Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10976667primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/08/2015reporttype1serious2receivedateformat102Date Received01/04/2015receiptdateformat102Date Last Updated25/05/2015fulfillexpeditecriteria2companynumbUS-JNJFOC-20131112924duplicate1

Report Duplicate

duplicatesourceJANSSENduplicatenumbUS-JNJFOC-20131112924

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age32Unit of Onset Ageyearspatientagegroup5SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionWeight increasedOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb2drugstructuredosageunit003drugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationSLEEP DISORDER

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)

drugcharacterization1medicinalproductRISPERDAL CONSTAdrugbatchnumbUNAVAILABLEdrugauthorizationnumb021346drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformMICROSPHERESdrugadministrationroute030drugindicationSCHIZOPHRENIAdrugstartdateformat610drugstartdate/04/2013actiondrug4drugrecurreadministration2

activesubstance

activesubstancenameRISPERIDONE

openFDA Info on Medication

Application NumberNDA021346Brand NameRISPERDAL CONSTAGeneric NameRISPERIDONEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-306, 50458-309, 50458-307, 50458-308Product TypeHUMAN PRESCRIPTION DRUGRXCUI402010, 402011, 402012, 706822, 706825, 706827, 706829, 706831spl_id3a507d5d-658a-4aa4-9e67-6855000dcfa4spl_set_idbb34ee82-d2c2-43b8-ba21-2825c0954691Package NDC50458-309-11, 50458-306-11, 50458-307-11, 50458-308-11

3)

drugcharacterization2medicinalproductLISDEXAMFETAMINE DIMESYLATEdrugstructuredosagenumb70drugstructuredosageunit003drugadministrationroute065drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDER

activesubstance

activesubstancenameLISDEXAMFETAMINE DIMESYLATE

openFDA Info on Medication

Application NumberNDA021977, NDA208510Brand NameVYVANSEGeneric NameLISDEXAMFETAMINE DIMESYLATEManufacturersTakeda Pharmaceuticals America, Inc.product_ndc 59417-101, 59417-102, 59417-103, 59417-104, 59417-105, 59417-106, 59417-107, 594 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISDEXAMFETAMINE DIMESYLATERXCUI 854830, 854832, 854834, 854836, 854838, 854840, 854842, 854844, 854846, 854848, ... spl_idc866f583-3021-403d-81a1-2ab757bf28ccspl_set_id704e4378-ca83-445c-8b45-3cfa51c1ecadPackage NDC 59417-101-10, 59417-102-10, 59417-103-10, 59417-104-10, 59417-105-10, 59417-106- ... UNIISJT761GEGS

summary

narrativeincludeclinicalCASE EVENT DATE: 2013