Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11565351primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received28/09/2015receiptdateformat102Date Last Updated28/09/2015fulfillexpeditecriteria2companynumbUS-OTSUKA-US-2015-11349duplicate1

Report Duplicate

duplicatesourceOTSUKAduplicatenumbUS-OTSUKA-US-2015-11349

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Reaction

1)

reactionmeddraversionpt18.1ReactionTremorOutcomeUnknown

2)

reactionmeddraversionpt18.1ReactionInappropriate schedule of drug administrationOutcomeUnknown

3)

reactionmeddraversionpt18.1ReactionIncorrect dose administeredOutcomeUnknown

4)

reactionmeddraversionpt18.1ReactionHead titubationOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductABILIFY MAINTENAdrugbatchnumbUNKNOWNdrugauthorizationnumb021436drugstructuredosagenumb300drugstructuredosageunit003drugdosagetext300 MG, UNKdrugdosageformSUSPENSION FOR INJECTIONdrugadministrationroute030drugindicationSCHIZOAFFECTIVE DISORDERdrugstartdateformat610drugstartdate/12/2014actiondrug2

activesubstance

activesubstancenameARIPIPRAZOLE

openFDA Info on Medication

Application NumberNDA202971Brand NameABILIFY MAINTENAGeneric NameARIPIPRAZOLEManufacturersOtsuka America Pharmaceutical, Inc.product_ndc59148-018, 59148-019, 59148-045, 59148-072Product TypeHUMAN PRESCRIPTION DRUGRXCUI1602163, 1602171, 1602604, 1602607, 1659812, 1659814, 1659816, 1659818spl_id1bb09ce4-c128-4f90-9258-6c579c7c0854spl_set_idee49f3b1-1650-47ff-9fb1-ea53fe0b92b6Package NDC59148-018-71, 59148-019-71, 59148-045-80, 59148-072-80

2)

drugcharacterization1medicinalproductABILIFY MAINTENAdrugbatchnumbUNKNOWNdrugauthorizationnumb021436drugstructuredosagenumb300drugstructuredosageunit003drugdosagetext300 MG, UNKdrugdosageformSUSPENSION FOR INJECTIONdrugadministrationroute030drugstartdateformat102drugstartdate20/03/2015actiondrug2

activesubstance

activesubstancenameARIPIPRAZOLE

openFDA Info on Medication

Application NumberNDA202971Brand NameABILIFY MAINTENAGeneric NameARIPIPRAZOLEManufacturersOtsuka America Pharmaceutical, Inc.product_ndc59148-018, 59148-019, 59148-045, 59148-072Product TypeHUMAN PRESCRIPTION DRUGRXCUI1602163, 1602171, 1602604, 1602607, 1659812, 1659814, 1659816, 1659818spl_id1bb09ce4-c128-4f90-9258-6c579c7c0854spl_set_idee49f3b1-1650-47ff-9fb1-ea53fe0b92b6Package NDC59148-018-71, 59148-019-71, 59148-045-80, 59148-072-80

3)

drugcharacterization2medicinalproductCLONAZEPAM.drugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, BIDdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application Number ANDA077194, ANDA077171, ANDA074569, ANDA077147, ANDA211033, ANDA077856, NDA01753 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Teva Pharmaceuticals USA, Inc., Par Pharmaceutical, Inc., Accord Healthcare Inc. ... product_ndc 0093-9290, 0093-9291, 0093-9292, 0093-9293, 0093-9294, 49884-306, 49884-307, 498 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id 0a290597-0942-4e2e-bcf7-7486bf8b933e, a95f8799-0bb3-41d6-aa27-8a291127ad54, e7a6 ... spl_set_id cb2e209e-e69b-422b-8abb-34df2bc92caa, 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069 ... Package NDC 0093-9290-67, 0093-9291-67, 0093-9292-67, 0093-9293-67, 0093-9294-67, 49884-306- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

4)

drugcharacterization2medicinalproductDEPAKOTEdrugstructuredosagenumb1500drugstructuredosageunit003drugdosagetext1500 MG, UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameDIVALPROEX SODIUM

openFDA Info on Medication

Application NumberNDA021168, NDA018723, NDA019680Brand NameDEPAKOTE ER, DEPAKOTE, DEPAKOTE SPRINKLESGeneric NameDIVALPROEX SODIUMManufacturersAbbVie Inc.product_ndc 0074-3826, 0074-7401, 0074-7126, 0074-7402, 0074-6212, 0074-6214, 0074-6215, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIVALPROEX SODIUMRXCUI 1099563, 1099565, 1099569, 1099571, 1099625, 1099626, 1099678, 1099679, 1099870, ... spl_id 94b6d88a-6c23-4f4a-b3bd-3c8b451ffb43, 7a9c5c8b-3192-4305-b360-ca106a4c85e1, fc9c ... spl_set_id 0dc024ce-efc8-4690-7cb5-639c728fccac, 08a65cf4-7749-4ceb-6895-8f4805e2b01f, 4619 ... Package NDC 0074-3826-13, 0074-3826-11, 0074-7401-13, 0074-7126-13, 0074-7126-53, 0074-7126- ... UNII644VL95AO6

5)

drugcharacterization1medicinalproductZYPREXAdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugenddateformat610drugenddate/09/2014actiondrug1

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)

drugcharacterization2medicinalproductCOGENTINdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, BIDdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameBENZTROPINE MESYLATE

7)

drugcharacterization1medicinalproductABILIFY MAINTENAdrugbatchnumbUNKNOWNdrugauthorizationnumb021436drugstructuredosagenumb400drugstructuredosageunit003drugdosagetext400 MG, UNKdrugdosageformSUSPENSION FOR INJECTIONdrugadministrationroute030drugindicationSCHIZOPHRENIAdrugstartdateformat610drugstartdate/03/2014actiondrug2

activesubstance

activesubstancenameARIPIPRAZOLE

openFDA Info on Medication

Application NumberNDA202971Brand NameABILIFY MAINTENAGeneric NameARIPIPRAZOLEManufacturersOtsuka America Pharmaceutical, Inc.product_ndc59148-018, 59148-019, 59148-045, 59148-072Product TypeHUMAN PRESCRIPTION DRUGRXCUI1602163, 1602171, 1602604, 1602607, 1659812, 1659814, 1659816, 1659818spl_id1bb09ce4-c128-4f90-9258-6c579c7c0854spl_set_idee49f3b1-1650-47ff-9fb1-ea53fe0b92b6Package NDC59148-018-71, 59148-019-71, 59148-045-80, 59148-072-80

8)

drugcharacterization2medicinalproductLUNESTAdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK UNK, HS (AT BED TIME)drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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: 201412