Drug adverse event reports (FAERS)

Intestinal obstruction, Malaise, Neoplasm malignant

Drugs: SKYRIZI

SeriousHospitalizationOther seriousReport 27325239
Safetyreportversion
1
Safetyreportid
27325239
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20261010
Reporttype
2
Serious
1
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
1
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
1
Receivedateformat
102
Receivedate
20260930
Receiptdateformat
102
Receiptdate
20260930
Fulfillexpeditecriteria
1
Companynumb
US-ABBVIE-6950156
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
ABBVIE
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientagegroup
6
Patientsex
2
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Intestinal obstruction
    Reactionoutcome
    2
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Malaise
    Reactionoutcome
    2
  3. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Neoplasm malignant
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    SKYRIZI
    Drugauthorizationnumb
    761105
    Drugseparatedosagenumb
    1
    Drugindication
    Product used for unknown indication
    Actiondrug
    5
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    RISANKIZUMAB-RZAA
    Harmonized identifiers (openFDA)
    Application number
    BLA761105, BLA761262
    Brand name
    SKYRIZI
    Generic name
    RISANKIZUMAB-RZAA
    Manufacturer name
    AbbVie Inc.
    Product NDC
    0074-1050, 0074-2042, 0074-2100, 0074-1070, 0074-5015, 0074-1065, 0074-7034, 0074-7036, 0074-7040, 0074-7042, 0074-8300, 0074-8350, 0074-4059
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    SUBCUTANEOUS, INTRAVENOUS
    Substance name
    RISANKIZUMAB
    RxCUI
    797544, 2166136, 2166137, 2166142, 2166143, 2540692, 2540695, 2540698, 2540699, 2604618, 2604622, 2604625, 2604628, 2613758, 2613759, 2632994, 2632997, 2632999, 2633000, 2633001, 2633002, 2723331, 2723332, 2745412, 2745415
    SPL ID
    388f783d-f41e-4f04-bf64-ec637fe05bdf
    SPL set ID
    7148c8eb-b39e-e20a-6494-a6df82392858
    Package NDC
    0074-2042-02, 0074-2042-71, 0074-1050-70, 0074-1050-01, 0074-2100-70, 0074-2100-01, 0074-1070-01, 0074-1070-02, 0074-1069-01, 0074-1069-02, 0074-5015-01, 0074-5015-02, 0074-1065-01, 0074-1065-02, 0074-1066-01, 0074-1066-02, 0074-7034-02, 0074-7032-01, 0074-7032-90, 0074-7036-04, 0074-7040-02, 0074-7042-04, 0074-8300-01, 0074-8350-01, 0074-4059-01, 0074-4059-71
    Nui
    N0000192799, N0000192798
    Pharm class epc
    Interleukin-23 Antagonist [EPC]
    Pharm class moa
    Interleukin-23 Antagonists [MoA]
    UNII
    90ZX3Q3FR7
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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.