Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11384801primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received11/08/2015receiptdateformat102Date Last Updated11/08/2015fulfillexpeditecriteria2companynumbUS-ELI_LILLY_AND_COMPANY-US201109002667duplicate1

Report Duplicate

duplicatesourceELI LILLY AND COduplicatenumbUS-ELI_LILLY_AND_COMPANY-US201109002667

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age45Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionPain in extremityOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.1ReactionIntentional product misuseOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3 MG, PRNdrugstartdateformat602drugstartdate//2011actiondrug5

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)

drugcharacterization1medicinalproductCIALISdrugauthorizationnumb54553drugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKNOWNdrugdosageformTABLETdrugstartdateformat610drugstartdate/08/2011drugenddateformat610drugenddate/08/2011actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameTADALAFIL

openFDA Info on Medication

Application NumberNDA021368Brand NameCIALISGeneric NameTADALAFILManufacturersEli Lilly and Companyproduct_ndc0002-4462, 0002-4465, 0002-4463, 0002-4464Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTADALAFILRXCUI402019, 402096, 402097, 403957, 404711, 484814, 757707, 762660spl_id05dbd8b6-1b9d-436a-a67c-8a16713f753fspl_set_idbcd8f8ab-81a2-4891-83db-24a0b0e25895Package NDC 0002-4465-79, 0002-4465-34, 0002-4462-30, 0002-4462-79, 0002-4462-34, 0002-4463- ... NUIN0000175599, N0000020026Established Pharmacologic ClassPhosphodiesterase 5 Inhibitor [EPC]Mechanism of ActionPhosphodiesterase 5 Inhibitors [MoA]UNII742SXX0ICT

3)

drugcharacterization2medicinalproductDEPO-TESTOSTERONEdrugdosagetextUNKdrugstartdateformat602drugstartdate//2010actiondrug5

activesubstance

activesubstancenameTESTOSTERONE CYPIONATE

openFDA Info on Medication

Application NumberANDA085635Brand NameDEPO-TESTOSTERONEGeneric NameTESTOSTERONE CYPIONATEManufacturersPharmacia and Upjohn Company LLCproduct_ndc0009-0085, 0009-0086, 0009-0347, 0009-0417Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULARActive IngredientsTESTOSTERONE CYPIONATERXCUI835829, 835831, 835840, 835842spl_id304a4928-e4fe-44ab-8219-81967dfe77e8, 94d37908-39b9-4eac-9320-f8c2263275f0spl_set_id735b5bf3-4464-412c-a072-1bd02f2e5380, cfbb53d4-b868-4a28-8436-f9112eb01c39Package NDC 0009-0085-10, 0009-0086-01, 0009-0086-10, 0009-0347-02, 0009-0417-01, 0009-0417- ... UNIIM0XW1UBI14

summary

narrativeincludeclinicalCASE EVENT DATE: 201108