Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10042309serious1Date Last Updated27/03/2014receiptdateformat102companynumbUS-BAYER-2014-044112occurcountryUSseriousnessother1duplicate1Date Received27/03/2014transmissiondate02/10/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age60Unit of Onset AgeyearsWeight125.17SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionAnaemiaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductBETASERONdrugauthorizationnumb103471drugstructuredosagenumb.25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition804drugdosagetext0.25 MG, QODdrugdosageformPOWDER AND SOLVENT FOR SOLUTION FOR INJECTIONdrugadministrationroute058drugindicationMULTIPLE SCLEROSISactiondrug1

openFDA Info on Medication

Application NumberBLA103471Brand NameBETASERONGeneric NameINTERFERON BETA-1BManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-524Product TypeHUMAN PRESCRIPTION DRUGRXCUI198360, 207059spl_ide83fd950-7d5e-40a8-b712-1f0e446b8569spl_set_id66311f74-0472-4fa3-848a-06002ca0def5Package NDC50419-524-01, 50419-524-35, 50419-524-05, 50419-524-09, 50419-524-81

2)

drugcharacterization2medicinalproductALEVE LIQUID GELSdrugdosageformCAPSULE, SOFTdrugadministrationroute048

3)

drugcharacterization2medicinalproductALEVE LIQUID GELSdrugstructuredosagenumb220drugstructuredosageunit003drugdosagetext220 MG, UNKdrugdosageformCAPSULE, SOFTdrugadministrationroute048

4)

drugcharacterization2medicinalproductKLONOPINdrugstructuredosagenumb.5drugstructuredosageunit003drugdosagetext0.5 MG, UNKdrugadministrationroute048

openFDA Info on Medication

Application NumberNDA017533Brand NameKLONOPINGeneric NameCLONAZEPAMManufacturersGenentech, Inc.product_ndc0004-0058, 0004-0068, 0004-0098Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI197527, 197528, 197529, 206157, 206159, 206160spl_id7a882463-5215-477c-bc1c-2cce0801bf4bspl_set_id542f22e8-dad2-47a8-93b6-30936715d73bPackage NDC0004-0068-01, 0004-0058-01, 0004-0098-01NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

5)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MG, UNKdrugadministrationroute048

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

6)

drugcharacterization2medicinalproductVICODINdrugstructuredosagenumb300drugstructuredosageunit003drugdosagetext300 MG, UNKdrugadministrationroute048

7)

drugcharacterization2medicinalproductTRICORdrugstructuredosagenumb48drugstructuredosageunit003drugdosagetext48 MG, UNKdrugadministrationroute048

openFDA Info on Medication

Application NumberNDA021656Brand NameTRICORGeneric NameFENOFIBRATEManufacturersAbbVie Inc.product_ndc0074-3173, 0074-6122, 0074-6123, 0074-3189Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFENOFIBRATERXCUI477560, 477562, 540281, 544518spl_id370b42b9-051b-ed87-a804-174e5fd7fef4spl_set_idb693e68d-f812-4993-54b6-852e3517c344Package NDC 0074-6122-90, 0074-6122-71, 0074-6123-90, 0074-6123-71, 0074-3173-90, 0074-3189- ... NUIN0000175596, N0000175375, M0199111Established Pharmacologic ClassPeroxisome Proliferator Receptor alpha Agonist [EPC]Mechanism of ActionPeroxisome Proliferator-activated Receptor alpha Agonists [MoA]Chemical StructurePPAR alpha [CS]UNIIU202363UOS

8)

drugcharacterization2medicinalproductGLUCOPHAGEdrugstructuredosagenumb500drugstructuredosageunit003drugdosagetext500 MG, UNKdrugadministrationroute048

openFDA Info on Medication

Application NumberNDA021202Brand NameGLUCOPHAGE XRGeneric NameMETFORMIN HYDROCHLORIDEManufacturersBristol-Myers Squibb Companyproduct_ndc0087-6063, 0087-6060, 0087-6070, 0087-6071, 0087-6064Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI860975, 860977, 860981, 860983, 861004, 861006, 861007, 861008, 861010, 861012spl_id390c09cf-cc7c-4684-8d7c-d9709a5484faspl_set_id4a0166c7-7097-4e4a-9036-6c9a60d08fc6Package NDC 0087-6060-05, 0087-6060-10, 0087-6070-05, 0087-6071-11, 0087-6063-13, 0087-6064- ... UNII786Z46389E

9)

drugcharacterization2medicinalproductSIMVASTATINdrugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MG, UNKdrugadministrationroute048

openFDA Info on Medication

Application Number NDA206679, ANDA078155, ANDA077691, ANDA078103, ANDA090383, ANDA078034, ANDA07783 ... Brand NameFLOLIPID, SIMVASTATIN, ZOCORGeneric NameSIMVASTATINManufacturers Salerno Pharmaceuticals Co., Accord Healthcare, Inc., NorthStar Rx LLC, Lupin Ph ... product_ndc 29273-401, 29273-402, 16729-004, 16729-156, 16729-005, 16729-006, 16729-007, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSIMVASTATINRXCUI 1790679, 1944262, 1944264, 1944266, 198211, 200345, 312961, 312962, 314231, 1044 ... spl_id 37ec6157-4088-4638-8eba-74a6aa1238d3, a467e8e1-fe36-61f4-e053-2a95a90a3c3c, 81d3 ... spl_set_id 6ee17d10-6eb1-452a-99e8-02381368b3fe, 871251c0-36a1-4a32-9eab-ff6c1e925ca9, 0376 ... Package NDC 29273-401-04, 29273-402-04, 16729-156-10, 16729-156-15, 16729-156-17, 16729-004- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNIIAGG2FN16EV

10)

drugcharacterization2medicinalproductNOVOLOGdrugstructuredosagenumb100drugstructuredosageunit012drugdosagetext100 ML, UNKdrugadministrationroute058

openFDA Info on Medication

Application NumberBLA020986Brand NameNOVOLOGGeneric NameINSULIN ASPARTManufacturersNovo Nordiskproduct_ndc0169-3303, 0169-7501, 0169-6339, 0169-6338, 0169-2001Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, SUBCUTANEOUSActive IngredientsINSULIN ASPARTRXCUI311040, 351926, 1653196, 1653198, 1653202, 1653204spl_id952147fd-80b2-481b-bc17-e94ac49f1bb1spl_set_id3a1e73a2-3009-40d0-876c-b4cb2be56fc5Package NDC 0169-7501-11, 0169-7501-90, 0169-3303-12, 0169-3303-91, 0169-3303-90, 0169-6339- ... NUIM0011417, N0000175453Chemical StructureInsulin [CS]Established Pharmacologic ClassInsulin Analog [EPC]UNII059QF0KO0R, D933668QVX

11)

drugcharacterization2medicinalproductLOVAZAdrugstructuredosagenumb1drugstructuredosageunit002drugdosagetext1 G, UNKdrugadministrationroute048

openFDA Info on Medication

Application NumberNDA021654Brand NameLOVAZAGeneric NameOMEGA-3-ACID ETHYL ESTERSManufacturersGlaxoSmithKline LLCproduct_ndc0173-0884, 0173-0783Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEGA-3-ACID ETHYL ESTERSRXCUI577208, 607044spl_ide4239cb8-fd3c-41bd-96e5-20ecfe426351spl_set_id5ada82f0-a5fd-46c9-aecc-f106f614c9f0Package NDC0173-0783-02, 0173-0884-08UNIID87YGH4Z0Q

12)

drugcharacterization2medicinalproductVITAMIN B12 NOSdrugdosagetext1000 MCG, UNKdrugadministrationroute048

13)

drugcharacterization2medicinalproductCALCIUM W/VITAMIN D NOSdrugdosagetextUNKdrugadministrationroute048

14)

drugcharacterization2medicinalproductVESICAREdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKdrugadministrationroute048

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

15)

drugcharacterization2medicinalproductFOLIC ACIDdrugadministrationroute048

openFDA Info on Medication

Application Number ANDA040796, ANDA204418, ANDA202437, ANDA091145, ANDA211064, ANDA202522, ANDA0407 ... Brand NameFOLIC ACID, VENEXA, VITREXYL, VITRANOLGeneric NameFOLIC ACIDManufacturers Leading Pharma, LLC, Marlex Pharmaceuticals Inc, PureTek Corporation, Cadila Pha ... product_ndc 69315-127, 10135-182, 59088-176, 71209-007, 58657-150, 11534-165, 58657-151, 731 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSActive Ingredients FOLIC ACID, .ALPHA.-TOCOPHEROL ACETATE, DL-, MAGNESIUM OXIDE, CHROMIUM NICOTINAT ... RXCUI310410, 237786spl_id 92322e52-3179-4738-8c8a-14fef62311d4, ba726c8a-bfad-11f7-e053-2995a90a239e, ba13 ... spl_set_id 1ba8c407-9613-4319-ac40-0a429cb0f3f4, 35cd5498-0af8-4bcc-a755-bf30f37b091a, ba13 ... Package NDC 69315-127-01, 69315-127-10, 10135-182-01, 10135-182-10, 59088-176-54, 71209-007- ... UNII 935E97BOY8, WR1WPI7EW8, 3A3U0GI71G, A150AY412V, 68Y4CF58BV, 81AH48963U, H6241UJ2 ... NUIM0022797, N0000175952, N0000193618, M0001797, M0022794, N0000175951Chemical StructureVitamin D [CS], Ascorbic Acid [CS], Vitamin B 12 [CS]Established Pharmacologic ClassVitamin D [EPC], Vitamin C [EPC], Vitamin B12 [EPC]

16)

drugcharacterization2medicinalproductLORTAB

openFDA Info on Medication

Application NumberANDA040881Brand NameLORTABGeneric NameHYDROCODONE BITARTRATE AND ACETAMINOPHENManufacturersAkorn, Inc.product_ndc17478-450Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCODONE BITARTRATE, ACETAMINOPHENRXCUI1044427, 1442445spl_id3354ff15-0cde-4f2a-a05b-5ee5b04a6c65spl_set_id21def91d-b6e3-4dde-983c-6925aedf0df0Package NDC17478-450-16UNIINO70W886KK, 362O9ITL9D

17)

drugcharacterization2medicinalproductIRON

openFDA Info on Medication

Brand NameFERRUM METALLICUM, BILIOUSNESS DIARRHEAGeneric NameIRONManufacturersWashington Homeopathic Products, Boiron, Natural Health Supply, Seroyal USAproduct_ndc 71919-289, 0220-2055, 0220-2085, 0220-2051, 0220-2050, 0220-2047, 64117-791, 022 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIRONspl_id 7e4e7e58-41be-89a2-e053-2a91aa0a790b, 8591b12c-51c9-9839-e053-2a91aa0aa937, 8737 ... spl_set_id bbca0ba2-37e5-4667-80ff-365490b25624, 8591b12c-51c8-9839-e053-2a91aa0aa937, 8737 ... Package NDC 71919-289-07, 71919-289-08, 71919-289-09, 71919-289-10, 0220-2055-41, 0220-2085- ... UNIIE1UOL152H7

18)

drugcharacterization2medicinalproductMAXZIDEdrugdosagetextUNKdrugadministrationroute048

openFDA Info on Medication

Application NumberNDA019129Brand NameMAXZIDE, MAXZIDE-25Generic NameMAXZIDEManufacturersMylan Pharmaceuticals Inc.product_ndc0378-0460, 0378-0464Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTRIAMTERENE, HYDROCHLOROTHIAZIDERXCUI93252, 93253, 310812, 310818spl_id4efba34f-eb98-4cf0-b3c6-cb03f1ea37c5spl_set_ide92eda49-861e-4c79-b446-ec1213151d92Package NDC0378-0464-01, 0378-0460-01NUIN0000008859, N0000175359, N0000175418, N0000175419, M0471776Physiologic/Pharmacodynamic EffectDecreased Renal K+ Excretion [PE], Increased Diuresis [PE]Established Pharmacologic ClassPotassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNIIWS821Z52LQ, 0J48LPH2TH

19)

drugcharacterization2medicinalproductALTACEdrugstructuredosagenumb1.25drugstructuredosageunit003drugdosagetext1.25 MG, UNKdrugadministrationroute048

openFDA Info on Medication

Application NumberNDA019901Brand NameALTACEGeneric NameRAMIPRILManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc61570-110, 61570-111, 61570-112, 61570-120Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRAMIPRILRXCUI104384, 104385, 198188, 198189, 260333, 261962, 845488, 845489spl_idadc257d2-f5aa-4353-b61b-5827e44040c9spl_set_id0fc34cd8-86e6-4034-73bd-4263a68ba046Package NDC61570-110-01, 61570-111-01, 61570-112-01, 61570-120-01NUIN0000175562, N0000000181Established Pharmacologic ClassAngiotensin Converting Enzyme Inhibitor [EPC]Mechanism of ActionAngiotensin-converting Enzyme Inhibitors [MoA]UNIIL35JN3I7SJ

20)

drugcharacterization2medicinalproductSTOOL SOFTENER

openFDA Info on Medication

Application Numberpart334Brand Name STOOL SOFTENER WITH LAXATIVE, STOOL SOFTENER, STOOL SOFTENER EXTRA STRENGTH, STO ... Generic Name DOCUSATE SODIUM AND SENNOSIDES, DOCUSATE SODIUM, DOCUSATE CALCIUM, MARC GLASSMAN ... Manufacturers AmerisourceBergen (Good Neighbor Pharmacy) 46122, CVS PHARMACY, INC., CVS Pharma ... product_ndc 46122-567, 69842-169, 69842-483, 68016-408, 0363-2570, 55301-655, 46122-451, 683 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsDOCUSATE SODIUM, SENNOSIDES, DOCUSATE CALCIUMRXCUI998740, 1115005, 1245376, 1245468, 1791612spl_id 0a092a40-e3dc-4509-a613-6fed0ae94255, 468f2bab-b388-4bfc-af88-abacdd46a129, 7b62 ... spl_set_id 0cf2f610-bff4-48b8-b640-2c3c708a47a8, 9665721c-40bf-4674-8430-399c70bdca47, 14b0 ... Package NDC 46122-567-78, 69842-169-48, 69842-483-10, 68016-408-01, 68016-408-25, 68016-408- ... UNIIF05Q2T2JA0, 3FYP5M0IJX, 6K7YS503HC

Report Duplicate

duplicatesourceBAYERduplicatenumbUS-BAYER-2014-044112

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use