Drug adverse event reports (FAERS)

Cardiotoxicity

Drugs: HERCEPTIN

SeriousOther seriousReport 26940063
Safetyreportversion
1
Safetyreportid
26940063
Primarysourcecountry
CN
Occurcountry
CN
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
CN-ROCHE-10000614504
Primarysource
Reportercountry
CN
Qualification
3
Sender
Sendertype
6
Senderorganization
ROCHE
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientsex
2
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Cardiotoxicity
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    HERCEPTIN
    Drugseparatedosagenumb
    1
    Drugindication
    Invasive ductal breast carcinoma
    Actiondrug
    5
    Drugrecurreadministration
    3
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    TRASTUZUMAB
    Harmonized identifiers (openFDA)
    Application number
    BLA103792
    Brand name
    HERCEPTIN
    Generic name
    TRASTUZUMAB
    Manufacturer name
    Genentech, Inc.
    Product NDC
    50242-132
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    INTRAVENOUS
    Substance name
    TRASTUZUMAB
    RxCUI
    1922509, 1922512
    SPL ID
    7517f775-6a10-4ddd-8dfb-6704ece413d0
    SPL set ID
    492dbdb2-077e-4064-bff3-372d6af0a7a2
    Package NDC
    50242-132-01
    Nui
    N0000175661, N0000020008
    Pharm class epc
    HER2/neu Receptor Antagonist [EPC]
    Pharm class moa
    HER2/Neu/cerbB2 Antagonists [MoA]
    UNII
    P188ANX8CK
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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.