Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10068188serious1Date Last Updated13/05/2014receiptdateformat102companynumbUS-PFIZER INC-2014096763occurcountryUSseriousnessother1duplicate1Date Received09/04/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age59Unit of Onset AgeyearsWeight79.37SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionCerebrovascular accidentOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionMyocardial infarctionOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionConvulsionOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionGastrointestinal disorderOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCELEBREXdrugauthorizationnumb020998drugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext200 MG, 2X/DAYdrugdosageformCAPSULE, HARDdrugindicationMUSCULOSKELETAL DISCOMFORTdrugstartdateformat602drugstartdate//1995drugenddateformat602drugenddate//2000actiondrug5

openFDA Info on Medication

Application NumberNDA020998Brand NameCELEBREXGeneric NameCELECOXIBManufacturersG.D. Searle LLC Division of Pfizer Incproduct_ndc0025-1515, 0025-1520, 0025-1525, 0025-1530Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCELECOXIBRXCUI205322, 205323, 213468, 213469, 349514, 352314, 686379, 686381spl_idd2a1146b-f1a6-4467-9ba8-b10f94494f8espl_set_id8d52185d-421f-4e34-8db7-f7676db2a226Package NDC 0025-1515-01, 0025-1520-31, 0025-1520-51, 0025-1520-34, 0025-1525-31, 0025-1525- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIJCX84Q7J1L

2)

drugcharacterization1medicinalproductCELEBREXdrugauthorizationnumb020998drugstructuredosagenumb200drugstructuredosageunit003drugdosagetext200 MG, DAILYdrugdosageformCAPSULE, HARDdrugindicationBACK DISORDERdrugstartdateformat102drugstartdate27/08/2001actiondrug5

openFDA Info on Medication

Application NumberNDA020998Brand NameCELEBREXGeneric NameCELECOXIBManufacturersG.D. Searle LLC Division of Pfizer Incproduct_ndc0025-1515, 0025-1520, 0025-1525, 0025-1530Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCELECOXIBRXCUI205322, 205323, 213468, 213469, 349514, 352314, 686379, 686381spl_idd2a1146b-f1a6-4467-9ba8-b10f94494f8espl_set_id8d52185d-421f-4e34-8db7-f7676db2a226Package NDC 0025-1515-01, 0025-1520-31, 0025-1520-51, 0025-1520-34, 0025-1525-31, 0025-1525- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIJCX84Q7J1L

3)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, DAILYdrugadministrationroute048drugstartdateformat102drugstartdate05/07/2001drugenddateformat102drugenddate03/10/2001

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

4)

drugcharacterization2medicinalproductSOMAdrugstructuredosagenumb350drugstructuredosageunit003drugdosagetext350 MG, UNK (1 PO)drugadministrationroute048drugstartdateformat102drugstartdate05/07/2001

openFDA Info on Medication

Application NumberNDA011792Brand NameSOMAGeneric NameCARISOPRODOLManufacturersMeda Pharmaceuticalsproduct_ndc0037-2001, 0037-2250Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCARISOPRODOLRXCUI197446, 213695, 730794, 730918spl_idf1040579-1917-4488-9df8-ca3424ebd03bspl_set_id6297cf20-830a-11dc-94c8-0002a5d5c51bPackage NDC0037-2250-10, 0037-2250-30, 0037-2001-01NUIN0000175730, N0000175737Physiologic/Pharmacodynamic EffectCentrally-mediated Muscle Relaxation [PE]Established Pharmacologic ClassMuscle Relaxant [EPC]UNII21925K482H

5)

drugcharacterization2medicinalproductSOMAdrugdosagetext1 PO X3drugstartdateformat102drugstartdate27/08/2001

openFDA Info on Medication

Application NumberNDA011792Brand NameSOMAGeneric NameCARISOPRODOLManufacturersMeda Pharmaceuticalsproduct_ndc0037-2001, 0037-2250Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCARISOPRODOLRXCUI197446, 213695, 730794, 730918spl_idf1040579-1917-4488-9df8-ca3424ebd03bspl_set_id6297cf20-830a-11dc-94c8-0002a5d5c51bPackage NDC0037-2250-10, 0037-2250-30, 0037-2001-01NUIN0000175730, N0000175737Physiologic/Pharmacodynamic EffectCentrally-mediated Muscle Relaxation [PE]Established Pharmacologic ClassMuscle Relaxant [EPC]UNII21925K482H

6)

drugcharacterization2medicinalproductLORTABdrugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, UNK (Q 4-6 PO)drugadministrationroute048

openFDA Info on Medication

Application NumberANDA040881Brand NameLORTABGeneric NameHYDROCODONE BITARTRATE AND ACETAMINOPHENManufacturersAkorn, Inc.product_ndc17478-450Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCODONE BITARTRATE, ACETAMINOPHENRXCUI1044427, 1442445spl_id3354ff15-0cde-4f2a-a05b-5ee5b04a6c65spl_set_id21def91d-b6e3-4dde-983c-6925aedf0df0Package NDC17478-450-16UNIINO70W886KK, 362O9ITL9D

7)

drugcharacterization2medicinalproductALLEGRA-Ddrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, 2X/DAY (1DF Q 12 HRS)drugstartdateformat102drugstartdate14/11/2001

8)

drugcharacterization2medicinalproductBEXTRAdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, DAILY

9)

drugcharacterization2medicinalproductDEPAKOTEdrugstructuredosagenumb1500drugstructuredosageunit003drugdosagetext1500 MG, DAILY (500MG 3QD)

openFDA Info on Medication

Application NumberNDA021168, NDA018723, NDA019680Brand NameDEPAKOTE ER, DEPAKOTE, DEPAKOTE SPRINKLESGeneric NameDIVALPROEX SODIUMManufacturersAbbVie Inc.product_ndc0074-3826, 0074-7126, 0074-6212, 0074-6214, 0074-6215, 0074-6114Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIVALPROEX SODIUMspl_id 94344b70-6db3-4dd1-891a-16ccf096a3eb, bb31c7ee-b0a3-42ab-a6b3-b27b3441db1e, 9aef ... spl_set_id 0dc024ce-efc8-4690-7cb5-639c728fccac, 08a65cf4-7749-4ceb-6895-8f4805e2b01f, 4619 ... Package NDC 0074-3826-11, 0074-3826-13, 0074-7126-11, 0074-7126-72, 0074-7126-13, 0074-7126- ... UNII644VL95AO6

10)

drugcharacterization2medicinalproductDILANTINdrugstructuredosagenumb400drugstructuredosageunit003drugdosagetext400 MG, DAILY (100MG 4QHS)

openFDA Info on Medication

Application NumberANDA084349Brand NameDILANTINGeneric NameEXTENDED PHENYTOIN SODIUMManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0369, 0071-3740Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPHENYTOIN SODIUMRXCUI855671, 855673, 855869, 855871spl_id7193d60a-5479-455c-bd53-ced4b79e3a0aspl_set_id8848de76-8d74-4620-bcc7-a86a596e5dd9Package NDC0071-3740-66, 0071-0369-24, 0071-0369-32, 0071-0369-40UNII4182431BJH

11)

drugcharacterization2medicinalproductLIPITORdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, DAILY

openFDA Info on Medication

Application NumberNDA020702Brand NameLIPITORGeneric NameATORVASTATIN CALCIUMManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0155, 0071-0156, 0071-0157, 0071-0158Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATORVASTATIN CALCIUM TRIHYDRATERXCUI259255, 262095, 617310, 617311, 617312, 617314, 617318, 617320spl_id0ba214c6-250e-42a0-aea8-5e44aba04882spl_set_idc6e131fe-e7df-4876-83f7-9156fc4e8228Package NDC 0071-0155-23, 0071-0155-40, 0071-0155-10, 0071-0155-97, 0071-0156-23, 0071-0156- ... UNII48A5M73Z4Q

12)

drugcharacterization2medicinalproductTOPROL XLdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, DAILY

openFDA Info on Medication

Application NumberNDA019962Brand NameTOPROL XLGeneric NameMETOPROLOL SUCCINATEManufacturersAstraZeneca Pharmaceuticals LP, Aralez Pharmaceuticals US Inc.product_ndc 0186-1088, 0186-1090, 0186-1092, 0186-1094, 70347-025, 70347-050, 70347-100, 703 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOPROLOL SUCCINATERXCUI866412, 866414, 866419, 866421, 866427, 866429, 866436, 866438spl_id03b2ba2e-c4b7-449d-8e07-9c0e08171f66, 259b9a5f-b63a-44a0-8d05-1bb38cfc85bdspl_set_id4a5762c6-d7a2-4e4c-10b7-8832b36fa5f4, 991fe00b-498b-400e-9e5b-921cb07d9b2cPackage NDC 0186-1088-05, 0186-1088-39, 0186-1088-30, 0186-1088-35, 0186-1090-05, 0186-1090- ... UNIITH25PD4CCB

13)

drugcharacterization2medicinalproductIMDURdrugstructuredosagenumb30drugstructuredosageunit003drugdosagetext30 MG, DAILY

14)

drugcharacterization2medicinalproductASAdrugstructuredosagenumb350drugstructuredosageunit003drugdosagetext350 MG, DAILY

15)

drugcharacterization2medicinalproductZANAFLEXdrugdosagetextUNKdrugindicationABDOMINAL DISCOMFORTdrugstartdateformat102drugstartdate10/05/2002

openFDA Info on Medication

Application NumberNDA020397, NDA021447Brand NameZANAFLEXGeneric NameTIZANIDINE HYDROCHLORIDEManufacturersCovis Pharmaproduct_ndc70515-594, 70515-602, 70515-604, 70515-606Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTIZANIDINE HYDROCHLORIDERXCUI153735, 313413, 485484, 485485, 485486, 580267, 583165, 583211spl_id8f9774b0-1a53-4e5e-913b-d9f0055e8daaspl_set_id043d9e51-bfa2-4add-9058-5ece332f7e99Package NDC70515-602-15, 70515-604-15, 70515-606-15, 70515-594-15UNIIB53E3NMY5C

16)

drugcharacterization2medicinalproductULTRACETdrugdosagetextUNK

openFDA Info on Medication

Application NumberNDA021123Brand NameULTRACETGeneric NameTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-650Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTRAMADOL HYDROCHLORIDE, ACETAMINOPHENRXCUI836395, 836397spl_id71a33ae6-67ea-11e9-bb58-66d80099106dspl_set_id2d20df3c-8b5b-4bdf-a49f-ec904522575dPackage NDC50458-650-60, 50458-650-10UNII9N7R477WCK, 362O9ITL9D

17)

drugcharacterization2medicinalproductALBUTEROLdrugstructuredosagenumb180drugstructuredosageunit004drugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext180 UG, 4X/DAY (90MCG, 2 PUFFS Q 6 HOURS)drugstartdateformat102drugstartdate12/06/2002

openFDA Info on Medication

Application Number ANDA210948, ANDA213657, ANDA211397, ANDA208804, ANDA207046, ANDA072894, ANDA2088 ... Brand NameALBUTEROLGeneric NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, Aurobindo Pharma Limited, Virtus Pharmaceuticals LL ... product_ndc 75834-273, 75834-274, 59651-333, 59651-334, 69543-290, 69543-291, 69238-1344, 69 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALBUTEROL SULFATERXCUI197316, 197318spl_id b736135f-6e13-3e29-e053-2a95a90a67f4, ff9b287b-e4a4-4c12-ad2f-6b7d55b20dc6, b9cd ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, ff9b287b-e4a4-4c12-ad2f-6b7d55b20dc6, 3f81 ... Package NDC 75834-273-01, 75834-274-01, 59651-333-01, 59651-333-05, 59651-334-01, 59651-334- ... UNII021SEF3731

18)

drugcharacterization2medicinalproductMECLIZINEdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25 MG, 2X/DAY (1DF PO BID)drugstartdateformat102drugstartdate14/06/2002

openFDA Info on Medication

Application Numberpart336, ANDA201451Brand NameMECLIZINE, MECLIZINE HYDROCHLORIDEGeneric NameMECLIZINE HCL 25MG, MECLIZINE HCL 12.5 MG, MECLIZINE, MECLIZINE HCL 12.5MGManufacturers Ulai Health LLC, Pharbest Pharmaceuticals, Inc., SDA Laboratories, Inc., RUGBY L ... product_ndc 73057-387, 16103-386, 66424-386, 66424-387, 0536-1297, 16103-387, 65162-441, 651 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMECLIZINE HYDROCHLORIDERXCUI995632, 995624, 995666, 995686spl_id 3c884e11-5f9b-4a8a-9a2b-179a19b20244, 4e199df3-49f3-42f2-add2-00b99d78cc10, 01ec ... spl_set_id ea2e6834-c11a-40f8-887c-e02419023e7b, 8b3c9283-b618-4d57-9f15-7cf73e8737f5, f258 ... Package NDC 73057-387-11, 73057-387-08, 16103-386-08, 16103-386-11, 66424-386-01, 66424-386- ... UNIIHDP7W44CIO

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014096763

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use