Drug adverse event reports (FAERS)

Death

Drugs: OLAPARIB

SeriousDeathOther seriousReport 27325176
Safetyreportversion
1
Safetyreportid
27325176
Primarysourcecountry
MX
Occurcountry
MX
Transmissiondateformat
102
Transmissiondate
20261008
Reporttype
2
Serious
1
Seriousnessdeath
1
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
1
Receivedateformat
102
Receivedate
20260930
Receiptdateformat
102
Receiptdate
20260930
Fulfillexpeditecriteria
1
Companynumb
MX-AstraZeneca-CH-01209878A
Primarysource
Reportercountry
MX
Qualification
5
Sender
Sendertype
6
Senderorganization
ALEXION PHARMACEUTICALS
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientagegroup
5
Patientweight
65
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Death
    Reactionoutcome
    5
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    OLAPARIB
    Drugauthorizationnumb
    208558
    Drugstructuredosagenumb
    300
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    1
    Drugintervaldosagedefinition
    804
    Drugdosagetext
    300 MILLIGRAM, QD
    Drugadministrationroute
    065
    Drugindication
    Prostate cancer
    Drugstartdateformat
    610
    Drugstartdate
    202606
    Actiondrug
    6
    Drugrecurreadministration
    3
    Drugadditional
    4
    Activesubstance
    Activesubstancename
    OLAPARIB
    Harmonized identifiers (openFDA)
    Application number
    NDA208558
    Brand name
    LYNPARZA
    Generic name
    OLAPARIB
    Manufacturer name
    AstraZeneca Pharmaceuticals LP
    Product NDC
    0310-0569, 0310-0668, 0310-0679, 0310-0578
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    OLAPARIB
    RxCUI
    1942482, 1942485, 1942487, 1942489
    SPL ID
    0142c57f-6211-4638-8c48-c215686871b8
    SPL set ID
    741ff3e3-dc1a-45a6-84e5-2481b27131aa
    Package NDC
    0310-0668-60, 0310-0668-12, 0310-0668-95, 0310-0679-60, 0310-0679-12, 0310-0679-95, 0310-0569-60, 0310-0569-12, 0310-0578-60, 0310-0578-12
    Nui
    N0000191623, N0000191622
    Pharm class epc
    Poly(ADP-Ribose) Polymerase Inhibitor [EPC]
    Pharm class moa
    Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
    UNII
    WOH1JD9AR8
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

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.