Adverse Event Report

Report

reporttype1Version of Safety Report ID10receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10058173serious1Date Last Updated01/10/2015receiptdateformat102companynumbUS-PFIZER INC-2014094977occurcountryUSseriousnessother1duplicate1Date Received04/04/2014seriousnesshospitalization1transmissiondate04/03/2016primarysourcecountryUSseriousnessdisabling1

Primary Source

reportercountryUSqualification3

Patient

Onset Age56Unit of Onset AgeyearsWeight104SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionFoot fractureOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.1ReactionDrug ineffectiveOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.1ReactionCartilage injuryOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.1ReactionArthritisOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt18.1ReactionNasal congestionOutcomeUnknown

6)

reactionmeddraversionpt18.1ReactionCondition aggravatedOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt18.1ReactionBlood glucose decreasedOutcomeRecovered/resolved

8)

reactionmeddraversionpt18.1ReactionLoss of consciousnessOutcomeRecovered/resolved

9)

reactionmeddraversionpt18.1ReactionDepressionOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt18.1ReactionCondition aggravatedOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt18.1ReactionHearing impairedOutcomeUnknown

12)

reactionmeddraversionpt18.1ReactionFallOutcomeRecovered/resolved

13)

reactionmeddraversionpt18.1ReactionCerebrovascular accidentOutcomeRecovered/resolved

14)

reactionmeddraversionpt18.1ReactionPeripheral swellingOutcomeRecovered/resolved

15)

reactionmeddraversionpt18.1ReactionAbasiaOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductPRAVASTATINdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, 1X/DAYdrugindicationBLOOD CHOLESTEROL ABNORMALdrugstartdateformat602drugstartdate//2014

activesubstance

activesubstancenamePRAVASTATIN\PRAVASTATIN SODIUM

2)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, 1X/DAYdrugadministrationroute048drugindicationDEPRESSIONdrugstartdateformat602drugstartdate//2010

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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)

drugcharacterization1medicinalproductLYRICAdrugauthorizationnumb021446drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext300 MG, 2X/DAYdrugdosageformCAPSULE, HARDdrugindicationNEUROPATHY PERIPHERALdrugstartdateformat602drugstartdate//2000actiondrug5

activesubstance

activesubstancenamePREGABALIN

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)

drugcharacterization2medicinalproductSINGULAIRdrugstructuredosagenumb2drugstructuredosageunit003drugdosagetext2 MG, DAILY

activesubstance

activesubstancenameMONTELUKAST SODIUM

openFDA Info on Medication

Application NumberNDA020829, NDA020830, NDA021409Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersMerck Sharp & Dohme Corp.product_ndc0006-9117, 0006-3841, 0006-1711, 0006-9275Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id96717981-6ea2-4720-a749-e14f1559511fspl_set_id8c166755-7711-4df9-d689-8836a1a70885Package NDC 0006-3841-30, 0006-3841-14, 0006-1711-31, 0006-1711-54, 0006-9275-31, 0006-9275- ... UNIIU1O3J18SFL

5)

drugcharacterization2medicinalproductSINGULAIRdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, 1X/DAYdrugindicationHYPERSENSITIVITYdrugstartdateformat602drugstartdate//2013

activesubstance

activesubstancenameMONTELUKAST SODIUM

openFDA Info on Medication

Application NumberNDA020829, NDA020830, NDA021409Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersMerck Sharp & Dohme Corp.product_ndc0006-9117, 0006-3841, 0006-1711, 0006-9275Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id96717981-6ea2-4720-a749-e14f1559511fspl_set_id8c166755-7711-4df9-d689-8836a1a70885Package NDC 0006-3841-30, 0006-3841-14, 0006-1711-31, 0006-1711-54, 0006-9275-31, 0006-9275- ... UNIIU1O3J18SFL

6)

drugcharacterization2medicinalproductSINGULAIRdrugdosagetextUNKdrugstartdateformat602drugstartdate//2012

activesubstance

activesubstancenameMONTELUKAST SODIUM

openFDA Info on Medication

Application NumberNDA020829, NDA020830, NDA021409Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersMerck Sharp & Dohme Corp.product_ndc0006-9117, 0006-3841, 0006-1711, 0006-9275Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id96717981-6ea2-4720-a749-e14f1559511fspl_set_id8c166755-7711-4df9-d689-8836a1a70885Package NDC 0006-3841-30, 0006-3841-14, 0006-1711-31, 0006-1711-54, 0006-9275-31, 0006-9275- ... UNIIU1O3J18SFL

7)

drugcharacterization2medicinalproductLOSARTAN.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100/25 MG, 1X/DAYdrugdosageformTABLETdrugadministrationroute048drugindicationHYPERTENSIONdrugstartdateformat602drugstartdate//2000

activesubstance

activesubstancenameLOSARTAN

8)

drugcharacterization1medicinalproductLYRICAdrugauthorizationnumb021446drugdosageformCAPSULE, HARDdrugindicationBURNING SENSATIONactiondrug5

activesubstance

activesubstancenamePREGABALIN

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

9)

drugcharacterization1medicinalproductLYRICAdrugauthorizationnumb021446drugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext200 MG, 2X/DAYdrugdosageformCAPSULE, HARDdrugadministrationroute048drugindicationPAIN IN EXTREMITYdrugstartdateformat610drugstartdate/05/2015actiondrug5

activesubstance

activesubstancenamePREGABALIN

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

10)

drugcharacterization2medicinalproductOMEPRAZOLE.drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, 1X/DAYdrugdosageformCAPSULEdrugadministrationroute048drugindicationREFLUX GASTRITISdrugstartdateformat602drugstartdate//2000

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

11)

drugcharacterization2medicinalproductSINGULAIRdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, DAILYdrugstartdateformat602drugstartdate//2014

activesubstance

activesubstancenameMONTELUKAST SODIUM

openFDA Info on Medication

Application NumberNDA020829, NDA020830, NDA021409Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersMerck Sharp & Dohme Corp.product_ndc0006-9117, 0006-3841, 0006-1711, 0006-9275Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id96717981-6ea2-4720-a749-e14f1559511fspl_set_id8c166755-7711-4df9-d689-8836a1a70885Package NDC 0006-3841-30, 0006-3841-14, 0006-1711-31, 0006-1711-54, 0006-9275-31, 0006-9275- ... UNIIU1O3J18SFL

12)

drugcharacterization2medicinalproductZYRTECdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, ONCE/TWICE A DAYdrugindicationHYPERSENSITIVITYdrugstartdateformat602drugstartdate//2012

activesubstance

activesubstancenameCETIRIZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022429Brand NameZYRTECGeneric NameCETIRIZINE HYDROCHLORIDEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-779Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCETIRIZINE HYDROCHLORIDERXCUI1014675, 1020023spl_idd7532844-79d8-4648-ab9b-e5d3d3ad76f9spl_set_id605adf29-734f-451a-8ff3-74be7b5814a6Package NDC50580-779-12, 50580-779-25, 50580-779-40, 50580-779-65UNII64O047KTOA

summary

narrativeincludeclinicalCASE EVENT DATE: 2003

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014094977

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use