    1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56
    Package NDC
    57894-650-01, 57894-650-02, 57894-640-01, 57894-640-04, 57894-640-11, 57894-640-99, 57894-640-03, 57894-640-06, 57894-651-01, 57894-651-02, 57894-651-04, 57894-651-11, 57894-651-22, 57894-651-99, 57894-651-92
    Nui
    N0000192799, N0000192798
    Pharm class epc
    Interleukin-23 Antagonist [EPC]
    Pharm class moa
    Interleukin-23 Antagonists [MoA]
    UNII
    089658A12D
Summary
Narrativeincludeclinical
CASE EVENT DATE: 20260603
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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.