Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10060865serious1Date Last Updated04/04/2014receiptdateformat102companynumbUS-ABBVIE-14P-163-1218225-00occurcountryUSseriousnessother1duplicate1Date Received04/04/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age66Unit of Onset AgeyearsWeight66.74SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionRhabdomyolysisOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionMyalgiaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionPain in extremityOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumbUNKNOWNdrugauthorizationnumb125057drugstructuredosagenumb160drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextLOADING DOSEdrugdosageformSolution for injection in pre-filled pendrugadministrationroute058drugindicationCROHN^S DISEASEdrugstartdateformat102drugstartdate12/03/2014drugenddateformat102drugenddate12/03/2014actiondrug1

openFDA Info on Medication

Application NumberBLA125057Brand NameHUMIRAGeneric NameADALIMUMABManufacturersAbbVie Inc.product_ndc 0074-0067, 0074-3799, 0074-6347, 0074-4339, 0074-9374, 0074-0243, 0074-0554, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 351290, 352334, 727703, 727705, 763564, 763565, 797544, 825169, 825170, 1551887, ... spl_id7a967019-f452-7b99-ba3d-e9b3ac703363spl_set_id608d4f0d-b19f-46d3-749a-7159aa5f933dPackage NDC 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-6347-02, 0074-4339- ...

2)

drugcharacterization2medicinalproductOMEPRAZOLEdrugindicationGASTROOESOPHAGEAL REFLUX DISEASE

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

3)

drugcharacterization2medicinalproductPENTASAdrugindicationCROHN^S DISEASE

openFDA Info on Medication

Application NumberNDA020049Brand NamePENTASAGeneric NameMESALAMINEManufacturersTakeda Pharmaceuticals America, Inc.product_ndc54092-189, 54092-191Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMESALAMINERXCUI206791, 314092, 476362, 580286spl_idc69ba849-555c-4b23-8010-e32ab00dee21spl_set_ide39d9a3d-5d3a-4bb6-aab1-fdbb2a598606Package NDC54092-189-81, 54092-191-08, 54092-191-12NUIN0000175781, M0000971Established Pharmacologic ClassAminosalicylate [EPC]Chemical StructureAminosalicylic Acids [CS]UNII4Q81I59GXC

4)

drugcharacterization2medicinalproductPRAVACHOLdrugindicationBLOOD CHOLESTEROL INCREASED

openFDA Info on Medication

Application NumberNDA019898Brand NamePRAVACHOLGeneric NamePRAVASTATIN SODIUMManufacturersE.R. Squibb & Sons, L.L.C.product_ndc0003-5178, 0003-5194Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPRAVASTATIN SODIUMRXCUI904467, 904469, 904475, 904477spl_id94e23dcc-1a10-4e2f-80e3-9b1d15bd9d89spl_set_id897ad8b7-921d-eb02-a61c-3419e662a2daPackage NDC0003-5178-05, 0003-5194-10UNII3M8608UQ61

5)

drugcharacterization2medicinalproductREMERONdrugindicationDEPRESSION

openFDA Info on Medication

Application NumberNDA020415Brand NameREMERONGeneric NameMIRTAZAPINEManufacturersOrganon USA Inc.product_ndc 0052-0105, 0052-0109, 0052-0107, 0052-4364, 0052-4365, 0052-0106, 0052-0108, 005 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMIRTAZAPINERXCUI 211322, 211323, 261135, 283406, 283407, 283485, 311725, 311726, 314111, 752869, ... spl_id82ba8b77-c4df-42ac-8826-e30ae796fe47spl_set_id010f9162-9f7f-4b6d-a6e4-4f832f26f38ePackage NDC 0052-0109-30, 0052-0107-30, 0052-0105-30, 0052-4364-01, 0052-4365-01, 0052-0106- ... UNIIA051Q2099Q

6)

drugcharacterization2medicinalproductSUCRALFATEdrugindicationCROHN^S DISEASE

openFDA Info on Medication

Application NumberNDA019183, ANDA070848, NDA018333, ANDA074415, ANDA209356Brand NameSUCRALFATE, CARAFATEGeneric NameSUCRALFATE, SUCRALFATE ORALManufacturers Dash Pharmaceuticals LLC, Teva Pharmaceuticals USA, Inc., Greenstone LLC, Allerg ... product_ndc 69339-148, 0093-2210, 59762-0401, 58914-170, 29033-003, 0254-1011, 58914-171, 65 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSUCRALFATERXCUI313123, 314234, 208094, 208097spl_id 299e00e3-81f0-47ff-81bf-dfe78e21a323, 69aa8666-9a38-413f-8732-c8a3db6f419c, 37d3 ... spl_set_id c76c7bcb-d481-43ff-809b-da8e0e88f096, c7a43df7-eb37-4273-9250-87953b1fd270, ae58 ... Package NDC 69339-148-01, 69339-148-17, 69339-148-19, 0093-2210-01, 0093-2210-05, 0093-2210- ... NUIN0000175801, M0015420Established Pharmacologic ClassAluminum Complex [EPC]Chemical StructureOrganometallic Compounds [CS]UNIIXX73205DH5

7)

drugcharacterization2medicinalproductZOLOFTdrugindicationDEPRESSION

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

8)

drugcharacterization2medicinalproductVENTOLINdrugadministrationroute055drugindicationASTHMA

openFDA Info on Medication

Application NumberNDA020983Brand NameVENTOLIN HFAGeneric NameALBUTEROL SULFATEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0682Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsALBUTEROL SULFATERXCUI801092, 801095, 859088, 2123076spl_id9c3b22af-a4d1-4807-a725-00458d4733b2spl_set_idd92c5d6b-ff10-4087-36a2-1cfc464cb967Package NDC0173-0682-20, 0173-0682-24UNII021SEF3731

9)

drugcharacterization2medicinalproductHYDRALAZINEdrugindicationHYPERTENSION

openFDA Info on Medication

Application NumberANDA203845Brand NameHYDRALAZINEGeneric NameHYDRALAZINE HYDROCHLORIDEManufacturersNivagen Pharmaceuticals, Inc.product_ndc75834-126, 75834-127, 75834-128Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDRALAZINE HYDROCHLORIDERXCUI905222, 905225, 905395spl_id7bb9db08-2d7a-476a-a1c2-a2b2834c632fspl_set_id1fd8cf42-66ae-4af5-a5ae-7c9679a0e532Package NDC 75834-126-01, 75834-126-00, 75834-127-01, 75834-127-00, 75834-128-01, 75834-128- ... UNIIFD171B778Y

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1218225-00

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use