Drug adverse event reports (FAERS)

Brain natriuretic peptide increased, Cardiac failure

Drugs: SKYCLARYS

SeriousOther seriousReport 26940053
Safetyreportversion
1
Safetyreportid
26940053
Primarysourcecountry
EU
Occurcountry
EU
Transmissiondateformat
102
Transmissiondate
20260709
Reporttype
1
Serious
1
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
1
Receivedateformat
102
Receivedate
20260630
Receiptdateformat
102
Receiptdate
20260630
Fulfillexpeditecriteria
1
Authoritynumb
EU-AFSSAPS-RS2026000507
Primarysource
Reportercountry
EU
Qualification
1
Sender
Sendertype
6
Senderorganization
BIOGEN
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
77
Patientonsetageunit
801
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Brain natriuretic peptide increased
    Reactionoutcome
    3
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Cardiac failure
    Reactionoutcome
    3
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    SKYCLARYS
    Drugstructuredosagenumb
    150
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    1
    Drugintervaldosagedefinition
    804
    Drugindication
    Friedreich^s ataxia
    Drugstartdateformat
    102
    Drugstartdate
    20260401
    Drugenddateformat
    102
    Drugenddate
    20260512
    Drugtreatmentduration
    41
    Drugtreatmentdurationunit
    804
    Actiondrug
    1
    Drugrecurreadministration
    3
    Drugadditional
    2
    Activesubstance
    Activesubstancename
    OMAVELOXOLONE
    Harmonized identifiers (openFDA)
    Application number
    NDA216718
    Brand name
    SKYCLARYS
    Generic name
    OMAVELOXOLONE
    Manufacturer name
    Biogen
    Product NDC
    64406-250
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    OMAVELOXOLONE
    RxCUI
    2631936, 2631942
    SPL ID
    4fa5df55-d5bf-44d1-856e-937b48e69bb0
    SPL set ID
    2709e870-df3d-f30f-e063-6394a90aeda1
    Package NDC
    64406-250-90
    Nui
    N0000185506, N0000187063
    Pharm class moa
    Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA]
    UNII
    G69Z98951Q
Summary
Narrativeincludeclinical
CASE EVENT DATE: 20260401
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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.