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)
Rash pruritic23.03.13.030--Not Available
Rash vesicular23.03.13.0090.000282%Not Available
Renal failure20.01.03.0050.001129%Not Available
Rhabdomyolysis15.05.05.0020.000423%
Seizure17.12.03.0010.000847%
Skin disorder23.03.03.007--Not Available
Sleep disorder19.02.04.0010.001129%Not Available
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.0050.000282%
Stillbirth18.01.02.002; 08.04.01.0060.001411%Not Available
Suicidal ideation19.12.01.0030.001976%
Supraventricular extrasystoles02.03.03.0110.000282%Not Available
Tinnitus17.04.07.004; 04.04.01.0020.001440%
Tremor17.01.06.0020.000903%
Tunnel vision17.17.01.013; 06.02.07.0050.000282%Not Available
Umbilical hernia07.16.03.0010.000423%Not Available
Urethral disorder20.07.01.002--Not Available
Urinary tract disorder20.08.01.001--Not Available
Vaginal haemorrhage24.07.03.005; 21.08.01.0010.000282%
Ventricular extrasystoles02.03.04.0070.000282%Not Available
Vertigo17.02.12.002; 04.04.01.0030.000282%
Vocal cord paralysis22.04.01.002; 17.04.06.0020.000282%
Vomiting07.01.07.003--
Fat redistribution14.08.04.0020.000960%Not Available
Musculoskeletal disorder15.03.05.025--Not Available
Balance disorder08.01.03.081; 17.02.02.0070.000282%Not Available
Lipase13.05.01.011--Not Available
Self-injurious ideation19.12.01.007--Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.0150.000282%Not Available
Musculoskeletal stiffness15.03.05.0270.000282%Not Available
Transaminases increased13.03.04.036--Not Available
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