Report

Version of Safety Report ID5Safety Report ID10868037primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate25/11/2015reporttype2serious1seriousnessother1receivedateformat102Date Received25/02/2015receiptdateformat102Date Last Updated28/09/2015fulfillexpeditecriteria1companynumbPHHY2014JP130120duplicate1

Report Duplicate

duplicatesourceNOVARTISduplicatenumbPHHY2014JP130120

Primary Source

reportercountryJPqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age18Unit of Onset AgeyearsSexFemale

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
- 5)
- 6)
- 7)
- 8)
- 9)
- 10)
- 11)
- 12)
- 13)
- 14)
- 15)
Drug
summary

Reaction

1)

reactionmeddraversionpt18.1ReactionPleural effusionOutcomeRecovering/resolving

2)

reactionmeddraversionpt18.1ReactionSalivary hypersecretionOutcomeRecovering/resolving

3)

reactionmeddraversionpt18.1ReactionNeutrophil percentage increasedOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.1ReactionSalivary hypersecretionOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.1ReactionPyrexiaOutcomeRecovering/resolving

6)

reactionmeddraversionpt18.1ReactionC-reactive protein increasedOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt18.1ReactionBlood pressure decreasedOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt18.1ReactionPneumonia aspirationOutcomeRecovered/resolved

9)

reactionmeddraversionpt18.1ReactionBronchitis chronicOutcomeRecovered/resolved

10)

reactionmeddraversionpt18.1ReactionAmenorrhoeaOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt18.1ReactionWeight increasedOutcomeNot recovered/not resolved

12)

reactionmeddraversionpt18.1ReactionTachycardiaOutcomeNot recovered/not resolved

13)

reactionmeddraversionpt18.1ReactionDizziness posturalOutcomeNot recovered/not resolved

14)

reactionmeddraversionpt18.1ReactionConstipationOutcomeRecovering/resolving

15)

reactionmeddraversionpt18.1ReactionWhite blood cell count increasedOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb250drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext250 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate09/05/2013drugenddateformat102drugenddate20/05/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

Application NumberNDA019758Brand NameCLOZARILGeneric NameCLOZAPINEManufacturersHLS Therapeutics (USA), Inc.product_ndc69809-0126, 69809-0127, 69809-0130, 69809-0135Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLOZAPINERXCUI104775, 104776, 197535, 197536, 309374, 429212, 2269079, 2269081spl_id29feed9f-c971-4c63-bcfc-0776c12215cfspl_set_id90876802-0e3a-44c9-9ff7-1754dfbe736aPackage NDC69809-0126-5, 69809-0127-5, 69809-0130-5, 69809-0135-5NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIJ60AR2IKIC

2)

drugcharacterization1medicinalproductAKINETONdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb207drugcumulativedosageunit003drugdosagetext3 MG, QDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate11/04/2013drugenddateformat102drugenddate01/05/2013actiondrug1

activesubstance

activesubstancenameBIPERIDEN HYDROCHLORIDE

3)

drugcharacterization1medicinalproductLONASENdrugstructuredosagenumb24drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb120drugcumulativedosageunit003drugdosagetext24 MG, QDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate11/04/2013drugenddateformat102drugenddate15/04/2013actiondrug1

activesubstance

activesubstancenameBLONANSERIN

4)

drugcharacterization1medicinalproductLEVOTOMINdrugstructuredosagenumb200drugstructuredosageunit003drugdosagetext200 MG, QDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate11/04/2013drugenddateformat102drugenddate30/04/2013actiondrug1

activesubstance

activesubstancenameLEVOMEPROMAZINE

5)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext100 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate20/04/2013drugenddateformat102drugenddate21/04/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

6)

drugcharacterization1medicinalproductAKINETONdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb207drugcumulativedosageunit003drugdosagetext2 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate21/11/2013drugenddateformat102drugenddate27/11/2013actiondrug1

activesubstance

activesubstancenameBIPERIDEN HYDROCHLORIDE

7)

drugcharacterization2medicinalproductCONSTANdrugstructuredosagenumb.8drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.8 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate19/12/2013drugenddateformat102drugenddate25/12/2013actiondrug1

activesubstance

activesubstancenameALPRAZOLAM

8)

drugcharacterization2medicinalproductWYPAXdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate26/09/2013drugenddateformat102drugenddate02/10/2013actiondrug1

activesubstance

activesubstancenameLORAZEPAM

9)

drugcharacterization2medicinalproductHORIZONdrugstructuredosagenumb6drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext6 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIA, PARANOID TYPEdrugstartdateformat102drugstartdate07/04/2014actiondrug4

activesubstance

activesubstancenameDIAZEPAM

10)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb325drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext325 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate11/07/2013drugenddateformat102drugenddate17/07/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

11)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb350drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext350 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate18/07/2013drugenddateformat102drugenddate31/07/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

12)

drugcharacterization1medicinalproductAKINETONdrugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb207drugcumulativedosageunit003drugdosagetext4 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate24/10/2013drugenddateformat102drugenddate06/11/2013actiondrug1

activesubstance

activesubstancenameBIPERIDEN HYDROCHLORIDE

13)

drugcharacterization2medicinalproductNELBONdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb270drugcumulativedosageunit003drugdosagetext10 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate28/05/2013drugenddateformat102drugenddate17/06/2013actiondrug1

activesubstance

activesubstancenameNITRAZEPAM

14)

drugcharacterization2medicinalproductWYPAXdrugstructuredosagenumb1.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1.5 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate31/10/2013drugenddateformat102drugenddate18/12/2013actiondrug1

activesubstance

activesubstancenameLORAZEPAM

15)

drugcharacterization2medicinalproductWYPAXdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate19/12/2013drugenddateformat102drugenddate25/12/2013actiondrug1

activesubstance

activesubstancenameLORAZEPAM

16)

drugcharacterization2medicinalproductMEILAXdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIA, PARANOID TYPEdrugstartdateformat102drugstartdate16/10/2013drugenddateformat102drugenddate15/01/2014actiondrug1

activesubstance

activesubstancenameETHYL LOFLAZEPATE

17)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb250drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext250 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate04/06/2013drugenddateformat102drugenddate19/06/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

18)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb375drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext375 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate01/08/2013drugenddateformat102drugenddate14/08/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

19)

drugcharacterization1medicinalproductAKINETONdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb207drugcumulativedosageunit003drugdosagetext3 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate18/10/2013drugenddateformat102drugenddate23/10/2013actiondrug1

activesubstance

activesubstancenameBIPERIDEN HYDROCHLORIDE

20)

drugcharacterization1medicinalproductAKINETONdrugstructuredosagenumb6drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb207drugcumulativedosageunit003drugdosagetext6 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate07/11/2013drugenddateformat102drugenddate13/11/2013actiondrug1

activesubstance

activesubstancenameBIPERIDEN HYDROCHLORIDE

21)

drugcharacterization1medicinalproductSERENACEdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb134drugcumulativedosageunit003drugdosagetext5 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate20/04/2013drugenddateformat102drugenddate26/04/2013actiondrug1

activesubstance

activesubstancenameHALOPERIDOL

22)

drugcharacterization2medicinalproductCEREKINONdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext200 MG, QDdrugadministrationroute048drugindicationCHRONIC GASTRITISdrugstartdateformat102drugstartdate11/04/2013actiondrug4

activesubstance

activesubstancenameTRIMEBUTINE

23)

drugcharacterization2medicinalproductCONSTANdrugstructuredosagenumb1.2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1.2 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIA, PARANOID TYPEdrugstartdateformat102drugstartdate03/10/2013drugenddateformat102drugenddate11/10/2013actiondrug1

activesubstance

activesubstancenameALPRAZOLAM

24)

drugcharacterization2medicinalproductDEPAKENEdrugstructuredosagenumb600drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext600 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIA, PARANOID TYPEdrugstartdateformat102drugstartdate26/07/2013drugenddateformat102drugenddate30/10/2013actiondrug1

activesubstance

activesubstancenameVALPROIC ACID

25)

drugcharacterization2medicinalproductLEXOTANdrugstructuredosagenumb12drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb216drugcumulativedosageunit003drugdosagetext12 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIA, PARANOID TYPEdrugstartdateformat102drugstartdate11/04/2013drugenddateformat102drugenddate07/05/2013actiondrug1

activesubstance

activesubstancenameBROMAZEPAM

26)

drugcharacterization2medicinalproductROZEREMdrugstructuredosagenumb8drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext8 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIA, PARANOID TYPEdrugstartdateformat102drugstartdate30/01/2014actiondrug4

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

27)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext50 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate15/04/2013drugenddateformat102drugenddate17/04/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

28)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb75drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext75 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate18/04/2013drugenddateformat102drugenddate19/04/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

29)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb175drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext175 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate28/04/2013drugenddateformat102drugenddate30/04/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

30)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb400drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext400 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate15/08/2013drugenddateformat102drugenddate27/11/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

31)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb325drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext325 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate12/12/2013drugenddateformat102drugenddate18/12/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

32)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb275drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext275 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate04/01/2014drugenddateformat102drugenddate08/01/2014actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

33)

drugcharacterization2medicinalproductNELBONdrugstructuredosagenumb15drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb270drugcumulativedosageunit003drugdosagetext15 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIA, PARANOID TYPEdrugstartdateformat102drugstartdate11/04/2013drugenddateformat102drugenddate27/05/2013actiondrug1

activesubstance

activesubstancenameNITRAZEPAM

34)

drugcharacterization2medicinalproductNELBONdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb270drugcumulativedosageunit003drugdosagetext5 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate18/06/2013drugenddateformat102drugenddate08/07/2013actiondrug1

activesubstance

activesubstancenameNITRAZEPAM

35)

drugcharacterization2medicinalproductCONSTANdrugstructuredosagenumb1.2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1.2 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate12/11/2013drugenddateformat102drugenddate18/12/2013actiondrug1

activesubstance

activesubstancenameALPRAZOLAM

36)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb12.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext12.5 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationSCHIZOPHRENIA, PARANOID TYPEdrugstartdateformat102drugstartdate11/04/2013drugenddateformat102drugenddate11/04/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

37)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext200 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate01/05/2013drugenddateformat102drugenddate08/05/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

38)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext300 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate21/05/2013drugenddateformat102drugenddate03/06/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

39)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb375drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext375 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate28/11/2013drugenddateformat102drugenddate04/12/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

40)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb350drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext350 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate05/12/2013drugenddateformat102drugenddate11/12/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

41)

drugcharacterization1medicinalproductAKINETONdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb207drugcumulativedosageunit003drugdosagetext2 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate23/08/2013drugenddateformat102drugenddate17/10/2013actiondrug1

activesubstance

activesubstancenameBIPERIDEN HYDROCHLORIDE

42)

drugcharacterization1medicinalproductSERENACEdrugstructuredosagenumb11drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb134drugcumulativedosageunit003drugdosagetext11 MG, QDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate11/04/2013drugenddateformat102drugenddate19/04/2013actiondrug1

activesubstance

activesubstancenameHALOPERIDOL

43)

drugcharacterization2medicinalproductMEILAXdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate16/01/2014drugenddateformat102drugenddate19/03/2014actiondrug1

activesubstance

activesubstancenameETHYL LOFLAZEPATE

44)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext25 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate12/04/2013drugenddateformat102drugenddate14/04/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

45)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb125drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext125 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate22/04/2013drugenddateformat102drugenddate24/04/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

46)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb250drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext250 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate09/01/2014drugenddateformat102drugenddate15/01/2014actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

47)

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

48)

drugcharacterization1medicinalproductAKINETONdrugstructuredosagenumb6drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb207drugcumulativedosageunit003drugdosagetext6 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate02/05/2013drugenddateformat102drugenddate22/07/2013actiondrug1

activesubstance

activesubstancenameBIPERIDEN HYDROCHLORIDE

49)

drugcharacterization2medicinalproductSELENICA-Rdrugstructuredosagenumb600drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb10800drugcumulativedosageunit003drugdosagetext600 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate31/10/2013drugenddateformat102drugenddate20/11/2013actiondrug1

activesubstance

activesubstancenameSELENIUM

50)

drugcharacterization2medicinalproductLEXOTANdrugstructuredosagenumb6drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb216drugcumulativedosageunit003drugdosagetext6 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate08/05/2013drugenddateformat102drugenddate09/05/2013actiondrug1

activesubstance

activesubstancenameBROMAZEPAM

51)

drugcharacterization2medicinalproductBENZALINdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIA, PARANOID TYPEdrugstartdateformat102drugstartdate20/02/2014drugenddateformat102drugenddate26/02/2014actiondrug1

activesubstance

activesubstancenameNITRAZEPAM

52)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb150drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext150 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate25/04/2013drugenddateformat102drugenddate27/04/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

53)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb275drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext275 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate20/06/2013drugenddateformat102drugenddate03/07/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

54)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext300 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate04/07/2013drugenddateformat102drugenddate10/07/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

55)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext300 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate19/12/2013drugenddateformat102drugenddate03/01/2014actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

56)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb225drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb8037drugcumulativedosageunit003drugdosagetext225 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate16/01/2014drugenddateformat102drugenddate22/01/2014actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

57)

drugcharacterization1medicinalproductAKINETONdrugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb207drugcumulativedosageunit003drugdosagetext4 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate23/07/2013drugenddateformat102drugenddate25/07/2013actiondrug1

activesubstance

activesubstancenameBIPERIDEN HYDROCHLORIDE

58)

drugcharacterization1medicinalproductAKINETONdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb207drugcumulativedosageunit003drugdosagetext3 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate26/07/2013drugenddateformat102drugenddate22/08/2013actiondrug1

activesubstance

activesubstancenameBIPERIDEN HYDROCHLORIDE

59)

drugcharacterization1medicinalproductAKINETONdrugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb207drugcumulativedosageunit003drugdosagetext4 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate14/11/2013drugenddateformat102drugenddate20/11/2013actiondrug1

activesubstance

activesubstancenameBIPERIDEN HYDROCHLORIDE

60)

drugcharacterization2medicinalproductSELENICA-Rdrugstructuredosagenumb600drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb10800drugcumulativedosageunit003drugdosagetext600 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIA, PARANOID TYPEdrugstartdateformat102drugstartdate11/04/2013drugenddateformat102drugenddate25/07/2013actiondrug1

activesubstance

activesubstancenameSELENIUM

61)

drugcharacterization2medicinalproductWYPAXdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIA, PARANOID TYPEdrugstartdateformat102drugstartdate30/07/2013drugenddateformat102drugenddate25/09/2013actiondrug1

activesubstance

activesubstancenameLORAZEPAM

62)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIA, PARANOID TYPEdrugstartdateformat102drugstartdate13/02/2014drugenddateformat102drugenddate19/02/2014actiondrug1

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: 20130411

Adverse Event Report

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