Drug adverse event reports (FAERS)

Fall, Off label use

Drugs: LUMAKRAS

SeriousOther seriousReport 27325187
Safetyreportversion
1
Safetyreportid
27325187
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-USCT2026286834
Primarysource
Reportercountry
US
Qualification
3
Sender
Sendertype
6
Senderorganization
AMGEN
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Fall
    Reactionoutcome
    6
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Off label use
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    LUMAKRAS
    Drugauthorizationnumb
    214665
    Drugstructuredosagenumb
    960
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    1
    Drugintervaldosagedefinition
    804
    Drugdosagetext
    960MG (4 TABLETS) ORALLY ONCE DAILY
    Drugadministrationroute
    061
    Drugindication
    Rectal cancer
    Actiondrug
    1
    Activesubstance
    Activesubstancename
    SOTORASIB
    Harmonized identifiers (openFDA)
    Application number
    NDA214665
    Brand name
    LUMAKRAS
    Generic name
    SOTORASIB
    Manufacturer name
    Amgen Inc
    Product NDC
    55513-488, 55513-504, 55513-512
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    SOTORASIB
    RxCUI
    2550719, 2550725, 2628240, 2628242, 2687205, 2687207
    SPL ID
    8f611e67-8c58-4413-8b81-a200fa7f30e8
    SPL set ID
    c80a362c-7ac3-4894-a076-0691e68ef8c1
    Package NDC
    55513-488-01, 55513-488-02, 55513-488-40, 55513-488-24, 55513-488-96, 55513-504-50, 55513-512-60
    UNII
    2B2VM6UC8G
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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.