Adverse Event Report

Report

Version of Safety Report ID3Safety Report ID10489253primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate28/05/2015reporttype1serious1seriousnessdeath1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received02/10/2014receiptdateformat102Date Last Updated09/12/2014fulfillexpeditecriteria2companynumbJP-JNJFOC-20140924412duplicate1

Report Duplicate

duplicatesourceJANSSENduplicatenumbJP-JNJFOC-20140924412

Primary Source

reportercountryJPqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age41Unit of Onset Ageyearspatientagegroup5SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionDeathOutcomeFatal

2)

reactionmeddraversionpt18.0ReactionDepressed moodOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionHaemorrhageOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionAspirationOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionContusionOutcomeUnknown

6)

reactionmeddraversionpt18.0ReactionRoad traffic accidentOutcomeUnknown

7)

reactionmeddraversionpt18.0ReactionFallOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETSdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate31/07/2013

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)

drugcharacterization1medicinalproductLEVOTOMINdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugstartdateformat102drugstartdate17/09/2014drugenddateformat102drugenddate21/09/2014

activesubstance

activesubstancenameLEVOMEPROMAZINE

3)

drugcharacterization1medicinalproductLEVOTOMINdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugstartdateformat102drugstartdate18/12/2013

activesubstance

activesubstancenameLEVOMEPROMAZINE

4)

drugcharacterization1medicinalproductLEVOTOMINdrugstructuredosagenumb15drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextAS AND WHEN NECESSARY (P.R.N)drugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugenddateformat102drugenddate17/09/2014

activesubstance

activesubstancenameLEVOMEPROMAZINE

5)

drugcharacterization1medicinalproductZYPREXAdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugstartdateformat102drugstartdate25/09/2013drugenddateformat102drugenddate16/09/2014

activesubstance

activesubstancenameOLANZAPINE

openFDA Info on Medication

Application NumberNDA020592, NDA021086, NDA021253, NDA022173Brand NameZYPREXA, ZYPREXA ZYDIS, ZYPREXA INTRAMUSCULAR, ZYPREXA RELPREVVGeneric NameOLANZAPINE, OLANZAPINE PAMOATEManufacturersEli Lilly and Companyproduct_ndc 0002-4112, 0002-4115, 0002-4116, 0002-4117, 0002-4415, 0002-4420, 0002-4453, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULARActive IngredientsOLANZAPINERXCUI 153046, 153047, 153048, 200034, 212405, 261337, 283639, 284514, 312076, 312077, ... spl_id7184cd07-6f72-4413-9d11-daa74ef14b03, b222aade-353e-401c-b7d4-cb0da936e374spl_set_idd5051fbc-846b-4946-82df-341fb1216341, f9a73185-88de-4d7b-b3c0-bbf231483241Package NDC 0002-4112-30, 0002-4115-30, 0002-4116-30, 0002-4117-30, 0002-4415-30, 0002-4420- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIN7U69T4SZR

6)

drugcharacterization1medicinalproductEVAMYLdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETSdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate06/06/2012

activesubstance

activesubstancenameLORMETAZEPAM

7)

drugcharacterization1medicinalproductLEVOTOMINdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate17/09/2014drugenddateformat102drugenddate21/09/2014

activesubstance

activesubstancenameLEVOMEPROMAZINE

8)

drugcharacterization1medicinalproductLEVOTOMINdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate18/12/2013

activesubstance

activesubstancenameLEVOMEPROMAZINE

9)

drugcharacterization1medicinalproductRILMAZAFONEdrugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate11/09/2013drugenddateformat102drugenddate21/09/2014

activesubstance

activesubstancenameRILMAZAFONE

10)

drugcharacterization1medicinalproductZYPREXAdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugstartdateformat102drugstartdate17/09/2014drugenddateformat102drugenddate21/09/2014

activesubstance

activesubstancenameOLANZAPINE

openFDA Info on Medication

Application NumberNDA020592, NDA021086, NDA021253, NDA022173Brand NameZYPREXA, ZYPREXA ZYDIS, ZYPREXA INTRAMUSCULAR, ZYPREXA RELPREVVGeneric NameOLANZAPINE, OLANZAPINE PAMOATEManufacturersEli Lilly and Companyproduct_ndc 0002-4112, 0002-4115, 0002-4116, 0002-4117, 0002-4415, 0002-4420, 0002-4453, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULARActive IngredientsOLANZAPINERXCUI 153046, 153047, 153048, 200034, 212405, 261337, 283639, 284514, 312076, 312077, ... spl_id7184cd07-6f72-4413-9d11-daa74ef14b03, b222aade-353e-401c-b7d4-cb0da936e374spl_set_idd5051fbc-846b-4946-82df-341fb1216341, f9a73185-88de-4d7b-b3c0-bbf231483241Package NDC 0002-4112-30, 0002-4115-30, 0002-4116-30, 0002-4117-30, 0002-4415-30, 0002-4420- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIN7U69T4SZR

11)

drugcharacterization1medicinalproductNITRAZEPAMdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate13/02/2013drugenddateformat102drugenddate21/09/2014

activesubstance

activesubstancenameNITRAZEPAM

12)

drugcharacterization1medicinalproductXEPLIONdrugbatchnumbDHB4M01drugauthorizationnumb022264drugstructuredosagenumb150drugstructuredosageunit003drugdosageformINJECTIONdrugadministrationroute030drugindicationSCHIZOPHRENIAdrugstartdateformat102drugstartdate17/09/2014drugrecurreadministration2

activesubstance

activesubstancenamePALIPERIDONE PALMITATE

13)

drugcharacterization1medicinalproductXEPLIONdrugbatchnumbDHB4M01drugstructuredosagenumb100drugstructuredosageunit003drugdosageformINJECTIONdrugadministrationroute030drugindicationSCHIZOPHRENIAdrugstartdateformat102drugstartdate08/01/2014drugenddateformat102drugenddate16/09/2014drugrecurreadministration2

activesubstance

activesubstancenamePALIPERIDONE PALMITATE

14)

drugcharacterization1medicinalproductLEVOTOMINdrugstructuredosagenumb15drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextAS AND WHEN NECESSARY (P.R.N)drugdosageformTABLETdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugenddateformat102drugenddate17/09/2014

activesubstance

activesubstancenameLEVOMEPROMAZINE

15)

drugcharacterization1medicinalproductROZEREMdrugstructuredosagenumb8drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate05/03/2014drugenddateformat102drugenddate21/09/2014

activesubstance

activesubstancenameRAMELTEON

openFDA Info on Medication

Application NumberNDA021782Brand NameROZEREMGeneric NameRAMELTEONManufacturersTakeda Pharmaceuticals America, Inc.product_ndc64764-805Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRAMELTEONRXCUI577348, 603162spl_idab007fde-2fd9-4b4c-9b1a-39b9e3e2fe0bspl_set_id9de82310-70e8-47b9-b1fc-6c6848b99455Package NDC64764-805-30, 64764-805-10, 64764-805-22NUIN0000175743, N0000000250Established Pharmacologic ClassMelatonin Receptor Agonist [EPC]Mechanism of ActionMelatonin Receptor Agonists [MoA]UNII901AS54I69

16)

drugcharacterization1medicinalproductQUAZEPAM.drugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate13/03/2013drugenddateformat102drugenddate21/09/2014

activesubstance

activesubstancenameQUAZEPAM

openFDA Info on Medication

Application NumberNDA018708Brand NameQUAZEPAM, DORALGeneric NameQUAZEPAMManufacturersAtland Pharmaceuticals, LLC, Galt Pharmaceuticals, LLCproduct_ndc71993-265, 61825-165Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUAZEPAMRXCUI198183, 207889spl_idbaff9baa-f149-c7e9-e053-2995a90a4306, ba9a5b9e-7a98-5de2-e053-2995a90a43b9spl_set_idf7d63f3f-5303-48ab-bce2-35fd62c45799, 9727e8b4-14f1-451d-9630-84eabc772e42Package NDC71993-265-30, 71993-265-10, 61825-165-10, 61825-165-30NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIJF8V0828ZI

summary

narrativeincludeclinicalCASE EVENT DATE: 201409