Drug adverse event reports (FAERS)

Product dose omission issue, Drug ineffective

Drugs: BIMZELX

Not seriousReport 27325174
Safetyreportversion
1
Safetyreportid
27325174
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-UCBSA-1043300
Primarysource
Reportercountry
US
Qualification
3
Sender
Sendertype
6
Senderorganization
UCB
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
56
Patientonsetageunit
801
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Product dose omission issue
    Reactionoutcome
    6
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Drug ineffective
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    BIMZELX
    Drugauthorizationnumb
    761151
    Drugstructuredosagenumb
    160
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    4
    Drugintervaldosagedefinition
    803
    Drugdosageform
    Solution for injection in pre-filled pen
    Drugindication
    Psoriatic arthropathy
    Actiondrug
    4
    Drugrecurreadministration
    3
    Activesubstance
    Activesubstancename
    BIMEKIZUMAB-BKZX
    Harmonized identifiers (openFDA)
    Application number
    BLA761151
    Brand name
    BIMZELX
    Generic name
    BIMEKIZUMAB
    Manufacturer name
    UCB, Inc.
    Product NDC
    50474-780, 50474-781, 50474-782, 50474-783
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    SUBCUTANEOUS
    Substance name
    BIMEKIZUMAB
    RxCUI
    2668086, 2668093, 2668099, 2668103, 2699121, 2699122, 2699123, 2699124
    SPL ID
    37b310bd-f6a0-9d4e-e063-6294a90a889d
    SPL set ID
    26b88358-871f-4c80-9d80-b2fb16477f81
    Package NDC
    50474-781-85, 50474-781-87, 50474-781-84, 50474-781-86, 50474-780-79, 50474-780-78, 50474-782-84, 50474-782-86, 50474-783-78
    UNII
    09495UIM6V
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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.