Adverse Event Report

Report

reporttype2Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10063976serious1Date Last Updated11/06/2014receiptdateformat102companynumbUS-BIOGENIDEC-2014BI031480occurcountryUSduplicate1Date Received08/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age57Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionUrinary tract infectionOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionMental status changesOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionFallOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionHallucinationOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductTECFIDERAdrugbatchnumbP12016drugauthorizationnumb204063drugstructuredosagenumb120drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformPROLONGED-RELEASE CAPSULEdrugadministrationroute048drugindicationMULTIPLE SCLEROSISdrugstartdateformat102drugstartdate20/02/2014actiondrug1

openFDA Info on Medication

Application NumberNDA204063Brand NameTECFIDERAGeneric NameDIMETHYL FUMARATEManufacturersBiogen Inc.product_ndc64406-005, 64406-007, 64406-006Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIMETHYL FUMARATERXCUI1373483, 1373489, 1373491, 1373493, 1373497, 1373498spl_id9b17ffc0-f173-4a40-af22-80f21d069ebaspl_set_id665d7e74-036c-5f68-5b67-ab84b9b49151Package NDC64406-007-03, 64406-005-01, 64406-006-02UNIIFO2303MNI2

2)

drugcharacterization1medicinalproductTECFIDERAdrugauthorizationnumb204063drugstructuredosagenumb240drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformPROLONGED-RELEASE CAPSULEdrugadministrationroute048drugindicationMULTIPLE SCLEROSISdrugenddateformat102drugenddate23/03/2014actiondrug1

openFDA Info on Medication

Application NumberNDA204063Brand NameTECFIDERAGeneric NameDIMETHYL FUMARATEManufacturersBiogen Inc.product_ndc64406-005, 64406-007, 64406-006Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIMETHYL FUMARATERXCUI1373483, 1373489, 1373491, 1373493, 1373497, 1373498spl_id9b17ffc0-f173-4a40-af22-80f21d069ebaspl_set_id665d7e74-036c-5f68-5b67-ab84b9b49151Package NDC64406-007-03, 64406-005-01, 64406-006-02UNIIFO2303MNI2

3)

drugcharacterization2medicinalproductKLONOPINdrugstructuredosagenumb0drugstructuredosageunit003drugdosageformTABLET

openFDA Info on Medication

Application NumberNDA017533Brand NameKLONOPINGeneric NameCLONAZEPAMManufacturersGenentech, Inc.product_ndc0004-0058, 0004-0068, 0004-0098Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMspl_id69abc49f-2bef-43ee-bbc9-05bca26caefespl_set_id542f22e8-dad2-47a8-93b6-30936715d73bPackage NDC0004-0068-01, 0004-0058-01, 0004-0098-01NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

4)

drugcharacterization2medicinalproductREQUIPdrugstructuredosagenumb0drugstructuredosageunit003drugdosageformTABLET

5)

drugcharacterization2medicinalproductSANCTURAdrugstructuredosagenumb20drugstructuredosageunit003drugdosageformTABLET

6)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb100drugstructuredosageunit003drugdosageformTABLET

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

7)

drugcharacterization2medicinalproductLIPITORdrugstructuredosagenumb40drugstructuredosageunit003drugdosageformTABLET

openFDA Info on Medication

Application NumberNDA020702Brand NameLIPITORGeneric NameATORVASTATIN CALCIUMManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0155, 0071-0156, 0071-0157, 0071-0158Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATORVASTATIN CALCIUM TRIHYDRATERXCUI259255, 262095, 617310, 617311, 617312, 617314, 617318, 617320spl_id0ba214c6-250e-42a0-aea8-5e44aba04882spl_set_idc6e131fe-e7df-4876-83f7-9156fc4e8228Package NDC 0071-0155-23, 0071-0155-40, 0071-0155-10, 0071-0155-97, 0071-0156-23, 0071-0156- ... UNII48A5M73Z4Q

8)

drugcharacterization2medicinalproductFENOFIBRATEdrugstructuredosagenumb134drugstructuredosageunit003drugdosageformTABLET

openFDA Info on Medication

Application Number ANDA211080, ANDA202676, ANDA209950, ANDA207378, ANDA211122, ANDA210606, ANDA2051 ... Brand NameFENOFIBRATE, FENOFIBRATE FILM COATED, ANTARA, TRICOR, FENOGLIDE, LIPOFENGeneric NameFENOFIBRATEManufacturers Solco Healthcare US, LLC, Mylan Pharmaceuticals Inc., Amneal Pharmaceuticals NY ... product_ndc 43547-430, 43547-431, 0378-8628, 0378-8629, 0378-8630, 69238-1262, 69238-1263, 1 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFENOFIBRATERXCUI 477560, 477562, 349287, 351133, 200311, 310288, 310289, 483425, 483427, 1442163, ... spl_id 165e6912-1ca0-4fad-8c3c-97a927d0d249, 1e5c1d27-15e1-465e-b19c-738bf855e6d4, 0be7 ... spl_set_id 085109a6-f006-44f0-a170-980d8899a365, 66d2c555-2880-4ac6-80f8-69a00f1fbc4c, 7e79 ... Package NDC 43547-430-09, 43547-430-50, 43547-431-09, 43547-431-50, 0378-8628-77, 0378-8629- ... NUIN0000175596, N0000175375, M0199111Established Pharmacologic ClassPeroxisome Proliferator Receptor alpha Agonist [EPC]Mechanism of ActionPeroxisome Proliferator-activated Receptor alpha Agonists [MoA]Chemical StructurePPAR alpha [CS]UNIIU202363UOS

9)

drugcharacterization2medicinalproductGABAPENTINdrugstructuredosagenumb400drugstructuredosageunit003drugdosageformTABLET

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 6e41ce47-a6cc-4c34-84f1-305747df38c2, 5fc4 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

10)

drugcharacterization2medicinalproductAMITRIPTYLINEdrugstructuredosagenumb25drugstructuredosageunit003drugdosageformTABLET

11)

drugcharacterization2medicinalproductOMEPRAZOLEdrugstructuredosagenumb40drugstructuredosageunit003drugdosageformCAPSULE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

12)

drugcharacterization2medicinalproductLORATADINEdrugstructuredosagenumb10drugstructuredosageunit003drugdosageformTABLET

openFDA Info on Medication

Application Number ANDA210722, ANDA076471, ANDA076301, ANDA202538, ANDA076805, ANDA075209, ANDA0757 ... Brand Name LORATADINE, ALLERGY RELIEF, CHILDRENS LORATADINE SUGAR FREE, COUNTERACT ALLERGY, ... Generic NameLORATADINE, LORATADINE ORALManufacturers Granules India Ltd, Geri-Care Pharmaceutical Corp, Shopko Stores Operating Co., ... product_ndc 62207-787, 57896-788, 37012-612, 69452-211, 69842-540, 54473-166, 36800-608, 036 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLORATADINE, FAMOTIDINERXCUI 311372, 828269, 692783, 1087051, 311373, 665078, 744830, 206805, 1020126, 755478 ... spl_id 9aadc2f2-d0ea-5297-e053-2995a90ac51e, 9aa07ca9-ee19-89c7-e053-2a95a90ae9b5, 105d ... spl_set_id 0dee9036-d51f-4d7f-b5e2-4f6940249eef, 41fab408-35cb-47cc-bd4e-bba4ec10f6c7, 47b0 ... Package NDC 62207-787-51, 62207-787-59, 57896-788-03, 57896-788-09, 37012-612-65, 37012-612- ... UNII7AJO3BO7QN, 5QZO15J2Z8NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]

13)

drugcharacterization2medicinalproductXARELTOdrugstructuredosagenumb10drugstructuredosageunit003drugdosageformTABLET

openFDA Info on Medication

Application NumberNDA202439, NDA022406Brand NameXARELTOGeneric NameRIVAROXABANManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-577, 50458-580, 50458-578, 50458-579, 50458-584Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRIVAROXABANRXCUI 1114198, 1114202, 1232082, 1232084, 1232086, 1232088, 1549682, 1549683, 2059015, ... spl_idbc8e9efa-638a-11ea-9dc6-12fbfb2ca371spl_set_id10db92f9-2300-4a80-836b-673e1ae91610Package NDC 50458-577-60, 50458-577-18, 50458-577-14, 50458-577-01, 50458-577-10, 50458-580- ... NUIN0000175635, N0000175637Mechanism of ActionFactor Xa Inhibitors [MoA]Established Pharmacologic ClassFactor Xa Inhibitor [EPC]UNII9NDF7JZ4M3

14)

drugcharacterization2medicinalproductPERCOCETdrugdosageformTABLET

openFDA Info on Medication

Application NumberANDA040330Brand NamePERCOCETGeneric NameOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENManufacturersEndo Pharmaceuticals Inc.product_ndc63481-623, 63481-627, 63481-628, 63481-629Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDE, ACETAMINOPHENRXCUI1049214, 1049221, 1049225, 1049625, 1049635, 1049637, 1049640, 1049642spl_id8a04ce2f-d576-469f-91bc-5ed75e27e47espl_set_id4dd36cf5-8f73-404a-8b1d-3bd53bd90c25Package NDC63481-627-70, 63481-623-70, 63481-623-85, 63481-628-70, 63481-629-70UNII362O9ITL9D, C1ENJ2TE6C

Report Duplicate

duplicatesourceBIOGENduplicatenumbUS-BIOGENIDEC-2014BI031480

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use