Adverse Event Report

Report

Version of Safety Report ID5Safety Report ID12166743primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate15/08/2016reporttype1serious1seriousnesshospitalization1receivedateformat102Date Received10/03/2016receiptdateformat102Date Last Updated27/04/2016fulfillexpeditecriteria1companynumbJP-009507513-1603JPN003177duplicate1

Report Duplicate

duplicatesourceMERCKduplicatenumbJP-009507513-1603JPN003177

Primary Source

reportercountryJPqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age64Unit of Onset AgeyearsWeight50SexMale

Reaction

1)

reactionmeddraversionpt19.0ReactionSudden onset of sleepOutcomeRecovered/resolved

2)

reactionmeddraversionpt19.0ReactionOedema peripheralOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductLENDORMIN Ddrugstructuredosagenumb.25drugstructuredosageunit003drugdosagetextAT THE ONSET OF SLEEPLESSNESSdrugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate07/01/2015actiondrug4

activesubstance

activesubstancenameBROTIZOLAM

2)

drugcharacterization2medicinalproductDEPAKENEdrugstructuredosagenumb400drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext400 MG, BIDdrugdosageformTABLETdrugadministrationroute048drugindicationBRAIN INJURYdrugstartdateformat102drugstartdate02/10/2011

activesubstance

activesubstancenameVALPROIC ACID

3)

drugcharacterization2medicinalproductLONASENdrugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext4 MG, BIDdrugdosageformTABLETdrugadministrationroute048drugindicationBRAIN INJURYdrugstartdateformat102drugstartdate09/12/2014

activesubstance

activesubstancenameBLONANSERIN

4)

drugcharacterization2medicinalproductAKINETONdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, BIDdrugdosageformTABLETdrugadministrationroute048drugindicationBRAIN INJURYdrugstartdateformat102drugstartdate23/07/2007

activesubstance

activesubstancenameBIPERIDEN HYDROCHLORIDE

5)

drugcharacterization1medicinalproductBELSOMRAdrugauthorizationnumb204569drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb480drugcumulativedosageunit003drugdosagetext20 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate02/02/2016drugenddateformat102drugenddate25/02/2016actiondrug1

activesubstance

activesubstancenameSUVOREXANT

openFDA Info on Medication

Application NumberNDA204569Brand NameBELSOMRAGeneric NameSUVOREXANTManufacturersMerck Sharp & Dohme LLCproduct_ndc0006-0005, 0006-0033, 0006-0325, 0006-0335Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSUVOREXANTRXCUI1547104, 1547110, 1547112, 1547114, 1547116, 1547118, 1547573, 1547575spl_id170ce41c-112a-46c9-956f-91ab07287bbfspl_set_ide5b72731-1acb-45b7-9c13-290ad12d3951Package NDC 0006-0005-10, 0006-0005-30, 0006-0005-13, 0006-0033-10, 0006-0033-30, 0006-0033- ... NUIN0000191000, N0000190998, N0000185503, N0000190114Established Pharmacologic ClassOrexin Receptor Antagonist [EPC]Mechanism of Action Orexin Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA], Cytochrome P ... UNII081L192FO9

6)

drugcharacterization2medicinalproductTHYRADIN-Sdrugstructuredosagenumb50drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MICROGRAM, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate04/02/2016

activesubstance

activesubstancenameLEVOTHYROXINE

7)

drugcharacterization2medicinalproductRISPERDALdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, TIDdrugdosageformTABLETdrugadministrationroute048drugindicationBRAIN INJURYdrugstartdateformat102drugstartdate08/06/2011

activesubstance

activesubstancenameRISPERIDONE

openFDA Info on Medication

Application NumberNDA020272, NDA020588Brand NameRISPERDALGeneric NameRISPERIDONEManufacturersJanssen Pharmaceuticals, Inc.product_ndc 50458-300, 50458-301, 50458-302, 50458-320, 50458-330, 50458-350, 50458-395, 504 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRISPERIDONERXCUI 104781, 104782, 104783, 104784, 199387, 211489, 262077, 262222, 312828, 312829, ... spl_idebac424e-3ee1-4b30-9bc5-739c8eb7f87fspl_set_id7e117c7e-02fc-4343-92a1-230061dfc5e0Package NDC 50458-301-04, 50458-301-50, 50458-301-01, 50458-302-06, 50458-302-50, 50458-302- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIL6UH7ZF8HC

8)

drugcharacterization1medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext3 MG, QD (1MG, 2MG)drugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate04/07/2011actiondrug4

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: 20160225