Adverse Event Report

Report

reporttype2Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10163867serious1Date Last Updated09/05/2014receiptdateformat102companynumbUS-ABBVIE-14P-163-1232792-00occurcountryUSseriousnessother1duplicate1Date Received09/05/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification5

Patient

Onset Age27Unit of Onset AgeyearsWeight53.57SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionAbdominal adhesionsOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionMusculoskeletal stiffnessOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionMuscle atrophyOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionMusculoskeletal disorderOutcomeRecovering/resolving

5)

reactionmeddraversionpt17.0ReactionAlopeciaOutcomeRecovered/resolved

6)

reactionmeddraversionpt17.0ReactionAmnesiaOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt17.0ReactionInjection site bruisingOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1008289drugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformSolution for injection in pre-filled pendrugadministrationroute058drugindicationCROHN^S DISEASEdrugstartdateformat102drugstartdate28/04/2014actiondrug5

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)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1008289drugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformSolution for injection in pre-filled pendrugstartdateformat610drugstartdate/07/2013drugenddateformat610drugenddate/03/2014actiondrug5

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- ...

3)

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

4)

drugcharacterization2medicinalproductPEPCID ACdrugindicationGASTROOESOPHAGEAL REFLUX DISEASE

openFDA Info on Medication

Application NumberNDA020325Brand NamePEPCID AC MAXIMUM STRENGTH, PEPCID AC, PEPCID AC ORIGINAL STRENGTHGeneric NameFAMOTIDINEManufacturers Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Lil' Drug ... product_ndc16837-855, 66715-9748, 16837-872Product TypeHUMAN OTC DRUGRouteORALActive IngredientsFAMOTIDINEspl_id 75438f69-0982-498f-999f-948f63a29570, b685e70b-6f93-294c-e053-2a95a90aeaa3, 487b ... spl_set_id 2854047f-c5c4-43c3-8ef2-5c0a84a307f2, 14406cd8-468b-403d-9be2-43decd304214, 54f4 ... Package NDC 16837-855-05, 16837-855-25, 16837-855-49, 16837-855-50, 16837-855-52, 16837-855- ... NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]UNII5QZO15J2Z8RXCUI104094, 310273, 199047, 212072

5)

drugcharacterization2medicinalproductVITAMIN DdrugindicationVITAMIN SUPPLEMENTATION

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

6)

drugcharacterization2medicinalproductPRO AIRdrugindicationASTHMA

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1232792-00

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use