Adverse Event Report

Report

Version of Safety Report ID5Safety Report ID10644941primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate09/04/2020reporttype1serious1seriousnessother1receivedateformat102Date Received11/12/2014receiptdateformat102Date Last Updated12/02/2020fulfillexpeditecriteria1companynumbJP-009507513-1412JPN003258duplicate1

Report Duplicate

duplicatesourceMERCKduplicatenumbJP-009507513-1412JPN003258

Primary Source

reportercountryJPqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age42Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt22.1ReactionDrug level increasedOutcomeRecovering/resolving

2)

reactionmeddraversionpt22.1ReactionBlood bilirubin increasedOutcomeRecovering/resolving

3)

reactionmeddraversionpt22.1ReactionSuicidal ideationOutcomeUnknown

4)

reactionmeddraversionpt22.1ReactionVentricular extrasystolesOutcomeRecovered/resolved

5)

reactionmeddraversionpt22.1ReactionPsychiatric symptomOutcomeUnknown

6)

reactionmeddraversionpt22.1ReactionOverdoseOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductTRUVADAdrugdosagetextUNKdrugdosageformTABLETdrugadministrationroute048drugindicationHIV INFECTIONactiondrug5drugadditional3

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

2)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3 MILLIGRAM/DAYdrugdosageformTABLETdrugadministrationroute048drugindicationDEPRESSIONactiondrug5drugadditional3

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)

drugcharacterization1medicinalproductISENTRESSdrugauthorizationnumb022145drugstructuredosagenumb400drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext400 MILLIGRAM, BIDdrugdosageformTABLETdrugadministrationroute048actiondrug1drugadditional1

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

4)

drugcharacterization1medicinalproductSTOCRIN TABLETS 600MGdrugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugindicationHIV INFECTIONactiondrug6

activesubstance

activesubstancenameEFAVIRENZ

5)

drugcharacterization1medicinalproductISENTRESSdrugauthorizationnumb022145drugdosagetextUNKdrugdosageformTABLETdrugadministrationroute048drugindicationHIV INFECTIONactiondrug1drugadditional1

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

6)

drugcharacterization2medicinalproductSOLANAXdrugstructuredosagenumb.8drugstructuredosageunit003drugdosagetext0.8 MILLIGRAM/DAYdrugdosageformTABLETdrugadministrationroute048drugindicationDEPRESSIONactiondrug5drugadditional3

activesubstance

activesubstancenameALPRAZOLAM

7)

drugcharacterization1medicinalproductISENTRESSdrugauthorizationnumb022145drugstructuredosagenumb24000drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext24000 MILLIGRAM, QDdrugdosageformTABLETdrugadministrationroute048actiondrug1drugadditional1

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