Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10156341serious1Date Last Updated01/10/2015receiptdateformat102companynumbGB-DRREDDYS-GER/UKI/14/0040056occurcountryGBduplicate1Date Received07/05/2014transmissiondate04/03/2016primarysourcecountryGBseriousnessdisabling1

Primary Source

reportercountryGBqualification5

Patient

Onset Age21Unit of Onset AgeyearsWeight152.4SexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionInsomniaOutcomeRecovered/resolved with sequelae (consequent health issues)

2)

reactionmeddraversionpt18.1ReactionAggressionOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.1ReactionDecreased appetiteOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.1ReactionMusculoskeletal stiffnessOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.1ReactionDisturbance in sexual arousalOutcomeRecovered/resolved

6)

reactionmeddraversionpt18.1ReactionThirstOutcomeRecovered/resolved

7)

reactionmeddraversionpt18.1ReactionIrritabilityOutcomeRecovered/resolved

8)

reactionmeddraversionpt18.1ReactionLethargyOutcomeRecovered/resolved with sequelae (consequent health issues)

9)

reactionmeddraversionpt18.1ReactionEjaculation delayedOutcomeRecovered/resolved

10)

reactionmeddraversionpt18.1ReactionDry mouthOutcomeRecovered/resolved

11)

reactionmeddraversionpt18.1ReactionMigraineOutcomeRecovered/resolved with sequelae (consequent health issues)

Drug

1)

drugcharacterization1medicinalproductFLUOXETINEdrugbatchnumbUNKNOWNdrugauthorizationnumb075465drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1drugrecurreadministration3

activesubstance

activesubstancenameFLUOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA090223, ANDA209695, ANDA078619, ANDA079209, ANDA210935, ANDA211282, ANDA2132 ... Brand NameFLUOXETINEGeneric NameFLUOXETINE, FLUOXETINE HYDROCHLORIDEManufacturers Alembic Pharmaceuticals Limited, Nivagen Pharmaceuticals, Inc., BluePoint Labora ... product_ndc 46708-271, 46708-272, 46708-273, 75834-148, 68001-399, 68001-400, 68001-401, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFLUOXETINE HYDROCHLORIDERXCUI310384, 310385, 313989, 1190110, 310386, 248642, 313990spl_id 40ef6547-f80f-45f4-8719-ebc913b4df7d, 789b1507-b5c0-4a50-bf82-f1fe9bb3c8d6, b697 ... spl_set_id 6b9c2d73-866b-44c4-8718-e7e4a9a0fb55, f4cbf9a9-1d7f-4aa0-a18d-fba50d49bd2b, f89a ... Package NDC 46708-271-30, 46708-271-31, 46708-271-71, 46708-271-91, 46708-272-30, 46708-272- ... UNIII9W7N6B1KJ

2)

drugcharacterization1medicinalproductSERTRALINEdrugbatchnumbUNKNOWNdrugauthorizationnumb076442drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationDEPRESSIONdrugstartdateformat102drugstartdate01/12/2012drugenddateformat102drugenddate31/01/2013actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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/14/0040056

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use