Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10801975primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/07/2015reporttype2serious2receivedateformat102Date Received17/02/2015receiptdateformat102Date Last Updated17/02/2015fulfillexpeditecriteria2companynumbUS-ABBVIE-14K-163-1266594-00duplicate1

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14K-163-1266594-00

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age63Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionInjection site painOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionInappropriate schedule of drug administrationOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductTYLENOL WITH CODEINEdrugdosagetextTHREE TIMES A DAYdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameACETAMINOPHEN\CODEINE PHOSPHATE

openFDA Info on Medication

2)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumbUNKNOWNdrugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformSOLUTION FOR INJECTION IN PRE-FILLED PENdrugindicationCROHN^S DISEASEdrugstartdateformat102drugstartdate25/04/2014actiondrug4

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_id1b259c93-37f5-4845-92ff-224dacfe1d50spl_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)

drugcharacterization2medicinalproductLUNESTAdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextAT BEDTIMEdrugindicationINSOMNIA

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

summary

narrativeincludeclinicalCASE EVENT DATE: 20140425