Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11452484primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received31/08/2015receiptdateformat102Date Last Updated31/08/2015fulfillexpeditecriteria2companynumbUS-ELI_LILLY_AND_COMPANY-US200910001747duplicate1

Report Duplicate

duplicatesourceELI LILLY AND COduplicatenumbUS-ELI_LILLY_AND_COMPANY-US200910001747

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age29Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionGingival painOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.1ReactionGlossodyniaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.1ReactionDrug interactionOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNK, UNKNOWNdrugadministrationroute065actiondrug5drugrecurreadministration3

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

2)

drugcharacterization1medicinalproductCYMBALTAdrugauthorizationnumb38838drugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext60 MG, DAILY (1/D)drugdosageformCAPSULEdrugadministrationroute065drugindicationANXIETYactiondrug4

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

3)

drugcharacterization2medicinalproductKLONOPINdrugdosagetextUNK, UNKNOWNdrugadministrationroute065actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application NumberNDA017533Brand NameKLONOPINGeneric NameCLONAZEPAMManufacturersH2-Pharma, LLC, Genentech, Inc.product_ndc61269-605, 61269-610, 61269-620, 0004-0058, 0004-0068, 0004-0098Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI197527, 197528, 197529, 206157, 206159, 206160spl_id65d5607d-3926-4b60-97dc-18509af3f271, 0d423291-6115-4522-88db-dcd1096bd432spl_set_idcfa0d79a-843c-4b88-95a1-e9511d649ca1, 542f22e8-dad2-47a8-93b6-30936715d73bPackage NDC 61269-605-10, 61269-610-10, 61269-620-10, 0004-0068-01, 0004-0058-01, 0004-0098- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

4)

drugcharacterization2medicinalproductVYVANSEdrugdosagetextUNK, UNKNOWNdrugadministrationroute065actiondrug5drugrecurreadministration3

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

summary

narrativeincludeclinicalCASE EVENT DATE: 200908