Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10133792serious1Date Last Updated28/04/2014receiptdateformat102companynumbBR-DSJP-DSJ-2014-106223occurcountryBRseriousnessother1duplicate1Date Received28/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryBR

Primary Source

reportercountryBRqualification5

Patient

SexUnknown

Reaction

1)

reactionmeddraversionpt17.0ReactionProstate cancerOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionNosocomial infectionOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionUrethral stenosisOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionBlood pressure increasedOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductBENICAR ANLOdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40/10 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationHYPERTENSIONdrugstartdateformat602drugstartdate//2005drugenddateformat602drugenddate//2010actiondrug1

2)

drugcharacterization2medicinalproductCLONAZEPAM NORTHIAdrugdosagetextUNKdrugadministrationroute065

3)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextUNKdrugadministrationroute065

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 6dce ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

Report Duplicate

duplicatesourceDAIICHIduplicatenumbBR-DSJP-DSJ-2014-106223

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use