Drug adverse event reports (FAERS)

Death

Drugs: DURVALUMAB

SeriousDeathOther seriousReport 26940076
Safetyreportversion
1
Safetyreportid
26940076
Primarysourcecountry
IN
Occurcountry
IN
Transmissiondateformat
102
Transmissiondate
20260709
Reporttype
2
Serious
1
Seriousnessdeath
1
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
1
Receivedateformat
102
Receivedate
20260630
Receiptdateformat
102
Receiptdate
20260630
Fulfillexpeditecriteria
1
Companynumb
IN-AstraZeneca-CH-01149014A
Primarysource
Reportercountry
IN
Qualification
5
Sender
Sendertype
6
Senderorganization
ALEXION PHARMACEUTICALS
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
75
Patientonsetageunit
801
Patientagegroup
6
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Death
    Reactionoutcome
    5
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    DURVALUMAB
    Drugauthorizationnumb
    761069
    Drugstructuredosagenumb
    1500
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    3
    Drugintervaldosagedefinition
    803
    Drugindication
    Hepatocellular carcinoma
    Actiondrug
    1
    Drugrecurreadministration
    3
    Activesubstance
    Activesubstancename
    DURVALUMAB
    Harmonized identifiers (openFDA)
    Application number
    BLA761069
    Brand name
    IMFINZI
    Generic name
    DURVALUMAB
    Manufacturer name
    AstraZeneca Pharmaceuticals LP
    Product NDC
    0310-4500, 0310-4611
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    INTRAVENOUS
    Substance name
    DURVALUMAB
    RxCUI
    1919507, 1919512, 1919515, 1919516
    SPL ID
    5826517b-d2d2-4636-ad9c-0dc676abad9e
    SPL set ID
    8baba4ea-2855-42fa-9bd9-5a7548d4cec3
    Package NDC
    0310-4500-12, 0310-4611-50
    Nui
    N0000193338, N0000193337, N0000193336, M0001357
    Pharm class epc
    Programmed Death Ligand-1 Blocker [EPC]
    Pharm class moa
    Programmed Death Ligand-1 Antagonists [MoA], Programmed Death Ligand-1-directed Antibody Interactions [MoA]
    Pharm class cs
    Antibodies, Monoclonal [CS]
    UNII
    28X28X9OKV
Summary
Narrativeincludeclinical
CASE EVENT DATE: 20260617
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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.