Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Elvitegravir
Drug ID BADD_D00762
Description Elvitegravir is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) used for the treatment of HIV-1 infection in antiretroviral treatment-experienced adults. Because integrase is necessary for viral replication, inhibition prevents the integration of HIV-1 DNA into the host genome and thereby blocks the formation of the HIV-1 provirus and resulting propagation of the viral infection. Although available as a single dose tablet, elvitegravir must be used in combination with an HIV protease inhibitor coadministered with ritonavir and another antiretroviral drug. Elvitegravir was first licensed from Japan Tobacco in 2008 and developed by Gilead Sciences. It was FDA approved on August 27, 2012. On September 24, 2014, the FDA approved the single pill form of elvitegravir.
Indications and Usage Elvitegravir in combination with an HIV protease inhibitor coadministered with ritonavir and with other antiretroviral drug(s) is indicated for the treatment of HIV-1 infection in antiretroviral treatment-experienced adults.
Marketing Status approved
ATC Code J05AJ02
DrugBank ID DB09101
KEGG ID D06677
MeSH ID C509700
PubChem ID 5277135
TTD Drug ID D0QD1G
NDC Product Code 69766-027; 65015-839; 66721-600; 48087-0107; 69037-0002; 65015-866
UNII 4GDQ854U53
Synonyms elvitegravir | Vitekta | GS-9137 | GS9137 | GS 9137 | JTK-303 | JTK303 | JTK 303
Chemical Information
Molecular Formula C23H23ClFNO5
CAS Registry Number 697761-98-1
SMILES CC(C)C(CO)N1C=C(C(=O)C2=C1C=C(C(=C2)CC3=C(C(=CC=C3)Cl)F)OC)C(=O)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)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Alanine aminotransferase13.03.04.002--Not Available
Amylase13.05.01.010--Not Available
Aspartate aminotransferase13.03.04.008--Not Available
Asthenia08.01.01.001--Not Available
Blood bilirubin13.03.04.015--Not Available
Blood cholesterol13.12.01.014--Not Available
Blood creatine phosphokinase13.04.01.009--Not Available
Blood triglycerides13.12.03.004--Not Available
Depression19.15.01.001--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.001--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Gamma-glutamyltransferase13.03.04.022--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Glucose urine present13.13.02.001--Not Available
Haematuria21.10.01.018; 20.02.01.006; 24.07.01.047--
Headache17.14.01.001--
Hyperglycaemia14.06.02.002; 05.06.02.002--
Insomnia19.02.01.002; 17.15.03.002--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Neutrophil count13.01.06.046--Not Available
Opportunistic infection11.01.08.007--Not Available
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