Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10188225serious1Date Last Updated22/05/2014receiptdateformat102companynumbIT-TEVA-481416ISRoccurcountryITduplicate1Date Received22/05/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryIT

Primary Source

reportercountryITqualification1

Patient

Onset Age34Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionBradykinesiaOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionHypotensionOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.0ReactionIntentional self-injuryOutcomeRecovering/resolving

4)

reactionmeddraversionpt17.0ReactionRhabdomyolysisOutcomeRecovering/resolving

5)

reactionmeddraversionpt17.0ReactionBradyphreniaOutcomeRecovering/resolving

6)

reactionmeddraversionpt17.0ReactionSoporOutcomeRecovering/resolving

7)

reactionmeddraversionpt17.0ReactionDrug abuseOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductSERTRALINEdrugauthorizationnumb076465drugstructuredosagenumb500drugstructuredosageunit003drugdosagetext500 MG TOTALdrugadministrationroute048drugindicationINTENTIONAL SELF-INJURYdrugstartdateformat102drugstartdate16/04/2014drugenddateformat102drugenddate16/04/2014actiondrug1

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)

drugcharacterization1medicinalproductLEXOTAN - 2,5MG/ML GOCCE ORALI, SOLUZIONEdrugstructuredosagenumb60drugstructuredosageunit012drugdosagetext60 ML TOTAL,SOLUTIONdrugdosageformORAL DROPSdrugadministrationroute048drugindicationINTENTIONAL SELF-INJURYdrugstartdateformat102drugstartdate16/04/2014drugenddateformat102drugenddate16/04/2014actiondrug1

3)

drugcharacterization1medicinalproductDEPAKIN CHRONO - 500 MG COMPRESSE A RILASCIO PROLUNGATO - BB FARMA SRLdrugstructuredosagenumb5drugstructuredosageunit032drugdosagetext5 DF TOTALdrugdosageformPROLONGED-RELEASE TABLETdrugadministrationroute048drugindicationINTENTIONAL SELF-INJURYdrugstartdateformat102drugstartdate16/04/2014drugenddateformat102drugenddate16/04/2014actiondrug1

4)

drugcharacterization1medicinalproductSEROQUEL - 25 MG COMPRESSE RIVESTITE CON FILMdrugstructuredosagenumb5drugstructuredosageunit032drugdosagetext5 DF TOTALdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugindicationINTENTIONAL SELF-INJURYdrugstartdateformat102drugstartdate16/04/2014drugenddateformat102drugenddate16/04/2014actiondrug1

Report Duplicate

duplicatesourceTEVAduplicatenumbIT-TEVA-481416ISR

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use