Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10379220primarysourcecountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious1seriousnessother1receivedateformat102Date Received11/08/2014receiptdateformat102Date Last Updated11/08/2014fulfillexpeditecriteria2

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age36Unit of Onset AgeyearsWeight81.65SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionProduct size issue

2)

reactionmeddraversionpt17.1ReactionDiarrhoea

3)

reactionmeddraversionpt17.1ReactionHyperhidrosis

4)

reactionmeddraversionpt17.1ReactionDyspepsia

5)

reactionmeddraversionpt17.1ReactionSleep disorder due to general medical condition, insomnia type

6)

reactionmeddraversionpt17.1ReactionBody temperature increased

7)

reactionmeddraversionpt17.1ReactionDizziness

8)

reactionmeddraversionpt17.1ReactionProduct substitution issue

9)

reactionmeddraversionpt17.1ReactionNausea

10)

reactionmeddraversionpt17.1ReactionDysphagia

11)

reactionmeddraversionpt17.1ReactionProduct taste abnormal

12)

reactionmeddraversionpt17.1ReactionRetching

13)

reactionmeddraversionpt17.1ReactionVomiting

14)

reactionmeddraversionpt17.1ReactionDysgeusia

Drug

1)

drugcharacterization1medicinalproductESZOPICLONE.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationPOST-TRAUMATIC STRESS DISORDERdrugstartdateformat102drugstartdate31/07/2014drugenddateformat102drugenddate06/08/2014drugrecurreadministration1drugadditional1

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

2)

drugcharacterization1medicinalproductESZOPICLONE.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationSLEEP TERRORdrugstartdateformat102drugstartdate31/07/2014drugenddateformat102drugenddate06/08/2014drugrecurreadministration1drugadditional1

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

3)

drugcharacterization1medicinalproductESZOPICLONE.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate31/07/2014drugenddateformat102drugenddate06/08/2014drugrecurreadministration1drugadditional1

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: 20140726