Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10086643serious1Date Last Updated27/05/2014receiptdateformat102seriousnessdeath1companynumbGB-PFIZER INC-2014109055occurcountryGBduplicate1Date Received18/04/2014transmissiondate12/12/2014primarysourcecountryGB

Primary Source

reportercountryGBqualification2

Patient

Onset Age81Unit of Onset AgeyearsWeight90SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionCerebrovascular accidentOutcomeFatal

2)

reactionmeddraversionpt17.0ReactionComplex partial seizuresOutcomeFatal

Drug

1)

drugcharacterization1medicinalproductPHENYTOIN SODIUMdrugauthorizationnumb010151drugstructuredosagenumb1800drugstructuredosageunit003drugdosagetext1800 MG UNIT DOSE 20MG/KGdrugdosageformSOLUTION FOR INJECTIONdrugadministrationroute042drugindicationCOMPLEX PARTIAL SEIZURESdrugstartdateformat102drugstartdate26/10/2013

openFDA Info on Medication

Application NumberANDA084307, ANDA040298, ANDA040684, ANDA204309, ANDA040731, ANDA040765Brand NamePHENYTOIN SODIUM, PHENYTEK, EXTENDED PHENYTOIN SODIUMGeneric NamePHENYTOIN SODIUMManufacturers West-Ward Pharmaceuticals Corp., Mylan Pharmaceuticals Inc., Sun Pharmaceutical ... product_ndc 0641-0493, 0641-2555, 0378-3750, 0378-2670, 57664-808, 51672-4111, 65862-692, 03 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsPHENYTOIN SODIUMRXCUI1670351, 1670353, 855861, 855863, 855873, 855875, 855671spl_id d79eeef8-8731-45e8-80e8-b90d66364d55, f55e5605-6f6c-467c-b5bb-b6f5a31acc63, 4236 ... spl_set_id 035a8d4e-2063-4240-83cb-d7eebcabe301, 0f94c791-8b07-4b41-927e-c9f28bec5f60, 92e9 ... Package NDC 0641-0493-21, 0641-0493-25, 0641-2555-41, 0641-2555-45, 0378-2670-93, 0378-2670- ... UNII4182431BJH

2)

drugcharacterization2medicinalproductAMLODIPINEdrugdosagetextUNK

openFDA Info on Medication

Application NumberNDA211340Brand NameKATERZIAGeneric NameAMLODIPINEManufacturersAzurity Pharmaceuticals, Inc.product_ndc52652-5001Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BENZOATERXCUI2184120, 2184126spl_id33926064-be3f-4380-b051-ac4136524317spl_set_iddf673a4d-acb8-444c-a472-c87ab8cbd366Package NDC52652-5001-1UNIIXD75TQ8A2P

3)

drugcharacterization2medicinalproductATENOLOLdrugdosagetextUNK

openFDA Info on Medication

Application Number NDA018240, ANDA078512, ANDA213136, ANDA077443, ANDA076900, ANDA074052, ANDA07302 ... Brand NameTENORMIN, ATENOLOLGeneric NameATENOLOLManufacturers Almatica Pharma LLC, Aurobindo Pharma Limited, Unichem Pharmaceuticals (USA), In ... product_ndc 52427-429, 52427-430, 52427-431, 65862-168, 65862-169, 65862-170, 29300-410, 293 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATENOLOLRXCUI150750, 152414, 197379, 197380, 197381, 201322spl_id 70291313-c4f6-7c2a-cd07-04fd6a07b634, 2f8a6d3c-fbcd-4b11-aa14-d0522fa7600e, d850 ... spl_set_id 746db603-a6e1-4dc3-c2d8-92314419098c, 1b8a4689-3916-4f4b-b54a-bbb4e322d79b, 35d9 ... Package NDC 52427-429-90, 52427-430-90, 52427-431-90, 65862-168-01, 65862-168-99, 65862-169- ... NUIN0000000161, N0000175556Mechanism of ActionAdrenergic beta-Antagonists [MoA]Established Pharmacologic Classbeta-Adrenergic Blocker [EPC]UNII50VV3VW0TI

4)

drugcharacterization2medicinalproductCLOPIDOGRELdrugdosagetextUNK

openFDA Info on Medication

Application Number ANDA076999, ANDA090540, ANDA203751, ANDA201686, ANDA206376, ANDA202925, ANDA2029 ... Brand NameCLOPIDOGREL, PLAVIXGeneric NameCLOPIDOGREL, CLOPIDOGREL BISULFATEManufacturers Teva Pharmaceuticals USA, Inc., Rising Pharmaceuticals, Inc., Amneal Pharmaceuti ... product_ndc 0093-7314, 64980-343, 65162-414, 70710-1417, 43547-484, 43547-485, 16729-218, 16 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLOPIDOGREL BISULFATERXCUI309362, 749196, 213169, 749198spl_id eabdb8dc-24aa-4457-b0ec-5e152a1046b9, a8ba2342-855a-42ed-ac81-a9c44c24a08e, 0fc6 ... spl_set_id bc747f6d-f52c-4dcb-bda5-2d0a9f954147, 36c48914-b1be-4c51-9b06-c9d9d7353e92, 0d01 ... Package NDC 0093-7314-05, 0093-7314-56, 0093-7314-98, 64980-343-03, 64980-343-09, 64980-343- ... UNII08I79HTP27

5)

drugcharacterization2medicinalproductDONEPEZILdrugdosagetextUNK

openFDA Info on Medication

Application NumberANDA203034Brand NameDONEPEZILGeneric NameDONEPEZIL HYDROCHLORIDEManufacturersCamber Pharmaceuticals, Inc.product_ndc31722-737, 31722-738Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDONEPEZIL HYDROCHLORIDERXCUI997223, 997229spl_id9aa92875-4b9e-480f-99ca-ba0d49594761spl_set_id11ac01f4-d26e-47b2-9660-d514ab097fdbPackage NDC 31722-737-30, 31722-737-90, 31722-737-01, 31722-737-05, 31722-737-31, 31722-738- ... UNII3O2T2PJ89D

6)

drugcharacterization2medicinalproductHUMULINdrugdosagetextUNK

openFDA Info on Medication

Application NumberBLA018780, BLA018781, BLA019717Brand Name HUMULIN R, HUMULIN R U-500 KWIKPEN, HUMULIN R U-500, HUMULIN N, HUMULIN 70/30 K ... Generic NameINSULIN HUMANManufacturersEli Lilly and Companyproduct_ndc 0002-8215, 0002-8824, 0002-8501, 0002-8315, 0002-8805, 0002-0800, 0002-8803, 000 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRoutePARENTERAL, SUBCUTANEOUSActive IngredientsINSULIN HUMANRXCUI 311034, 311036, 249220, 351859, 1731315, 1731317, 311026, 311028, 847199, 165486 ... spl_id d2e3e7a4-7ef8-4b3c-a025-dbd2c4d5dd27, 19370fb9-9449-453a-8883-8defa365b120, 6621 ... spl_set_id b519bd83-038c-4ec5-a231-a51ec5cc291f, b60e8dd0-1d48-4dc9-87fd-e14675255e8c, f6ed ... Package NDC 0002-8215-01, 0002-8215-17, 0002-8215-99, 0002-8501-01, 0002-8824-27, 0002-8315- ... NUIM0011417, N0000175944Chemical StructureInsulin [CS]Established Pharmacologic ClassInsulin [EPC]UNII1Y17CTI5SR, 059QF0KO0R

7)

drugcharacterization2medicinalproductLANSOPRAZOLEdrugdosagetextUNK

openFDA Info on Medication

Application Number ANDA202319, ANDA203306, ANDA203187, ANDA202366, NDA208025, ANDA091269, ANDA20217 ... Brand Name EQUALINE LANSOPRAZOLE, LANSOPRAZOLE, EQUATE LANSOPRAZOLE DELAYED RELEASE, EQUATE ... Generic NameLANSOPRAZOLE, LANSOPRAZOLE DELAYED RELEASEManufacturers Supervalu Inc, HEB, Chain Drug Consortium, LLC, Cadila Healthcare Limited, Perri ... product_ndc 41163-117, 37808-448, 68016-758, 65841-769, 65841-770, 45802-245, 49035-411, 490 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLANSOPRAZOLERXCUI596843, 311277, 351261, 206205, 206206, 351260, 596918, 866152spl_id a9daca89-e2f8-40bf-9beb-4267aaac7d3e, c7379031-b622-41be-8afd-ac1f44ff4e33, a60e ... spl_set_id ea8efda5-9d08-446b-9424-68a98122589a, 3496e421-3d42-4b1e-9ea2-0ffc03bb81ed, 5452 ... Package NDC 41163-117-01, 41163-117-02, 41163-117-03, 37808-448-14, 37808-448-42, 68016-758- ... NUIN0000175525, N0000000147, N0000009724Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA]Physiologic/Pharmacodynamic EffectInhibition Gastric Acid Secretion [PE]UNII0K5C5T2QPG

8)

drugcharacterization2medicinalproductLEVOTHYROXINEdrugdosagetextUNK

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

9)

drugcharacterization2medicinalproductMETRONIDAZOLEdrugdosagetextUNK

openFDA Info on Medication

Application Number ANDA077264, ANDA077549, ANDA070772, NDA020208, NDA018657, ANDA070027, ANDA070033 ... Brand Name METRONIDAZOLE, ROSADAN, FLAGYL, METRONIDAZOLE 500 MG, METRONIDAZOLE TOPICAL GEL, ... Generic NameMETRONIDAZOLEManufacturers Sandoz Inc., Cosette Pharmaceuticals, Inc., AMICI PHARMACEUTICALS LLC, Oceanside ... product_ndc 0781-7077, 0713-0757, 69292-208, 68682-455, 0338-1055, 50111-333, 50111-334, 516 ... Product TypeHUMAN PRESCRIPTION DRUGRouteVAGINAL, TOPICAL, ORAL, INTRAVENOUSActive IngredientsMETRONIDAZOLERXCUI 142046, 311678, 311681, 311683, 314106, 311679, 199055, 1148398, 207287, 207290, ... spl_id a00b814a-ba5f-4af8-b50d-fa231339148b, 7c04e645-f7ea-4931-9451-05bd8d55bece, 3fe7 ... spl_set_id 0030514f-879d-416d-b422-24b67e334b36, 5a7065b2-e729-46d5-8da5-865dc1ea58f7, 9f1f ... Package NDC 0781-7077-87, 0713-0757-37, 69292-208-01, 69292-208-50, 68682-455-70, 0338-1055- ... NUIN0000175435, M0014907Established Pharmacologic ClassNitroimidazole Antimicrobial [EPC]Chemical StructureNitroimidazoles [CS]UNII140QMO216E

10)

drugcharacterization2medicinalproductPARACETAMOLdrugdosagetextUNK

11)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextUNK

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

12)

drugcharacterization2medicinalproductSIMVASTATINdrugdosagetextUNK

openFDA Info on Medication

Application Number NDA206679, ANDA078155, ANDA077691, ANDA078103, ANDA090383, ANDA078034, ANDA07783 ... Brand NameFLOLIPID, SIMVASTATIN, ZOCORGeneric NameSIMVASTATINManufacturers Salerno Pharmaceuticals Co., Accord Healthcare, Inc., NorthStar Rx LLC, Lupin Ph ... product_ndc 29273-401, 29273-402, 16729-004, 16729-156, 16729-005, 16729-006, 16729-007, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSIMVASTATINRXCUI 1790679, 1944262, 1944264, 1944266, 198211, 200345, 312961, 312962, 314231, 1044 ... spl_id 37ec6157-4088-4638-8eba-74a6aa1238d3, a467e8e1-fe36-61f4-e053-2a95a90a3c3c, 81d3 ... spl_set_id 6ee17d10-6eb1-452a-99e8-02381368b3fe, 871251c0-36a1-4a32-9eab-ff6c1e925ca9, 0376 ... Package NDC 29273-401-04, 29273-402-04, 16729-156-10, 16729-156-15, 16729-156-17, 16729-004- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNIIAGG2FN16EV

13)

drugcharacterization2medicinalproductVALPROATE SODIUMdrugstructuredosagenumb250drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext250 MG, 2X/DAYdrugadministrationroute042

openFDA Info on Medication

Application NumberANDA078523, ANDA076539Brand NameVALPROATE SODIUMGeneric NameVALPROATE SODIUMManufacturersWest-Ward Pharmaceuticals Corp, Fresenius Kabi USA, LLCproduct_ndc0143-9637, 63323-494, 0143-9785Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsVALPROATE SODIUMRXCUI1099648spl_id 354c62ac-74f2-42d2-bdd3-80451fd3f770, 93f4e66d-4012-9cf8-e053-2a95a90a09cc, 797e ... spl_set_id 7a687b2f-246d-4736-a20c-92421c263268, 3dfb6da1-f66a-4618-9f74-d2d6c16c0b58, c572 ... Package NDC 0143-9637-01, 0143-9637-10, 63323-494-41, 63323-494-16, 63323-494-01, 63323-494- ... UNII5VOM6GYJ0D

14)

drugcharacterization2medicinalproductVALPROATE SODIUMdrugstructuredosagenumb350drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext350 MG, 2X/DAYdrugadministrationroute042

openFDA Info on Medication

Application NumberANDA078523, ANDA076539Brand NameVALPROATE SODIUMGeneric NameVALPROATE SODIUMManufacturersWest-Ward Pharmaceuticals Corp, Fresenius Kabi USA, LLCproduct_ndc0143-9637, 63323-494, 0143-9785Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsVALPROATE SODIUMRXCUI1099648spl_id 354c62ac-74f2-42d2-bdd3-80451fd3f770, 93f4e66d-4012-9cf8-e053-2a95a90a09cc, 797e ... spl_set_id 7a687b2f-246d-4736-a20c-92421c263268, 3dfb6da1-f66a-4618-9f74-d2d6c16c0b58, c572 ... Package NDC 0143-9637-01, 0143-9637-10, 63323-494-41, 63323-494-16, 63323-494-01, 63323-494- ... UNII5VOM6GYJ0D

15)

drugcharacterization2medicinalproductDIAZEPAMdrugstructuredosagenumb5drugstructuredosageunit003drugdosagetext5 MG, SINGLEdrugadministrationroute042

openFDA Info on Medication

Application Number ANDA072079, ANDA071134, ANDA071135, ANDA071136, NDA020124, ANDA210363, NDA020648 ... Brand NameDIAZEPAM, DIASTAT, VALTOCO, VALIUMGeneric NameDIAZEPAMManufacturers Hospira, Inc., Mayne Pharma, Meridian Medical Technologies, Inc., Dash Pharmaceu ... product_ndc 0409-1273, 51862-062, 51862-063, 51862-064, 11704-600, 69339-136, 66490-650, 686 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORAL, RECTAL, NASALActive IngredientsDIAZEPAMRXCUI 1807459, 197589, 197590, 197591, 1807452, 2120550, 801957, 801961, 801966, 22726 ... spl_id c2374258-57c6-4be5-89df-27d6cf5dc832, 49cd2631-74e5-4291-a491-b15b2fa31ee3, 8861 ... spl_set_id 41044928-dd1f-40bf-1fa6-709dff559124, 7d81850c-ad3f-4e2e-ac41-ed9c567aea4b, fa35 ... Package NDC 0409-1273-03, 0409-1273-32, 51862-062-01, 51862-062-05, 51862-062-10, 51862-063- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

16)

drugcharacterization2medicinalproductSODIUM CHLORIDEdrugstructuredosagenumb100drugstructuredosageunit012drugdosagetext100 ML, UNKdrugstartdateformat102drugstartdate26/10/2013drugenddateformat102drugenddate26/10/2013

openFDA Info on Medication

Application Number NDA018897, NDA019635, ANDA201833, ANDA201850, NDA018314, part349, NDA016677, AND ... Brand Name SODIUM CHLORIDE, LICEFREEE EVERYDAY, AQUA MARINA, NATRUM MURIATICUM, MURO 128, C ... Generic NameSODIUM CHLORIDE, SODIUM CHLORIDE OPHTHALMIC OINTMENTManufacturers Hospira, Inc., B. Braun Medical Inc., Tec Laboratories,Inc., West-Ward Pharmaceu ... product_ndc 0409-6660, 0409-6657, 0264-9375, 51879-191, 0641-0497, 0641-6144, 0641-1512, 022 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRoute INTRAVENOUS, TOPICAL, INTRAMUSCULAR, SUBCUTANEOUS, ORAL, IRRIGATION, OPHTHALMIC, ... Active IngredientsSODIUM CHLORIDERXCUI 1807578, 1807580, 1807637, 1807636, 313016, 486515, 1298435, 1299626, 1807634, 1 ... spl_id a1599a5f-a627-426c-a32b-30d7110ac4c6, a19ca124-1f76-42ea-9fed-6426f9d1cd22, 9586 ... spl_set_id 018a8807-1331-41c3-4889-c7ec502a9043, 24a08a93-df23-474b-873e-c59ec8855f9f, 407b ... Package NDC 0409-6657-01, 0409-6657-73, 0409-6660-01, 0409-6660-75, 0264-9375-88, 51879-191- ... UNII451W47IQ8X

Report Duplicate

duplicatesourcePFIZERduplicatenumbGB-PFIZER INC-2014109055

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use