Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-BIOGENIDEC-2014BI027448occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10046380Date Received31/03/2014transmissiondate02/10/2014serious2Date Last Updated31/03/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age61Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionAlopeciaOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionAbdominal distensionOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionAbdominal pain upperOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductTECFIDERAdrugauthorizationnumb204063drugstructuredosagenumb240drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformPROLONGED-RELEASE CAPSULEdrugadministrationroute048drugindicationMULTIPLE SCLEROSISactiondrug4

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)

drugcharacterization2medicinalproductAMANTADINE HCLdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA078720Brand NameAMANTADINE HCLGeneric NameAMANTADINE HYDROCHLORIDEManufacturersBionpharma Inc.product_ndc69452-142Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMANTADINE HYDROCHLORIDERXCUI849389spl_id2ace017d-fb67-4265-9106-e30eed548622spl_set_idd6ca4d20-72c5-496c-9ac7-1f5cb407a742Package NDC69452-142-20, 69452-142-30UNIIM6Q1EO9TD0

3)

drugcharacterization2medicinalproductBACLOFENdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

4)

drugcharacterization2medicinalproductZOLOFTdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

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

5)

drugcharacterization2medicinalproductASPIRIN EC LO-DOSE

6)

drugcharacterization2medicinalproductIBUPROFEN

openFDA Info on Medication

Application Number ANDA077349, ANDA206568, ANDA074937, ANDA091355, ANDA075139, ANDA078682, ANDA0791 ... Brand Name CAREONE IBUPROFEN, IBUPROFEN, HEALTH MART CHILDRENS IBUPROFEN, IBUPROFEN MINIS, ... Generic Name IBUPROFEN, IBUPROFEN TABLETS, IBUPROFEN 200MG, IBUPROFEN ORAL, IBUPFROFEN, IBUPR ... Manufacturers American Sales Company, Family Dollar (FAMILY WELLNESS), Strategic Sourcing Serv ... product_ndc 41520-495, 55319-745, 62011-0214, 49738-510, 59779-392, 11822-3307, 50804-199, 7 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsIBUPROFEN, IBUPROFEN SODIUMRXCUI 310965, 310964, 197803, 204442, 310963, 731536, 197805, 197806, 197807, 206905, ... spl_id 0647c7c2-b153-4d8c-b72b-f63d43c41853, 720dc13b-5778-44fa-a4d2-e35db0b2d589, 397d ... spl_set_id 03cdff8a-8890-440d-82b5-54ce809f88cc, 135f910d-a5cd-46e9-9436-015170cc7e38, 1d81 ... Package NDC 41520-495-71, 41520-495-78, 55319-745-30, 55319-745-80, 55319-745-16, 62011-0214 ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, RM1CE97Z4N

7)

drugcharacterization2medicinalproductPEPCID

openFDA Info on Medication

Application NumberNDA019527, ANDA075805Brand NamePEPCIDGeneric NameFAMOTIDINEManufacturersSalix Pharmaceuticals, Inc, Bausch Health Americas Inc.product_ndc65649-211, 0187-4420, 0187-4440Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFAMOTIDINERXCUI206873, 310274, 104094, 104095, 284245, 310273spl_id9e8f6a6d-4f04-4201-8d8e-802f08125adc, 117ab388-f0c2-4d9b-9cd0-1b7c478a665cspl_set_id4f1a0b58-f7c8-485e-a317-432e1c374d2f, a06502d9-7903-4f37-833e-e5763d502defPackage NDC65649-211-24, 0187-4420-30, 0187-4420-10, 0187-4440-30, 0187-4440-10NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]UNII5QZO15J2Z8

8)

drugcharacterization2medicinalproductVITAMIN D

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

Report Duplicate

duplicatesourceBIOGENduplicatenumbUS-BIOGENIDEC-2014BI027448