Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10647401primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate29/05/2015reporttype1serious1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received11/12/2014receiptdateformat102Date Last Updated19/12/2014fulfillexpeditecriteria1companynumbJP-GILEAD-2014-0126227duplicate1

Report Duplicate

duplicatesourceGILEADduplicatenumbJP-GILEAD-2014-0126227

Primary Source

reportercountryJPqualification1literaturereference TOMOHIRO HOSODA ET AL (KAWASAKI MUNICIPAL MUCOCUTANEOUS LYMPH NODE SYNDROME ACAD ...

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age42Unit of Onset Ageyearspatientagegroup5SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionSuicidal ideationOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionExtrasystolesOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductSTOCRINdrugadministrationroute065drugindicationHIV INFECTION

activesubstance

activesubstancenameEFAVIRENZ

2)

drugcharacterization1medicinalproductTRUVADAdrugauthorizationnumb021752drugdosagetextUNKdrugdosageformTABLETdrugadministrationroute048drugindicationHIV INFECTIONactiondrug4

activesubstance

activesubstancenameEMTRICITABINE\TENOFOVIR DISOPROXIL FUMARATE

openFDA Info on Medication

Application NumberNDA021752Brand NameTRUVADAGeneric NameEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEManufacturersGilead Sciences, Incproduct_ndc61958-0701, 61958-0703, 61958-0704, 61958-0705Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsEMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATERXCUI476556, 639888, 1744001, 1744003, 1744005, 1744007, 1744009, 1744011spl_id10db9adb-eef9-4595-8d1a-42e98e298b8bspl_set_id54e82b13-a037-49ed-b4b3-030b37c0ecddPackage NDC61958-0701-1, 61958-0703-1, 61958-0704-1, 61958-0705-1NUIN0000175462, M0015066, N0000009947Established Pharmacologic Class Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [ ... Chemical StructureNucleosides [CS]Mechanism of ActionNucleoside Reverse Transcriptase Inhibitors [MoA]UNIIG70B4ETF4S, OTT9J7900I

3)

drugcharacterization2medicinalproductLUNESTAdrugadministrationroute048drugindicationDEPRESSIONactiondrug5

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)

drugcharacterization2medicinalproductISENTRESSdrugdosagetextUNKdrugadministrationroute048actiondrug1

activesubstance

activesubstancenameRALTEGRAVIR POTASSIUM

openFDA Info on Medication

Application NumberNDA022145, NDA203045, NDA205786Brand NameISENTRESSGeneric NameRALTEGRAVIRManufacturersMerck Sharp & Dohme LLCproduct_ndc0006-0227, 0006-0477, 0006-0473, 0006-3603, 0006-3080Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRALTEGRAVIR POTASSIUMRXCUI 744842, 744846, 1235588, 1235591, 1235593, 1235595, 1486838, 1486841, 1924313, 1 ... spl_id66b7309b-5f40-4c42-abd4-ae9c7772686fspl_set_id89a5ec53-d956-4329-8004-0f40f51c88a3Package NDC 0006-0227-61, 0006-0477-61, 0006-0473-61, 0006-3603-01, 0006-3603-60, 0006-3603- ... UNII43Y000U234

5)

drugcharacterization2medicinalproductALPRAZOLAM.drugadministrationroute048drugindicationDEPRESSION

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA074174 ... Brand NameALPRAZOLAM, XANAX XR, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZOLAM XRGeneric NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 687022, 687023, ... spl_id 94163352-f78e-400a-b7da-b3075e9213eb, 35398b0f-4f2a-4504-b254-bb6010a4101e, f364 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

6)

drugcharacterization2medicinalproductLUNESTAdrugadministrationroute048actiondrug5

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

7)

drugcharacterization2medicinalproductISENTRESSdrugstructuredosagenumb2400drugstructuredosageunit003drugdosagetext2400 MG, UNKdrugadministrationroute048drugindicationHIV INFECTIONactiondrug1

activesubstance

activesubstancenameRALTEGRAVIR POTASSIUM

openFDA Info on Medication

Application NumberNDA022145, NDA203045, NDA205786Brand NameISENTRESSGeneric NameRALTEGRAVIRManufacturersMerck Sharp & Dohme LLCproduct_ndc0006-0227, 0006-0477, 0006-0473, 0006-3603, 0006-3080Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRALTEGRAVIR POTASSIUMRXCUI 744842, 744846, 1235588, 1235591, 1235593, 1235595, 1486838, 1486841, 1924313, 1 ... spl_id66b7309b-5f40-4c42-abd4-ae9c7772686fspl_set_id89a5ec53-d956-4329-8004-0f40f51c88a3Package NDC 0006-0227-61, 0006-0477-61, 0006-0473-61, 0006-3603-01, 0006-3603-60, 0006-3603- ... UNII43Y000U234

8)

drugcharacterization2medicinalproductISENTRESSdrugdosagetextUNKdrugadministrationroute048actiondrug1

activesubstance

activesubstancenameRALTEGRAVIR POTASSIUM

openFDA Info on Medication

Application NumberNDA022145, NDA203045, NDA205786Brand NameISENTRESSGeneric NameRALTEGRAVIRManufacturersMerck Sharp & Dohme LLCproduct_ndc0006-0227, 0006-0477, 0006-0473, 0006-3603, 0006-3080Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRALTEGRAVIR POTASSIUMRXCUI 744842, 744846, 1235588, 1235591, 1235593, 1235595, 1486838, 1486841, 1924313, 1 ... spl_id66b7309b-5f40-4c42-abd4-ae9c7772686fspl_set_id89a5ec53-d956-4329-8004-0f40f51c88a3Package NDC 0006-0227-61, 0006-0477-61, 0006-0473-61, 0006-3603-01, 0006-3603-60, 0006-3603- ... UNII43Y000U234