Drug adverse event reports (FAERS)

Fatigue, Injection site erythema, Injection site pruritus +2

Drugs: ENBREL

Not seriousReport 26940078
Safetyreportversion
1
Safetyreportid
26940078
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-AMGEN-USPM2026215852
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
AMGEN
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
60
Patientonsetageunit
801
Patientagegroup
5
Patientsex
2
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Fatigue
    Reactionoutcome
    3
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Injection site erythema
    Reactionoutcome
    3
  3. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Injection site pruritus
    Reactionoutcome
    3
  4. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Injection site swelling
    Reactionoutcome
    3
  5. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Injection site pain
    Reactionoutcome
    3
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    ENBREL
    Drugbatchnumb
    1207285
    Drugauthorizationnumb
    103795
    Drugstructuredosagenumb
    50
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    1
    Drugintervaldosagedefinition
    803
    Drugdosagetext
    WEEKLY
    Drugindication
    Product used for unknown indication
    Actiondrug
    4
    Activesubstance
    Activesubstancename
    ETANERCEPT
    Harmonized identifiers (openFDA)
    Application number
    BLA103795
    Brand name
    ENBREL
    Generic name
    ETANERCEPT
    Manufacturer name
    Immunex Corporation
    Product NDC
    58406-010, 58406-425, 58406-021, 58406-032, 58406-044, 58406-055
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    SUBCUTANEOUS
    Substance name
    ETANERCEPT
    RxCUI
    253014, 261105, 727757, 802652, 809158, 809159, 1653223, 1653225, 2182338, 2182340, 2392140, 2392142
    SPL ID
    de3ee3bd-0047-4365-a4c7-5786521a1649
    SPL set ID
    a002b40c-097d-47a5-957f-7a7b1807af7f
    Package NDC
    58406-425-41, 58406-425-34, 58406-424-01, 58406-910-01, 58406-021-01, 58406-021-04, 58406-021-96, 58406-032-01, 58406-032-04, 58406-032-96, 58406-032-90, 58406-010-01, 58406-010-04, 58406-010-96, 58406-044-01, 58406-044-04, 58406-044-96, 58406-044-24, 58406-044-90, 58406-055-01, 58406-055-04, 58406-055-96, 58406-055-90
    Nui
    N0000175610, N0000175451
    Pharm class epc
    Tumor Necrosis Factor Blocker [EPC]
    Pharm class moa
    Tumor Necrosis Factor Receptor Blocking Activity [MoA]
    UNII
    OP401G7OJC
  2. Drugcharacterization
    1
    Medicinalproduct
    ENBREL
    Drugbatchnumb
    1207283
    Drugauthorizationnumb
    103795
    Drugstructuredosagenumb
    50
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    1
    Drugintervaldosagedefinition
    803
    Drugdosagetext
    WEEKLY
    Actiondrug
    4
    Activesubstance
    Activesubstancename
    ETANERCEPT
    Harmonized identifiers (openFDA)
    Application number
    BLA103795
    Brand name
    ENBREL
    Generic name
    ETANERCEPT
    Manufacturer name
    Immunex Corporation
    Product NDC
    58406-010, 58406-425, 58406-021, 58406-032, 58406-044, 58406-055
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    SUBCUTANEOUS
    Substance name
    ETANERCEPT
    RxCUI
    253014, 261105, 727757, 802652, 809158, 809159, 1653223, 1653225, 2182338, 2182340, 2392140, 2392142
    SPL ID
    de3ee3bd-0047-4365-a4c7-5786521a1649
    SPL set ID
    a002b40c-097d-47a5-957f-7a7b1807af7f
    Package NDC
    58406-425-41, 58406-425-34, 58406-424-01, 58406-910-01, 58406-021-01, 58406-021-04, 58406-021-96, 58406-032-01, 58406-032-04, 58406-032-96, 58406-032-90, 58406-010-01, 58406-010-04, 58406-010-96, 58406-044-01, 58406-044-04, 58406-044-96, 58406-044-24, 58406-044-90, 58406-055-01, 58406-055-04, 58406-055-96, 58406-055-90
    Nui
    N0000175610, N0000175451
    Pharm class epc
    Tumor Necrosis Factor Blocker [EPC]
    Pharm class moa
    Tumor Necrosis Factor Receptor Blocking Activity [MoA]
    UNII
    OP401G7OJC
Summary
Narrativeincludeclinical
CASE EVENT DATE: 20260601
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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.