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
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abnormal dreams17.15.02.001; 19.02.03.001--Not Available
Alanine aminotransferase13.03.01.031--Not Available
Alanine aminotransferase increased13.03.01.003--
Aspartate aminotransferase13.03.01.032--Not Available
Asthenia08.01.01.001--Not Available
Basedow's disease05.02.02.003; 06.09.04.003; 10.04.08.004--Not Available
Blood bilirubin13.03.01.040--Not Available
Blood bilirubin increased13.03.01.008--
Blood cholesterol13.12.01.014--Not Available
Blood creatine phosphokinase13.04.01.009--Not Available
Blood creatinine increased13.13.01.004--
Blood triglycerides13.12.03.004--Not Available
Breast enlargement21.05.04.001--Not Available
Cachexia08.01.01.009; 14.03.02.001; 16.32.03.011--Not Available
Completed suicide08.04.01.010; 19.12.01.001--Not Available
Cushingoid05.01.01.002; 14.11.01.006; 19.07.03.001; 24.08.02.004--
Depression19.15.01.001--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Dizziness02.01.02.004; 17.02.05.003; 24.06.02.007--
Drug eruption08.01.06.015; 10.01.01.005; 23.03.05.001--Not Available
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Headache17.14.01.001--
Hepatitis09.01.07.004--Not Available
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