Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10061950serious1Date Last Updated07/04/2014receiptdateformat102seriousnessdeath1companynumbUS-ASTELLAS-2014US002651occurcountryUSseriousnessother1duplicate1Date Received07/04/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age79Unit of Onset AgeyearsWeight71SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionDeathOutcomeFatal

2)

reactionmeddraversionpt17.0ReactionMalaiseOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionProductive coughOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionAbdominal distensionOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionRetchingOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionCoughOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionDecreased appetiteOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionFatigueOutcomeUnknown

9)

reactionmeddraversionpt17.0ReactionAstheniaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductXTANDIdrugauthorizationnumb203415drugstructuredosagenumb160drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb800drugcumulativedosageunit003drugdosagetext160 MG, UID/QDdrugdosageformCAPSULEdrugadministrationroute048drugindicationPROSTATE CANCERdrugstartdateformat102drugstartdate04/03/2014drugenddateformat102drugenddate08/03/2014

openFDA Info on Medication

Application NumberNDA213674, NDA203415Brand NameXTANDIGeneric NameENZALUTAMIDEManufacturersAstellas Pharma US, Inc.product_ndc0469-0625, 0469-0725, 0469-0125Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsENZALUTAMIDERXCUI2390644, 2390646, 2390648, 2390650, 1307303, 1307309spl_id381cd215-78c9-4208-8595-7ae7a279b236, 4cbd6a58-1000-4c43-bbca-0739f106abf9spl_set_id381cd215-78c9-4208-8595-7ae7a279b236, b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdfPackage NDC0469-0625-99, 0469-0725-60, 0469-0125-99NUIN0000175560, N0000000243, N0000185506, N0000185507, N0000185607Established Pharmacologic ClassAndrogen Receptor Inhibitor [EPC]Mechanism of Action Androgen Receptor Antagonists [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochr ... UNII93T0T9GKNU

2)

drugcharacterization2medicinalproductVESICAREdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MG, UID/QDdrugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA021518, NDA209529Brand NameVESICARE, VESICARE LSGeneric NameSOLIFENACIN SUCCINATEManufacturersAstellas Pharma US, Inc.product_ndc51248-150, 51248-151, 51248-250Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSOLIFENACIN SUCCINATERXCUI477367, 477372, 539815, 539817, 2375321, 2375325spl_id1d7a7ff5-31d2-4957-90e5-173d2200ddb1, 47710f09-a9ef-4007-8a89-cbb8fadc6b4bspl_set_id9acee910-cdb2-4052-b8b3-c26aff1c8716, e0300384-e980-45d5-8ed4-48a2618671aePackage NDC 51248-150-52, 51248-150-03, 51248-150-01, 51248-151-52, 51248-151-03, 51248-151- ... UNIIKKA5DLD701

3)

drugcharacterization2medicinalproductCIMETIDINEdrugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext4 MG, BIDdrugadministrationroute048drugindicationGASTROOESOPHAGEAL REFLUX DISEASE

openFDA Info on Medication

Application NumberANDA074151, ANDA074463, ANDA075285, ANDA074246, NDA020238Brand Name CIMETIDINE, CIMETIDINE ACID REDUCER, GOOD SENSE HEARTBURN RELIEF, ACID REDUCER, ... Generic NameCIMETIDINEManufacturers Teva Pharmaceuticals USA, Inc., Walgreen Company, L. Perrigo Company, Kroger Com ... product_ndc 0093-8192, 0093-8204, 0093-8305, 0363-0022, 0113-0022, 30142-323, 24385-111, 368 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsCIMETIDINERXCUI197506, 197507, 197508, 197505, 104062spl_id a631a243-834a-432b-84a6-7e3cebbb8b5c, 702a0ec1-f349-4fe2-92c3-f9fd4cf1efb0, 8a4c ... spl_set_id 496e258d-a5fd-42da-9a86-73afc8be359b, 7087f4bb-992b-4680-a9a7-452ce74eed2d, f78c ... Package NDC 0093-8192-01, 0093-8192-05, 0093-8204-01, 0093-8204-05, 0093-8305-01, 0093-8305- ... NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]UNII80061L1WGD

4)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, UID/QDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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

5)

drugcharacterization2medicinalproductHYDROCHLOROTHIAZIDEdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25 MG, UID/QDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA040780, ANDA203018, ANDA040412, ANDA085182, ANDA203561, ANDA078164, ANDA0870 ... Brand NameHYDROCHLOROTHIAZIDEGeneric NameHYDROCHLOROTHIAZIDEManufacturers Aurobindo Pharma Limited, ScieGen Pharmaceuticals, Inc., Solco Healthcare U.S., ... product_ndc 65862-133, 65862-134, 50228-111, 50228-112, 43547-397, 43547-398, 23155-008, 231 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCHLOROTHIAZIDERXCUI197770, 310798, 199903, 429503spl_id 9d73930e-75b8-4a7b-9d12-2049f593ca9d, 5c6f4c6a-cc43-4f4d-bc16-688310c98c72, d8ce ... spl_set_id 01f1f478-5493-439f-9b99-f4f82023781c, 02e96a51-1d56-460c-8c20-3d6f37e0ce46, 60c9 ... Package NDC 65862-133-01, 65862-133-99, 65862-134-01, 65862-134-99, 50228-111-30, 50228-111- ... NUIN0000175359, N0000175419, M0471776Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNII0J48LPH2TH

6)

drugcharacterization2medicinalproductCLONAZEPAMdrugstructuredosagenumb.75drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.75 MG, UID/QDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA077171, ANDA074569, ANDA074869, ANDA077194, ANDA077147, ANDA074979, ANDA2110 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Par Pharmaceutical, Inc., Teva Pharmaceuticals USA, Inc., Actavis Pharma, Inc., ... product_ndc 49884-306, 49884-307, 49884-308, 49884-309, 49884-310, 0093-0832, 0093-3212, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529spl_id a95f8799-0bb3-41d6-aa27-8a291127ad54, 90dc0b61-37a3-4e54-bde3-7e4c3f7dae98, 9b58 ... spl_set_id 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069b1a0-7c06-4252-b44e-e2eef065d9b8, a58f ... Package NDC 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 0093-0832- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

Report Duplicate

duplicatesourceASTELLASduplicatenumbUS-ASTELLAS-2014US002651

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use