Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10229936primarysourcecountryUStransmissiondateformat102transmissiondate12/12/2014reporttype1serious2receivedateformat102Date Received10/06/2014receiptdateformat102Date Last Updated10/06/2014fulfillexpeditecriteria2

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age58Unit of Onset AgeyearsWeight78.93SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionProduct substitution issue

2)

reactionmeddraversionpt17.0ReactionHeadache

3)

reactionmeddraversionpt17.0ReactionSomnolence

Drug

1)

drugcharacterization1medicinalproductESZOPICLONEdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 PILL, ONCE DAILY, TAKEN BY MOUTHdrugadministrationroute048drugindicationINSOMNIAdrugrecurreadministration1

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