Adverse Event Report

Report

reporttype1receiptdateformat102seriousnessdeath1companynumbAUR-APL-2014-04088Version of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10077240Date Received10/04/2014transmissiondate26/03/2015serious1Date Last Updated04/08/2014primarysourcecountryGB

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryGBqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age37Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionOverdose

2)

reactionmeddraversionpt17.1ReactionDrug interaction

3)

reactionmeddraversionpt17.1ReactionVomiting

4)

reactionmeddraversionpt17.1ReactionPain

5)

reactionmeddraversionpt17.1ReactionConvulsion

Drug

1)

drugcharacterization1medicinalproductOXYCODONE HYDROCHLORIDE.drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate08/10/2013drugenddateformat102drugenddate08/10/2013

activesubstance

activesubstancenameOXYCODONE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA205853, ANDA207418, NDA022272, ANDA203638, ANDA208795, ANDA204021, ANDA20989 ... Brand NameOXYCODONE HYDROCHLORIDE, OXYCONTIN, ROXICODONE, OXAYDOGeneric NameOXYCODONE HYDROCHLORIDE, OXYCODONEManufacturers Rhodes Pharmaceuticals L.P., Camber Pharmaceuticals Inc, Purdue Pharma LP, Amnea ... product_ndc 42858-010, 31722-917, 31722-918, 59011-410, 59011-480, 59011-415, 59011-420, 590 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDERXCUI 1049615, 1049611, 1049618, 1049504, 1049545, 1049565, 1049576, 1049586, 1049595, ... spl_id bab5f88d-95e5-6e41-c800-4e3b85583d10, 69cd1131-3a4e-4e63-9734-1b1e3f4ee5c9, 21ec ... spl_set_id bab5f88d-95e5-6e41-c800-4e3b85583d10, 01db4606-d49c-4b10-a78a-1cf41880a9fb, bfdf ... Package NDC 42858-010-15, 31722-917-01, 31722-917-05, 31722-918-01, 31722-918-05, 59011-480- ... UNIIC1ENJ2TE6C

2)

drugcharacterization1medicinalproductSERTRALINEdrugauthorizationnumb077206drugadministrationroute048drugindicationANXIETYdrugstartdateformat102drugstartdate08/10/2013drugenddateformat102drugenddate08/10/2013

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

3)

drugcharacterization2medicinalproductOMEPRAZOLE (OMEPRAZOLE)

activesubstance

activesubstancenameOMEPRAZOLE

4)

drugcharacterization2medicinalproductPREGAMBLIN (PREGAMBLIN)

summary

narrativeincludeclinicalCASE EVENT DATE: 20131008

Report Duplicate

duplicatesourceAUROBINDOduplicatenumbAUR-APL-2014-04088