Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dolutegravir sodium
Drug ID BADD_D00704
Description Dolutegravir is a HIV-1 intergrase inhibitor that blocks the strand transfer step of the integration of the viral genome into the host cell (INSTI).[A7514] The effect of this drug has no homology in human host cells which gives it an excellent tolerability and minimal toxicity.[A31342] Dolutegravir was developed by ViiV Healthcare and FDA approved on August 12, 2013.[L1035] On November 21, 2017, dolutegravir, in combination with rilpivirine, was approved as part of the first complete treatment regimen with only two drugs for the treatment of adults with HIV-1 named Juluca.[L1031]
Indications and Usage Dolutegravir is indicated in combination with other antiretroviral agents for the treatment of patients with HIV-1 infection that comply with the characteristics of being adults or children aged 12 years and older and present at least a weight of 40 kg.[A7520] The FDA combination therapy approval of dolutegravir and rilpivirine is indicated for adults with HIV-1 infections whose virus is currently suppressed (< 50 copies/ml) on a stable regimen for at least six months, without history of treatment failure and no known substitutions associated to resistance to any of the two components of the therapy.[L1031]
Marketing Status Prescription
ATC Code J05AJ03
DrugBank ID DB08930
KEGG ID D10113
MeSH ID C562325
PubChem ID 46216142
TTD Drug ID D00YZD
NDC Product Code 63379-067; 49702-228; 49702-255; 70518-1487; 63379-062; 69766-023; 52482-016; 53808-1130; 49702-226; 65862-962; 49702-227; 53044-001; 68554-0093; 69037-0044; 63379-077; 42931-242; 63379-063
Synonyms dolutegravir | (4R,9aS)-5-hydroxy-4-methyl-6,10-dioxo-3,4,6,9,9a,10-hexahydro-2H-1-oxa-4a,8a-diaza-anthracene-7-carboxylic acid- 2,4 difluorobenzylamide | (4R,12aS)-N-((2,4-difluorophenyl)methyl)-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2H-Pyrido(1',2':4,5)pyrazino(2,1-b)(1,3)oxazine-9-carboxamide | dolutegravir sodium | S-GSK1349572 | GSK-1349572 | dolutegravir sodium monohydrate | Tivicay | GSK 1349572A | GSK1349572A
Chemical Information
Molecular Formula C20H18F2N3NaO5
CAS Registry Number 1051375-19-9
SMILES CC1CCOC2N1C(=O)C3=C(C(=O)C(=CN3C2)C(=O)NCC4=C(C=C(C=C4)F)F)[O-].[Na+]
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Hepatitis C11.05.06.004; 09.01.09.005--Not Available
High density lipoprotein13.12.01.015--Not Available
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hypersensitivity10.01.03.003--
Immune system disorder10.02.01.001--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Low density lipoprotein13.12.01.011--Not Available
Myositis15.05.01.001--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Neutropenia01.02.03.004--Not Available
Neutrophil count13.01.06.046--Not Available
Opportunistic infection11.01.08.007--Not Available
Prurigo23.03.04.017--Not Available
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Rash generalised23.03.13.002--Not Available
Rash macular23.03.13.003--Not Available
Rash maculo-papular23.03.13.004--
Rash pruritic23.03.12.002--Not Available
Renal failure20.01.03.005--Not Available
Skin disorder23.03.03.007--Not Available
Suicidal ideation19.12.01.003--
Urethral disorder20.07.01.002--Not Available
Urinary tract disorder20.08.01.001--Not Available
Vertigo17.02.12.002; 04.04.01.003--
Vomiting07.01.07.003--
Fat redistribution14.08.04.002--Not Available
Musculoskeletal disorder15.03.01.004--Not Available
Lipase13.05.01.011--Not Available
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