Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10153807serious1Date Last Updated06/05/2014receiptdateformat102companynumbGB-DRREDDYS-GER/UKI/14/0040047occurcountryGBseriousnessother1duplicate1Date Received06/05/2014transmissiondate12/12/2014primarysourcecountryGBseriousnessdisabling1

Primary Source

reportercountryGBqualification5

Patient

Onset Age20Unit of Onset AgeyearsWeight78SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionCognitive disorderOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionCoordination abnormalOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionDepressionOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionDyspraxiaOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionMemory impairmentOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt17.0ReactionAmnesiaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductSERTRALINEdrugbatchnumbUNKNOWNdrugstructuredosagenumb100drugstructuredosageunit003drugadministrationroute048drugindicationANXIETYdrugstartdateformat102drugstartdate26/03/2011drugenddateformat102drugenddate26/03/2014actiondrug1drugrecurreadministration3

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, 5c8d ... 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

2)

drugcharacterization1medicinalproductSERTRALINEdrugbatchnumbUNKNOWNdrugindicationDEPRESSIONactiondrug1drugrecurreadministration3

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, 5c8d ... 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

duplicatesourceDR REDDYSduplicatenumbGB-DRREDDYS-GER/UKI/14/0040047

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use