Adverse Event Report

Report

reporttype1Version of Safety Report ID9receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10150865serious1Date Last Updated29/04/2015receiptdateformat102companynumbUS-PFIZER INC-2014119854occurcountryUSseriousnessother1duplicate1Date Received02/05/2014transmissiondate21/08/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age75Unit of Onset AgeyearsWeight120SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionDiarrhoeaOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionBlisterOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionOral candidiasisOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionDry mouthOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionNauseaOutcomeUnknown

6)

reactionmeddraversionpt18.0ReactionDizzinessOutcomeUnknown

7)

reactionmeddraversionpt18.0ReactionInsomniaOutcomeUnknown

8)

reactionmeddraversionpt18.0ReactionPain in extremityOutcomeUnknown

9)

reactionmeddraversionpt18.0ReactionActivities of daily living impairedOutcomeUnknown

10)

reactionmeddraversionpt18.0ReactionAsthmaOutcomeUnknown

11)

reactionmeddraversionpt18.0ReactionFatigueOutcomeUnknown

12)

reactionmeddraversionpt18.0ReactionOral painOutcomeUnknown

13)

reactionmeddraversionpt18.0ReactionGlossodyniaOutcomeUnknown

14)

reactionmeddraversionpt18.0ReactionAgeusiaOutcomeUnknown

15)

reactionmeddraversionpt18.0ReactionBalance disorderOutcomeUnknown

16)

reactionmeddraversionpt18.0ReactionDyspnoeaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductSUTENTdrugauthorizationnumb021938drugstructuredosagenumb37.5drugstructuredosageunit003drugdosagetext37.5 MG, CYCLIC (28 DAYS ON AND 14 DAYS OFF)drugdosageformCAPSULE, HARDactiondrug4

activesubstance

activesubstancenameSUNITINIB MALATE

openFDA Info on Medication

Application NumberNDA021938Brand NameSUTENTGeneric NameSUNITINIB MALATEManufacturersU.S. Pharmaceuticals, Pfizer Laboratories Div Pfizer Incproduct_ndc63539-017, 63539-019, 0069-0550, 0069-0770, 0069-0980, 0069-0830Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSUNITINIB MALATERXCUI616279, 616283, 616289, 616292, 616285, 616287, 1541890, 1541928spl_id23a46318-098e-48f1-a0cf-413d6a546c73, 4adc8f75-4938-4420-bd95-a146d04ae109spl_set_ida5d555f5-d66a-4f94-abcf-96fa6d71a32f, 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9cPackage NDC 63539-019-01, 63539-017-01, 0069-0550-38, 0069-0770-38, 0069-0980-38, 0069-0830- ... UNIILVX8N1UT73

2)

drugcharacterization2medicinalproductOMEPRAZOLE.drugdosagetextUNK

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

3)

drugcharacterization2medicinalproductLORAZEPAM.drugdosagetextUNK

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, West-Ward Pharmaceuticals Corp., Auro ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 763028, 763029 ... spl_id decb713d-bc45-4bf5-8f61-c0e2f23051b0, eb500b8e-b94e-4900-bc8a-8217fc718704, e1fa ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-10, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

4)

drugcharacterization2medicinalproductCARVEDILOL.drugdosagetextUNK

activesubstance

activesubstancenameCARVEDILOL

openFDA Info on Medication

Application Number ANDA076373, ANDA078384, ANDA077316, ANDA077614, NDA020297, ANDA078332, ANDA07822 ... Brand NameCARVEDILOL, COREGGeneric NameCARVEDILOLManufacturers Teva Pharmaceuticals USA, Inc., Bayshore Pharmaceuticals LLC, Mylan Pharmaceutic ... product_ndc 0093-0051, 0093-0135, 0093-7295, 0093-7296, 76385-110, 76385-111, 76385-112, 763 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCARVEDILOLRXCUI200031, 200032, 200033, 686924, 212388, 212389, 212390, 686926spl_id a369c0d5-8f93-4b0d-a5a0-8125af1309f7, 8df8b35d-dade-43e2-9f28-d47a452efb36, d19e ... spl_set_id 68c275e8-992a-4520-8065-ab6d615d89cc, 33dfcf29-19d6-46ba-b8ed-d59d2226ad07, e502 ... Package NDC 0093-0051-01, 0093-0051-05, 0093-0135-01, 0093-0135-05, 0093-7295-01, 0093-7295- ... NUIN0000000099, N0000009923, N0000009924, N0000175553, N0000175556Mechanism of Action Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenerg ... Established Pharmacologic Classalpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]UNII0K47UL67F2

5)

drugcharacterization2medicinalproductTAMSULOSINdrugdosagetextUNK

activesubstance

activesubstancenameTAMSULOSIN

6)

drugcharacterization2medicinalproductIMODIUMdrugdosagetextUNKdrugindicationDIARRHOEA

activesubstance

activesubstancenameLOPERAMIDE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA075232, NDA019487, NDA021140Brand NameIMODIUM A-D, IMODIUM MULTI-SYMPTOM RELIEFGeneric NameLOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE AND DIMETHICONEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-317, 50580-134, 50580-338Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLOPERAMIDE HYDROCHLORIDE, DIMETHICONERXCUI978010, 978013, 1250685, 1250693, 978001, 1426827spl_id ad65b05d-75aa-4f88-b17b-fa90f8b93683, 8e311966-8e66-4598-a287-ca4417461eb5, f8f9 ... spl_set_id 01da76d0-1979-4c45-9d39-c72ae4e4ffe2, 76a976d5-8bee-4158-a94d-7fbfc5544fd4, ecb9 ... Package NDC 50580-317-01, 50580-317-03, 50580-317-04, 50580-317-05, 50580-317-06, 50580-134- ... UNII77TI35393C, 92RU3N3Y1ONUIN0000010282Physiologic/Pharmacodynamic EffectSkin Barrier Activity [PE]

7)

drugcharacterization1medicinalproductSUTENTdrugauthorizationnumb021938drugdosagetextUNKdrugdosageformCAPSULE, HARDdrugstartdateformat102drugstartdate01/06/2013actiondrug4

activesubstance

activesubstancenameSUNITINIB MALATE

openFDA Info on Medication

Application NumberNDA021938Brand NameSUTENTGeneric NameSUNITINIB MALATEManufacturersU.S. Pharmaceuticals, Pfizer Laboratories Div Pfizer Incproduct_ndc63539-017, 63539-019, 0069-0550, 0069-0770, 0069-0980, 0069-0830Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSUNITINIB MALATERXCUI616279, 616283, 616289, 616292, 616285, 616287, 1541890, 1541928spl_id23a46318-098e-48f1-a0cf-413d6a546c73, 4adc8f75-4938-4420-bd95-a146d04ae109spl_set_ida5d555f5-d66a-4f94-abcf-96fa6d71a32f, 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9cPackage NDC 63539-019-01, 63539-017-01, 0069-0550-38, 0069-0770-38, 0069-0980-38, 0069-0830- ... UNIILVX8N1UT73

8)

drugcharacterization2medicinalproductSINGULAIRdrugdosagetextUNK

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

9)

drugcharacterization2medicinalproductFINASTERIDE.drugdosagetextUNK

activesubstance

activesubstancenameFINASTERIDE

openFDA Info on Medication

Application Number ANDA203687, ANDA090121, ANDA091643, ANDA090061, ANDA207750, ANDA078341, NDA02078 ... Brand NameFINASTERIDE, PROPECIA, PROSCARGeneric NameFINASTERIDEManufacturers Aurobindo Pharma Limited, Rising Health, LLC, Accord Healthcare, Inc., Camber Ph ... product_ndc 65862-927, 65862-686, 57237-061, 16729-090, 16729-089, 31722-525, 67877-455, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFINASTERIDERXCUI200172, 310346, 213178, 201961spl_id 7f209776-8fde-4aac-b266-f342525ea9ca, 019ae597-49a2-40c1-b87a-e656f9c471fc, 42b2 ... spl_set_id 7d140366-2388-488e-bd86-67e6edf44345, 01b88593-99d3-4dd6-a7b6-5438c15bd7b7, adfb ... Package NDC 65862-927-30, 65862-927-90, 65862-927-99, 65862-686-30, 65862-686-90, 65862-686- ... NUIN0000175836, N0000000126Established Pharmacologic Class5-alpha Reductase Inhibitor [EPC]Mechanism of Action5-alpha Reductase Inhibitors [MoA]UNII57GNO57U7G

10)

drugcharacterization2medicinalproductPREDNISONE.drugdosagetextUNK, (PRN)

activesubstance

activesubstancenamePREDNISONE

openFDA Info on Medication

Application Number NDA202020, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA040584, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., GeneYork Pharmaceuticals Group LLC, Mylan Pharma ... product_ndc 75987-020, 75987-021, 75987-022, 71329-106, 0378-0640, 0378-0641, 0378-0642, 060 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id be29c86d-242b-42a7-9488-ecf6f76426cd, 4384c1d1-059b-4689-9f3d-1078de814ce8, 88a6 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, be50449f-3aa8-46b7-9246-2dbd5f04f2b1, fec0 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

11)

drugcharacterization2medicinalproductPROCHLORPERAZINE.drugdosagetextUNK

activesubstance

activesubstancenamePROCHLORPERAZINE

openFDA Info on Medication

Application NumberANDA040058, ANDA040246Brand NamePROCHLORPERAZINE, COMPROGeneric NamePROCHLORPERAZINEManufacturersCosette Pharmaceuticals, Inc., Paddock Laboratories, LLCproduct_ndc0713-0135, 0574-7226Product TypeHUMAN PRESCRIPTION DRUGRouteRECTALActive IngredientsPROCHLORPERAZINERXCUI198159, 284254spl_idca1e6e40-c2e6-46a6-ad10-6a881d91e1e3, 9fece974-eb12-49e0-8975-97b0b9a1b27cspl_set_id9595346e-76e5-e155-341b-ffaaafb885ab, ea381bc5-0957-4c91-826a-0ff680cebaccPackage NDC0713-0135-12, 0713-0135-10, 0574-7226-12NUIN0000175746, M0016525Established Pharmacologic ClassPhenothiazine [EPC]Chemical StructurePhenothiazines [CS]UNIIYHP6YLT61T

12)

drugcharacterization2medicinalproductNYSTATIN.drugdosagetextSWISH AND SWALLOWdrugadministrationroute048

activesubstance

activesubstancenameNYSTATIN

openFDA Info on Medication

Application Number ANDA203621, ANDA064142, ANDA211838, ANDA062124, ANDA062838, ANDA065148, ANDA0651 ... Brand NameNYSTATIN, NYAMYC, NYSTOPGeneric NameNYSTATIN, NYSTATIN ORAL SUSPENSION, NYSTATIN OINTMENT, NYSTATIN CREAMManufacturers Pharmaceutical Associates, Inc., VistaPharm, Inc., Torrent Pharmaceuticals Limit ... product_ndc 0121-0810, 0121-4810, 66689-037, 13668-534, 0168-0007, 53489-400, 80432-003, 083 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, TOPICALActive IngredientsNYSTATINRXCUI312055, 884308, 312059, 584414, 646456, 543546, 261178spl_id a9034435-e353-7bf6-e053-2995a90a4867, 91e9fe62-a1e7-46e6-8357-cdc2a93cc62f, bede ... spl_set_id 31e3da10-5a7b-4bc5-8a4f-3e786b64c13a, 41034d7b-33a1-4d6d-b425-9cfefff8d518, 4949 ... Package NDC 0121-0810-02, 0121-0810-16, 0121-4810-05, 0121-4810-40, 0121-4810-00, 0121-4810- ... NUIN0000175498, M0017172Established Pharmacologic ClassPolyene Antifungal [EPC]Chemical StructurePolyenes [CS]UNIIBDF1O1C72E

13)

drugcharacterization2medicinalproductZOLOFTdrugdosagetextUNK

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

14)

drugcharacterization1medicinalproductSUTENTdrugauthorizationnumb021938drugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG, CYCLICdrugdosageformCAPSULE, HARDdrugindicationMETASTATIC RENAL CELL CARCINOMAactiondrug4

activesubstance

activesubstancenameSUNITINIB MALATE

openFDA Info on Medication

Application NumberNDA021938Brand NameSUTENTGeneric NameSUNITINIB MALATEManufacturersU.S. Pharmaceuticals, Pfizer Laboratories Div Pfizer Incproduct_ndc63539-017, 63539-019, 0069-0550, 0069-0770, 0069-0980, 0069-0830Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSUNITINIB MALATERXCUI616279, 616283, 616289, 616292, 616285, 616287, 1541890, 1541928spl_id23a46318-098e-48f1-a0cf-413d6a546c73, 4adc8f75-4938-4420-bd95-a146d04ae109spl_set_ida5d555f5-d66a-4f94-abcf-96fa6d71a32f, 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9cPackage NDC 63539-019-01, 63539-017-01, 0069-0550-38, 0069-0770-38, 0069-0980-38, 0069-0830- ... UNIILVX8N1UT73

15)

drugcharacterization2medicinalproductLOSARTANdrugdosagetextUNK

activesubstance

activesubstancenameLOSARTAN

16)

drugcharacterization2medicinalproductASPIRIN.drugstructuredosagenumb325drugstructuredosageunit003drugdosagetext325 MG, UNK

activesubstance

activesubstancenameASPIRIN

openFDA Info on Medication

Application Numberpart343Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN 81MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 0363-0587, 70000-0218, 70000-0170, 6 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 198471, 825180, 198464 ... spl_id a1833a99-76cc-47fb-80fb-3a6507a2db3e, acc2acbd-b310-e26a-e053-2a95a90a1874, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014119854

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use