Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10896737primarysourcecountryUStransmissiondateformat102transmissiondate21/07/2015reporttype1serious1seriousnessdisabling1receivedateformat102Date 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 quality issue

3)

reactionmeddraversionpt18.0ReactionRestlessness

4)

reactionmeddraversionpt18.0ReactionProduct substitution issue

5)

reactionmeddraversionpt18.0ReactionNervous system disorder

6)

reactionmeddraversionpt18.0ReactionReaction to drug excipients

7)

reactionmeddraversionpt18.0ReactionCondition aggravated

8)

reactionmeddraversionpt18.0ReactionPanic attack

9)

reactionmeddraversionpt18.0ReactionTremor

10)

reactionmeddraversionpt18.0ReactionVision blurred

Drug

1)

drugcharacterization2medicinalproductASTELIN SPRAY

2)

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

3)

drugcharacterization2medicinalproductEPT BIOIDENTICAL HRT

4)

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

5)

drugcharacterization2medicinalproductECHINACEA

activesubstance

activesubstancenameECHINACEA, UNSPECIFIED

openFDA Info on Medication

Brand NameECHINACEAGeneric Name ECHINACEA ANGUSTIFOLIA, HAMAMMELIS VIRGINIANA, CALCAREA PHOSPHORICA, HYDRASTIS C ... ManufacturersMarco Pharma International LLC.product_ndc60986-2020Product TypeHUMAN OTC DRUGRouteORALActive Ingredients CONIUM MACULATUM FLOWERING TOP, ECHINACEA ANGUSTIFOLIA, FUCUS VESICULOSUS, GOLDE ... spl_iddca2a913-bd6b-eae2-e053-2995a90ac61fspl_set_id7efadb70-99e4-428b-a8ef-a2797327c6faPackage NDC60986-2020-2UNII Q28R5GF371, VB06AV5US8, 535G2ABX9M, ZW3Z11D0JV, T7S323PKJS, VSW71SS07I, 2E32821G ...

6)

drugcharacterization1medicinalproductESZOPICLONE.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugindicationSLEEP 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

7)

drugcharacterization2medicinalproductCALCIUM SUPPLEMENT (WITHOUT MAGNESIUM)

8)

drugcharacterization2medicinalproductMETAMUCIL CAPS

summary

narrativeincludeclinicalCASE EVENT DATE: 20141127