Adverse Event Report

Report

Version of Safety Report ID7Safety Report ID10869514primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate28/04/2017reporttype1serious1seriousnesslifethreatening1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received26/02/2015receiptdateformat102Date Last Updated09/02/2017fulfillexpeditecriteria1companynumbJP-GLAXOSMITHKLINE-JP2015JPN022427duplicate1

Report Duplicate

duplicatesourceGLAXOSMITHKLINEduplicatenumbJP-GLAXOSMITHKLINE-JP2015JPN022427

Primary Source

reportercountryJPqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age31Unit of Onset AgeyearsWeight44SexFemale

Reaction

1)

reactionmeddraversionpt19.1ReactionDisseminated intravascular coagulationOutcomeUnknown

2)

reactionmeddraversionpt19.1ReactionSeizureOutcomeRecovering/resolving

3)

reactionmeddraversionpt19.1ReactionMumpsOutcomeUnknown

4)

reactionmeddraversionpt19.1ReactionEnanthemaOutcomeUnknown

5)

reactionmeddraversionpt19.1ReactionEyelid erosionOutcomeUnknown

6)

reactionmeddraversionpt19.1ReactionConjunctivitisOutcomeUnknown

7)

reactionmeddraversionpt19.1ReactionMouth haemorrhageOutcomeRecovering/resolving

8)

reactionmeddraversionpt19.1ReactionFace oedemaOutcomeUnknown

9)

reactionmeddraversionpt19.1ReactionToxicity to various agentsOutcomeRecovered/resolved with sequelae (consequent health issues)

10)

reactionmeddraversionpt19.1ReactionFluid intake reducedOutcomeUnknown

11)

reactionmeddraversionpt19.1ReactionOral mucosal eruptionOutcomeUnknown

12)

reactionmeddraversionpt19.1ReactionOral mucosal erythemaOutcomeUnknown

13)

reactionmeddraversionpt19.1ReactionEye dischargeOutcomeUnknown

14)

reactionmeddraversionpt19.1ReactionFeeling hotOutcomeUnknown

15)

reactionmeddraversionpt19.1ReactionConjunctival hyperaemiaOutcomeUnknown

16)

reactionmeddraversionpt19.1ReactionLocal swellingOutcomeRecovering/resolving

17)

reactionmeddraversionpt19.1ReactionDepressed level of consciousnessOutcomeRecovering/resolving

18)

reactionmeddraversionpt19.1ReactionDyslaliaOutcomeNot recovered/not resolved

19)

reactionmeddraversionpt19.1ReactionGeneral physical health deteriorationOutcomeUnknown

20)

reactionmeddraversionpt19.1ReactionSwelling faceOutcomeUnknown

21)

reactionmeddraversionpt19.1ReactionHeadacheOutcomeUnknown

22)

reactionmeddraversionpt19.1ReactionOral mucosa erosionOutcomeUnknown

23)

reactionmeddraversionpt19.1ReactionScabOutcomeUnknown

24)

reactionmeddraversionpt19.1ReactionPharyngeal erythemaOutcomeRecovering/resolving

25)

reactionmeddraversionpt19.1ReactionSkin exfoliationOutcomeUnknown

26)

reactionmeddraversionpt19.1ReactionGait disturbanceOutcomeUnknown

27)

reactionmeddraversionpt19.1ReactionFlushingOutcomeRecovering/resolving

28)

reactionmeddraversionpt19.1ReactionPleural effusionOutcomeRecovering/resolving

29)

reactionmeddraversionpt19.1ReactionHyperthermiaOutcomeRecovering/resolving

30)

reactionmeddraversionpt19.1ReactionRashOutcomeRecovering/resolving

31)

reactionmeddraversionpt19.1ReactionPyrexiaOutcomeRecovering/resolving

32)

reactionmeddraversionpt19.1ReactionErythema of eyelidOutcomeUnknown

33)

reactionmeddraversionpt19.1ReactionMental disorderOutcomeUnknown

34)

reactionmeddraversionpt19.1ReactionIrritabilityOutcomeUnknown

35)

reactionmeddraversionpt19.1ReactionOropharyngeal painOutcomeRecovering/resolving

36)

reactionmeddraversionpt19.1ReactionLip haemorrhageOutcomeRecovering/resolving

37)

reactionmeddraversionpt19.1ReactionEyelid oedemaOutcomeUnknown

38)

reactionmeddraversionpt19.1ReactionRash erythematousOutcomeUnknown

39)

reactionmeddraversionpt19.1ReactionDrug eruptionOutcomeRecovering/resolving

40)

reactionmeddraversionpt19.1ReactionLymphadenopathyOutcomeUnknown

41)

reactionmeddraversionpt19.1ReactionShockOutcomeRecovering/resolving

42)

reactionmeddraversionpt19.1ReactionOcular hyperaemiaOutcomeUnknown

43)

reactionmeddraversionpt19.1ReactionErythemaOutcomeRecovering/resolving

44)

reactionmeddraversionpt19.1ReactionNeck painOutcomeUnknown

45)

reactionmeddraversionpt19.1ReactionStevens-Johnson syndromeOutcomeRecovering/resolving

46)

reactionmeddraversionpt19.1ReactionPharyngitisOutcomeUnknown

47)

reactionmeddraversionpt19.1ReactionOculomucocutaneous syndromeOutcomeRecovering/resolving

48)

reactionmeddraversionpt19.1ReactionLip erosionOutcomeUnknown

49)

reactionmeddraversionpt19.1ReactionEyelid function disorderOutcomeUnknown

50)

reactionmeddraversionpt19.1ReactionChillsOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductLIMASdrugdosagetextUNK UNK, 1Ddrugadministrationroute048drugenddateformat102drugenddate21/01/2015actiondrug1drugadditional1

activesubstance

activesubstancenameLITHIUM CARBONATE

2)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb16drugcumulativedosageunit003drugdosagetext2 MG, QDdrugstartdateformat102drugstartdate09/01/2015drugenddateformat102drugenddate21/01/2015

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)

drugcharacterization1medicinalproductLIMASdrugstructuredosagenumb400drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext400 MG, BIDdrugadministrationroute048actiondrug1drugadditional1

activesubstance

activesubstancenameLITHIUM CARBONATE

4)

drugcharacterization2medicinalproductLAC-Bdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb120drugcumulativedosageunit032drugdosagetext1 DF, TIDdrugstartdateformat102drugstartdate08/12/2014drugenddateformat102drugenddate21/01/2015

activesubstance

activesubstancenameBIFIDOBACTERIUM SPP.

5)

drugcharacterization1medicinalproductLAMICTALdrugauthorizationnumb020241drugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb200drugcumulativedosageunit003drugdosagetext25 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationBIPOLAR DISORDERdrugstartdateformat102drugstartdate09/01/2015drugenddateformat102drugenddate22/01/2015actiondrug1drugrecurreadministration1drugadditional1

activesubstance

activesubstancenameLAMOTRIGINE

drugrecurrence

1)

drugrecuractionDrug eruption

2)

drugrecuractionPyrexia

3)

drugrecuractionHyperthermia

4)

drugrecuractionLip haemorrhage

5)

drugrecuractionMouth haemorrhage

6)

drugrecuractionStevens-Johnson syndrome

7)

drugrecuractionOculomucocutaneous syndrome

8)

drugrecuractionErythema

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

6)

drugcharacterization2medicinalproductMAGMITTdrugstructuredosagenumb660drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb79200drugcumulativedosageunit003drugdosagetext660 MG, TIDdrugstartdateformat102drugstartdate08/12/2014drugenddateformat102drugenddate21/01/2015

activesubstance

activesubstancenameMAGNESIUM OXIDE

7)

drugcharacterization2medicinalproductABILIFYdrugstartdateformat102drugstartdate16/02/2015

activesubstance

activesubstancenameARIPIPRAZOLE

openFDA Info on Medication

Application NumberNDA021436Brand NameABILIFYGeneric NameARIPIPRAZOLEManufacturersOtsuka America Pharmaceutical, Inc.product_ndc 59148-006, 59148-007, 59148-008, 59148-009, 59148-010, 59148-011, 59148-013, 591 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsARIPIPRAZOLERXCUI 349490, 349545, 349547, 349553, 352307, 352308, 352309, 352310, 402131, 404602, ... spl_idfa6e0346-2760-404e-bfea-23fc6403cdffspl_set_idc040bd1d-45b7-49f2-93ea-aed7220b30acPackage NDC 59148-006-13, 59148-006-92, 59148-007-13, 59148-007-35, 59148-007-94, 59148-008- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNII82VFR53I78

8)

drugcharacterization1medicinalproductLIMASdrugstructuredosagenumb1000drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1000 MG, 1Ddrugadministrationroute048drugindicationBIPOLAR DISORDERdrugstartdateformat102drugstartdate08/12/2014actiondrug1drugadditional1

activesubstance

activesubstancenameLITHIUM CARBONATE

9)

drugcharacterization2medicinalproductBROTIZOLAMdrugstartdateformat102drugstartdate08/12/2014drugenddateformat102drugenddate21/01/2015

activesubstance

activesubstancenameBROTIZOLAM

10)

drugcharacterization2medicinalproductROHYPNOLdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb40drugcumulativedosageunit003drugdosagetext1 MG, QDdrugstartdateformat102drugstartdate08/12/2014drugenddateformat102drugenddate21/01/2015

activesubstance

activesubstancenameFLUNITRAZEPAM

summary

narrativeincludeclinicalCASE EVENT DATE: 201501