Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11453575primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received31/08/2015receiptdateformat102Date Last Updated31/08/2015fulfillexpeditecriteria2companynumbUS-ELI_LILLY_AND_COMPANY-US200912001235duplicate1

Report Duplicate

duplicatesourceELI LILLY AND COduplicatenumbUS-ELI_LILLY_AND_COMPANY-US200912001235

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age39Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionParanoiaOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.1ReactionMood alteredOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.1ReactionSomnolenceOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.1ReactionAngerOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.1ReactionSerotonin syndromeOutcomeRecovered/resolved

6)

reactionmeddraversionpt18.1ReactionAbnormal behaviourOutcomeRecovered/resolved

7)

reactionmeddraversionpt18.1ReactionHyperhidrosisOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt18.1ReactionHeart rate increasedOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt18.1ReactionPsychiatric symptomOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductLIBRAXdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 D/F, 4/DdrugdosageformTABLETactiondrug4

activesubstance

activesubstancenameCHLORDIAZEPOXIDE HYDROCHLORIDE\CLIDINIUM BROMIDE

openFDA Info on Medication

Application NumberNDA012750Brand NameLIBRAXGeneric NameCHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDEManufacturersBausch Health US LLCproduct_ndc0187-4100Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCHLORDIAZEPOXIDE HYDROCHLORIDE, CLIDINIUM BROMIDERXCUI889614, 889616spl_id9b5484a4-2f90-44b2-b5df-917474056264spl_set_idf99ebf66-f207-4a97-9666-4da1d72b061cPackage NDC0187-4100-10UNIIMFM6K1XWDK, 91ZQW5JF1Z

2)

drugcharacterization2medicinalproductACIPHEXdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, DAILY (1/D)drugdosageformPILLULESactiondrug4

activesubstance

activesubstancenameRABEPRAZOLE SODIUM

openFDA Info on Medication

Application NumberNDA020973Brand NameACIPHEXGeneric NameRABEPRAZOLE SODIUMManufacturersEisai Inc., Woodward Pharma Services LLCproduct_ndc62856-243, 69784-243Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRABEPRAZOLE SODIUMRXCUI854868, 854870spl_ide00fa711-01d4-48ba-9c3a-594fb6abff02, be3a78bc-4f9c-473f-bb62-bd1d6920b5ecspl_set_id5d103551-978f-472a-9c62-51e6e4dea068, 42282e11-3179-420e-b979-e53dd5bd4b12Package NDC62856-243-30, 62856-243-90, 62856-243-41, 69784-243-30UNII3L36P16U4R

3)

drugcharacterization2medicinalproductLASIXdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, DAILY (1/D)actiondrug4

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application NumberNDA016273Brand NameLASIXGeneric NameFUROSEMIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-060, 30698-067, 30698-066Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFUROSEMIDERXCUI197732, 200801, 200809, 205732, 310429, 313988spl_id95a46760-e587-41a3-9ff3-c8dd8505f694spl_set_id2c9b4d8f-0770-482d-a9e6-9c616a440b1aPackage NDC 30698-067-01, 30698-067-10, 30698-060-01, 30698-060-10, 30698-060-50, 30698-066- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

4)

drugcharacterization2medicinalproductVYVANSEactiondrug1

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

5)

drugcharacterization2medicinalproductDARVOCETdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 D/F, AS NEEDEDactiondrug4

activesubstance

activesubstancenameACETAMINOPHEN\PROPOXYPHENE HYDROCHLORIDE

6)

drugcharacterization2medicinalproductVITAMINSactiondrug4

activesubstance

activesubstancenameVITAMINS

7)

drugcharacterization2medicinalproductLEVSINEXdrugstructuredosagenumb.375drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.375 MG, 2/Dactiondrug4

activesubstance

activesubstancenameHYOSCYAMINE SULFATE

8)

drugcharacterization2medicinalproductLORAZEPAM.drugstructuredosagenumb1drugstructuredosageunit003drugdosagetext1 MG, AS NEEDEDactiondrug4

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, LOREEV XR, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, Hikma Pharmaceuticals USA Inc., Aurol ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 2569564, 25695 ... spl_id 8b30da4f-e5a1-4e8a-9971-b5c687508d81, 4f2988b1-2854-4051-962f-07cc925608ab, 66ed ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-11, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

9)

drugcharacterization2medicinalproductPOTASSIUMdrugstructuredosagenumb20drugstructuredosageunit029drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MEQ, DAILY (1/D)actiondrug4

activesubstance

activesubstancenamePOTASSIUM

10)

drugcharacterization2medicinalproductLYRICAdrugdosagetextUNK, OTHERactiondrug4

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application NumberNDA021446, NDA022488Brand NameLYRICAGeneric NamePREGABALINManufacturersParke-Davis Div of Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0071-1012, 0071-1013, 0071-1014, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, ... spl_idb9b1285a-2cb3-4789-8b0e-8d5e1b253534, bfdec19d-6a54-449c-95b4-908d28e5369aspl_set_id60185c88-ecfd-46f9-adb9-b97c6b00a553, ce1a4b9d-3127-4416-8bf2-fee5899fc0baPackage NDC 0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015- ... UNII55JG375S6M

11)

drugcharacterization2medicinalproductFLEXERILdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, 3/Dactiondrug4

activesubstance

activesubstancenameCYCLOBENZAPRINE HYDROCHLORIDE

12)

drugcharacterization2medicinalproductBACLOFEN.drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, 3/DdrugdosageformPILLULESactiondrug4

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA209102, ANDA215885, ANDA209594, ANDA074584, ANDA2100 ... Brand NameBACLOFEN, BACLOFEN (INTRATHECAL), LYVISPAH, OZOBAX, FLEQSUVYGeneric NameBACLOFENManufacturers Northstar RxLLC, TruPharma LLC, Lifestar Pharma LLC, Mylan Institutional LLC, Up ... product_ndc 16714-071, 16714-072, 52817-319, 52817-320, 52817-321, 70756-085, 70756-288, 707 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 430902, 1300890, 308517, 1666613, 2586589, 2586595, 2586596, 258 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, b8da4a75-4c34-1d06-e053-2a95a90a7886, f4a6 ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 68aa591e-ea98-4438-9a4a-4f7e9ea2b285, f9dd ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 52817-319-10, 52817-320- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

13)

drugcharacterization2medicinalproductHYDROCODONEdrugstructuredosagenumb7.5drugstructuredosageunit003drugdosagetext7.5 MG, AS NEEDEDactiondrug4

activesubstance

activesubstancenameHYDROCODONE

14)

drugcharacterization1medicinalproductCYMBALTAdrugbatchnumbA639305Adrugauthorizationnumb38838drugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext60 MG, DAILY (1/D)drugdosageformCAPSULEdrugadministrationroute048drugindicationMULTIPLE SCLEROSISdrugstartdateformat610drugstartdate/03/2009actiondrug4

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

15)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext3 MG, EACH EVENINGactiondrug4

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

16)

drugcharacterization2medicinalproductTRAMADOL.drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, 3/DdrugdosageformTABLETactiondrug4

activesubstance

activesubstancenameTRAMADOL

summary

narrativeincludeclinicalCASE EVENT DATE: 200903