Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10149944serious1Date Last Updated02/06/2014receiptdateformat102companynumbFR-ACTAVIS-2014-08536occurcountryFRseriousnessother1duplicate1Date Received02/05/2014transmissiondate12/12/2014primarysourcecountryFR

Primary Source

reportercountryFRqualification1

Patient

Onset Age42Unit of Onset AgeyearsWeight67SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionDeliriumOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionRoad traffic accidentOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionPhotopsiaOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionFeeling abnormalOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.0ReactionProduct substitution issueOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionSuicide attemptOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductSERTRALINEdrugbatchnumbUNKNOWNdrugauthorizationnumb077663drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb350drugcumulativedosageunit003drugdosagetext50 MG, DAILYdrugdosageformCAPSULEdrugadministrationroute048drugindicationDYSTHYMIC DISORDERdrugstartdateformat102drugstartdate08/04/2014drugenddateformat102drugenddate15/04/2014actiondrug1

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)

drugcharacterization1medicinalproductZYPREXA VELOTABdrugbatchnumbUNKNOWNdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, DAILYdrugadministrationroute048drugindicationPSYCHOTIC DISORDERdrugstartdateformat602drugstartdate//1998

3)

drugcharacterization1medicinalproductZYPREXA VELOTABdrugbatchnumbUNKNOWNdrugstructuredosagenumb15drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext15 MG, DAILYdrugadministrationroute048

Report Duplicate

duplicatesourceWATSONduplicatenumbFR-ACTAVIS-2014-08536

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use