Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10435073primarysourcecountryUStransmissiondateformat102transmissiondate28/05/2015reporttype1serious2receivedateformat102Date Received15/08/2014receiptdateformat102Date Last Updated08/12/2014fulfillexpeditecriteria2companynumb2014TUS005349duplicate1

Report Duplicate

duplicatesourceTAKEDAduplicatenumb2014TUS005349

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age51Unit of Onset AgeyearsWeight110SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionMemory impairment

2)

reactionmeddraversionpt18.0ReactionNausea

3)

reactionmeddraversionpt18.0ReactionBalance disorder

4)

reactionmeddraversionpt18.0ReactionClumsiness

Drug

1)

drugcharacterization2medicinalproductXYREM (OXBATE SODIUM)

2)

drugcharacterization2medicinalproduct ADDERALL (AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SCACCARATE, DE ...

3)

drugcharacterization2medicinalproductCYTOMEL (LIOTHYRONINE SODIUM)

4)

drugcharacterization2medicinalproductPROGESTERONE MICRONIZED (PROGESTERONE)

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)

drugcharacterization2medicinalproductLAMOTRIGINE (LAMOTRIGIINE)

7)

drugcharacterization2medicinalproductLYRICA

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application NumberNDA021446, NDA022488Brand NameLYRICAGeneric NamePREGABALINManufacturersParke-Davis Div of Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0071-1012, 0071-1013, 0071-1014, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, ... spl_idb9b1285a-2cb3-4789-8b0e-8d5e1b253534, bfdec19d-6a54-449c-95b4-908d28e5369aspl_set_id60185c88-ecfd-46f9-adb9-b97c6b00a553, ce1a4b9d-3127-4416-8bf2-fee5899fc0baPackage NDC 0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015- ... UNII55JG375S6M

8)

drugcharacterization1medicinalproductBRINTELLIXdrugauthorizationnumb204447drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationMAJOR DEPRESSIONdrugstartdateformat102drugstartdate03/06/2014drugenddateformat102drugenddate23/06/2014drugadditional1

activesubstance

activesubstancenameVORTIOXETINE HYDROBROMIDE

9)

drugcharacterization2medicinalproductPREMARIN (ESTROGENS CONJUGATED)

summary

narrativeincludeclinicalCASE EVENT DATE: 20140603