Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-PURDUE-USA-2003-0013548occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10091769Date Received21/04/2014transmissiondate12/12/2014serious2Date Last Updated21/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Weight90.7SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionPelvic painOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionNauseaOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionArthralgiaOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionVomitingOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionPain in extremityOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionPolymenorrhoeaOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionDepressionOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductOXYFASTdrugbatchnumbUNKNOWNdrugauthorizationnumb091490drugdosageformORAL SOLUTIONdrugindicationPELVIC PAINdrugrecurreadministration3

2)

drugcharacterization2medicinalproductOXYCONTIN TABLETSdrugbatchnumbUNKNOWNdrugdosageformPROLONGED-RELEASE TABLETdrugadministrationroute048drugindicationPAINactiondrug5

3)

drugcharacterization2medicinalproductROXICODONEdrugbatchnumbUNKNOWNdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

openFDA Info on Medication

Application NumberNDA021011Brand NameROXICODONEGeneric NameOXYCODONE HYDROCHLORIDEManufacturersSpecGx LLCproduct_ndc23635-580, 23635-581, 23635-582Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDERXCUI1049611, 1049613, 1049618, 1049620, 1049621, 1049623spl_ide315b901-11eb-4a90-8c87-cd5b010f5e2fspl_set_id5a8157d3-ba20-4abf-b0d4-6ad141b31d63Package NDC23635-580-25, 23635-580-10, 23635-581-10, 23635-582-10UNIIC1ENJ2TE6C

4)

drugcharacterization2medicinalproductZOLOFTdrugbatchnumbUNKNOWNdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

Report Duplicate

duplicatesourcePURDUEduplicatenumbUS-PURDUE-USA-2003-0013548