Adverse Event Report

Report

Version of Safety Report ID3Safety Report ID11218856primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate28/04/2017reporttype1serious1seriousnessother1receivedateformat102Date Received25/06/2015receiptdateformat102Date Last Updated06/03/2017fulfillexpeditecriteria1companynumbUS-ELI_LILLY_AND_COMPANY-US201506006839duplicate1

Report Duplicate

duplicatesourceELI LILLY AND COduplicatenumbUS-ELI_LILLY_AND_COMPANY-US201506006839

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Weight101.59SexFemale

Reaction

1)

reactionmeddraversionpt19.1ReactionMood swingsOutcomeUnknown

2)

reactionmeddraversionpt19.1ReactionDrug withdrawal syndromeOutcomeUnknown

3)

reactionmeddraversionpt19.1ReactionPhotosensitivity reactionOutcomeUnknown

4)

reactionmeddraversionpt19.1ReactionParaesthesiaOutcomeUnknown

5)

reactionmeddraversionpt19.1ReactionInsomniaOutcomeUnknown

6)

reactionmeddraversionpt19.1ReactionNightmareOutcomeUnknown

7)

reactionmeddraversionpt19.1ReactionHeadacheOutcomeUnknown

8)

reactionmeddraversionpt19.1ReactionHyperhidrosisOutcomeUnknown

9)

reactionmeddraversionpt19.1ReactionAffect labilityOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductVOLTARENdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, TIDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameDICLOFENAC SODIUM

openFDA Info on Medication

Application NumberNDA022122Brand NameVOLTAREN ARTHRITIS PAINGeneric NameDICLOFENAC SODIUMManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLCproduct_ndc0067-8152, 0067-8153Product TypeHUMAN OTC DRUGRouteTOPICALActive IngredientsDICLOFENAC SODIUMRXCUI855633, 855635spl_id051c7983-b0ec-4d0b-8212-66415f6e3058spl_set_id30a94282-0892-442a-aa10-6525cbd4fe88Package NDC 0067-8152-01, 0067-8152-02, 0067-8152-03, 0067-8152-04, 0067-8152-05, 0067-8152- ... UNIIQTG126297Q

2)

drugcharacterization2medicinalproductJANUVIAdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameSITAGLIPTIN PHOSPHATE

openFDA Info on Medication

Application NumberNDA021995Brand NameJANUVIAGeneric NameSITAGLIPTINManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0112, 0006-0221, 0006-0277Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSITAGLIPTIN PHOSPHATERXCUI665033, 665036, 665038, 665040, 665042, 665044spl_id64f3aad9-143d-4e53-a43b-fab092d1ea83spl_set_idf85a48d0-0407-4c50-b0fa-7673a160bf01Package NDC 0006-0221-01, 0006-0221-28, 0006-0221-31, 0006-0221-54, 0006-0112-01, 0006-0112- ... UNIITS63EW8X6F

3)

drugcharacterization2medicinalproductAMARYLdrugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameGLIMEPIRIDE

openFDA Info on Medication

Application NumberNDA020496Brand NameAMARYLGeneric NameGLIMEPIRIDEManufacturersSanofi-Aventis U.S. LLCproduct_ndc0039-0221, 0039-0222, 0039-0223Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGLIMEPIRIDERXCUI153591, 153843, 153845, 199245, 199246, 199247spl_idf54571bb-4a69-4326-aad3-96b1b7198b6dspl_set_id222b630b-7e09-43b4-9894-3d87f10add91Package NDC0039-0221-10, 0039-0222-10, 0039-0223-10NUIN0000175608, M0020795Established Pharmacologic ClassSulfonylurea [EPC]Chemical StructureSulfonylurea Compounds [CS]UNII6KY687524K

4)

drugcharacterization2medicinalproductAVAPROdrugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameIRBESARTAN

openFDA Info on Medication

Application NumberNDA020757Brand NameAVAPROGeneric NameIRBESARTANManufacturersSanofi-Aventis U.S. LLCproduct_ndc0024-5850, 0024-5851, 0024-5852Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsIRBESARTANRXCUI153665, 153666, 153667, 200094, 200095, 200096spl_idcf3ca8df-5a3f-413d-a895-65685cc17313spl_set_id7885b2a8-be4e-48ab-8113-4e6ab791eb98Package NDC 0024-5850-30, 0024-5850-90, 0024-5851-30, 0024-5851-90, 0024-5852-30, 0024-5852- ... NUIN0000000070, N0000175561Mechanism of ActionAngiotensin 2 Receptor Antagonists [MoA]Established Pharmacologic ClassAngiotensin 2 Receptor Blocker [EPC]UNIIJ0E2756Z7N

5)

drugcharacterization1medicinalproductCYMBALTAdrugauthorizationnumb021427drugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext60 MG, QDdrugdosageformCAPSULEdrugadministrationroute048actiondrug6drugrecurreadministration3

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

6)

drugcharacterization2medicinalproductLUNESTAdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

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

7)

drugcharacterization2medicinalproductGLUCOPHAGEdrugstructuredosagenumb2000drugstructuredosageunit003drugdosagetext2000 MG, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameMETFORMIN HYDROCHLORIDE

8)

drugcharacterization2medicinalproductVYTORINdrugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameEZETIMIBE\SIMVASTATIN

openFDA Info on Medication

Application NumberNDA021687Brand NameVYTORINGeneric NameEZETIMIBE AND SIMVASTATINManufacturersOrganon LLCproduct_ndc78206-174, 78206-175, 78206-176, 78206-177Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsEZETIMIBE, SIMVASTATINRXCUI476345, 476349, 476350, 476351, 1245420, 1245430, 1245441, 1245449spl_ida5b011e5-bb5e-4c3e-90ee-2c040c3420f1spl_set_id89b860d2-de83-468e-b7e8-76aeec2edca2Package NDC 78206-174-01, 78206-174-02, 78206-175-01, 78206-175-02, 78206-176-01, 78206-176- ... NUIN0000175589, N0000000121, N0000008553, N0000175911Established Pharmacologic Class HMG-CoA Reductase Inhibitor [EPC], Dietary Cholesterol Absorption Inhibitor [EPC ... Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Cholesterol Absorption [PE]UNIIAGG2FN16EV, EOR26LQQ24

9)

drugcharacterization2medicinalproductCHANTIXdrugdosagetextUNK, PRNdrugadministrationroute065actiondrug5drugadditional3

activesubstance

activesubstancenameVARENICLINE TARTRATE

openFDA Info on Medication

Application NumberNDA021928Brand NameCHANTIXGeneric NameVARENICLINE TARTRATEManufacturersU.S. Pharmaceuticals, Pfizer Labs, Division of Pfizer Inc.product_ndc63539-473, 0069-0468, 0069-0469, 0069-0471Product TypeHUMAN PRESCRIPTION DRUGRXCUI636671, 636676, 637188, 637190, 749289, 795737, 749788, 795735spl_id3e5ba0e7-3dc1-414c-a66a-042f0aa3908c, b98d3e2a-7091-4a12-9139-e0f94683292bspl_set_idd52bc40b-db7b-4243-888c-9ee95bbc6545, f0ff4f27-5185-4881-a749-c6b7a0ca5696Package NDC63539-473-10, 0069-0468-56, 0069-0469-56, 0069-0469-03, 0069-0471-03RouteORALActive IngredientsVARENICLINE TARTRATEUNII82269ASB48

10)

drugcharacterization2medicinalproductFLEXERILdrugdosagetextUNK, PRNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameCYCLOBENZAPRINE HYDROCHLORIDE

11)

drugcharacterization1medicinalproductCYMBALTAdrugauthorizationnumb021427drugdosagetextUNKdrugdosageformCAPSULEdrugindicationDEPRESSIONdrugstartdateformat102drugstartdate19/05/2009drugenddateformat610drugenddate/11/2012actiondrug6drugrecurreadministration3

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

12)

drugcharacterization2medicinalproductLORCETdrugdosagetextUNK, PRNdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE BITARTRATE