Adverse Event Report

Report

reporttype1receiptdateformat102Version of Safety Report ID1receivedateformat102seriousnessother1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10086253Date Received17/04/2014transmissiondate12/12/2014serious1Date Last Updated17/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age69Unit of Onset AgeyearsWeight116.12SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionArthralgia

Drug

1)

drugcharacterization1medicinalproductELIQUISdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextONCE TABdrugadministrationroute048drugindicationATRIAL FIBRILLATIONdrugstartdateformat102drugstartdate15/03/2014

openFDA Info on Medication

Application NumberNDA202155Brand NameELIQUIS, ELIQUIS 30-DAY STARTER PACKGeneric NameAPIXABANManufacturersE.R. Squibb & Sons, L.L.C.product_ndc0003-0893, 0003-0894, 0003-3764Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAPIXABANRXCUI1364435, 1364441, 1364445, 1364447, 1992427, 1992428spl_id203e085f-cf8a-41f8-8a24-0aab5f198e67spl_set_ide9481622-7cc6-418a-acb6-c5450daae9b0Package NDC 0003-0893-21, 0003-0893-31, 0003-0893-91, 0003-0894-21, 0003-0894-70, 0003-0894- ... NUIN0000175637, N0000175635Established Pharmacologic ClassFactor Xa Inhibitor [EPC]Mechanism of ActionFactor Xa Inhibitors [MoA]UNII3Z9Y7UWC1J

2)

drugcharacterization2medicinalproductCRESTOR

openFDA Info on Medication

Application NumberNDA021366Brand NameCRESTORGeneric NameROSUVASTATIN CALCIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0310-0751, 0310-0755, 0310-0752, 0310-0754Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROSUVASTATIN CALCIUMRXCUI859419, 859421, 859424, 859426, 859747, 859749, 859751, 859753spl_id0abd2d1e-ee9a-4738-ad7e-610a2caa24abspl_set_idbb0f3b5e-4bc6-41c9-66b9-6257e2513512Package NDC 0310-0755-90, 0310-0751-90, 0310-0751-39, 0310-0752-90, 0310-0752-39, 0310-0754- ... UNII83MVU38M7Q

3)

drugcharacterization2medicinalproductLISINOPRIL

openFDA Info on Medication

Application Number ANDA076063, ANDA077321, NDA208401, ANDA078402, ANDA212041, ANDA076180, ANDA07616 ... Brand NameLISINOPRIL, QBRELIS, PRINIVIL, ZESTRILGeneric NameLISINOPRILManufacturers Hikma Pharmaceuticals USA Inc., International Laboratories, LLC, Azurity Pharmac ... product_ndc 0143-9713, 0143-9715, 0143-9714, 54458-872, 54458-877, 54458-874, 54458-873, 526 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 311354, 314076, 314077, 197884, 1806884, 1806890, 205326, 311353, 206764, 206765 ... spl_id 533f6e0f-04a0-4ef7-81b8-0a7be07ddd1a, b685bb45-44a6-4afc-bb3e-940bce536bda, 2fdc ... spl_set_id b70933da-55b2-4025-a00e-63ce3e6b7fdf, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, 9f6e ... Package NDC 0143-9715-01, 0143-9715-10, 0143-9715-99, 0143-9714-01, 0143-9714-10, 0143-9714- ... UNIIE7199S1YWR

4)

drugcharacterization2medicinalproductHYDROCHLOROTHIAZIDE

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

5)

drugcharacterization2medicinalproductMETOPROLOL SUCCINATE

openFDA Info on Medication

Application Number ANDA090617, ANDA203028, ANDA203894, ANDA203699, ANDA076862, ANDA077298, NDA01996 ... Brand NameMETOPROLOL SUCCINATE, TOPROL XL, KAPSPARGOGeneric NameMETOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETSManufacturers BluePoint Laboratories, Pharmadax Inc., Zydus Pharmaceuticals (USA) Inc., Actavi ... product_ndc 68001-121, 68001-122, 60050-001, 60050-002, 68382-564, 68382-565, 68382-566, 683 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOPROLOL SUCCINATE, METOPROLOL TARTRATERXCUI 866427, 866436, 866412, 866419, 866414, 866421, 866429, 866438, 1999031, 1999033 ... spl_id 98f8056c-5885-e243-e053-2995a90a68d1, a2d8f185-a2c4-bc6f-e053-2995a90aeea9, b573 ... spl_set_id 7bacd1ea-5546-47a1-8cff-a30327cadec3, b292330e-c69c-4915-a984-e3a62a327796, bd77 ... Package NDC 68001-121-00, 68001-121-03, 68001-122-00, 68001-122-03, 60050-001-01, 60050-001- ... UNIITH25PD4CCB, W5S57Y3A5L

6)

drugcharacterization2medicinalproductMONTELUKAST

openFDA Info on Medication

Application Number ANDA204604, ANDA202843, ANDA203366, ANDA202859, ANDA203037, ANDA205107, ANDA0914 ... Brand NameMONTELUKAST SODIUM, MONTELUKASTGeneric NameMONTELUKASTManufacturers Amneal Pharmaceuticals LLC, XLCare Pharmaceuticals Inc., BluePoint Laboratories, ... product_ndc 65162-732, 72865-175, 68001-361, 69452-105, 69452-106, 69452-107, 31722-726, 651 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI200224, 242438, 311759, 351246spl_id 21e6eac4-35e5-488a-8d38-626e9569b200, bb0f591e-db58-2061-e053-2a95a90aaf29, 031a ... spl_set_id ccbbf0d6-efd9-4fdd-9e7b-e3d293062609, 82d65eea-c7c9-4e16-9176-46c43f00f0f6, 4c41 ... Package NDC 65162-732-03, 65162-732-09, 65162-732-11, 72865-175-30, 72865-175-90, 72865-175- ... UNIIU1O3J18SFL

7)

drugcharacterization2medicinalproductNEXIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id416c365d-7271-4804-9285-643858cf578b, ac4ba22b-f431-4ab4-b239-0e220ad804ddspl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H

8)

drugcharacterization2medicinalproductSERTRALINE

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

9)

drugcharacterization2medicinalproductULORIC

openFDA Info on Medication

Application NumberNDA021856Brand NameULORICGeneric NameFEBUXOSTATManufacturersTakeda Pharmaceuticals America, Inc.product_ndc64764-677, 64764-918Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFEBUXOSTATRXCUI834235, 834239, 834241, 834243spl_id61bbeaf5-8037-4bed-8193-3f12ff39b3a0spl_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