Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-JNJFOC-20140107226occurcountryUSVersion of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10938217Date Received21/03/2015transmissiondate21/08/2015serious2Date Last Updated25/05/2015primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionDiarrhoeaOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionGastrointestinal disorderOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductACCUTANEdrugdosageformUNSPECIFIEDdrugadministrationroute065

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA202099Brand NameACCUTANEGeneric NameISOTRETINOINManufacturersJG Pharma Inc.product_ndc72143-231, 72143-232, 72143-234, 72143-233Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 206880, 206883, 206902, 403930, 2473107spl_ida599c5e2-aeaa-4667-b6fa-ddc56bbb71daspl_set_ida41ceb83-aaca-4f9d-ae33-c53b1ca71e41Package NDC 72143-231-10, 72143-231-30, 72143-232-10, 72143-232-30, 72143-234-10, 72143-234- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

2)

drugcharacterization1medicinalproductSTELARAdrugauthorizationnumb125261drugstructuredosagenumb45drugstructuredosageunit003drugdosageformSOLUTION FOR INJECTIONdrugadministrationroute058drugindicationPSORIASISactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameUSTEKINUMAB

openFDA Info on Medication

Application NumberBLA761044, BLA125261Brand NameSTELARAGeneric NameUSTEKINUMABManufacturersJanssen Biotech, Inc.product_ndc57894-054, 57894-060, 57894-061Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, SUBCUTANEOUSActive IngredientsUSTEKINUMABRXCUI 853350, 853354, 853355, 853356, 1654077, 1654079, 1654082, 1654083, 1811255, 181 ... spl_ide96f17df-5745-452d-87d1-7d6385b135c4spl_set_idc77a9664-e3bb-4023-b400-127aa53bca2bPackage NDC 57894-060-02, 57894-060-03, 57894-060-04, 57894-061-02, 57894-061-03, 57894-061- ... NUIN0000192797, N0000192796, N0000192799, N0000192798Established Pharmacologic ClassInterleukin-12 Antagonist [EPC], Interleukin-23 Antagonist [EPC]Mechanism of ActionInterleukin-12 Antagonists [MoA], Interleukin-23 Antagonists [MoA]UNIIFU77B4U5Z0

Report Duplicate

duplicatesourceJANSSENduplicatenumbUS-JNJFOC-20140107226