Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID11482598primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious1seriousnessother1receivedateformat102Date Received03/09/2015receiptdateformat102Date Last Updated03/09/2015fulfillexpeditecriteria2companynumbUS-ELI_LILLY_AND_COMPANY-US201202005823duplicate1

Report Duplicate

duplicatesourceELI LILLY AND COduplicatenumbUS-ELI_LILLY_AND_COMPANY-US201202005823

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionFlushingOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.1ReactionBlood pressure increasedOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.1ReactionChest discomfortOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.1ReactionNauseaOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductDUROGESICactiondrug5

activesubstance

activesubstancenameFENTANYL

2)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3 MG, UNKactiondrug5

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)

drugcharacterization2medicinalproductBACLOFEN.drugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKactiondrug5

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

4)

drugcharacterization2medicinalproductHYDROCODONEactiondrug5

activesubstance

activesubstancenameHYDROCODONE

5)

drugcharacterization1medicinalproductCYMBALTAdrugauthorizationnumb38838drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DFdrugdosageformCAPSULEdrugadministrationroute048drugstartdateformat102drugstartdate31/01/2012drugenddateformat102drugenddate07/02/2012actiondrug1

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