Drug adverse event reports (FAERS)

Renal mass

Drugs: OTEZLA

SeriousOther seriousReport 27325236
Safetyreportversion
1
Safetyreportid
27325236
Primarysourcecountry
US
Occurcountry
US
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
US-AMGEN-USCT2026289668
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
AMGEN
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Renal mass
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    OTEZLA
    Drugauthorizationnumb
    205437
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNKNOWN/NOT PROVIDED
    Drugindication
    Psoriatic arthropathy
    Actiondrug
    6
    Drugadditional
    4
    Activesubstance
    Activesubstancename
    APREMILAST
    Harmonized identifiers (openFDA)
    Application number
    NDA205437, NDA210745
    Brand name
    OTEZLA
    Generic name
    APREMILAST
    Manufacturer name
    Amgen, Inc
    Product NDC
    55513-137, 55513-369, 55513-485, 55513-497, 55513-508, 55513-996, 55513-519, 55513-516
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    APREMILAST
    RxCUI
    1492732, 1492738, 1492740, 1492742, 1492744, 1492746, 1492747, 1492748, 1605454, 1605455, 2682429, 2682430, 2682431, 2682432, 2723448, 2723452, 2724366, 2724367
    SPL ID
    8d1d49ca-6dc1-4580-b2d5-f69ccb4f1c8e
    SPL set ID
    f6b1f516-4972-4d82-bced-113e47b41cc5
    Package NDC
    55513-137-60, 55513-137-95, 55513-369-55, 55513-485-95, 55513-485-96, 55513-497-60, 55513-508-55, 55513-518-04, 55513-497-51, 55513-996-96, 55513-996-95, 55513-497-23, 55513-519-30, 55513-516-41, 55513-517-04, 55513-523-04, 55513-521-19, 55513-522-14
    Nui
    N0000182961, N0000182960
    Pharm class epc
    Phosphodiesterase 4 Inhibitor [EPC]
    Pharm class moa
    Phosphodiesterase 4 Inhibitors [MoA]
    UNII
    UP7QBP99PN
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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.