Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-PFIZER INC-2014081085occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10035390Date Received25/03/2014transmissiondate02/10/2014serious2Date Last Updated25/03/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age58Unit of Onset AgeyearsWeight102.95SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionArthralgiaOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionMyalgiaOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionBursitisOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionSleep disorderOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionMusculoskeletal painOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionEcchymosisOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionRashOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionPain in extremityOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductLYRICAdrugauthorizationnumb021446drugstructuredosagenumb75drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext75 MG, 3X/DAYdrugadministrationroute048drugindicationFIBROMYALGIAactiondrug5

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

2)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb020990drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, 1X/DAYdrugdosageformORAL SOLUTIONactiondrug5

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)

drugcharacterization2medicinalproductCENTRUM SILVERdrugdosagetextUNK

4)

drugcharacterization2medicinalproductADVILdrugstructuredosagenumb400drugstructuredosageunit003drugdosagetext400 MG, AS NEEDEDdrugdosageformTABLET

openFDA Info on Medication

Application NumberNDA201803, NDA018989, NDA020402Brand NameADVILGeneric NameIBUPROFEN SODIUM, IBUPROFENManufacturers GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, Lil' Drug Store Products, ... product_ndc 0573-0133, 0573-0134, 0573-0150, 0573-0165, 0573-0154, 0573-0151, 0573-0161, 057 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIBUPROFEN SODIUM, IBUPROFENRXCUI153008, 310965, 310964, 731533spl_id fc3f9fd1-0569-4374-bcc4-bdbdbcb5411b, 943017cf-1b80-44e5-bef9-20f6604dfb43, 4dc1 ... spl_set_id 5be198b8-396e-4b44-8819-e2e3b5d2ad0e, 1a665e64-9f30-be37-4a83-38789f1f1e89, 1f01 ... Package NDC 0573-0133-20, 0573-0133-40, 0573-0133-80, 0573-0133-02, 0573-0133-04, 0573-0133- ... UNIIRM1CE97Z4N, WK2XYI10QMNUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]

5)

drugcharacterization2medicinalproductESTRADIOLdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, 1X/DAYdrugdosageformTABLET

openFDA Info on Medication

Application Number NDA020538, NDA020655, ANDA040197, NDA020908, ANDA075182, NDA020375, ANDA205256, ... Brand Name ESTRADIOL, ALORA, ESTRACE, VAGIFEM, MENOSTAR, YUVAFEM, ESTRADIOL VAGINAL INSERTS ... Generic NameESTRADIOL, ESTRADIOL,Manufacturers Sandoz Inc, Qualgen LLC, Allergan, Inc., Novo Nordisk, Mylan Pharmaceuticals Inc ... product_ndc 0781-7129, 0781-7138, 0781-7144, 0781-7156, 0781-7167, 69761-006, 0023-5885, 002 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteTRANSDERMAL, ORAL, VAGINAL, TOPICALActive IngredientsESTRADIOL, ESTRADIOL HEMIHYDRATERXCUI 241946, 242891, 242892, 248478, 1149632, 310173, 310180, 486155, 1149645, 197657 ... spl_id 16615373-38bc-49ef-a7df-e48aad6f5325, abe65034-0a2d-4a1f-8452-25f211563f2f, 157d ... spl_set_id c4da6de7-9ab1-4fcf-88f3-fe785019e6e7, 1536dc3b-ec2a-40a8-90b6-42e1d4f5326b, ac67 ... Package NDC 0781-7129-58, 0781-7129-83, 0781-7129-40, 0781-7138-58, 0781-7138-83, 0781-7138- ... NUIM0447348, N0000175825, N0000000100Chemical StructureEstradiol Congeners [CS]Established Pharmacologic ClassEstrogen [EPC]Mechanism of ActionEstrogen Receptor Agonists [MoA]UNII4TI98Z838E, CXY7B3Q98Z

6)

drugcharacterization2medicinalproductZOLPIDEM

openFDA Info on Medication

Application NumberANDA077214Brand NameZOLPIDEMGeneric NameZOLPIDEM TARTRATEManufacturersACI Healthcare USA, Incproduct_ndc71093-155, 71093-156Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854873, 854876spl_idad76e67e-f0d0-4f39-b3d8-68d43560b07fspl_set_id021153ce-fe27-4ed1-8d88-b4157b0ed734Package NDC71093-155-06, 71093-155-04, 71093-156-04, 71093-156-06UNIIWY6W63843K

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014081085