Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10070015serious1Date Last Updated08/04/2014receiptdateformat102companynumbAUR-APL-2014-04020seriousnessother1duplicate1Date Received08/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryGBseriousnessdisabling1

Primary Source

reportercountryGBqualification5

Patient

Onset Age35Unit of Onset AgeyearsWeight98SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionImpaired work ability

2)

reactionmeddraversionpt17.0ReactionExtrasystoles

3)

reactionmeddraversionpt17.0ReactionPanic attack

4)

reactionmeddraversionpt17.0ReactionHallucination, visual

5)

reactionmeddraversionpt17.0ReactionMental disorder

6)

reactionmeddraversionpt17.0ReactionAltered state of consciousness

7)

reactionmeddraversionpt17.0ReactionSpeech disorder

8)

reactionmeddraversionpt17.0ReactionHeadache

9)

reactionmeddraversionpt17.0ReactionChronic fatigue syndrome

10)

reactionmeddraversionpt17.0ReactionPain in extremity

11)

reactionmeddraversionpt17.0ReactionCondition aggravated

12)

reactionmeddraversionpt17.0ReactionPalpitations

13)

reactionmeddraversionpt17.0ReactionDepression

14)

reactionmeddraversionpt17.0ReactionDrug interaction

Drug

1)

drugcharacterization1medicinalproductSERTRALINEdrugauthorizationnumb77206drugstructuredosagenumb50drugstructuredosageunit003drugadministrationroute048drugindicationDEPRESSED MOODdrugstartdateformat102drugstartdate22/11/2013drugadditional2

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)

drugcharacterization1medicinalproductAMITRIPTYLINEdrugstructuredosagenumb50drugstructuredosageunit003drugindicationNEURALGIAdrugstartdateformat102drugstartdate22/11/2013

3)

drugcharacterization2medicinalproductDIAZEPAM (DIAZEPAM)

Report Duplicate

duplicatesourceAUROBINDOduplicatenumbAUR-APL-2014-04020

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use