Adverse Event Report

Report

reporttype2Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10856231serious1Date Last Updated23/02/2015receiptdateformat102companynumbUS-MYLANLABS-2015M1004159occurcountryUSduplicate1Date Received23/02/2015seriousnesshospitalization1transmissiondate21/07/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Reaction

1)

reactionmeddraversionpt18.0ReactionGastrointestinal disorderOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionMigraineOutcomeRecovering/resolving

3)

reactionmeddraversionpt18.0ReactionVomitingOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductAMNESTEEMdrugauthorizationnumb075945drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK, BIDdrugdosageformCAPSULEdrugindicationACNEdrugstartdateformat610drugstartdate/06/2014drugenddateformat102drugenddate30/01/2015actiondrug1

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA075945Brand NameAMNESTEEMGeneric NameISOTRETINOINManufacturersMylan Pharmaceuticals Inc.product_ndc0378-6611, 0378-6612, 0378-6614Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 404058, 404061, 404064spl_id47bb51b9-0613-4708-905f-e950dbfa5127spl_set_idb2cb63c9-f825-4991-9a2c-6260f1bbcc2cPackage NDC 0378-6611-85, 0378-6611-93, 0378-6612-85, 0378-6612-93, 0378-6614-85, 0378-6614- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

2)

drugcharacterization2medicinalproductPRILOSECdrugdosagetextUNKdrugindicationGASTROOESOPHAGEAL REFLUX DISEASEdrugstartdateformat602drugstartdate//2014

activesubstance

activesubstancenameOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022056Brand NamePRILOSECGeneric NameOMEPRAZOLE MAGNESIUMManufacturersCovis Pharmaproduct_ndc70515-610, 70515-625Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE MAGNESIUMRXCUI797058, 797061, 797063, 797065spl_id1bd73b0f-b2c2-4409-94ce-1955c6ab119bspl_set_idb6761f84-53ac-4745-a8c8-1e5427d7e179Package NDC70515-625-01, 70515-610-01UNII426QFE7XLK

summary

narrativeincludeclinicalCASE EVENT DATE: 2014

Report Duplicate

duplicatesourceMYLANduplicatenumbUS-MYLANLABS-2015M1004159

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use