Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11109417primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/08/2015reporttype1serious1seriousnessother1receivedateformat102Date Received13/05/2015receiptdateformat102Date Last Updated13/05/2015fulfillexpeditecriteria1companynumb2015SP001516duplicate1

Report Duplicate

duplicatesourceSUNOVIONduplicatenumb2015SP001516

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionMuscular weaknessOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionHeadacheOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.0ReactionPituitary tumour recurrentOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.0ReactionColectomyOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionVision blurredOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductESZOPICLONE.drugbatchnumbUNKNOWNdrugauthorizationnumb021476drugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat610drugstartdate/03/2015

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)

drugcharacterization2medicinalproductLEVOTHYROXINdrugstructuredosagenumb0drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationHYPOTHYROIDISM

activesubstance

activesubstancenameLEVOTHYROXINE

3)

drugcharacterization1medicinalproductLUNESTAdrugbatchnumbUNKNOWNdrugauthorizationnumb021476drugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat602drugstartdate//2008drugenddateformat610drugenddate/03/2015actiondrug4

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

4)

drugcharacterization2medicinalproductMULTIVITAMIN /00097801/

activesubstance

activesubstancenameVITAMINS

5)

drugcharacterization2medicinalproductALL OTHER THERAPEUTIC PRODUCTS

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

6)

drugcharacterization2medicinalproductLEXAPROdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationDEPRESSION

activesubstance

activesubstancenameESCITALOPRAM OXALATE

openFDA Info on Medication

Application NumberNDA021323Brand NameLEXAPROGeneric NameESCITALOPRAMManufacturersAllergan, Inc.product_ndc0456-2005, 0456-2010, 0456-2020, 0456-2101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESCITALOPRAM OXALATERXCUI349332, 351249, 351250, 351285, 352272, 352273, 404408, 404420spl_idd6a08762-d20a-47c9-b92e-b5dde195489cspl_set_id13bb8267-1cab-43e5-acae-55a4d957630aPackage NDC 0456-2005-01, 0456-2010-01, 0456-2010-11, 0456-2010-63, 0456-2020-01, 0456-2020- ... UNII5U85DBW7LO

7)

drugcharacterization2medicinalproductTRAZODONEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationINSOMNIA

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

openFDA Info on Medication

summary

narrativeincludeclinicalCASE EVENT DATE: 201404