Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10179460primarysourcecountryUStransmissiondateformat102transmissiondate28/05/2015reporttype1serious1seriousnesshospitalization1receivedateformat102Date Received15/05/2014receiptdateformat102Date Last Updated27/10/2014fulfillexpeditecriteria1companynumb2014-US-005464duplicate1

Report Duplicate

duplicatesourceJAZZduplicatenumb2014-US-005464

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age31Unit of Onset AgeyearsWeight86.2SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionTherapy cessation

2)

reactionmeddraversionpt18.0ReactionInsomnia

3)

reactionmeddraversionpt18.0ReactionMania

4)

reactionmeddraversionpt18.0ReactionEconomic problem

Drug

1)

drugcharacterization1medicinalproductXYREMdrugbatchnumb3110338drugauthorizationnumb021196drugstructuredosagenumb4.5drugstructuredosageunit002drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationCATAPLEXYdrugstartdateformat610drugstartdate/09/2013drugenddateformat610drugenddate/03/2014

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)

drugcharacterization2medicinalproductSYNTHROID(LEVOTHYROXINE SODIUM)

3)

drugcharacterization2medicinalproductFANAPT(LLOPERIDONE)

4)

drugcharacterization2medicinalproductLUNESTA

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

5)

drugcharacterization2medicinalproductZOLOFT(SERTRALINE HYDROCHLORIDE)

6)

drugcharacterization2medicinalproductNEURONTIN(GABAPENTIN)

7)

drugcharacterization2medicinalproductATIVAN(LORAZEPAM)

8)

drugcharacterization1medicinalproductXYREMdrugbatchnumb3110338drugauthorizationnumb021196drugstructuredosagenumb4.5drugstructuredosageunit002drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationNARCOLEPSYdrugstartdateformat610drugstartdate/09/2013drugenddateformat610drugenddate/03/2014

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

9)

drugcharacterization2medicinalproductLAMICTAL(LAMOTRIGINE)

summary

narrativeincludeclinicalCASE EVENT DATE: 201403