Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10896715primarysourcecountryUStransmissiondateformat102transmissiondate21/07/2015reporttype1serious1seriousnessdisabling1receivedateformat102Date Received02/03/2015receiptdateformat102Date Last Updated02/03/2015fulfillexpeditecriteria2

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age62Unit of Onset AgeyearsWeight54.43SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionInsomnia

2)

reactionmeddraversionpt18.0ReactionProduct substitution issue

3)

reactionmeddraversionpt18.0ReactionProduct quality issue

4)

reactionmeddraversionpt18.0ReactionCerebral disorder

5)

reactionmeddraversionpt18.0ReactionQuality of life decreased

6)

reactionmeddraversionpt18.0ReactionNeurological symptom

7)

reactionmeddraversionpt18.0ReactionAnxiety disorder

8)

reactionmeddraversionpt18.0ReactionRestlessness

9)

reactionmeddraversionpt18.0ReactionCondition aggravated

10)

reactionmeddraversionpt18.0ReactionPanic attack

11)

reactionmeddraversionpt18.0ReactionTremor

12)

reactionmeddraversionpt18.0ReactionVision blurred

Drug

1)

drugcharacterization1medicinalproductESZOPICLONE.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 TABLET AT BEDTIMEdrugindicationSLEEP DISORDERdrugstartdateformat102drugstartdate01/08/2014drugenddateformat102drugenddate26/02/2015drugrecurreadministration1drugadditional2

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)

drugcharacterization2medicinalproductEPT BIODIENTICAL HRT

3)

drugcharacterization2medicinalproductMETAMUCIL

activesubstance

activesubstancenamePLANTAGO SEED

openFDA Info on Medication

Application Numberpart334Brand NameMETAMUCIL THERAPY FOR REGULARITYGeneric NamePSYLLIUM HUSKManufacturersThe Procter & Gamble Manufacturing Companyproduct_ndc37000-024, 37000-023Product TypeHUMAN OTC DRUGRouteORALActive IngredientsPSYLLIUM HUSKRXCUI824586, 880853spl_ide16d8c54-f125-c7f4-e053-2a95a90a1066, e16cc409-d5a0-7812-e053-2995a90a0ecbspl_set_ida9824f73-5ea2-4a65-a926-3a57561441b8, 12d030b0-df97-4dd6-88ba-e9fe863c95eaPackage NDC37000-024-10, 37000-024-04, 37000-023-10, 37000-023-04UNII0SHO53407G

4)

drugcharacterization2medicinalproductASTELIN

activesubstance

activesubstancenameAZELASTINE HYDROCHLORIDE

5)

drugcharacterization2medicinalproductLUNESTA

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

6)

drugcharacterization2medicinalproductDOXEPIN

activesubstance

activesubstancenameDOXEPIN

openFDA Info on Medication

Application NumberANDA202337, ANDA201951Brand NameDOXEPINGeneric NameDOXEPINManufacturersArchis Pharma LLC, Actavis Pharma, Inc.product_ndc72819-161, 72819-162, 0228-3315, 0228-3316Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDOXEPIN HYDROCHLORIDERXCUI966787, 966793spl_idd9a42f8a-b632-8bbb-e053-2a95a90a5408, aeefed70-09dc-4efa-809e-b80fe14656a6spl_set_ide3eac8e4-224e-4b7b-81d3-071301f914fa, c42333f8-1add-4f33-9458-6fe4436874a1Package NDC 72819-161-03, 72819-161-10, 72819-161-11, 72819-162-03, 72819-162-10, 72819-162- ... UNII3U9A0FE9N5

7)

drugcharacterization2medicinalproductCALCIUM SUPPLEMENT (WITHOUT MAGNESIUM)

summary

narrativeincludeclinicalCASE EVENT DATE: 20141127