Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-CELGENEUS-163-10004-14081285occurcountryUSVersion of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10701230Date Received09/01/2015transmissiondate21/07/2015serious2Date Last Updated09/01/2015primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age30Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionAbdominal discomfortOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionDecreased appetiteOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductACCUTANEdrugdosagetext30-60MGdrugdosageformUNKNOWNdrugadministrationroute065drugindicationACNEdrugstartdateformat102drugstartdate12/12/2013drugenddateformat102drugenddate12/04/2014

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)

drugcharacterization2medicinalproductPROPECIAdrugdosageformUNKNOWNdrugadministrationroute065drugindicationALOPECIA

activesubstance

activesubstancenameFINASTERIDE

openFDA Info on Medication

Application NumberNDA020788Brand NamePROPECIAGeneric NameFINASTERIDEManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0071Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFINASTERIDERXCUI200172, 213178spl_id52756d47-4ff2-4829-9fc4-ea346253b47cspl_set_id4e07adb4-7807-47d3-b9a9-2332a3047410Package NDC0006-0071-54, 0006-0071-31, 0006-0071-07NUIN0000175836, N0000000126Established Pharmacologic Class5-alpha Reductase Inhibitor [EPC]Mechanism of Action5-alpha Reductase Inhibitors [MoA]UNII57GNO57U7G

3)

drugcharacterization1medicinalproductOTEZLAdrugauthorizationnumb205437drugstructuredosagenumb30drugstructuredosageunit003drugdosageformTABLETSdrugadministrationroute048drugindicationPSORIATIC ARTHROPATHYdrugstartdateformat102drugstartdate15/05/2014drugenddateformat602drugenddate//2014actiondrug1drugrecurreadministration1

activesubstance

activesubstancenameAPREMILAST

openFDA Info on Medication

Application NumberNDA205437Brand NameOTEZLAGeneric NameAPREMILASTManufacturersCelgene Corporation, Amgen Incproduct_ndc59572-630, 59572-631, 59572-632, 55513-137, 55513-369, 55513-485Product TypeHUMAN PRESCRIPTION DRUGRouteORALRXCUI 1492732, 1492738, 1492740, 1492742, 1492744, 1492746, 1492747, 1492748, 1605454, ... spl_id4b03ba80-afc7-4904-8c87-ef84b8fd25ea, c0c9cadc-efb8-4bff-8fc3-a13addedd3daspl_set_id3acf6751-827d-11e2-9e96-0800200c9a66, f6b1f516-4972-4d82-bced-113e47b41cc5Package NDC 59572-630-27, 59572-630-99, 59572-631-06, 59572-631-28, 59572-632-55, 55513-137- ... UNIIUP7QBP99PNActive IngredientsAPREMILAST

summary

narrativeincludeclinicalCASE EVENT DATE: 20140516

Report Duplicate

duplicatesourceCELGENEduplicatenumbUS-CELGENEUS-163-10004-14081285