Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID11150198primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate25/11/2015reporttype2serious1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received29/05/2015receiptdateformat102Date Last Updated11/09/2015fulfillexpeditecriteria1companynumbJP-ASTRAZENECA-2015SE41739duplicate1

Report Duplicate

duplicatesourceASTRAZENECAduplicatenumbJP-ASTRAZENECA-2015SE41739

Primary Source

reportercountryJPqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age11889Unit of Onset AgedaysWeight53SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionAnaphylactoid reactionOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.1ReactionSuicide attemptOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.1ReactionToxicity to various agentsOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductABILIFYdrugdosagetextSTRENGTH: 6 MG, DOSE UNKNOWNdrugadministrationroute048drugindicationBIPOLAR II DISORDERdrugstartdateformat102drugstartdate26/04/2015drugenddateformat102drugenddate26/04/2015actiondrug1

activesubstance

activesubstancenameARIPIPRAZOLE

openFDA Info on Medication

Application NumberNDA021436Brand NameABILIFYGeneric NameARIPIPRAZOLEManufacturersOtsuka America Pharmaceutical, Inc.product_ndc 59148-006, 59148-007, 59148-008, 59148-009, 59148-010, 59148-011, 59148-013, 591 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsARIPIPRAZOLERXCUI 349490, 349545, 349547, 349553, 352307, 352308, 352309, 352310, 402131, 404602, ... spl_idfa6e0346-2760-404e-bfea-23fc6403cdffspl_set_idc040bd1d-45b7-49f2-93ea-aed7220b30acPackage NDC 59148-006-13, 59148-006-92, 59148-007-13, 59148-007-35, 59148-007-94, 59148-008- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNII82VFR53I78

2)

drugcharacterization1medicinalproductQUETIAPINEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationBIPOLAR II DISORDERdrugstartdateformat102drugstartdate20/04/2015drugenddateformat102drugenddate25/04/2015actiondrug1

activesubstance

activesubstancenameQUETIAPINE

openFDA Info on Medication

Application Number ANDA207655, NDA022047, ANDA201109, ANDA077745, NDA020639, ANDA202152, ANDA211405 ... Brand Name QUETIAPINE FUMARATE, SEROQUEL XR, QUETIAPINE, SEROQUEL, QUETIAPINE EXTENDED RELE ... Generic NameQUETIAPINE, QUETIAPINE EXTENDED-RELEASEManufacturers Aurobindo Pharma Limited, AstraZeneca Pharmaceuticals LP, BluePoint Laboratories ... product_ndc 65862-873, 65862-874, 65862-875, 65862-876, 65862-877, 0310-0280, 0310-0282, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI 721791, 721794, 721796, 853201, 895670, 721793, 721795, 721797, 853202, 895671, ... spl_id 9f1cee1e-be60-4cb5-b17d-0b5af10920f4, c3b26ed5-6f3a-4ca5-80a5-b98380040294, dd14 ... spl_set_id 6562eb60-0d70-4909-bd07-88d5c9241516, 473a3ac4-67f4-4782-baa9-7f9bdd8761f4, 874e ... Package NDC 65862-873-60, 65862-873-01, 65862-873-05, 65862-874-60, 65862-874-01, 65862-874- ... UNII2S3PL1B6UJ

3)

drugcharacterization2medicinalproductGASTERdrugdosageformINJECTIONdrugstartdateformat102drugstartdate10/04/2015drugenddateformat102drugenddate10/04/2015

activesubstance

activesubstancenameFAMOTIDINE

4)

drugcharacterization2medicinalproductSAXIZONdrugdosageformINJECTIONdrugstartdateformat102drugstartdate10/04/2015drugenddateformat102drugenddate10/04/2015

activesubstance

activesubstancenameHYDROCORTISONE SODIUM SUCCINATE

5)

drugcharacterization1medicinalproductCARBAMAZEPINE.drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationBIPOLAR II DISORDERdrugstartdateformat102drugstartdate20/04/2015drugenddateformat102drugenddate25/04/2015actiondrug1

activesubstance

activesubstancenameCARBAMAZEPINE

openFDA Info on Medication

Application Number ANDA212948, ANDA076697, ANDA070541, NDA206030, ANDA214328, ANDA073524, ANDA21162 ... Brand Name CARBAMAZEPINE ER, CARBAMAZEPINE, EPITOL, CARNEXIV, TEGRETOL, TEGRETOL XR, CARBAM ... Generic NameCARBAMAZEPINEManufacturers Eywa Pharma Inc, Nostrum Laboratories, Inc., Teva Pharmaceuticals USA, Inc., Lun ... product_ndc 71930-072, 71930-073, 71930-074, 29033-004, 29033-019, 29033-020, 0093-0090, 673 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsCARBAMAZEPINERXCUI 199378, 402505, 402506, 200131, 200133, 388311, 211817, 308979, 2119860, 2119862 ... spl_id fe788fd8-8083-4201-af83-010af795d108, 9fcd6487-e123-44ca-a48f-3aa2e5858979, 6a0f ... spl_set_id 48010b2b-526b-4bd6-87fd-87745c22cb8f, fbca2152-0022-47a5-a1ea-58950b45bcbf, 32bb ... Package NDC 71930-072-12, 71930-073-12, 71930-074-90, 71930-074-12, 29033-019-12, 29033-020- ... NUI N0000008486, N0000175751, N0000185506, N0000191266, N0000187064, N0000185507, N0 ... Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Established Pharmacologic ClassMood Stabilizer [EPC]Mechanism of Action Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochro ... UNII33CM23913M

6)

drugcharacterization1medicinalproductNITRAZEPAMdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationBIPOLAR II DISORDERdrugstartdateformat102drugstartdate20/04/2015drugenddateformat102drugenddate25/04/2015actiondrug1

activesubstance

activesubstancenameNITRAZEPAM

7)

drugcharacterization1medicinalproductNITRAZEPAMdrugdosagetextSTRENGTH: 5 MG, DOSE UNKNOWNdrugdosageformTABLETdrugadministrationroute048drugindicationBIPOLAR II DISORDERdrugstartdateformat102drugstartdate26/04/2015drugenddateformat102drugenddate26/04/2015actiondrug1

activesubstance

activesubstancenameNITRAZEPAM

8)

drugcharacterization2medicinalproductLUNESTAdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate17/03/2015drugenddateformat102drugenddate12/04/2015

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

9)

drugcharacterization2medicinalproductFAVOIRdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate24/03/2015drugenddateformat102drugenddate26/04/2015

10)

drugcharacterization2medicinalproductYOKUKANSANdrugdosageformGRANULESdrugstartdateformat102drugstartdate13/04/2015drugenddateformat102drugenddate26/04/2015

activesubstance

activesubstancenameHERBALS

11)

drugcharacterization1medicinalproductCARBAMAZEPINE.drugdosagetextSTRENGTH: 100 MG, DOSE UNKNOWNdrugdosageformTABLETdrugadministrationroute048drugindicationBIPOLAR II DISORDERdrugstartdateformat102drugstartdate26/04/2015drugenddateformat102drugenddate26/04/2015actiondrug1

activesubstance

activesubstancenameCARBAMAZEPINE

openFDA Info on Medication

Application Number ANDA212948, ANDA076697, ANDA070541, NDA206030, ANDA214328, ANDA073524, ANDA21162 ... Brand Name CARBAMAZEPINE ER, CARBAMAZEPINE, EPITOL, CARNEXIV, TEGRETOL, TEGRETOL XR, CARBAM ... Generic NameCARBAMAZEPINEManufacturers Eywa Pharma Inc, Nostrum Laboratories, Inc., Teva Pharmaceuticals USA, Inc., Lun ... product_ndc 71930-072, 71930-073, 71930-074, 29033-004, 29033-019, 29033-020, 0093-0090, 673 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsCARBAMAZEPINERXCUI 199378, 402505, 402506, 200131, 200133, 388311, 211817, 308979, 2119860, 2119862 ... spl_id fe788fd8-8083-4201-af83-010af795d108, 9fcd6487-e123-44ca-a48f-3aa2e5858979, 6a0f ... spl_set_id 48010b2b-526b-4bd6-87fd-87745c22cb8f, fbca2152-0022-47a5-a1ea-58950b45bcbf, 32bb ... Package NDC 71930-072-12, 71930-073-12, 71930-074-90, 71930-074-12, 29033-019-12, 29033-020- ... NUI N0000008486, N0000175751, N0000185506, N0000191266, N0000187064, N0000185507, N0 ... Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Established Pharmacologic ClassMood Stabilizer [EPC]Mechanism of Action Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochro ... UNII33CM23913M

12)

drugcharacterization2medicinalproductPOLARAMINEdrugdosageformINJECTIONdrugstartdateformat102drugstartdate10/04/2015drugenddateformat102drugenddate10/04/2015

activesubstance

activesubstancenameDEXCHLORPHENIRAMINE MALEATE

13)

drugcharacterization2medicinalproductSOLULACTdrugstartdateformat102drugstartdate10/04/2015drugenddateformat102drugenddate10/04/2015

14)

drugcharacterization1medicinalproductQUETIAPINEdrugdosagetextSTRENGTH: 25 MG, DOSE UNKNOWNdrugdosageformTABLETdrugadministrationroute048drugindicationBIPOLAR II DISORDERdrugstartdateformat102drugstartdate26/04/2015drugenddateformat102drugenddate26/04/2015actiondrug1

activesubstance

activesubstancenameQUETIAPINE

openFDA Info on Medication

Application Number ANDA207655, NDA022047, ANDA201109, ANDA077745, NDA020639, ANDA202152, ANDA211405 ... Brand Name QUETIAPINE FUMARATE, SEROQUEL XR, QUETIAPINE, SEROQUEL, QUETIAPINE EXTENDED RELE ... Generic NameQUETIAPINE, QUETIAPINE EXTENDED-RELEASEManufacturers Aurobindo Pharma Limited, AstraZeneca Pharmaceuticals LP, BluePoint Laboratories ... product_ndc 65862-873, 65862-874, 65862-875, 65862-876, 65862-877, 0310-0280, 0310-0282, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI 721791, 721794, 721796, 853201, 895670, 721793, 721795, 721797, 853202, 895671, ... spl_id 9f1cee1e-be60-4cb5-b17d-0b5af10920f4, c3b26ed5-6f3a-4ca5-80a5-b98380040294, dd14 ... spl_set_id 6562eb60-0d70-4909-bd07-88d5c9241516, 473a3ac4-67f4-4782-baa9-7f9bdd8761f4, 874e ... Package NDC 65862-873-60, 65862-873-01, 65862-873-05, 65862-874-60, 65862-874-01, 65862-874- ... UNII2S3PL1B6UJ

15)

drugcharacterization1medicinalproductABILIFYdrugstructuredosagenumb6drugstructuredosageunit003drugadministrationroute048drugindicationBIPOLAR II DISORDERdrugstartdateformat102drugstartdate13/04/2015drugenddateformat102drugenddate25/04/2015actiondrug1

activesubstance

activesubstancenameARIPIPRAZOLE

openFDA Info on Medication

Application NumberNDA021436Brand NameABILIFYGeneric NameARIPIPRAZOLEManufacturersOtsuka America Pharmaceutical, Inc.product_ndc 59148-006, 59148-007, 59148-008, 59148-009, 59148-010, 59148-011, 59148-013, 591 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsARIPIPRAZOLERXCUI 349490, 349545, 349547, 349553, 352307, 352308, 352309, 352310, 402131, 404602, ... spl_idfa6e0346-2760-404e-bfea-23fc6403cdffspl_set_idc040bd1d-45b7-49f2-93ea-aed7220b30acPackage NDC 59148-006-13, 59148-006-92, 59148-007-13, 59148-007-35, 59148-007-94, 59148-008- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNII82VFR53I78

16)

drugcharacterization1medicinalproductSEROQUEL XRdrugdosageformPROLONGED-RELEASE TABLETdrugadministrationroute048drugindicationBIPOLAR II DISORDERdrugstartdateformat102drugstartdate31/03/2015drugenddateformat102drugenddate09/04/2015

activesubstance

activesubstancenameQUETIAPINE FUMARATE

openFDA Info on Medication

Application NumberNDA022047Brand NameSEROQUEL XRGeneric NameQUETIAPINEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0310-0280, 0310-0282, 0310-0283, 0310-0284, 0310-0281Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671spl_idc3b26ed5-6f3a-4ca5-80a5-b98380040294spl_set_id473a3ac4-67f4-4782-baa9-7f9bdd8761f4Package NDC 0310-0282-39, 0310-0282-94, 0310-0282-60, 0310-0283-39, 0310-0283-55, 0310-0283- ... UNII2S3PL1B6UJ

17)

drugcharacterization2medicinalproductISOTONIC SODIUM CHLORIDE SOLUTIONdrugdosageformSOLUTION FOR INJECTIONdrugstartdateformat102drugstartdate10/04/2015drugenddateformat102drugenddate10/04/2015

activesubstance

activesubstancenameSODIUM CHLORIDE

summary

narrativeincludeclinicalCASE EVENT DATE: 20150410