Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11324625primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received30/07/2015receiptdateformat102Date Last Updated30/07/2015fulfillexpeditecriteria2companynumbUS-ASTRAZENECA-2015SE71931duplicate1

Report Duplicate

duplicatesourceASTRAZENECAduplicatenumbUS-ASTRAZENECA-2015SE71931

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age15703Unit of Onset AgedaysWeight136.1SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionChillsOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.1ReactionDrug dose omissionOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.1ReactionTremorOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductLORAZEPAM.drugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationANXIETYdrugstartdateformat602drugstartdate//2014

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, LOREEV XR, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, Hikma Pharmaceuticals USA Inc., Aurol ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 2569564, 25695 ... spl_id 8b30da4f-e5a1-4e8a-9971-b5c687508d81, 4f2988b1-2854-4051-962f-07cc925608ab, 66ed ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-11, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

2)

drugcharacterization2medicinalproductCYMBALTAdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationBIPOLAR DISORDERdrugstartdateformat602drugstartdate//2014

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_id892f05de-dd11-4ae3-9a85-ce9cfcbeaaccspl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

3)

drugcharacterization1medicinalproductQUETIAPINE FUMARATE.drugauthorizationnumb020639drugstructuredosagenumb400drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb146400drugcumulativedosageunit003drugdosageformTABLETdrugadministrationroute048drugindicationBIPOLAR DISORDERdrugstartdateformat602drugstartdate//2014actiondrug5

activesubstance

activesubstancenameQUETIAPINE FUMARATE

openFDA Info on Medication

Application Number ANDA091388, ANDA203390, ANDA077380, ANDA201504, ANDA207655, ANDA206260, ANDA0901 ... Brand NameQUETIAPINE FUMARATEGeneric NameQUETIAPINE FUMARATE, QUETIAPINEManufacturers Aurobindo Pharma Limited, Alembic Pharmaceuticals Limited, Dr.Reddy's Laboratori ... product_ndc 65862-489, 65862-490, 65862-491, 65862-492, 65862-493, 65862-494, 65862-495, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI 312743, 312744, 312745, 317174, 389201, 616483, 616487, 721791, 721794, 721796, ... spl_id dad1eafc-5ab8-4d83-82c2-aaac0ace6626, a99377c9-db66-4830-9fe8-98fd1d4fbb28, 032c ... spl_set_id 8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b6, 93ab6237-321e-4a2c-b0ca-3fc9acb31f9a, 26d9 ... Package NDC 65862-489-01, 65862-489-99, 65862-489-10, 65862-490-01, 65862-490-99, 65862-490- ... UNII2S3PL1B6UJ

4)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationSLEEP DISORDERdrugstartdateformat602drugstartdate//2014

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: 20150720