Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10182529primarysourcecountryUStransmissiondateformat102transmissiondate12/12/2014reporttype1serious2receivedateformat102Date Received19/05/2014receiptdateformat102Date Last Updated19/05/2014fulfillexpeditecriteria2

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age53Unit of Onset AgeyearsWeight90.72SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionInsomnia

2)

reactionmeddraversionpt17.0ReactionNausea

3)

reactionmeddraversionpt17.0ReactionProduct taste abnormal

4)

reactionmeddraversionpt17.0ReactionHangover

5)

reactionmeddraversionpt17.0ReactionProduct quality issue

6)

reactionmeddraversionpt17.0ReactionProduct substitution issue

Drug

1)

drugcharacterization1medicinalproductESZOPICLONEdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1?AT BEDTIME?TAKEN BY MOUTHdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate07/05/2014drugenddateformat102drugenddate17/05/2014drugadditional2

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