Adverse Event Report

Report

reporttype1Version of Safety Report ID9receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10083704serious1Date Last Updated15/05/2015receiptdateformat102companynumbUS-PFIZER INC-2014105501occurcountryUSduplicate1Date Received17/04/2014seriousnesshospitalization1transmissiondate21/08/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age71Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionDry skinOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionHair colour changesOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionConstipationOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.0ReactionBlisterOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.0ReactionTongue ulcerationOutcomeUnknown

6)

reactionmeddraversionpt18.0ReactionThyroid disorderOutcomeUnknown

7)

reactionmeddraversionpt18.0ReactionFatigueOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt18.0ReactionStomatitisOutcomeRecovered/resolved

9)

reactionmeddraversionpt18.0ReactionGlossodyniaOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt18.0ReactionHypophagiaOutcomeUnknown

11)

reactionmeddraversionpt18.0ReactionDisease progressionOutcomeUnknown

12)

reactionmeddraversionpt18.0ReactionOsteoarthritisOutcomeUnknown

13)

reactionmeddraversionpt18.0ReactionOral discomfortOutcomeUnknown

14)

reactionmeddraversionpt18.0ReactionPain in extremityOutcomeNot recovered/not resolved

15)

reactionmeddraversionpt18.0ReactionBlood pressure increasedOutcomeRecovered/resolved

16)

reactionmeddraversionpt18.0ReactionMadarosisOutcomeUnknown

17)

reactionmeddraversionpt18.0ReactionAgeusiaOutcomeUnknown

18)

reactionmeddraversionpt18.0ReactionSkin abrasionOutcomeUnknown

19)

reactionmeddraversionpt18.0ReactionOral painOutcomeUnknown

20)

reactionmeddraversionpt18.0ReactionDiarrhoeaOutcomeRecovered/resolved

21)

reactionmeddraversionpt18.0ReactionMucous membrane disorderOutcomeUnknown

22)

reactionmeddraversionpt18.0ReactionMetastatic renal cell carcinomaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductSUTENTdrugauthorizationnumb021938drugstructuredosagenumb37.5drugstructuredosageunit003drugdosagetext37.5 MG, CYCLICdrugdosageformCAPSULE, HARDactiondrug1

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)

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

3)

drugcharacterization2medicinalproductCHLORTHALIDONE.drugdosagetextUNK

activesubstance

activesubstancenameCHLORTHALIDONE

openFDA Info on Medication

Application Number ANDA211627, ANDA213412, ANDA207204, ANDA210742, ANDA207813, ANDA089286, ANDA2110 ... Brand NameCHLORTHALIDONEGeneric NameCHLORTHALIDONEManufacturers Unichem Pharmaceuticals (USA), Inc., Ascend Laboratories, LLC, Amneal Pharmaceut ... product_ndc 29300-333, 29300-334, 67877-696, 67877-697, 65162-247, 65162-250, 55801-146, 558 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCHLORTHALIDONERXCUI197499, 197500spl_id 40725204-0a44-49bd-99f5-a2949ecbe118, eea96cb7-4637-4520-967e-50950ee925d7, 162c ... spl_set_id 01065eda-7515-46bc-b858-a062c3aa35bd, d104583e-e983-4230-b6d1-4455ee1060a5, c4c1 ... Package NDC 29300-333-10, 29300-333-01, 29300-334-01, 29300-334-10, 67877-696-01, 67877-696- ... NUIN0000175359, N0000175420Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide-like Diuretic [EPC]UNIIQ0MQD1073Q

4)

drugcharacterization2medicinalproductPROTONIXdrugdosagetextUNK

activesubstance

activesubstancenamePANTOPRAZOLE SODIUM

openFDA Info on Medication

Application NumberNDA020988, NDA020987, NDA022020Brand NamePROTONIX I.V., PROTONIX DELAYED-RELEASEGeneric NamePANTOPRAZOLE SODIUMManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0923, 0008-2001, 0008-4001, 0008-0841, 0008-0843, 0008-0844Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsPANTOPRAZOLE SODIUMRXCUI283669, 885257, 251872, 284400, 314200, 352125, 763306, 763308spl_id b326d5db-8b20-4ec4-ac25-78190fb3ac36, 1e8fa399-506d-4bcd-9097-dbf7850147bf, 7bdf ... spl_set_id 51e4144a-489e-436c-609a-39305f8f56ba, 5b5ddedd-d429-41a7-8573-10c3e9ad4e52, f39b ... Package NDC 0008-0923-51, 0008-0923-60, 0008-0923-55, 0008-2001-01, 0008-2001-25, 0008-2001- ... UNII6871619Q5X

5)

drugcharacterization1medicinalproductSUTENTdrugauthorizationnumb021938drugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG, DAILY, CYCLIC (28 DAYS ON AND 14 DAYS OFF)drugdosageformCAPSULE, HARDdrugenddateformat610drugenddate/10/2014actiondrug1

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

6)

drugcharacterization1medicinalproductSUTENTdrugauthorizationnumb021938drugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, DAILY (CYCLIC)drugdosageformCAPSULE, HARDdrugindicationMETASTATIC RENAL CELL CARCINOMAactiondrug1

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20140502

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014105501

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use