Drug adverse event reports (FAERS)

Internal haemorrhage, Inflammation

Drugs: RINVOQ

SeriousHospitalizationReport 27325216
Safetyreportversion
1
Safetyreportid
27325216
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20261008
Reporttype
2
Serious
1
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
1
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
2
Receivedateformat
102
Receivedate
20260930
Receiptdateformat
102
Receiptdate
20260930
Fulfillexpeditecriteria
1
Companynumb
US-ABBVIE-6954983
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
ABBVIE
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
68
Patientonsetageunit
801
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Internal haemorrhage
    Reactionoutcome
    3
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Inflammation
    Reactionoutcome
    3
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    RINVOQ
    Drugbatchnumb
    Not Available
    Drugauthorizationnumb
    211675
    Drugseparatedosagenumb
    1
    Drugindication
    Crohn^s disease
    Actiondrug
    1
    Drugadditional
    2
    Activesubstance
    Activesubstancename
    UPADACITINIB
    Harmonized identifiers (openFDA)
    Application number
    NDA211675, NDA218347
    Brand name
    RINVOQ
    Generic name
    UPADACITINIB
    Manufacturer name
    AbbVie Inc.
    Product NDC
    0074-1043, 0074-2306, 0074-2310, 0074-2320
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    UPADACITINIB
    RxCUI
    2196894, 2196900, 2590051, 2590054, 2596957, 2596960, 2681015, 2681019
    SPL ID
    e17266e5-c861-46bf-9756-6447566101be
    SPL set ID
    2966aec7-2ef0-923c-d8ff-fe1a957bf095
    Package NDC
    0074-2306-30, 0074-2306-70, 0074-2310-30, 0074-2310-20, 0074-1043-28, 0074-1043-14, 0074-2320-01, 0074-2320-70
    Nui
    N0000190858, N0000190857
    Pharm class epc
    Janus Kinase Inhibitor [EPC]
    Pharm class moa
    Janus Kinase Inhibitors [MoA]
    UNII
    4RA0KN46E0
Summary
Narrativeincludeclinical
CASE EVENT DATE: 20260901
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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.