Adverse Event Report

Report

Version of Safety Report ID3Safety Report ID11510856primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate04/03/2016reporttype1serious1seriousnessother1receivedateformat102Date Received15/09/2015receiptdateformat102Date Last Updated13/10/2015fulfillexpeditecriteria1companynumbJP-PFIZER INC-2015297034duplicate1

Report Duplicate

duplicatesourcePFIZERduplicatenumbJP-PFIZER INC-2015297034

Primary Source

reportercountryJPqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age72Unit of Onset AgeyearsWeight55SexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionTachycardiaOutcomeUnknown

2)

reactionmeddraversionpt18.1ReactionNauseaOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.1ReactionAtrial fibrillationOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.1ReactionUrticariaOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, 1X/DAYdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate28/10/2013

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)

drugcharacterization1medicinalproductLANSOPRAZOLE.drugstructuredosagenumb15drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext15 MG, 1X/DAYdrugdosageformTABLETdrugadministrationroute048drugindicationGASTROOESOPHAGEAL REFLUX DISEASEdrugstartdateformat102drugstartdate17/08/2015actiondrug5

activesubstance

activesubstancenameLANSOPRAZOLE

openFDA Info on Medication

Application Number ANDA202319, ANDA203187, ANDA202366, NDA208025, ANDA091269, ANDA210465, ANDA20217 ... Brand Name BASIC CARE LANSOPRAZOLE, EQUALINE LANSOPRAZOLE, HEALTH MART LANSOPRAZOLE, LANSOP ... Generic NameLANSOPRAZOLE, LANSOPRAZOLE DELAYED RELEASEManufacturers Amazon.com Services LLC, Supervalu Inc, Strategic Sourcing Services LLC, Chain D ... product_ndc 72288-343, 41163-117, 62011-0472, 68016-758, 65841-769, 65841-770, 45802-245, 49 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLANSOPRAZOLERXCUI596843, 311277, 351261, 351260, 206205, 206206, 596918, 866152spl_id 618a52b6-812d-412b-8838-b059f8b92d9b, a9daca89-e2f8-40bf-9beb-4267aaac7d3e, 181f ... spl_set_id 6b57eb00-74fd-435f-bd08-086c9f8ac62c, ea8efda5-9d08-446b-9424-68a98122589a, 181f ... Package NDC 72288-343-03, 72288-343-01, 41163-117-01, 41163-117-02, 41163-117-03, 62011-0472 ... NUIN0000175525, N0000000147, N0000009724Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA]Physiologic/Pharmacodynamic EffectInhibition Gastric Acid Secretion [PE]UNII0K5C5T2QPG

3)

drugcharacterization1medicinalproductLYRICAdrugauthorizationnumb021446drugdosagetextUNKdrugdosageformCAPSULE, HARDdrugadministrationroute048drugindicationHYPOAESTHESIAdrugstartdateformat102drugstartdate24/08/2015drugenddateformat102drugenddate27/08/2015actiondrug1

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application NumberNDA021446, NDA022488Brand NameLYRICAGeneric NamePREGABALINManufacturersParke-Davis Div of Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0071-1012, 0071-1013, 0071-1014, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, ... spl_idb9b1285a-2cb3-4789-8b0e-8d5e1b253534, bfdec19d-6a54-449c-95b4-908d28e5369aspl_set_id60185c88-ecfd-46f9-adb9-b97c6b00a553, ce1a4b9d-3127-4416-8bf2-fee5899fc0baPackage NDC 0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015- ... UNII55JG375S6M

4)

drugcharacterization1medicinalproductFERROSTECdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, 2X/DAYdrugdosageformTABLETdrugadministrationroute048drugindicationIRON DEFICIENCY ANAEMIAdrugstartdateformat102drugstartdate18/06/2015actiondrug5

activesubstance

activesubstancenameSODIUM FERROUS CITRATE

summary

narrativeincludeclinicalCASE EVENT DATE: 20150825