Adverse Event Report

Report

reporttype2Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID11848531serious1Date Last Updated01/09/2016receiptdateformat102companynumbUS-PFIZER INC-2015396524occurcountryUSseriousnessother1duplicate1Date Received18/12/2015transmissiondate09/11/2016primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age66Unit of Onset AgeyearsWeight115SexFemale

Reaction

1)

reactionmeddraversionpt19.1ReactionRenal failureOutcomeRecovered/resolved with sequelae (consequent health issues)

2)

reactionmeddraversionpt19.1ReactionChronic kidney diseaseOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductIBUPROFEN.drugauthorizationnumb018989drugdosagetextUNKdrugdosageformTABLETdrugadministrationroute048drugindicationOSTEOARTHRITISdrugstartdateformat102drugstartdate22/09/2012drugenddateformat102drugenddate11/10/2012

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

Application Number ANDA077349, ANDA206568, ANDA074937, ANDA091355, ANDA075139, ANDA078682, ANDA0791 ... Brand Name CAREONE IBUPROFEN, IBUPROFEN, HEALTH MART CHILDRENS IBUPROFEN, IBUPROFEN MINIS, ... Generic Name IBUPROFEN, IBUPROFEN TABLETS, IBUPROFEN 200MG, IBUPROFEN ORAL, IBUPFROFEN, IBUPR ... Manufacturers American Sales Company, Family Dollar (FAMILY WELLNESS), Strategic Sourcing Serv ... product_ndc 41520-495, 55319-745, 62011-0214, 49738-510, 59779-392, 11822-3307, 50804-199, 7 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsIBUPROFEN, IBUPROFEN SODIUMRXCUI 310965, 310964, 197803, 204442, 310963, 731536, 197805, 197806, 197807, 206905, ... spl_id 0647c7c2-b153-4d8c-b72b-f63d43c41853, 720dc13b-5778-44fa-a4d2-e35db0b2d589, 397d ... spl_set_id 03cdff8a-8890-440d-82b5-54ce809f88cc, 135f910d-a5cd-46e9-9436-015170cc7e38, 1d81 ... Package NDC 41520-495-71, 41520-495-78, 55319-745-30, 55319-745-80, 55319-745-16, 62011-0214 ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, RM1CE97Z4N

2)

drugcharacterization2medicinalproductREGULAR INSULINdrugdosagetextUNKdrugindicationTYPE 2 DIABETES MELLITUS

activesubstance

activesubstancenameINSULIN NOS

3)

drugcharacterization2medicinalproductALEVEdrugdosagetextUNKdrugindicationOSTEOARTHRITIS

activesubstance

activesubstancenameNAPROXEN SODIUM

openFDA Info on Medication

Application NumberNDA020204, NDA021920Brand Name ALEVE GELCAPS, ALEVE CAPLETS - EASY OPEN ARTHRITIS CAP, ALEVE, ALEVE EASY OPEN A ... Generic NameNAPROXEN SODIUMManufacturersBayer HealthCare LLC., Lil' Drug Store Products, Incproduct_ndc 0280-6020, 0280-6050, 0280-6070, 0280-6010, 66715-9702, 0280-6080, 0280-6091, 02 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsNAPROXEN SODIUMRXCUI849574, 849728, 1112231, 1112233spl_id bb121b51-beb2-7343-e053-2995a90aed1b, bb627be2-090e-126a-e053-2a95a90ab9d5, ad26 ... spl_set_id 0ad8bbb9-dd5f-4273-b085-ee3e5ed22613, 94f09ef7-0695-4499-83c1-95f1e42baf98, acea ... Package NDC 0280-6020-20, 0280-6020-40, 0280-6020-80, 0280-6020-16, 0280-6050-50, 0280-6050- ... UNII9TN87S3A3C

4)

drugcharacterization2medicinalproductMULTIVITAMINSdrugdosagetextUNKdrugindicationSUPPLEMENTATION THERAPY

activesubstance

activesubstancenameVITAMINS

5)

drugcharacterization1medicinalproductIBUPROFEN.drugauthorizationnumb018989drugdosageformTABLETdrugindicationRHEUMATOID ARTHRITIS

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

Application Number ANDA077349, ANDA206568, ANDA074937, ANDA091355, ANDA075139, ANDA078682, ANDA0791 ... Brand Name CAREONE IBUPROFEN, IBUPROFEN, HEALTH MART CHILDRENS IBUPROFEN, IBUPROFEN MINIS, ... Generic Name IBUPROFEN, IBUPROFEN TABLETS, IBUPROFEN 200MG, IBUPROFEN ORAL, IBUPFROFEN, IBUPR ... Manufacturers American Sales Company, Family Dollar (FAMILY WELLNESS), Strategic Sourcing Serv ... product_ndc 41520-495, 55319-745, 62011-0214, 49738-510, 59779-392, 11822-3307, 50804-199, 7 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsIBUPROFEN, IBUPROFEN SODIUMRXCUI 310965, 310964, 197803, 204442, 310963, 731536, 197805, 197806, 197807, 206905, ... spl_id 0647c7c2-b153-4d8c-b72b-f63d43c41853, 720dc13b-5778-44fa-a4d2-e35db0b2d589, 397d ... spl_set_id 03cdff8a-8890-440d-82b5-54ce809f88cc, 135f910d-a5cd-46e9-9436-015170cc7e38, 1d81 ... Package NDC 41520-495-71, 41520-495-78, 55319-745-30, 55319-745-80, 55319-745-16, 62011-0214 ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, RM1CE97Z4N

6)

drugcharacterization2medicinalproductNEXIUMdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, DAILYdrugadministrationroute048drugindicationPROPHYLAXISdrugstartdateformat102drugstartdate22/09/2012drugenddateformat102drugenddate19/10/2012

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id416c365d-7271-4804-9285-643858cf578b, ac4ba22b-f431-4ab4-b239-0e220ad804ddspl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H

7)

drugcharacterization2medicinalproductZOLOFTdrugdosagetextUNKdrugindicationDEPRESSION

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

8)

drugcharacterization1medicinalproductIBUPROFEN.drugauthorizationnumb018989drugdosagetext4-5 200MG TABLETS AN AVERAGE OF 2-3 TIMES A WEEKdrugdosageformTABLETdrugadministrationroute048drugindicationHEADACHEdrugstartdateformat602drugstartdate//1985drugenddateformat602drugenddate//2014actiondrug1drugadditional1

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

Application Number ANDA077349, ANDA206568, ANDA074937, ANDA091355, ANDA075139, ANDA078682, ANDA0791 ... Brand Name CAREONE IBUPROFEN, IBUPROFEN, HEALTH MART CHILDRENS IBUPROFEN, IBUPROFEN MINIS, ... Generic Name IBUPROFEN, IBUPROFEN TABLETS, IBUPROFEN 200MG, IBUPROFEN ORAL, IBUPFROFEN, IBUPR ... Manufacturers American Sales Company, Family Dollar (FAMILY WELLNESS), Strategic Sourcing Serv ... product_ndc 41520-495, 55319-745, 62011-0214, 49738-510, 59779-392, 11822-3307, 50804-199, 7 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsIBUPROFEN, IBUPROFEN SODIUMRXCUI 310965, 310964, 197803, 204442, 310963, 731536, 197805, 197806, 197807, 206905, ... spl_id 0647c7c2-b153-4d8c-b72b-f63d43c41853, 720dc13b-5778-44fa-a4d2-e35db0b2d589, 397d ... spl_set_id 03cdff8a-8890-440d-82b5-54ce809f88cc, 135f910d-a5cd-46e9-9436-015170cc7e38, 1d81 ... Package NDC 41520-495-71, 41520-495-78, 55319-745-30, 55319-745-80, 55319-745-16, 62011-0214 ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, RM1CE97Z4N

9)

drugcharacterization2medicinalproductBUPROPION.drugdosagetextUNKdrugindicationDEPRESSION

activesubstance

activesubstancenameBUPROPION

openFDA Info on Medication

Application NumberANDA202304, ANDA201567Brand NameBUPROPIONGeneric NameBUPROPION HYDROCHLORIDE, BUPROPIONManufacturers Solco Healthcare US LLC, Zydus Pharmaceuticals (USA) Inc., BluePoint Laboratorie ... product_ndc 43547-288, 43547-289, 43547-290, 68382-353, 68382-354, 68001-264, 65841-780, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUPROPION HYDROCHLORIDERXCUI993503, 993518, 993536, 993541, 993557spl_id c9a8a04f-a91c-48f5-9fe7-40da0ff61902, 3a335702-b823-4e62-abba-f7743c3c1b51, 688c ... spl_set_id 39b2d509-1281-4464-9cf1-a94bbc18b84b, 8d937ca3-3351-40f1-8192-348ba0c68162, 1622 ... Package NDC 43547-288-06, 43547-288-09, 43547-288-10, 43547-288-50, 43547-289-06, 43547-289- ... UNIIZG7E5POY8O

10)

drugcharacterization2medicinalproductLEVOTHYROXINE.drugdosagetextUNKdrugindicationHYPOTHYROIDISM

activesubstance

activesubstancenameLEVOTHYROXINE

openFDA Info on Medication

Brand NameLEVOTHYROXINEGeneric NameLEVOTHYROXINEManufacturersDeseret Biologicals, Inc.product_ndc43742-0955Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOTHYROXINEspl_id7c431149-4f46-4c4f-a5bb-c1b1fb705283spl_set_id1a467f8b-2611-4936-af2b-098e4791d6aePackage NDC43742-0955-1NUIN0000175945, M0021504Established Pharmacologic Classl-Thyroxine [EPC]Chemical StructureThyroxine [CS]UNIIQ51BO43MG4

11)

drugcharacterization2medicinalproductHYDROCODONE/ACETAMINOPHENdrugdosagetextUNKdrugindicationOSTEOARTHRITIS

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE

12)

drugcharacterization2medicinalproductSENOKOTdrugdosagetextUNKdrugindicationSUPPLEMENTATION THERAPY

activesubstance

activesubstancenameSENNOSIDES

openFDA Info on Medication

Application Numberpart334Brand NameSENOKOTGeneric NameSTANDARDIZED SENNA CONCENTRATEManufacturersAvrio Health L.P.product_ndc67618-300, 67618-120Product TypeHUMAN OTC DRUGRouteORALActive IngredientsSENNOSIDESRXCUI312935, 404186, 602802, 1039965spl_id1fe7b543-518b-4096-1548-371189606b75, afa835fa-c05b-2d74-2470-c68c60d32e38spl_set_idc18dd7fa-993b-440b-8cdd-f1551abb99ca, d5bf67e5-82c6-edbf-e9ec-e027fdd47c84Package NDC 67618-300-20, 67618-300-50, 67618-300-10, 67618-120-12, 67618-120-36, 67618-120- ... UNII3FYP5M0IJX

13)

drugcharacterization2medicinalproductGABAPENTIN.drugdosagetextUNKdrugindicationDIABETIC NEUROPATHY

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 6e41ce47-a6cc-4c34-84f1-305747df38c2, 5fc4 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

14)

drugcharacterization1medicinalproductIBUPROFEN.drugauthorizationnumb018989drugdosageformTABLETdrugindicationOSTEOARTHRITISactiondrug1drugadditional1

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

Application Number ANDA077349, ANDA206568, ANDA074937, ANDA091355, ANDA075139, ANDA078682, ANDA0791 ... Brand Name CAREONE IBUPROFEN, IBUPROFEN, HEALTH MART CHILDRENS IBUPROFEN, IBUPROFEN MINIS, ... Generic Name IBUPROFEN, IBUPROFEN TABLETS, IBUPROFEN 200MG, IBUPROFEN ORAL, IBUPFROFEN, IBUPR ... Manufacturers American Sales Company, Family Dollar (FAMILY WELLNESS), Strategic Sourcing Serv ... product_ndc 41520-495, 55319-745, 62011-0214, 49738-510, 59779-392, 11822-3307, 50804-199, 7 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsIBUPROFEN, IBUPROFEN SODIUMRXCUI 310965, 310964, 197803, 204442, 310963, 731536, 197805, 197806, 197807, 206905, ... spl_id 0647c7c2-b153-4d8c-b72b-f63d43c41853, 720dc13b-5778-44fa-a4d2-e35db0b2d589, 397d ... spl_set_id 03cdff8a-8890-440d-82b5-54ce809f88cc, 135f910d-a5cd-46e9-9436-015170cc7e38, 1d81 ... Package NDC 41520-495-71, 41520-495-78, 55319-745-30, 55319-745-80, 55319-745-16, 62011-0214 ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, RM1CE97Z4N

15)

drugcharacterization2medicinalproductLANTUSdrugdosagetextUNKdrugindicationTYPE 2 DIABETES MELLITUS

activesubstance

activesubstancenameINSULIN GLARGINE

openFDA Info on Medication

Application NumberBLA021081Brand NameLANTUSGeneric NameINSULIN GLARGINEManufacturerssanofi-aventis U.S. LLCproduct_ndc0088-2220, 0088-2219, 0088-5021, 0088-5020Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsINSULIN GLARGINERXCUI285018, 311041, 847230, 847232spl_id0a57f187-f101-4268-851f-7f20c7f708f9, 4e455ace-94f4-4fa3-85eb-0152e5a06239spl_set_idd5e07a0c-7e14-4756-9152-9fea485d654a, 6328c99d-d75f-43ef-b19e-7e71f91e57f6Package NDC 0088-2220-33, 0088-2220-34, 0088-2219-00, 0088-2219-01, 0088-2219-05, 0088-5021- ... NUIN0000004931, N0000175453Chemical StructureInsulin [Chemical/Ingredient]Established Pharmacologic ClassInsulin Analog [EPC]UNII2ZM8CX04RZ

summary

narrativeincludeclinicalCASE EVENT DATE: 2013

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2015396524

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use