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

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
- 5)
- 6)
- 7)
Drug

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

Report Duplicate

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

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use

Adverse Event Report

Report

Primary Source

Patient

Reaction

1)

2)

3)

4)

5)

6)

7)

Drug

1)

openFDA Info on Medication

2)

openFDA Info on Medication

Report Duplicate

Receiver

Sender

Media

Newsletter

Follow us

Connect with us