Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11462293primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received31/08/2015receiptdateformat102Date Last Updated31/08/2015fulfillexpeditecriteria2companynumbUS-ELI_LILLY_AND_COMPANY-US201009002417duplicate1

Report Duplicate

duplicatesourceELI LILLY AND COduplicatenumbUS-ELI_LILLY_AND_COMPANY-US201009002417

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age50Unit of Onset AgeyearsWeight80.73SexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionBody temperature fluctuationOutcomeRecovering/resolving

2)

reactionmeddraversionpt18.1ReactionDrug withdrawal syndromeOutcomeUnknown

3)

reactionmeddraversionpt18.1ReactionParaesthesiaOutcomeRecovering/resolving

4)

reactionmeddraversionpt18.1ReactionDrug effect decreasedOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.1ReactionAltered state of consciousnessOutcomeUnknown

6)

reactionmeddraversionpt18.1ReactionDrug prescribing errorOutcomeRecovered/resolved

7)

reactionmeddraversionpt18.1ReactionHypophagiaOutcomeUnknown

8)

reactionmeddraversionpt18.1ReactionDecreased activityOutcomeUnknown

9)

reactionmeddraversionpt18.1ReactionDecreased appetiteOutcomeUnknown

10)

reactionmeddraversionpt18.1ReactionSomnolenceOutcomeRecovering/resolving

11)

reactionmeddraversionpt18.1ReactionShockOutcomeRecovered/resolved

12)

reactionmeddraversionpt18.1ReactionFatigueOutcomeRecovering/resolving

13)

reactionmeddraversionpt18.1ReactionAbnormal dreamsOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCYMBALTAdrugauthorizationnumb38838drugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugdosageformCAPSULEactiondrug1

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)

drugcharacterization2medicinalproductOXYCONTINdrugindicationPAINactiondrug5

activesubstance

activesubstancenameOXYCODONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022272Brand NameOXYCONTINGeneric NameOXYCODONE HYDROCHLORIDEManufacturersPurdue Pharma LPproduct_ndc59011-410, 59011-480, 59011-415, 59011-420, 59011-430, 59011-440, 59011-460Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDERXCUI 1049504, 1049545, 1049565, 1049576, 1049586, 1049595, 1049601, 1860127, 1860129, ... spl_id9686aad4-8ab9-47da-a74e-23e1d2496c2espl_set_idbfdfe235-d717-4855-a3c8-a13d26dadedePackage NDC 59011-480-20, 59011-480-10, 59011-410-10, 59011-410-20, 59011-415-10, 59011-415- ... UNIIC1ENJ2TE6C

3)

drugcharacterization2medicinalproductTRUVADAdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 D/F, DAILY (1/D)drugindicationHIV INFECTIONactiondrug5

activesubstance

activesubstancenameEMTRICITABINE\TENOFOVIR DISOPROXIL FUMARATE

openFDA Info on Medication

Application NumberNDA021752Brand NameTRUVADAGeneric NameEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEManufacturersGilead Sciences, Incproduct_ndc61958-0701, 61958-0703, 61958-0704, 61958-0705Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsEMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATERXCUI476556, 639888, 1744001, 1744003, 1744005, 1744007, 1744009, 1744011spl_id10db9adb-eef9-4595-8d1a-42e98e298b8bspl_set_id54e82b13-a037-49ed-b4b3-030b37c0ecddPackage NDC61958-0701-1, 61958-0703-1, 61958-0704-1, 61958-0705-1NUIN0000175462, M0015066, N0000009947Established Pharmacologic Class Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [ ... Chemical StructureNucleosides [CS]Mechanism of ActionNucleoside Reverse Transcriptase Inhibitors [MoA]UNIIG70B4ETF4S, OTT9J7900I

4)

drugcharacterization2medicinalproductATIVANdrugdosagetextUNK, AS NEEDEDactiondrug5

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application NumberNDA017794, NDA018140Brand NameATIVANGeneric NameLORAZEPAMManufacturersBausch Health US LLC, Hikma Pharmaceuticals USA Inc.product_ndc0187-0063, 0187-0064, 0187-0065, 0641-6000, 0641-6001, 0641-6003, 0641-6002Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsLORAZEPAMRXCUI 104719, 197900, 197901, 197902, 206821, 206828, 206819, 206820, 238100, 238101, ... spl_id0c599118-4213-4a51-bd2d-a162ac18a940, 2d4cea58-1dfe-4bc0-bd5a-415ced5420dbspl_set_id89057c93-8155-4040-acec-64e877bd2b4c, 5fc0e987-61c9-40c4-b0d5-fcea07c8733ePackage NDC 0187-0063-01, 0187-0063-50, 0187-0063-10, 0187-0064-01, 0187-0064-50, 0187-0064- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

5)

drugcharacterization2medicinalproductAMBIENactiondrug5

activesubstance

activesubstancenameZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberNDA021774, NDA019908Brand NameAMBIEN CR, AMBIENGeneric NameZOLPIDEM TARTRATEManufacturerssanofi-aventis U.S. LLCproduct_ndc0024-5501, 0024-5521, 0024-5401, 0024-5421Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896, 854873, 854875, 854876, 854878spl_id8138a0a9-168c-46d2-b13e-e7e84f27eaee, c8f05d12-bc35-43cb-8b65-588bec02c73dspl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76, c36cadf4-65a4-4466-b409-c82020b42452Package NDC 0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10, 0024-5401- ... UNIIWY6W63843K

6)

drugcharacterization2medicinalproductALLEGRAdrugstructuredosagenumb180drugstructuredosageunit003drugdosagetext180 MG, AS NEEDEDactiondrug5

activesubstance

activesubstancenameFEXOFENADINE HYDROCHLORIDE

7)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3 MG, AS NEEDEDdrugindicationINSOMNIAactiondrug5

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

8)

drugcharacterization1medicinalproductCYMBALTAdrugauthorizationnumb38838drugstructuredosagenumb30drugstructuredosageunit003drugdosagetext30 MG, UNKdrugdosageformCAPSULEdrugindicationANXIETYdrugstartdateformat610drugstartdate/03/2008drugenddateformat102drugenddate12/08/2010actiondrug1

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

9)

drugcharacterization1medicinalproductCYMBALTAdrugauthorizationnumb38838drugdosagetextUNK, UNKNOWNdrugdosageformCAPSULEactiondrug1

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

10)

drugcharacterization2medicinalproductKALETRAdrugstructuredosagenumb2drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 D/F, 2/DdrugindicationHIV INFECTIONactiondrug5

activesubstance

activesubstancenameLOPINAVIR\RITONAVIR

openFDA Info on Medication

Application NumberNDA021906, NDA021251Brand NameKALETRAGeneric NameLOPINAVIR AND RITONAVIRManufacturersAbbVie Inc.product_ndc0074-0522, 0074-3956, 0074-6799, 0074-2605, 0074-1575Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLOPINAVIR, RITONAVIRRXCUI311369, 597730, 746645, 847741, 847745, 847749spl_id487973e9-9f29-4707-9c99-962056e4c38aspl_set_id8290add3-4449-4e58-6c97-8fe1eec972e3Package NDC 0074-0522-60, 0074-3956-46, 0074-6799-22, 0074-6799-30, 0074-2605-21, 0074-1575- ... NUI N0000000246, N0000191001, N0000175889, N0000190114, N0000182137, N0000185607, N0 ... Mechanism of Action HIV Protease Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P ... Established Pharmacologic ClassCytochrome P450 3A Inhibitor [EPC], Protease Inhibitor [EPC]UNIIO3J8G9O825, 2494G1JF75

11)

drugcharacterization2medicinalproductVITAMIN B12drugindicationFATIGUEactiondrug5

activesubstance

activesubstancenameCYANOCOBALAMIN

12)

drugcharacterization1medicinalproductCYMBALTAdrugauthorizationnumb38838drugstructuredosagenumb30drugstructuredosageunit003drugdosagetext30 MG, UNKdrugdosageformCAPSULEactiondrug1

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

13)

drugcharacterization2medicinalproductVALTREXdrugstructuredosagenumb1000drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1000 MG, DAILY (1/D)actiondrug5

activesubstance

activesubstancenameVALACYCLOVIR HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020487Brand NameVALTREXGeneric NameVALACYCLOVIR HYDROCHLORIDEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0565, 0173-0933Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVALACYCLOVIR HYDROCHLORIDERXCUI108780, 212448, 313564, 313565spl_idd0622c81-8c82-4c02-8a19-de3d41912d6dspl_set_idf8e0d8f8-cb73-4206-a484-88f5c4fbd719Package NDC0173-0933-08, 0173-0933-10, 0173-0933-56, 0173-0565-04, 0173-0565-10UNIIG447S0T1VC