Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10071119serious1Date Last Updated10/04/2014receiptdateformat102companynumbGB-TEVA-472466ISRoccurcountryGBseriousnessother1duplicate1Date Received10/04/2014transmissiondate12/12/2014primarysourcecountryGB

Primary Source

reportercountryGBqualification5

Patient

SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionOedema peripheralOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionCoughOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionRenal impairmentOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionEar congestionOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionProteinuriaOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionDecreased appetiteOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionVomitingOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductSERTRALINEdrugauthorizationnumb076465drugstructuredosagenumb50drugstructuredosageunit003drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat610drugstartdate/10/2013drugenddateformat610drugenddate/02/2014actiondrug1drugrecurreadministration3

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)

drugcharacterization2medicinalproductWARFARINdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA090935, ANDA202202Brand NameWARFARIN SODIUMGeneric NameWARFARINManufacturersExelan Pharmaceuticals Inc., Amneal Pharmaceuticals LLCproduct_ndc 76282-327, 76282-328, 76282-329, 76282-330, 76282-331, 76282-332, 76282-333, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsWARFARIN SODIUMRXCUI855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344spl_id45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5, f0ce7015-9133-4b90-a624-77fb776fbfa7spl_set_idc0cc4511-e656-4b6d-96cd-e02e76173b9d, 558b7a0d-5490-4c1b-802e-3ab3f1efe760Package NDC 76282-327-01, 76282-327-10, 76282-328-01, 76282-328-10, 76282-329-01, 76282-329- ... UNII6153CWM0CL

Report Duplicate

duplicatesourceTEVAduplicatenumbGB-TEVA-472466ISR

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use