Drug adverse event reports (FAERS)

Pulmonary valve incompetence

Drugs: FINTEPLA

SeriousOther seriousReport 26940057
Safetyreportversion
1
Safetyreportid
26940057
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20260709
Reporttype
2
Serious
1
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
1
Receivedateformat
102
Receivedate
20260630
Receiptdateformat
102
Receiptdate
20260630
Fulfillexpeditecriteria
1
Companynumb
US-UCBSA-1026489
Primarysource
Reportercountry
US
Qualification
1
Sender
Sendertype
6
Senderorganization
UCB
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
23
Patientonsetageunit
801
Patientweight
29
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Pulmonary valve incompetence
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    FINTEPLA
    Drugauthorizationnumb
    212102
    Drugseparatedosagenumb
    1
    Drugdosagetext
    4.8 MILLIGRAM PER DAY
    Drugdosageform
    Oral solution
    Drugindication
    Product used for unknown indication
    Actiondrug
    5
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    FENFLURAMINE
    Harmonized identifiers (openFDA)
    Application number
    NDA212102
    Brand name
    FINTEPLA
    Generic name
    FENFLURAMINE
    Manufacturer name
    UCB, Inc.
    Product NDC
    43376-322
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    FENFLURAMINE
    RxCUI
    2381138, 2381144
    SPL ID
    42264a61-0fc3-3a99-e063-6294a90a9595
    SPL set ID
    e88f360e-33ad-4cd6-b2de-5ef885857c5d
    Package NDC
    43376-322-30, 43376-322-36
    UNII
    2DS058H2CF
Summary
Narrativeincludeclinical
CASE EVENT DATE: 20260531
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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.