Drug adverse event reports (FAERS)

Spinal cord disorder, Stress, Fatigue +15

Drugs: RINVOQ

SeriousOther seriousReport 27325232
Safetyreportversion
1
Safetyreportid
27325232
Primarysourcecountry
UY
Occurcountry
UY
Transmissiondateformat
102
Transmissiondate
20261010
Reporttype
2
Serious
1
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
1
Receivedateformat
102
Receivedate
20260930
Receiptdateformat
102
Receiptdate
20260930
Fulfillexpeditecriteria
1
Companynumb
UY-ABBVIE-6069188
Primarysource
Reportercountry
UY
Qualification
5
Sender
Sendertype
6
Senderorganization
ABBVIE
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
50
Patientonsetageunit
801
Patientsex
2
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Spinal cord disorder
    Reactionoutcome
    6
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Stress
    Reactionoutcome
    3
  3. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Fatigue
    Reactionoutcome
    3
  4. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Abdominal pain upper
    Reactionoutcome
    1
  5. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Arthralgia
    Reactionoutcome
    3
  6. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Intervertebral disc protrusion
    Reactionoutcome
    2
  7. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Neuralgia
    Reactionoutcome
    2
  8. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Pain in extremity
    Reactionoutcome
    6
  9. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Bone deformity
    Reactionoutcome
    1
  10. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Spinal pain
    Reactionoutcome
    2
  11. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Back pain
    Reactionoutcome
    6
  12. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Bone deformity
    Reactionoutcome
    3
  13. +7 more not shown
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    RINVOQ
    Drugbatchnumb
    1238096
    Drugauthorizationnumb
    211675
    Drugstructuredosagenumb
    15
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    1
    Drugintervaldosagedefinition
    804
    Drugdosagetext
    15 MILLIGRAM?PROLONGED-RELEASE FILM- COATED TABLET
    Drugindication
    Rheumatoid arthritis
    Drugstartdateformat
    102
    Drugstartdate
    20241130
    Actiondrug
    4
    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
  2. Drugcharacterization
    1
    Medicinalproduct
    RINVOQ
    Drugbatchnumb
    1273093
    Drugauthorizationnumb
    211675
    Drugstructuredosagenumb
    15
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    1
    Drugintervaldosagedefinition
    804
    Drugdosagetext
    FORM STRENGTH:15 MILLIGRAM RINVOQ 15MG X 30 TABLETS
    Drugdosageform
    Modified-release tablet
    Actiondrug
    4
    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
  3. Drugcharacterization
    1
    Medicinalproduct
    RINVOQ
    Drugbatchnumb
    1262618
    Drugauthorizationnumb
    211675
    Drugstructuredosagenumb
    15
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    1
    Drugintervaldosagedefinition
    804
    Drugdosagetext
    FORM STRENGTH:15 MILLIGRAM RINVOQ 15MG X 30 TABLETS
    Drugdosageform
    Modified-release tablet
    Drugenddateformat
    610
    Drugenddate
    202506
    Actiondrug
    4
    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
  4. Drugcharacterization
    1
    Medicinalproduct
    RINVOQ
    Drugbatchnumb
    1300913
    Drugauthorizationnumb
    211675
    Drugstructuredosagenumb
    15
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    1
    Drugintervaldosagedefinition
    804
    Drugdosagetext
    FORM STRENGTH:15 MILLIGRAM RINVOQ 15MG X 30 TABLETS
    Drugenddateformat
    102
    Drugenddate
    20260402
    Actiondrug
    4
    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: 20241216
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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.