Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cabotegravir
Drug ID BADD_D02537
Description Cabotegravir, or GSK1265744, is an HIV-1 integrase inhibitor that is prescribed with the non-nucleoside reverse transcriptase inhibitor, [rilpivirine].[A227668,L31188,L31193] Early research into cabotegravir showed it had lower oral bioavailability than [dolutegravir].[A227668] The devlopment of cabotegravir was later developed to create a long acting monthly intramuscular injection.[A227668,L31193] Cabotegravir was granted FDA approval on 21 January 2021.[L31198]
Indications and Usage Oral cabotegravir is indicated in combination with rilpivirine for the short term treatment of HIV-1 in virologically suppressed adults with no history of treatment failure to assess tolerability of cabotegravir or who have missed an injected dose of cabotegravir.[L31188] Intramuscular extended-release cabotegravir is indicated in combination with rilpivirine as a complete regimen for virologically suppressed adults with no history of treatment failure.[L31193] The intramuscular form is meant to replace their current antiretroviral treatment.[L31193]
Marketing Status approved; investigational
ATC Code J05AJ04
DrugBank ID DB11751
KEGG ID D10548
MeSH ID C584914
PubChem ID 54713659
TTD Drug ID D08LDB
NDC Product Code 49702-264; 52482-017
UNII HMH0132Z1Q
Synonyms cabotegravir | (3S,11aR)-N-((2,6-difluoropyridin-3-yl)methyl)-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro(1,3)oxazolo(3,2-a)pyrido(1,2-d)pyrazine-8-carboxamide | cabotegravir sodium | GSK-1265744B | sodium (3S,11aR)-8-(((2,4-difluorophenyl)methyl)carbamoyl)-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydrooxazolo(3,2-a)pyrido(1,2-d)pyrazin-6-olate | S-265744B | GSK1265744B | Vocabria | cabotegravir extended-release injectable suspension | Apretude | GSK1265744 | GSK744 | S-265744 | GSK-1265744A | GSK-1265744 | GSK1265744A | N-((2,4-difluorophenyl)methyl)-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro(1,3)oxazolo(3,2-a)pyrido(1,2-d)pyrazine-8-carboxamide
Chemical Information
Molecular Formula C19H17F2N3O5
CAS Registry Number 1051375-10-0
SMILES CC1COC2N1C(=O)C3=C(C(=O)C(=CN3C2)C(=O)NCC4=C(C=C(C=C4)F)F)O
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)
Abortion spontaneous18.01.04.0010.000565%Not Available
Condition aggravated08.01.03.0040.000423%Not Available
Depression19.15.01.0010.000282%
Diabetes mellitus14.06.01.001; 05.06.01.0010.000282%Not Available
Diabetes mellitus inadequate control14.06.01.004; 05.06.01.0040.000282%Not Available
Erythema23.03.06.0010.000423%Not Available
Haematoma24.07.01.0010.000282%
Hypersensitivity10.01.03.0030.000762%
Injection site extravasation12.07.03.002; 08.02.03.0020.000282%Not Available
Injection site pain12.07.03.011; 08.02.03.0100.000423%Not Available
Malaise08.01.01.0030.000282%
Nausea07.01.07.0010.000565%
Pain08.01.08.0040.000565%
Paralysis17.01.04.0040.000282%Not Available
Presyncope17.02.05.009; 02.11.04.013; 24.06.02.0100.000282%
Suicide attempt19.12.01.0040.000706%
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.000988%
Vasculitis24.12.04.027; 10.02.02.0060.000282%
Vertigo17.02.12.002; 04.04.01.0030.000282%
General physical health deterioration08.01.03.0180.000282%Not Available
Injection site nodule23.07.04.009; 12.07.03.034; 08.02.03.0340.000282%Not Available
Dyslipidaemia14.08.04.0150.000282%Not Available
Erectile dysfunction21.03.01.007; 19.08.04.0010.000282%
Post-traumatic stress disorder19.06.06.0020.000282%Not Available
Injection site panniculitis23.07.02.007; 12.07.03.067; 10.01.03.059; 08.02.03.0670.000282%Not Available
Treatment noncompliance12.09.02.006; 08.06.01.0670.000282%Not Available
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