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 approved
ATC Code J05AJ03
DrugBank ID DB08930
KEGG ID D10113
MeSH ID C562325
PubChem ID 46216142
TTD Drug ID D00YZD
NDC Product Code 42931-242; 65862-962; 53808-1130; 52482-016; 68554-0093; 49702-255; 53044-001; 63379-067; 63379-077; 69766-023; 63379-062; 63379-063; 82245-0202; 49702-226; 49702-227; 49702-228; 69037-0044
UNII 1Q1V9V5WYQ
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
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Foetal death18.01.02.003; 08.04.01.0110.000706%
Facial wasting14.08.04.004; 23.07.01.004--Not Available
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.000282%Not Available
Drug resistance08.06.01.0050.001185%Not Available
Hot flush21.02.02.001; 08.01.03.027; 24.03.01.0050.000621%
Inflammation10.02.01.089; 08.01.05.007--Not Available
Mental disorder19.07.01.0020.000423%Not Available
Erectile dysfunction21.03.01.007; 19.08.04.0010.000621%
Ill-defined disorder08.01.03.0490.000282%Not Available
Autoimmune disorder10.04.04.003--
Psychotic disorder19.03.01.0020.000565%
Hepatobiliary disease09.01.08.003--Not Available
Renal impairment20.01.03.0100.000988%Not Available
Lipohypertrophy23.07.01.005; 14.08.04.009--
Pulmonary arterial hypertension22.06.01.002; 24.08.03.0030.000282%Not Available
Immune reconstitution inflammatory syndrome10.02.01.043; 08.06.02.0140.001976%Not Available
Suicidal behaviour19.12.01.006--Not Available
Central obesity14.03.02.011--Not Available
Liver injury12.01.17.012; 09.01.07.022--Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.0040.000565%
Foetal growth restriction18.03.01.0020.000423%
Drug reaction with eosinophilia and systemic symptoms23.03.05.005; 10.01.01.021; 12.03.01.0640.000423%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000282%
Live birth18.08.02.0070.000903%Not Available
Morton's neuralgia17.02.07.0220.000282%Not Available
Cell death14.11.02.005; 08.03.03.0030.000282%Not Available
Asthmatic crisis22.03.01.0180.000423%Not Available
End stage renal disease20.01.03.0190.000621%Not Available
Anembryonic gestation18.01.03.0070.000282%Not Available
Disease complication08.01.03.0870.000282%Not Available
The 6th Page    First    Pre   6 7    Next   Last    Total 7 Pages