Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10068367serious1Date Last Updated09/04/2014receiptdateformat102companynumbUS-PFIZER INC-2014099246occurcountryUSseriousnessother1duplicate1Date Received09/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age37Unit of Onset AgeyearsWeight65.76SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionPneumoniaOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionWeight decreasedOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionPost-traumatic stress disorderOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionFatigueOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionLoss of libidoOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionDecreased appetiteOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionHyperhidrosisOutcomeUnknown

9)

reactionmeddraversionpt17.0ReactionActivities of daily living impairedOutcomeUnknown

10)

reactionmeddraversionpt17.0ReactionInsomniaOutcomeUnknown

11)

reactionmeddraversionpt17.0ReactionFeeling abnormalOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, UNKdrugindicationANXIETYdrugstartdateformat602drugstartdate//1990actiondrug4

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

2)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MG, DAILYdrugindicationDEPRESSIONactiondrug4

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

3)

drugcharacterization2medicinalproductLYRICAdrugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK, 3X/DAYdrugindicationFIBROMYALGIA

openFDA Info on Medication

Application NumberNDA021446, NDA022488Brand NameLYRICAGeneric NamePREGABALINManufacturersParke-Davis Div of Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0071-1012, 0071-1013, 0071-1014, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, ... spl_idb9b1285a-2cb3-4789-8b0e-8d5e1b253534, 0fbd5d1f-30cd-464d-a1d6-71e8057a9377spl_set_id60185c88-ecfd-46f9-adb9-b97c6b00a553, ce1a4b9d-3127-4416-8bf2-fee5899fc0baPackage NDC 0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015- ... UNII55JG375S6M

4)

drugcharacterization2medicinalproductPERCOCETdrugdosagetextUNK, EVERY SIX HOURSdrugindicationPAIN

openFDA Info on Medication

Application NumberANDA040330Brand NamePERCOCETGeneric NameOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENManufacturersEndo Pharmaceuticals Inc.product_ndc63481-623, 63481-627, 63481-628, 63481-629Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDE, ACETAMINOPHENRXCUI1049214, 1049221, 1049225, 1049625, 1049635, 1049637, 1049640, 1049642spl_id8a04ce2f-d576-469f-91bc-5ed75e27e47espl_set_id4dd36cf5-8f73-404a-8b1d-3bd53bd90c25Package NDC63481-627-70, 63481-623-70, 63481-623-85, 63481-628-70, 63481-629-70UNIIC1ENJ2TE6C, 362O9ITL9D

5)

drugcharacterization2medicinalproductMETHOCARBAMOLdrugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext500 MG, 4X/DAYdrugindicationPAIN

openFDA Info on Medication

Application Number ANDA208116, ANDA200958, ANDA207522, ANDA204404, ANDA208507, ANDA211504, ANDA0404 ... Brand NameMETHOCARBAMOL, ROBAXIN, METHOCARB 500-EZSGeneric NameMETHOCARBAMOL INJECTION, METHOCARBAMOL, METHOCARBAMOL TABLETSManufacturers Renaissance Lakewood LLC, Westminster Pharmaceuticals, LLC, Somerset Therapeutic ... product_ndc 49396-0711, 69367-255, 69367-256, 70069-101, 67457-273, 76385-123, 76385-124, 43 ... Product TypeHUMAN PRESCRIPTION DRUGRoutePARENTERAL, ORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsMETHOCARBAMOLRXCUI238175, 197943, 197944, 207014, 207016, 1010654spl_id 7d658860-a6e3-cb2f-e053-2991aa0a9461, ae9df131-66a3-0ec7-e053-2995a90a02e4, f868 ... spl_set_id 4a9d9920-c79a-4396-e054-00144ff8d46c, 2199b810-fb84-4dac-b787-ade2b5f67e92, 68dd ... Package NDC 49396-0711-1, 69367-256-01, 69367-256-05, 69367-255-01, 69367-255-05, 70069-101- ... NUIN0000175730, N0000175737Physiologic/Pharmacodynamic EffectCentrally-mediated Muscle Relaxation [PE]Established Pharmacologic ClassMuscle Relaxant [EPC]UNII125OD7737X

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014099246

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use