Adverse Event Report

Report

Version of Safety Report ID6Safety Report ID10215976primarysourcecountryJPtransmissiondateformat102transmissiondate21/08/2015reporttype2serious1seriousnesshospitalization1receivedateformat102Date Received02/06/2014receiptdateformat102Date Last Updated01/05/2015fulfillexpeditecriteria1companynumb2014JP004418duplicate1

Report Duplicate

duplicatesourceXENOPORTduplicatenumb2014JP004418

Primary Source

reportercountryJPqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age63Unit of Onset AgeyearsWeight68SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionInsomnia

2)

reactionmeddraversionpt18.0ReactionAkathisia

3)

reactionmeddraversionpt18.0ReactionDelirium

4)

reactionmeddraversionpt18.0ReactionBipolar I disorder

5)

reactionmeddraversionpt18.0ReactionCondition aggravated

Drug

1)

drugcharacterization2medicinalproductLENDORMIN (BROTIZOLAM)

2)

drugcharacterization2medicinalproductDEPAKENE (VALPROATE SODIUM)

3)

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

4)

drugcharacterization2medicinalproductMETGLUCO

activesubstance

activesubstancenameMETFORMIN HYDROCHLORIDE

5)

drugcharacterization1medicinalproductREGNITE (GABAPENTIN ENACARBIL) TABLET, 300MGdrugauthorizationnumb022399drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationRESTLESS LEGS SYNDROMEdrugstartdateformat102drugstartdate06/03/2013drugenddateformat102drugenddate07/03/2013drugadditional1

activesubstance

activesubstancenameGABAPENTIN ENACARBIL

6)

drugcharacterization2medicinalproductTETRAMIDE (MIANSERIN HYDROCHLORIDE)

7)

drugcharacterization2medicinalproductCLONAZEPAM (CLONAZEPAM)

activesubstance

activesubstancenameCLONAZEPAM

8)

drugcharacterization2medicinalproductBI SIFROL (PRAMIPEXOLE HYDROCHLORIDE)

9)

drugcharacterization2medicinalproductLULLAN (PEROSPIRONE HYDROCHLORIDE)

10)

drugcharacterization2medicinalproductLIMAS (LITHIUM CARBONATE)

11)

drugcharacterization2medicinalproductLAMICTAL

activesubstance

activesubstancenameLAMOTRIGINE

openFDA Info on Medication

Application NumberNDA020764, NDA020241, NDA022251, NDA022115Brand NameLAMICTAL, LAMICTAL ODT, LAMICTAL XRGeneric NameLAMOTRIGINEManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0526, 0173-0633, 0173-0642, 0173-0643, 0173-0644, 0173-0699, 0173-0527, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLAMOTRIGINERXCUI 103968, 105018, 105019, 108782, 198427, 198428, 198429, 198430, 201239, 201240, ... spl_id836ca780-3d75-4304-aded-c36bf096205d, e77aba1a-7ae8-42ef-b6d7-4db47796bd0espl_set_idd7e3572d-56fe-4727-2bb4-013ccca22678, 3e2c9a35-6a39-41d7-ad84-3c0bb8894b09Package NDC 0173-0633-02, 0173-0633-10, 0173-0642-55, 0173-0643-60, 0173-0644-60, 0173-0699- ... NUIN0000175753, N0000008486, N0000175751, N0000187061, N0000000191Established Pharmacologic ClassAnti-epileptic Agent [EPC], Mood Stabilizer [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Mechanism of Action Organic Cation Transporter 2 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor ... UNIIU3H27498KS

summary

narrativeincludeclinicalCASE EVENT DATE: 20130306