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

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

7)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugdosagetextDOSE ADJUSTMENTSdrugdosageformORAL SOLUTIONdrugadministrationroute048actiondrug5

activesubstance

activesubstancenameSODIUM OXYBATE

openFDA Info on Medication

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

Adverse Event Report

Report

Report Duplicate

Primary Source

Sender

Receiver

Patient

Reaction

1)

2)

3)

4)

5)

6)

Drug

1)

activesubstance

openFDA Info on Medication

2)

activesubstance

openFDA Info on Medication

3)

activesubstance

openFDA Info on Medication

4)

activesubstance

openFDA Info on Medication

5)

activesubstance

6)

activesubstance

openFDA Info on Medication

7)

activesubstance

openFDA Info on Medication

8)

activesubstance

openFDA Info on Medication

summary

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