Drug adverse event reports (FAERS)

Accidental exposure to product, Exposure via skin contact

Drugs: DUPIXENT

Not seriousReport 26940090
Safetyreportversion
1
Safetyreportid
26940090
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-SA-2026SA0117181
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
SANOFI AVENTIS
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
76
Patientonsetageunit
801
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Accidental exposure to product
    Reactionoutcome
    6
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Exposure via skin contact
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    DUPIXENT
    Drugbatchnumb
    5F881A
    Drugauthorizationnumb
    761055
    Drugseparatedosagenumb
    1
    Actiondrug
    5
    Drugrecurreadministration
    3
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    DUPILUMAB
    Harmonized identifiers (openFDA)
    Application number
    BLA761055
    Brand name
    DUPIXENT
    Generic name
    DUPILUMAB
    Manufacturer name
    Sanofi-Aventis U.S. LLC
    Product NDC
    0024-5914, 0024-5918, 0024-5915, 0024-5919
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    SUBCUTANEOUS
    Substance name
    DUPILUMAB
    RxCUI
    1876401, 1876406, 2099300, 2099302, 2375327, 2375329, 2559706, 2559707
    SPL ID
    06b9c64b-52b1-490b-b118-bd079e69264e
    SPL set ID
    595f437d-2729-40bb-9c62-c8ece1f82780
    Package NDC
    0024-5914-00, 0024-5914-01, 0024-5914-20, 0024-5914-02, 0024-5918-00, 0024-5918-01, 0024-5918-20, 0024-5918-02, 0024-5915-00, 0024-5915-02, 0024-5915-01, 0024-5915-20, 0024-5919-00, 0024-5919-02, 0024-5919-01, 0024-5919-20
    Nui
    N0000193342, N0000193341, M0001357
    Pharm class epc
    Interleukin-4 Receptor alpha Antagonist [EPC]
    Pharm class moa
    Interleukin 4 Receptor alpha Antagonists [MoA]
    Pharm class cs
    Antibodies, Monoclonal [CS]
    UNII
    420K487FSG
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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.