Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10791598primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/07/2015reporttype1serious2receivedateformat102Date Received13/02/2015receiptdateformat102Date Last Updated13/02/2015fulfillexpeditecriteria2companynumbUS-ASTRAZENECA-2015SE12171duplicate1

Report Duplicate

duplicatesourceASTRAZENECAduplicatenumbUS-ASTRAZENECA-2015SE12171

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Weight59SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionDyspepsiaOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionDrug ineffectiveOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextAT NIGHTdrugadministrationroute048drugindicationSLEEP DISORDER

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

2)

drugcharacterization1medicinalproductNEXIUMdrugauthorizationnumb204655drugdosageformCAPSULEdrugadministrationroute048drugindicationGASTROOESOPHAGEAL REFLUX DISEASEdrugstartdateformat610drugstartdate/01/2015actiondrug5

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id84c822de-ebe2-4a39-9944-7e38e1961dde, 24d37125-c3cf-48e0-9e50-75cbc818e7c1spl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H