Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-BIOGENIDEC-2014BI031464occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10088422Date Received21/04/2014transmissiondate12/12/2014serious2Date Last Updated21/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age61Unit of Onset AgeyearsWeight124SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionFace oedemaOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionFatigueOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionSwelling faceOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionUrinary tract infectionOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionChillsOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionFlushingOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.0ReactionNauseaOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt17.0ReactionErythemaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductTECFIDERAdrugbatchnumbR14010drugauthorizationnumb204063drugstructuredosagenumb120drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformPROLONGED-RELEASE CAPSULEdrugadministrationroute048drugindicationMULTIPLE SCLEROSISdrugstartdateformat102drugstartdate28/03/2014actiondrug4

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)

drugcharacterization2medicinalproductCALCIUM 500 TAB + D

3)

drugcharacterization2medicinalproductSTOOL SOFTEN CAP 100-30

4)

drugcharacterization2medicinalproductNOVOLG INJ 100/ML

5)

drugcharacterization2medicinalproductVITAMIN B12drugstructuredosagenumb1000drugstructuredosageunit004drugdosageformSOLUTION FOR INJECTION

6)

drugcharacterization2medicinalproductFOLIC ACIDdrugdosageformTABLET

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]

7)

drugcharacterization2medicinalproductIRONdrugdosageformTABLET

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

8)

drugcharacterization2medicinalproductGLUCOPHAGEdrugstructuredosagenumb500drugstructuredosageunit003drugdosageformTABLET

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)

drugcharacterization2medicinalproductVICODINdrugdosageformTABLET

10)

drugcharacterization2medicinalproductASA LOW DOSEdrugstructuredosagenumb81drugstructuredosageunit003drugdosageformTABLET

11)

drugcharacterization2medicinalproductAMPYRAdrugstructuredosagenumb10drugstructuredosageunit003drugdosageformTABLET

openFDA Info on Medication

Application NumberNDA022250Brand NameAMPYRAGeneric NameDALFAMPRIDINEManufacturersAcorda Therapeutics, Inc.product_ndc10144-427Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDALFAMPRIDINERXCUI897021, 897025spl_id99d8ffc6-164d-b055-e053-2995a90ad0c9spl_set_id550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783Package NDC10144-427-60NUIN0000192795, N0000175448Established Pharmacologic ClassPotassium Channel Blocker [EPC]Mechanism of ActionPotassium Channel Antagonists [MoA]UNIIBH3B64OKL9

12)

drugcharacterization2medicinalproductCLONAZEPAMdrugstructuredosagenumb0drugstructuredosageunit003drugdosageformTABLET

openFDA Info on Medication

Application Number ANDA077171, ANDA074569, ANDA074869, ANDA077194, ANDA077147, ANDA074979, ANDA2110 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Par Pharmaceutical, Inc., Teva Pharmaceuticals USA, Inc., Actavis Pharma, Inc., ... product_ndc 49884-306, 49884-307, 49884-308, 49884-309, 49884-310, 0093-0832, 0093-3212, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id a95f8799-0bb3-41d6-aa27-8a291127ad54, 90dc0b61-37a3-4e54-bde3-7e4c3f7dae98, 9b58 ... spl_set_id 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069b1a0-7c06-4252-b44e-e2eef065d9b8, a58f ... Package NDC 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 0093-0832- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

13)

drugcharacterization2medicinalproductLORTAB 5drugdosageformTABLET

14)

drugcharacterization2medicinalproductTRICORdrugstructuredosagenumb48drugstructuredosageunit003drugdosageformTABLET

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

15)

drugcharacterization2medicinalproductSIMVASTATINdrugstructuredosagenumb10drugstructuredosageunit003drugdosageformTABLET

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

16)

drugcharacterization2medicinalproductVESICAREdrugstructuredosagenumb10drugstructuredosageunit003drugdosageformTABLET

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

17)

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

18)

drugcharacterization2medicinalproductALTACEdrugstructuredosagenumb1drugstructuredosageunit003drugdosageformCAPSULE

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

19)

drugcharacterization2medicinalproductMAXZIDE-25drugdosageformTABLET

openFDA Info on Medication

Application NumberNDA019129Brand NameMAXZIDE-25Generic NameMAXZIDEManufacturersMylan Pharmaceuticals Inc.product_ndc0378-0464, 0378-0460Product 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

20)

drugcharacterization2medicinalproductLOVAZAdrugstructuredosagenumb1drugstructuredosageunit002drugdosageformCAPSULE

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

Report Duplicate

duplicatesourceBIOGENduplicatenumbUS-BIOGENIDEC-2014BI031464