Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10150067serious1Date Last Updated09/10/2014seriousnesslifethreatening1receiptdateformat102authoritynumbGB-MHRA-ADR 22496422companynumbGB-WATSON-2014-08655occurcountryGBseriousnessother1duplicate1Date Received02/05/2014transmissiondate28/05/2015primarysourcecountryGB

Primary Source

reportercountryGBqualification5

Patient

Onset Age23Unit of Onset AgeyearsWeight89SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionDyspnoeaOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionParaesthesiaOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.0ReactionAbdominal painOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.0ReactionFluid retentionOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.0ReactionPhotosensitivity reactionOutcomeRecovered/resolved

6)

reactionmeddraversionpt18.0ReactionAmnesiaOutcomeRecovered/resolved

7)

reactionmeddraversionpt18.0ReactionChest discomfortOutcomeRecovered/resolved

8)

reactionmeddraversionpt18.0ReactionDepressed level of consciousnessOutcomeRecovered/resolved

9)

reactionmeddraversionpt18.0ReactionDisturbance in attentionOutcomeRecovered/resolved

10)

reactionmeddraversionpt18.0ReactionAstheniaOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

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

2)

drugcharacterization1medicinalproductPREGABALIN (UNKNOWN)drugbatchnumbUNCONFIRMEDdrugstructuredosagenumb600drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext600 MG, DAILY; DOSE HAS BEEN ADJUSTEDdrugdosageformUnkdrugadministrationroute048drugindicationANXIETY DISORDERdrugstartdateformat102drugstartdate01/12/2013actiondrug5

activesubstance

activesubstancenamePREGABALIN

3)

drugcharacterization1medicinalproductPROPRANOLOLdrugbatchnumbUNCONFIRMEDdrugdosagetextUNKdrugdosageformUnkdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenamePROPRANOLOL\PROPRANOLOL HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA075826Brand NamePROPRANOLOLGeneric NamePROPRANOLOL HYDROCHLORIDEManufacturersFresenius Kabi USA, LLCproduct_ndc63323-604Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsPROPRANOLOL HYDROCHLORIDERXCUI856443spl_iddb24d808-268b-4bec-bd48-7b66d2bb5951spl_set_idf14ea537-dd5c-4c78-9037-9a85e9e610efPackage NDC63323-604-01UNIIF8A3652H1V

4)

drugcharacterization1medicinalproductOLANZAPINE (UNKNOWN)drugbatchnumbUNCONFIRMEDdrugdosagetextUNKdrugdosageformUnkdrugadministrationroute065drugindicationSLEEP DISORDERactiondrug5

activesubstance

activesubstancenameOLANZAPINE

5)

drugcharacterization1medicinalproductCLONAZEPAM (UNKNOWN)drugbatchnumbUNCONFIRMEDdrugauthorizationnumb074869drugdosagetextUNK UNK, PRN; RARELY USEDdrugdosageformUnkdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameCLONAZEPAM

Report Duplicate

duplicatesourceWATSONduplicatenumbGB-WATSON-2014-08655

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use