Drug adverse event reports (FAERS)

Rash, Arthralgia

Drugs: DUPIXENT

Not seriousReport 27325237
Safetyreportversion
1
Safetyreportid
27325237
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20261010
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-SA-2026SA0221043
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
SANOFI AVENTIS
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientagegroup
6
Patientweight
90.718
Patientsex
2
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Rash
    Reactionoutcome
    6
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Arthralgia
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    DUPIXENT
    Drugbatchnumb
    GW0372
    Drugauthorizationnumb
    761055
    Drugstructuredosagenumb
    300
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    2
    Drugintervaldosagedefinition
    803
    Drugdosagetext
    300.000MG QOW
    Drugindication
    Nasal polyps
    Actiondrug
    1
    Drugrecurreadministration
    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.