Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10812378primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/07/2015reporttype1serious2receivedateformat102Date Received18/02/2015receiptdateformat102Date Last Updated18/02/2015fulfillexpeditecriteria2companynumbUS-TEVA-530425USAduplicate1

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-530425USA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionOesophageal spasmOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionProduct solubility abnormalOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.0ReactionStomatitisOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.0ReactionDysgeusiaOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductESZOPICLONE.drugbatchnumbUNKNOWNdrugauthorizationnumb091169drugstructuredosagenumb2drugstructuredosageunit003drugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1

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