Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10349674primarysourcecountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious2receivedateformat102Date Received28/07/2014receiptdateformat102Date Last Updated28/07/2014fulfillexpeditecriteria2

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age35Unit of Onset AgeyearsWeight84.82SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionProduct substitution issue

2)

reactionmeddraversionpt17.1ReactionDrug ineffective

3)

reactionmeddraversionpt17.1ReactionMiddle insomnia

4)

reactionmeddraversionpt17.1ReactionVomiting

5)

reactionmeddraversionpt17.1ReactionNausea

6)

reactionmeddraversionpt17.1ReactionMigraine

Drug

1)

drugcharacterization1medicinalproductESZOPICLONE.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 PILL?AT BED TIMEdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate15/07/2014drugenddateformat102drugenddate25/07/2014drugrecurreadministration1drugadditional1

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application Number ANDA091124, ANDA091166, ANDA091103, ANDA091113, ANDA091024, ANDA208451, ANDA2029 ... Brand NameESZOPICLONE, LUNESTAGeneric NameESZOPICLONEManufacturers Lupin Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc. USA, Sun Pharmaceutic ... product_ndc 68180-322, 68180-323, 68180-324, 68462-382, 68462-383, 68462-384, 47335-586, 473 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, OROPHARYNGEALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id c15b2322-c078-46c1-8959-9288faaab19e, 8d6002b1-95d9-445c-8ace-e6dccea36852, 95e9 ... spl_set_id 7068c455-691e-4c56-9857-b7b4e13f4784, 584dc66c-063a-4552-a056-74b811e2bc80, 8bb1 ... Package NDC 68180-322-01, 68180-322-11, 68180-322-13, 68180-323-01, 68180-323-02, 68180-323- ... UNIIUZX80K71OE

summary

narrativeincludeclinicalCASE EVENT DATE: 20140715