Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11699201primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate04/03/2016reporttype1serious1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received04/11/2015receiptdateformat102Date Last Updated04/11/2015fulfillexpeditecriteria1companynumbUS-JAZZ-2015-US-017747duplicate1

Report Duplicate

duplicatesourceJAZZduplicatenumbUS-JAZZ-2015-US-017747

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age39Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionGait disturbanceOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.1ReactionPain in extremityOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.1ReactionHypoaesthesiaOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.1ReactionIntentional product use issueOutcomeUnknown

5)

reactionmeddraversionpt18.1ReactionMuscular weaknessOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt18.1ReactionLoss of consciousnessOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb5drugstructuredosageunit002drugdosagetext5 G, FIRST DOSEdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/08/2015actiondrug5

activesubstance

activesubstancenameSODIUM OXYBATE

openFDA Info on Medication

Application NumberNDA021196Brand NameXYREMGeneric NameSODIUM OXYBATEManufacturersJazz Pharmaceuticals, Inc.product_ndc68727-100Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSODIUM OXYBATERXCUI349482, 352257spl_id507868f6-2c1d-488d-8132-38d23218caf3spl_set_id926eb076-a4a8-45e4-91ef-411f0aa4f3caPackage NDC68727-100-01UNII7G33012534

2)

drugcharacterization2medicinalproductCYMBALTAdrugdosagetextUNKdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

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

3)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb6drugstructuredosageunit002drugdosagetext6 G, SECOND DOSEdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/08/2015actiondrug5

activesubstance

activesubstancenameSODIUM OXYBATE

openFDA Info on Medication

Application NumberNDA021196Brand NameXYREMGeneric NameSODIUM OXYBATEManufacturersJazz Pharmaceuticals, Inc.product_ndc68727-100Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSODIUM OXYBATERXCUI349482, 352257spl_id507868f6-2c1d-488d-8132-38d23218caf3spl_set_id926eb076-a4a8-45e4-91ef-411f0aa4f3caPackage NDC68727-100-01UNII7G33012534

4)

drugcharacterization2medicinalproductAMITRIPTYLINE HCLdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate10/04/2015drugrecurreadministration3

activesubstance

activesubstancenameAMITRIPTYLINE

openFDA Info on Medication

5)

drugcharacterization2medicinalproductORTHO-NOVUMdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameETHINYL ESTRADIOL\NORETHINDRONE

6)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb3drugstructuredosageunit002drugdosagetext3 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationNARCOLEPSYdrugstartdateformat610drugstartdate/01/2012actiondrug5

activesubstance

activesubstancenameSODIUM OXYBATE

openFDA Info on Medication

Application NumberNDA021196Brand NameXYREMGeneric NameSODIUM OXYBATEManufacturersJazz Pharmaceuticals, Inc.product_ndc68727-100Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSODIUM OXYBATERXCUI349482, 352257spl_id507868f6-2c1d-488d-8132-38d23218caf3spl_set_id926eb076-a4a8-45e4-91ef-411f0aa4f3caPackage NDC68727-100-01UNII7G33012534

7)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugdosagetextDOSE ADJUSTMENTSdrugdosageformORAL SOLUTIONdrugadministrationroute048actiondrug5

activesubstance

activesubstancenameSODIUM OXYBATE

openFDA Info on Medication

Application NumberNDA021196Brand NameXYREMGeneric NameSODIUM OXYBATEManufacturersJazz Pharmaceuticals, Inc.product_ndc68727-100Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSODIUM OXYBATERXCUI349482, 352257spl_id507868f6-2c1d-488d-8132-38d23218caf3spl_set_id926eb076-a4a8-45e4-91ef-411f0aa4f3caPackage NDC68727-100-01UNII7G33012534

8)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20151025