Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10069618serious1Date Last Updated25/04/2014receiptdateformat102companynumbUS-BIOGENIDEC-2014BI032591occurcountryUSduplicate1Date Received10/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age61Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionFibromyalgiaOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionSystemic lupus erythematosusOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionMuscular weaknessOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductAVONEXdrugauthorizationnumb103628drugstructuredosagenumb30drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosageformSolution for injection in pre-filled pendrugadministrationroute030drugindicationMULTIPLE SCLEROSISdrugstartdateformat102drugstartdate08/10/2012actiondrug4

openFDA Info on Medication

Application NumberBLA103628Brand NameAVONEXGeneric NameINTERFERON BETA-1AManufacturersBiogen Inc.product_ndc59627-111, 59627-333, 59627-222, 59627-003, 59627-002Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULARRXCUI153323, 153324, 727813, 727816, 797544, 1650899, 1650901spl_id2a66a68a-2391-4598-a662-d3c55b1547f7spl_set_idd70a39cc-de15-4c12-a1ec-8063b69ea0e1Package NDC 59627-333-04, 59627-222-05, 59627-111-04, 59627-111-03, 59627-003-01, 59627-003- ...

2)

drugcharacterization2medicinalproductADVAIR DISKUS

openFDA Info on Medication

Application NumberNDA021077Brand NameADVAIR DISKUSGeneric NameFLUTICASONE PROPIONATE AND SALMETEROLManufacturersGlaxoSmithKline LLCproduct_ndc0173-0695, 0173-0696, 0173-0697Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsSALMETEROL XINAFOATE, FLUTICASONE PROPIONATERXCUI 896161, 896165, 896184, 896185, 896186, 896190, 896209, 896212, 896218, 896222, ... spl_idc03442a4-17dc-4c49-ae07-3f8f7f26e0dfspl_set_id4eeb5f6a-593f-4a9e-9692-adefa2caf8fcPackage NDC 0173-0695-00, 0173-0695-04, 0173-0696-00, 0173-0696-04, 0173-0697-00, 0173-0697- ... UNIIO2GMZ0LF5W, 6EW8Q962A5

3)

drugcharacterization2medicinalproductALBUTEROL SULFATE

openFDA Info on Medication

Application Number ANDA210948, ANDA074454, NDA020983, ANDA074880, ANDA077788, ANDA077839, NDA021457 ... Brand Name ALBUTEROL, ALBUTEROL SULFATE, VENTOLIN HFA, ALBUTEROL SULFATE HFA, PROAIR HFA, P ... Generic NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, Actavis Pharma, Inc., GlaxoSmithKline LLC, Nephron ... product_ndc 75834-273, 75834-274, 0472-0825, 0173-0682, 0487-9501, 66689-100, 0378-8270, 765 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RESPIRATORY (INHALATION), INTRABRONCHIALActive IngredientsALBUTEROL SULFATERXCUI 197316, 197318, 755497, 801092, 801095, 859088, 2123076, 630208, 2123072, 745752 ... spl_id b736135f-6e13-3e29-e053-2a95a90a67f4, d30951c8-4054-4a94-85b1-8cdd7e22fe6a, 9c3b ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, 8bac1efe-c419-a615-fab5-0770b0ce90d9, d92c ... Package NDC 75834-273-01, 75834-274-01, 0472-0825-16, 0472-0825-04, 0173-0682-20, 0173-0682- ... UNII021SEF3731

4)

drugcharacterization2medicinalproductALDACTONE

openFDA Info on Medication

Application NumberNDA012151Brand NameALDACTONEGeneric NameSPIRONOLACTONEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0025-1001, 0025-1041, 0025-1031Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSPIRONOLACTONERXCUI198222, 198223, 200817, 200820, 200825, 313096spl_idba392fd1-82d0-4a79-a555-72ab9837d283spl_set_id0fed2822-3a03-4b64-9857-c682fcd462bcPackage NDC0025-1001-31, 0025-1041-31, 0025-1031-31NUIN0000175557, N0000011310Established Pharmacologic ClassAldosterone Antagonist [EPC]Mechanism of ActionAldosterone Antagonists [MoA]UNII27O7W4T232

5)

drugcharacterization2medicinalproductAMITIZA

openFDA Info on Medication

Application NumberNDA021908Brand NameAMITIZAGeneric NameLUBIPROSTONEManufacturersTakeda Pharmaceuticals America, Inc.product_ndc64764-080, 64764-240Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLUBIPROSTONERXCUI616578, 617768, 794639, 794641spl_id13cd7c3a-6e60-4f2d-a588-eb452fc711d0spl_set_idd474ac6a-444d-4aa6-9986-24be6fcf811dPackage NDC64764-080-60, 64764-240-60, 64764-240-10NUIN0000175573, N0000175456Established Pharmacologic ClassChloride Channel Activator [EPC]Mechanism of ActionChloride Channel Activators [MoA]UNII7662KG2R6K

6)

drugcharacterization2medicinalproductDELESTROGEN

openFDA Info on Medication

Application NumberNDA009402Brand NameDELESTROGENGeneric NameESTRADIOL VALERATEManufacturersPar Pharmaceutical, Inc.product_ndc42023-110, 42023-111, 42023-112Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULARActive IngredientsESTRADIOL VALERATERXCUI206620, 206715, 206813, 310189, 310190, 310191spl_id9b850a6c-5053-4728-ad4d-e8e4555d7571spl_set_ide8f94df9-0692-4462-a7f0-fe019a0a3f07Package NDC42023-110-01, 42023-111-01, 42023-112-01UNIIOKG364O896

7)

drugcharacterization2medicinalproductFUROSEMIDE

openFDA Info on Medication

Application Number ANDA077293, ANDA207552, ANDA213902, NDA016273, ANDA070655, ANDA212174, ANDA07043 ... Brand Name TOXYCOLOGY MEDICATED COLLECTION SYSTEM, FUROSEMIDE, LASIX, DIASCREEN 12-PANEL ME ... Generic NameFUROSEMIDEManufacturers IT3 Medical LLC, Amneal Pharmaceuticals LLC, Gland Pharma Limited, Validus Pharm ... product_ndc 70529-549, 70121-1076, 70121-1163, 70121-1164, 68083-432, 68083-433, 68083-434, ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 310429, 1038558, 1719286, 1719290, 1719291, 197732, 200801, 200809, 205732, 3139 ... spl_id 67969d0e-ce2a-4634-b46a-968c898b61ee, c22d0330-1b76-420a-a84b-8ea59f8733a7, e7bd ... spl_set_id a78407a8-3d3e-4eb5-9e3f-b32a1b8015e4, d5b9f12e-d1e9-42de-90f2-c9ba33a86457, 6447 ... Package NDC 70529-549-01, 70529-061-08, 68345-883-50, 70121-1163-1, 70121-1163-5, 70121-1164 ... RouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsFUROSEMIDENUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

8)

drugcharacterization2medicinalproductIMITREX

openFDA Info on Medication

Application NumberNDA020080, NDA020132, NDA020626Brand NameIMITREXGeneric NameSUMATRIPTANManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0449, 0173-0739, 0173-0479, 0173-0478, 0173-0735, 0173-0736, 0173-0737, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUS, ORAL, NASALActive IngredientsSUMATRIPTAN SUCCINATE, SUMATRIPTANRXCUI 208452, 313165, 758523, 860088, 1657160, 1657173, 208450, 209169, 284460, 313160 ... spl_id 09b593bc-1a39-4a59-83da-ff02b99aabc3, 38f8e92e-6b77-4c8d-9069-09973b45be2c, 8a09 ... spl_set_id fee7d073-0b99-48f2-7985-0d8cf970894b, 584abe73-8290-4484-ff8e-5890831c095e, cc11 ... Package NDC 0173-0739-00, 0173-0739-02, 0173-0479-00, 0173-0478-00, 0173-0449-02, 0173-0735- ... UNIIJ8BDZ68989, 8R78F6L9VONUIN0000175763, N0000175764, N0000175765Mechanism of ActionSerotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA]Established Pharmacologic ClassSerotonin-1b and Serotonin-1d Receptor Agonist [EPC]

9)

drugcharacterization2medicinalproductJANUVIA

openFDA Info on Medication

Application NumberNDA021995Brand NameJANUVIAGeneric NameSITAGLIPTINManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0112, 0006-0221, 0006-0277Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSITAGLIPTIN PHOSPHATERXCUI665033, 665036, 665038, 665040, 665042, 665044spl_id26191c72-2372-41ac-8ddf-e28322dcb9ccspl_set_idf85a48d0-0407-4c50-b0fa-7673a160bf01Package NDC 0006-0221-01, 0006-0221-28, 0006-0221-31, 0006-0221-54, 0006-0112-01, 0006-0112- ... UNIITS63EW8X6F

10)

drugcharacterization2medicinalproductKLOR-CON

openFDA Info on Medication

Application NumberNDA019123, ANDA209662Brand NameKLOR-CONGeneric NamePOTASSIUM CHLORIDEManufacturersSandoz Inc., Upsher-Smith Laboratories, LLCproduct_ndc66758-110, 66758-160, 0245-5315, 0245-5316, 0245-0360Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOTASSIUM CHLORIDERXCUI312529, 628953, 628958, 832718, 1867544, 1867547spl_id b6795c1c-762b-4589-a49c-cc2d6854ba65, 0907ea1c-82f3-4ba8-9d1b-3f4fa104d7a2, d947 ... spl_set_id 466170e9-e158-4ccd-b7a3-53dc8c3cd749, 1ff53330-065c-4213-9c0c-ac498621d09d, e61a ... Package NDC 66758-110-06, 66758-110-13, 66758-110-01, 66758-110-05, 66758-160-06, 66758-160- ... UNII660YQ98I10

11)

drugcharacterization2medicinalproductMETOCLOPRAMIDE HCL

12)

drugcharacterization2medicinalproductMYRBETRIQ

openFDA Info on Medication

Application NumberNDA202611Brand NameMYRBETRIQGeneric NameMIRABEGRONManufacturersAstellas Pharma US, Inc.product_ndc0469-2601, 0469-2602Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMIRABEGRONRXCUI1300791, 1300797, 1300801, 1300803spl_ide6e21040-1626-4bf0-b78e-a14d257656cespl_set_idba9e9e15-e666-4c56-9271-2e24739cfa2dPackage NDC 0469-2601-30, 0469-2601-90, 0469-2601-71, 0469-2602-30, 0469-2602-90, 0469-2602- ... NUIN0000185008, N0000185007, N0000182137Established Pharmacologic Classbeta3-Adrenergic Agonist [EPC]Mechanism of ActionAdrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA]UNIIMVR3JL3B2V

13)

drugcharacterization2medicinalproductNEXIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id416c365d-7271-4804-9285-643858cf578b, ac4ba22b-f431-4ab4-b239-0e220ad804ddspl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H

14)

drugcharacterization2medicinalproductNITROGLYCERIN ER

openFDA Info on Medication

15)

drugcharacterization2medicinalproductNORTRIPTYLINE HCL

openFDA Info on Medication

16)

drugcharacterization2medicinalproductOXYCONTIN

openFDA Info on Medication

Application NumberNDA022272Brand NameOXYCONTINGeneric NameOXYCODONE HYDROCHLORIDEManufacturersPurdue Pharma LPproduct_ndc59011-410, 59011-480, 59011-415, 59011-420, 59011-430, 59011-440, 59011-460Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDERXCUI 1049504, 1049545, 1049565, 1049576, 1049586, 1049595, 1049601, 1860127, 1860129, ... spl_id21ec1aed-af99-6d71-bc44-4755651ecd9espl_set_idbfdfe235-d717-4855-a3c8-a13d26dadedePackage NDC 59011-480-20, 59011-480-10, 59011-410-10, 59011-410-20, 59011-415-10, 59011-415- ... UNIIC1ENJ2TE6C

17)

drugcharacterization2medicinalproductPLAQUENIL

openFDA Info on Medication

Application NumberNDA009768Brand NamePLAQUENILGeneric NameHYDROXYCHLOROQUINE SULFATEManufacturersConcordia Pharmaceuticals Inc.product_ndc59212-562Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROXYCHLOROQUINE SULFATERXCUI979092, 979094spl_id763bd0fa-4ae7-451d-bf90-db9237f6a009spl_set_id34496b43-05a2-45fb-a769-52b12e099341Package NDC59212-562-10, 59212-562-60, 59212-562-11UNII8Q2869CNVH

18)

drugcharacterization2medicinalproductPREDNISONE

openFDA Info on Medication

Application Number NDA202020, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA040584, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., GeneYork Pharmaceuticals Group LLC, Mylan Pharma ... product_ndc 75987-020, 75987-021, 75987-022, 71329-106, 0378-0640, 0378-0641, 0378-0642, 060 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id be29c86d-242b-42a7-9488-ecf6f76426cd, 4384c1d1-059b-4689-9f3d-1078de814ce8, 88a6 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, be50449f-3aa8-46b7-9246-2dbd5f04f2b1, fec0 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

19)

drugcharacterization2medicinalproductSINGULAIR

openFDA Info on Medication

Application NumberNDA020829, NDA020830, NDA021409Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersMerck Sharp & Dohme Corp.product_ndc0006-9117, 0006-3841, 0006-1711, 0006-9275Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id96717981-6ea2-4720-a749-e14f1559511fspl_set_id8c166755-7711-4df9-d689-8836a1a70885Package NDC 0006-3841-30, 0006-3841-14, 0006-1711-31, 0006-1711-54, 0006-9275-31, 0006-9275- ... UNIIU1O3J18SFL

20)

drugcharacterization2medicinalproductTOPROL XL

openFDA Info on Medication

Application NumberNDA019962Brand NameTOPROL XLGeneric NameMETOPROLOL SUCCINATEManufacturersAstraZeneca Pharmaceuticals LP, Aralez Pharmaceuticals US Inc.product_ndc 0186-1088, 0186-1090, 0186-1092, 0186-1094, 70347-025, 70347-050, 70347-100, 703 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOPROLOL SUCCINATERXCUI866412, 866414, 866419, 866421, 866427, 866429, 866436, 866438spl_id03b2ba2e-c4b7-449d-8e07-9c0e08171f66, 259b9a5f-b63a-44a0-8d05-1bb38cfc85bdspl_set_id4a5762c6-d7a2-4e4c-10b7-8832b36fa5f4, 991fe00b-498b-400e-9e5b-921cb07d9b2cPackage NDC 0186-1088-05, 0186-1088-39, 0186-1088-30, 0186-1088-35, 0186-1090-05, 0186-1090- ... UNIITH25PD4CCB

21)

drugcharacterization2medicinalproductTRIAMTERENE-HCTZ

22)

drugcharacterization2medicinalproductZEMPLAR

openFDA Info on Medication

Application NumberNDA021606, NDA020819Brand NameZEMPLARGeneric NamePARICALCITOLManufacturersAbbVie Inc.product_ndc0074-9036, 0074-4314, 0074-4317, 0074-9037, 0074-1658, 0074-4637Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsPARICALCITOLRXCUI 577315, 577317, 606854, 606859, 200321, 213298, 352076, 1736919, 1736921, 173693 ... spl_id612781f7-dcfa-ac62-f5e4-da732da578a2, 2bf3cb38-b83d-75d3-a20e-3d08929b9b80spl_set_id1b27c026-2d60-47b4-2a9c-ded1818f21b5, 7259652f-81bc-4ad1-bba5-d01f9fac1b80Package NDC 0074-4314-30, 0074-4317-30, 0074-4317-73, 0074-9036-30, 0074-9037-30, 0074-4637- ... NUIM0004229, N0000175908Chemical StructureCholecalciferol [CS]Established Pharmacologic ClassVitamin D3 Analog [EPC]UNII6702D36OG5

23)

drugcharacterization2medicinalproductZOLOFT

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

Report Duplicate

duplicatesourceBIOGENduplicatenumbUS-BIOGENIDEC-2014BI032591

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use