Adverse Event Report

Report

reporttype1receiptdateformat102companynumb1000052376Version of Safety Report ID2receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10062460Date Received13/03/2014transmissiondate26/03/2015serious1Date Last Updated12/09/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age72Unit of Onset AgeyearsWeight122SexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionWeight decreased

Drug

1)

drugcharacterization2medicinalproductNORVASC

activesubstance

activesubstancenameAMLODIPINE BESYLATE

openFDA Info on Medication

Application NumberNDA019787Brand NameNORVASCGeneric NameAMLODIPINE BESYLATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-1520, 0069-1530, 0069-1540Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATERXCUI197361, 212542, 212549, 212575, 308135, 308136spl_id3f5ca9a3-9076-49ab-b247-669c337f3364spl_set_idabd6a2ca-40c2-485c-bc53-db1c652505edPackage NDC 0069-1520-68, 0069-1530-68, 0069-1530-41, 0069-1530-72, 0069-1540-68, 0069-1540- ... UNII864V2Q084H

2)

drugcharacterization2medicinalproductGLYBURIDE (GLIBENCLAMIDE)

activesubstance

activesubstancenameGLYBURIDE

3)

drugcharacterization2medicinalproductSPIRIVA (TIOTROPIUM BROMIDE)

4)

drugcharacterization2medicinalproductZOCOR

activesubstance

activesubstancenameSIMVASTATIN

openFDA Info on Medication

Application NumberNDA019766Brand NameZOCORGeneric NameSIMVASTATINManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0543, 0006-0749, 0006-0740, 0006-0735Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSIMVASTATINRXCUI104490, 104491, 152923, 198211, 200345, 213319, 312961, 314231spl_id41a60de3-6740-43c7-a8d7-7dbfd0a8d6a0spl_set_idfdbfe194-b845-42c5-bb87-a48118bc72e7Package NDC 0006-0543-31, 0006-0543-54, 0006-0749-31, 0006-0749-54, 0006-0740-54, 0006-0740- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNIIAGG2FN16EV

5)

drugcharacterization2medicinalproductATENOLOL.

activesubstance

activesubstancenameATENOLOL

openFDA Info on Medication

Application Number NDA018240, ANDA078512, ANDA213136, ANDA077443, ANDA076900, ANDA074052, ANDA07302 ... Brand NameTENORMIN, ATENOLOLGeneric NameATENOLOLManufacturers Almatica Pharma LLC, Aurobindo Pharma Limited, Unichem Pharmaceuticals (USA), In ... product_ndc 52427-429, 52427-430, 52427-431, 65862-168, 65862-169, 65862-170, 29300-410, 293 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATENOLOLRXCUI150750, 152414, 197379, 197380, 197381, 201322spl_id 70291313-c4f6-7c2a-cd07-04fd6a07b634, 2f8a6d3c-fbcd-4b11-aa14-d0522fa7600e, d850 ... spl_set_id 746db603-a6e1-4dc3-c2d8-92314419098c, 1b8a4689-3916-4f4b-b54a-bbb4e322d79b, 35d9 ... Package NDC 52427-429-90, 52427-430-90, 52427-431-90, 65862-168-01, 65862-168-99, 65862-169- ... NUIN0000000161, N0000175556Mechanism of ActionAdrenergic beta-Antagonists [MoA]Established Pharmacologic Classbeta-Adrenergic Blocker [EPC]UNII50VV3VW0TI

6)

drugcharacterization1medicinalproductDALIRESP (ROFLUMILAST)drugauthorizationnumb22522drugstructuredosagenumb500drugstructuredosageunit004drugdosagetext500MCG (500 MCG, 1 IN 1drugadministrationroute048drugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASEdrugstartdateformat102drugstartdate05/07/2012drugrecurreadministration1

activesubstance

activesubstancenameROFLUMILAST

7)

drugcharacterization2medicinalproductOXYGEN.

activesubstance

activesubstancenameOXYGEN

openFDA Info on Medication

Brand Name OXYGEN COMPRESSED U.S.P, OXYGEN REFRIGERATED LIQUID U.S.P, OXYGEN, MEDICAL OXYGE ... Generic NameOXYGEN, 0XYGENManufacturers Apria Healthcare LLC, In Home Medical, Inc., NLR Welding Supply, Inc., AGL Inhal ... product_ndc 51319-072, 51319-073, 60941-001, 62045-4333, 17575-001, 19979-000, 23650-001, 51 ... Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION), NASAL, CUTANEOUSActive IngredientsOXYGENRXCUI 312173, 312172, 542304, 348831, 312174, 348381, 348017, 312175, 311998, 899761, ... spl_id 92e3d064-473a-4e09-bfa1-7306c4aef38f, b12e14c8-af49-4578-e053-2a95a90a6532, d595 ... spl_set_id 105a5557-c1af-42b1-859e-76cc1e83d9aa, 2260d92d-9a68-4e4f-a4bf-c6961851fdda, 49d5 ... Package NDC 51319-072-01, 51319-072-02, 51319-072-03, 51319-072-04, 51319-072-05, 51319-072- ... UNIIS88TT14065, N762921K75Application Number NDA205849, NDA205865, NDA205767, NDA206023, NDA205889, NDA212314, NDA205712, NDA ...

8)

drugcharacterization2medicinalproductLASIX

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application NumberNDA016273Brand NameLASIXGeneric NameFUROSEMIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-060, 30698-067, 30698-066Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFUROSEMIDERXCUI197732, 200801, 200809, 205732, 310429, 313988spl_id95a46760-e587-41a3-9ff3-c8dd8505f694spl_set_id2c9b4d8f-0770-482d-a9e6-9c616a440b1aPackage NDC 30698-067-01, 30698-067-10, 30698-060-01, 30698-060-10, 30698-060-50, 30698-066- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

9)

drugcharacterization2medicinalproductMETFORMIN

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, a353 ... 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

10)

drugcharacterization2medicinalproductZOLOFT

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

11)

drugcharacterization2medicinalproductINSULIN

activesubstance

activesubstancenameINSULIN NOS

12)

drugcharacterization2medicinalproductLISINOPRIL.

activesubstance

activesubstancenameLISINOPRIL

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

13)

drugcharacterization2medicinalproductIMDUR

activesubstance

activesubstancenameISOSORBIDE MONONITRATE

14)

drugcharacterization2medicinalproductALBUTEROL.

activesubstance

activesubstancenameALBUTEROL

openFDA Info on Medication

Application Number ANDA210948, ANDA077788, ANDA213657, ANDA211397, ANDA208804, ANDA207046, ANDA0728 ... Brand NameALBUTEROL, ALBUTEROL SULFATEGeneric NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, VistaPharm, Inc., Aurobindo Pharma Limited, Virtus ... product_ndc 75834-273, 75834-274, 66689-100, 59651-333, 59651-334, 69543-290, 69543-291, 692 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALBUTEROL SULFATERXCUI197316, 197318, 755497spl_id b736135f-6e13-3e29-e053-2a95a90a67f4, 737932ca-a391-48c3-96c5-14de8ae1000e, ff9b ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, c7713a63-af2a-40d3-8deb-cbb92d5f1cd3, ff9b ... Package NDC 75834-273-01, 75834-274-01, 66689-100-16, 66689-100-08, 59651-333-01, 59651-333- ... UNII021SEF3731

15)

drugcharacterization2medicinalproductLOPID

activesubstance

activesubstancenameGEMFIBROZIL

openFDA Info on Medication

Application NumberNDA018422Brand NameLOPIDGeneric NameGEMFIBROZILManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGEMFIBROZILRXCUI205751, 310459spl_idef2b3c7e-b287-4cae-9bc3-86fb6ccbe9aespl_set_idc48855b7-215e-453b-b3b1-a0f9dee7221fPackage NDC0071-0737-20, 0071-0737-30NUIN0000175596, N0000175375, M0199111Established Pharmacologic ClassPeroxisome Proliferator Receptor alpha Agonist [EPC]Mechanism of ActionPeroxisome Proliferator-activated Receptor alpha Agonists [MoA]Chemical StructurePPAR alpha [CS]UNIIQ8X02027X3

summary

narrativeincludeclinicalCASE EVENT DATE: 201207

Report Duplicate

duplicatesourceFORESTduplicatenumb1000052376