Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10425453primarysourcecountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious2receivedateformat102Date Received25/07/2014receiptdateformat102Date Last Updated25/07/2014fulfillexpeditecriteria2companynumbAP356-00706-SPO-USduplicate1

Report Duplicate

duplicatesourceEISAIduplicatenumbAP356-00706-SPO-US

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age52Unit of Onset AgeyearsWeight81.6SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionFatigue

2)

reactionmeddraversionpt17.1ReactionAgitation

Drug

1)

drugcharacterization2medicinalproductSYNTHROID

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_ided6f6960-2439-4bb0-bb7f-c7d05e4d37a5spl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

2)

drugcharacterization2medicinalproductWELLBUTRIN (BUPROPION)

3)

drugcharacterization1medicinalproductBELVIQdrugauthorizationnumb022529drugstructuredosagenumb10drugstructuredosageunit003drugadministrationroute048drugindicationWEIGHT DECREASEDdrugstartdateformat610drugstartdate/03/2014drugenddateformat610drugenddate/03/2014drugadditional1

activesubstance

activesubstancenameLORCASERIN HYDROCHLORIDE

4)

drugcharacterization2medicinalproductVITAMIN B-12 (CYANOCOBALAMIN)

5)

drugcharacterization2medicinalproductLUNESTA

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: 201403