Drug adverse event reports (FAERS)

Dyspepsia

Drugs: CREON

SeriousOther seriousReport 27325213
Safetyreportversion
1
Safetyreportid
27325213
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20261008
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-ABBVIE-6953957
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
ABBVIE
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientagegroup
5
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Dyspepsia
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    CREON
    Drugauthorizationnumb
    020725
    Drugseparatedosagenumb
    1
    Drugindication
    Product used for unknown indication
    Actiondrug
    1
    Activesubstance
    Activesubstancename
    PANCRELIPASE AMYLASE\PANCRELIPASE LIPASE\PANCRELIPASE PROTEASE
    Harmonized identifiers (openFDA)
    Application number
    BLA020725
    Brand name
    CREON
    Generic name
    PANCRELIPASE
    Manufacturer name
    AbbVie Inc.
    Product NDC
    0032-0045, 0032-1203, 0032-1206, 0032-1212, 0032-1224, 0032-3016, 0032-0046, 0032-0047, 0032-2636, 0032-2637
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    PANCRELIPASE AMYLASE, PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE
    RxCUI
    855495, 855499, 855503, 863829, 863836, 863841, 1113042, 1113046, 1373325, 1373327
    SPL ID
    a43ddd93-7d01-4bb9-95e3-b0629fe8ac87
    SPL set ID
    073201aa-556d-4a70-918e-84e9616fd88d
    Package NDC
    0032-1203-70, 0032-1203-64, 0032-1206-07, 0032-1206-01, 0032-1206-56, 0032-1212-07, 0032-1212-01, 0032-1212-46, 0032-1212-13, 0032-1224-07, 0032-1224-01, 0032-1224-46, 0032-3016-28, 0032-3016-13, 0032-3016-50, 0032-3016-12, 0032-0045-70, 0032-0045-30, 0032-0046-30, 0032-0046-70, 0032-0047-30, 0032-0047-70, 0032-2636-70, 0032-2636-01, 0032-2636-30, 0032-2637-70, 0032-2637-01, 0032-2637-30
    UNII
    8MYC33932O, 3560D81V50, YOJ58O116E
  2. Drugcharacterization
    1
    Medicinalproduct
    CREON
    Drugauthorizationnumb
    020725
    Drugseparatedosagenumb
    1
    Actiondrug
    1
    Activesubstance
    Activesubstancename
    PANCRELIPASE AMYLASE\PANCRELIPASE LIPASE\PANCRELIPASE PROTEASE
    Harmonized identifiers (openFDA)
    Application number
    BLA020725
    Brand name
    CREON
    Generic name
    PANCRELIPASE
    Manufacturer name
    AbbVie Inc.
    Product NDC
    0032-0045, 0032-1203, 0032-1206, 0032-1212, 0032-1224, 0032-3016, 0032-0046, 0032-0047, 0032-2636, 0032-2637
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    PANCRELIPASE AMYLASE, PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE
    RxCUI
    855495, 855499, 855503, 863829, 863836, 863841, 1113042, 1113046, 1373325, 1373327
    SPL ID
    a43ddd93-7d01-4bb9-95e3-b0629fe8ac87
    SPL set ID
    073201aa-556d-4a70-918e-84e9616fd88d
    Package NDC
    0032-1203-70, 0032-1203-64, 0032-1206-07, 0032-1206-01, 0032-1206-56, 0032-1212-07, 0032-1212-01, 0032-1212-46, 0032-1212-13, 0032-1224-07, 0032-1224-01, 0032-1224-46, 0032-3016-28, 0032-3016-13, 0032-3016-50, 0032-3016-12, 0032-0045-70, 0032-0045-30, 0032-0046-30, 0032-0046-70, 0032-0047-30, 0032-0047-70, 0032-2636-70, 0032-2636-01, 0032-2636-30, 0032-2637-70, 0032-2637-01, 0032-2637-30
    UNII
    8MYC33932O, 3560D81V50, YOJ58O116E
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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.