Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Darunavir ethanolate
Drug ID BADD_D00587
Description Darunavir is a protease inhibitor used with other HIV protease inhibitor drugs as well as [ritonavir] for the effective management of HIV-1 infection.[L9227] As a second-generation protease inhibitor, darunavir is designed to combat resistance to standard HIV therapy.[A2278,A2281] It was initially approved by the FDA in 2006.[L9227] Darunavir is being studied as a possible treatment for SARS-CoV-2, the coronavirus responsible for COVID-19, due to in vitro evidence supporting its ability to combat this infection.[A191682] Clinical trials are underway and are expected to conclude in August 2020.[L12066]
Indications and Usage Darunavir, co-administered with ritonavir, and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.
Marketing Status Prescription; Discontinued
ATC Code J05AE10
DrugBank ID DB01264
KEGG ID D06478
MeSH ID D000069454
PubChem ID 23725083
TTD Drug ID D03IGH
NDC Product Code 17314-609; 65267-210; 68554-0113; 53104-7693; 69766-013; 17314-605; 75877-0007; 17314-603; 17314-607; 50370-0042
Synonyms Darunavir | Prezista | UIC-94017 | UIC 94017 | UIC94017 | Darunavir Ethanolate | Ethanolate, Darunavir | TMC 114 | 114, TMC | TMC114 | TMC-114
Chemical Information
Molecular Formula C29H43N3O8S
CAS Registry Number 635728-49-3
SMILES CCO.CC(C)CN(CC(C(CC1=CC=CC=C1)NC(=O)OC2COC3C2CCO3)O)S(=O)(=O)C4=CC=C(C=C4)N
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
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--
Abnormal dreams17.15.02.001; 19.02.03.001--Not Available
Alanine aminotransferase13.03.01.031--Not Available
Alanine aminotransferase increased13.03.01.003--
Amylase13.05.01.010--Not Available
Amylase increased13.05.01.009--
Angioedema23.04.01.001; 10.01.05.009--Not Available
Aspartate aminotransferase13.03.01.032--Not Available
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Blood alkaline phosphatase13.04.02.010--Not Available
Blood cholesterol13.12.01.014--Not Available
Blood cholesterol increased13.12.01.002--
Blood glucose increased13.02.02.002--Not Available
Blood triglycerides13.12.03.004--Not Available
Diabetes mellitus05.06.01.001; 14.06.01.001--Not Available
Diarrhoea07.02.01.001--
Dyspepsia07.01.02.001--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Headache17.14.01.001--
Hepatitis09.01.07.004--Not Available
Hepatitis acute09.01.07.005--Not Available
Hepatotoxicity12.03.01.008; 09.01.07.009--Not Available
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.003--Not Available
Hypercholesterolaemia14.08.01.001--Not Available
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hypersensitivity10.01.03.003--
Hypertriglyceridaemia14.08.02.001--
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