Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11452466primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received31/08/2015receiptdateformat102Date Last Updated31/08/2015fulfillexpeditecriteria2companynumbUS-ELI_LILLY_AND_COMPANY-US200910001484duplicate1

Report Duplicate

duplicatesourceELI LILLY AND COduplicatenumbUS-ELI_LILLY_AND_COMPANY-US200910001484

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age26Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionGlossitisOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.1ReactionTongue discolourationOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.1ReactionFatigueOutcomeUnknown

4)

reactionmeddraversionpt18.1ReactionDrug interactionOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCYMBALTAdrugauthorizationnumb38838drugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext60 MG, DAILY (1/D)drugdosageformCAPSULEdrugadministrationroute048drugstartdateformat602drugstartdate//2009actiondrug2

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_id892f05de-dd11-4ae3-9a85-ce9cfcbeaaccspl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

2)

drugcharacterization2medicinalproductLUNESTAdrugindicationSLEEP DISORDERactiondrug4

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

3)

drugcharacterization2medicinalproductVYVANSEdrugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERactiondrug4

activesubstance

activesubstancenameLISDEXAMFETAMINE DIMESYLATE

openFDA Info on Medication

Application NumberNDA021977, NDA208510Brand NameVYVANSEGeneric NameLISDEXAMFETAMINE DIMESYLATEManufacturersTakeda Pharmaceuticals America, Inc.product_ndc 59417-101, 59417-102, 59417-103, 59417-104, 59417-105, 59417-106, 59417-107, 594 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISDEXAMFETAMINE DIMESYLATERXCUI 854830, 854832, 854834, 854836, 854838, 854840, 854842, 854844, 854846, 854848, ... spl_idc866f583-3021-403d-81a1-2ab757bf28ccspl_set_id704e4378-ca83-445c-8b45-3cfa51c1ecadPackage NDC 59417-101-10, 59417-102-10, 59417-103-10, 59417-104-10, 59417-105-10, 59417-106- ... UNIISJT761GEGS

4)

drugcharacterization1medicinalproductCYMBALTAdrugauthorizationnumb38838drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, DAILY (1/D)drugdosageformCAPSULEdrugadministrationroute048drugindicationDEPRESSIONdrugstartdateformat610drugstartdate/07/2009drugenddateformat602drugenddate//2009actiondrug2

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_id892f05de-dd11-4ae3-9a85-ce9cfcbeaaccspl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

summary

narrativeincludeclinicalCASE EVENT DATE: 2009