Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10939862primarysourcecountryUStransmissiondateformat102transmissiondate21/07/2015reporttype1serious2receivedateformat102Date Received12/02/2015receiptdateformat102Date Last Updated12/02/2015fulfillexpeditecriteria2companynumbTPA2010A06275duplicate1

Report Duplicate

duplicatesourceTAKEDAduplicatenumbTPA2010A06275

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age69Unit of Onset AgeyearsWeight83.46SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionHypoaesthesia

Drug

1)

drugcharacterization1medicinalproductULORICdrugauthorizationnumb021856drugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, 1 IN 1 D, IN EVENINGdrugadministrationroute048drugindicationGOUTdrugstartdateformat102drugstartdate16/11/2010

activesubstance

activesubstancenameFEBUXOSTAT

openFDA Info on Medication

Application NumberNDA021856Brand NameULORICGeneric NameFEBUXOSTATManufacturersTakeda Pharmaceuticals America, Inc.product_ndc64764-677, 64764-918Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFEBUXOSTATRXCUI834235, 834239, 834241, 834243spl_id24d10877-2fcd-4556-8721-ff48edeb93despl_set_id54de10ef-fe5f-4930-b91d-6bbb04c664bdPackage NDC 64764-918-30, 64764-918-90, 64764-918-18, 64764-918-11, 64764-677-30, 64764-677- ... NUIN0000175698, N0000000206Established Pharmacologic ClassXanthine Oxidase Inhibitor [EPC]Mechanism of ActionXanthine Oxidase Inhibitors [MoA]UNII101V0R1N2E

2)

drugcharacterization2medicinalproductVYTORIN (SIMVASTATIN, EZETIMIBE)

3)

drugcharacterization2medicinalproductLUNESTA

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

4)

drugcharacterization2medicinalproductSPIRONOLACTONE.

activesubstance

activesubstancenameSPIRONOLACTONE

openFDA Info on Medication

Application Number ANDA091426, ANDA040750, ANDA203512, ANDA203253, ANDA202187, ANDA089424, ANDA2059 ... Brand NameSPIRONOLACTONE, ALDACTONEGeneric NameSPIRONOLACTONEManufacturers Amneal Pharmaceuticals LLC, Oxford Pharmaceuticals, LLC, Accord Healthcare, Inc. ... product_ndc 65162-511, 65162-514, 65162-515, 69584-852, 69584-853, 69584-854, 16729-225, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSPIRONOLACTONERXCUI198222, 198223, 313096, 200817, 200820, 200825spl_id 5c663162-67fb-4890-977c-70db2561d387, db73b6cc-b152-4ec1-8566-f4ead6f9ae6d, c2d4 ... spl_set_id fb66327e-8261-46ae-b39a-4fa79d520844, 852684dc-e1c6-4caa-bccb-10ac90bbb3bb, 8a96 ... Package NDC 65162-511-03, 65162-511-06, 65162-511-09, 65162-511-10, 65162-511-11, 65162-511- ... NUIN0000175557, N0000011310Established Pharmacologic ClassAldosterone Antagonist [EPC]Mechanism of ActionAldosterone Antagonists [MoA]UNII27O7W4T232

5)

drugcharacterization2medicinalproductLISINOPRIL.

activesubstance

activesubstancenameLISINOPRIL

openFDA Info on Medication

Application Number ANDA077321, ANDA077622, NDA208401, ANDA078402, ANDA208920, ANDA212041, ANDA07618 ... Brand NameLISINOPRIL, QBRELIS, ZESTRILGeneric NameLISINOPRILManufacturers International Laboratories, LLC, Rising Pharma Holdings, Inc., Azurity Pharmaceu ... product_ndc 54458-872, 54458-877, 54458-874, 54458-873, 16571-794, 16571-795, 16571-796, 165 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 197884, 311354, 314076, 314077, 205326, 311353, 1806884, 1806890, 104375, 104376 ... spl_id b685bb45-44a6-4afc-bb3e-940bce536bda, c031b428-c7d0-440a-90ab-d88ceef3c57c, 2fdc ... spl_set_id 6eef83b4-ce4c-462b-bcfa-eefa525e682d, c031b428-c7d0-440a-90ab-d88ceef3c57c, 9f6e ... Package NDC 54458-877-10, 54458-874-10, 54458-873-10, 54458-872-10, 16571-794-01, 16571-794- ... UNIIE7199S1YWR

6)

drugcharacterization1medicinalproductMETFORMINdrugadministrationroute048drugindicationDIABETES MELLITUS

activesubstance

activesubstancenameMETFORMIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA200690, ANDA209674, ANDA209313Brand NameMETFORMIN HYDROCHLORIDE, METFORMINGeneric NameMETFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MGManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Granules Pharmaceutica ... product_ndc0378-6001, 0378-6002, 50742-633, 50742-634, 70010-491, 70010-492Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI1807894, 1807917, 860975, 860981spl_id b1d71739-26c3-43d3-9088-60bef3689e74, d7e2ad60-7a17-4c65-b836-e56644be754d, d164 ... spl_set_id 7e41818c-60e9-4bcf-9586-7bb8d33d5e89, 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647, 6d6e ... Package NDC 0378-6002-91, 0378-6001-91, 50742-633-60, 50742-633-90, 50742-633-10, 50742-634- ... UNII786Z46389E

7)

drugcharacterization2medicinalproductASPIRIN (ACETYLSALICYLIC ACID)

activesubstance

activesubstancenameASPIRIN

8)

drugcharacterization2medicinalproductFUROSEMIDE.

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application Number ANDA077293, ANDA207552, ANDA213902, NDA016273, ANDA070655, ANDA212174, ANDA07043 ... Brand Name TOXYCOLOGY MEDICATED COLLECTION SYSTEM, FUROSEMIDE, LASIX, DIASCREEN 12-PANEL ME ... Generic NameFUROSEMIDEManufacturers IT3 Medical LLC, Amneal Pharmaceuticals LLC, Gland Pharma Limited, Validus Pharm ... product_ndc 70529-549, 70121-1076, 70121-1163, 70121-1164, 68083-432, 68083-433, 68083-434, ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 310429, 1038558, 1719286, 1719290, 1719291, 197732, 200801, 200809, 205732, 3139 ... spl_id 29531d06-4e7f-4e26-93d0-1d98e58966d2, c22d0330-1b76-420a-a84b-8ea59f8733a7, e7bd ... spl_set_id a78407a8-3d3e-4eb5-9e3f-b32a1b8015e4, d5b9f12e-d1e9-42de-90f2-c9ba33a86457, 6447 ... Package NDC 70529-549-01, 70529-061-08, 68345-883-50, 70121-1163-1, 70121-1163-5, 70121-1164 ... RouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsFUROSEMIDENUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

9)

drugcharacterization2medicinalproductCYMBALTA

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_id892f05de-dd11-4ae3-9a85-ce9cfcbeaaccspl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

10)

drugcharacterization2medicinalproductCOLCHICINE.

activesubstance

activesubstancenameCOLCHICINE

openFDA Info on Medication

Application Number NDA210942, ANDA208993, ANDA211250, ANDA204711, ANDA211519, NDA204820, ANDA204461 ... Brand NameGLOPERBA, COLCHICINE, MITIGARE, COLCRYSGeneric NameCOLCHICINEManufacturers Avion Pharmaceuticals, LLC, Camber Pharmaceuticals, Inc., Ascend Laboratories, L ... product_ndc 75854-801, 31722-899, 67877-589, 65162-710, 70771-1396, 70771-1590, 59467-318, 0 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCOLCHICINE, COLCHICEINERXCUI2118892, 2180558, 197541, 1550940, 1550946, 858071spl_id b85547d8-fce6-323d-e053-2995a90a4e7e, c9c0c7c1-6f07-596e-e053-2995a90aae1e, 3a77 ... spl_set_id 8f9ba661-b7aa-11fc-e053-2995a90a0bd1, 1e7ef16d-262b-4dc0-92d6-7afe4aa21ebd, a428 ... Package NDC 75854-801-01, 31722-899-30, 31722-899-01, 67877-589-30, 67877-589-60, 67877-589- ... NUIN0000182141, N0000000239, N0000193949, M0000713Mechanism of ActionCytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Interactions [MoA]Established Pharmacologic ClassAlkaloid [EPC]Chemical StructureAlkaloids [CS]UNIISML2Y3J35T, HJ30158L57

11)

drugcharacterization1medicinalproductCARVEDILOL (CARVEDILOL)drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationCARDIAC DISORDER

activesubstance

activesubstancenameCARVEDILOL