Adverse Event Report

Report

reporttype2Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10278476serious1Date Last Updated05/11/2014receiptdateformat102companynumbUS-ABBVIE-14K-163-1253442-00occurcountryUSduplicate1Date Received04/07/2014seriousnesshospitalization1transmissiondate28/05/2015primarysourcecountryUS

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification5

Patient

Onset Age52Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionFatigueOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionSeizureOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.0ReactionGlioblastomaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

2)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumbUNKNOWNdrugauthorizationnumb125057drugstructuredosagenumb160drugstructuredosageunit003drugdosageformSOLUTION FOR INJECTION IN PRE-FILLED PENdrugadministrationroute065drugindicationCROHN^S DISEASEdrugstartdateformat102drugstartdate03/05/2014drugenddateformat102drugenddate03/05/2014actiondrug1

activesubstance

activesubstancenameADALIMUMAB

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)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumbUNKNOWNdrugauthorizationnumb125057drugstructuredosagenumb80drugstructuredosageunit003drugdosageformSOLUTION FOR INJECTION IN PRE-FILLED PENdrugadministrationroute065drugstartdateformat102drugstartdate17/05/2014drugenddateformat102drugenddate17/05/2014actiondrug1

activesubstance

activesubstancenameADALIMUMAB

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- ...

4)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumbUNKNOWNdrugauthorizationnumb125057drugdosageformSOLUTION FOR INJECTION IN PRE-FILLED PENdrugadministrationroute065drugstartdateformat610drugstartdate/08/2014actiondrug1

activesubstance

activesubstancenameADALIMUMAB

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- ...

5)

drugcharacterization2medicinalproductQUINAPRILdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationHYPERTENSION

activesubstance

activesubstancenameQUINAPRIL\QUINAPRIL HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA077690, ANDA078457, ANDA205823, ANDA202725Brand NameQUINAPRILGeneric NameQUINAPRIL, QUINAPRIL HYDROCHLORIDEManufacturers BluePoint Laboratories, Cipla USA Inc., Solco Healthcare US, LLC, Lupin Pharmace ... product_ndc 68001-187, 68001-189, 68001-188, 68001-186, 68001-260, 69097-839, 69097-841, 690 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUINAPRIL HYDROCHLORIDERXCUI312748, 312749, 312750, 314203spl_id df08337a-79bd-47c9-858a-8ee32469cfe5, 05eee9cf-c17f-4f92-84f0-b28cd0ffca04, c6a6 ... spl_set_id 1b5809a8-873d-44cb-af59-e0d8fc81b385, e6d36e1e-8e35-4d06-83dc-45e0456365fd, cd46 ... Package NDC 68001-189-05, 68001-188-05, 68001-187-05, 68001-186-05, 68001-260-05, 69097-839- ... UNII33067B3N2M

summary

narrativeincludeclinicalCASE EVENT DATE: 2014

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14K-163-1253442-00

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use