Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11464053primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received31/08/2015receiptdateformat102Date Last Updated31/08/2015fulfillexpeditecriteria2companynumbUS-ELI_LILLY_AND_COMPANY-US201106003230duplicate1

Report Duplicate

duplicatesourceELI LILLY AND COduplicatenumbUS-ELI_LILLY_AND_COMPANY-US201106003230

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Weight73.9SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionCognitive disorderOutcomeUnknown

2)

reactionmeddraversionpt18.1ReactionDisturbance in attentionOutcomeUnknown

3)

reactionmeddraversionpt18.1ReactionMiddle insomniaOutcomeUnknown

4)

reactionmeddraversionpt18.1ReactionMemory impairmentOutcomeUnknown

5)

reactionmeddraversionpt18.1ReactionIschaemiaOutcomeUnknown

6)

reactionmeddraversionpt18.1ReactionAphasiaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCYMBALTAdrugauthorizationnumb38838drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, QDdrugdosageformCAPSULEdrugindicationDEPRESSIONactiondrug4

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)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3 MG, UNKNOWNdrugadministrationroute048drugindicationSLEEP DISORDERactiondrug5

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)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb1.5drugstructuredosageunit003drugdosagetext1.5 MG, UNKNOWNactiondrug5

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

4)

drugcharacterization2medicinalproductCALCIUMdrugdosagetextUNKactiondrug5

activesubstance

activesubstancenameCALCIUM

openFDA Info on Medication

Brand Name P D ALL, 7030 CALCIUM PREMIUM, ONLYCAL, RESTO L, P D M, RESTORATION TREATMENT, A ... Generic NameCALCIUMManufacturerscoexleaders co.,ltd., Apexel Co., Ltd, APEXEL CO., LTD.product_ndc 81445-0002, 55259-0002, 81445-0005, 81445-0006, 81445-0003, 81445-0001, 55259-00 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCALCIUMspl_id bcb38a08-7ca8-1e46-e053-2a95a90afef6, bdc7c088-83ef-20ce-e053-2995a90abd2f, bcb3 ... spl_set_id b9e7d869-d218-d60c-e053-2995a90af542, bdc7c833-daf7-48f9-e053-2995a90ad88e, b9eb ... Package NDC 81445-0002-1, 55259-0002-1, 81445-0005-1, 81445-0006-1, 81445-0003-1, 81445-0001 ... NUIM0003153, N0000175901, N0000175597, N0000020074Chemical StructureCalcium [CS]Established Pharmacologic ClassCalcium [EPC], Phosphate Binder [EPC]Mechanism of ActionPhosphate Chelating Activity [MoA]UNIISY7Q814VUP

5)

drugcharacterization2medicinalproductVITAMIN DdrugdosagetextUNKactiondrug5

activesubstance

activesubstancenameCHOLECALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturers Strides Pharma Science Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac ... product_ndc64380-737, 23155-809Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725, 9c09c2d2-ef29-4654-be7d-ed3b2b508f43spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36, 96da2c1e-6c5e-4df0-8166-3de53c08a701Package NDC64380-737-06, 64380-737-25, 23155-809-01NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

6)

drugcharacterization2medicinalproductVOLTARENdrugdosagetextUNKactiondrug5

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