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) in children age 3 or above and adults with HIV-1 infection.[L9227]
Marketing Status approved
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; 75877-0007; 17314-603; 53104-7693; 69766-013; 17314-605; 50370-0042; 68554-0113; 17314-607
UNII 33O78XF0BW
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
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--
Abnormal dreams17.15.02.001; 19.02.03.001---
Alanine aminotransferase13.03.04.002---
Alanine aminotransferase increased13.03.04.005--
Amylase13.05.01.010---
Amylase increased13.05.01.009--
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001---
Aspartate aminotransferase13.03.04.008---
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001---
Blood alkaline phosphatase13.04.02.010---
Blood cholesterol13.12.01.014---
Blood cholesterol increased13.12.01.002--
Blood glucose increased13.02.02.002---
Blood triglycerides13.12.03.004---
Diabetes mellitus05.06.01.001; 14.06.01.001---
Diarrhoea07.02.01.001--
Dyspepsia07.01.02.001--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Headache17.14.01.001--
Hepatitis09.01.07.004---
Hepatitis acute09.01.07.005---
Hepatotoxicity09.01.07.009; 12.03.01.008---
Hyperbilirubinaemia01.06.04.003; 09.01.01.003; 14.11.01.010---
Hypercholesterolaemia14.08.01.001---
Hyperglycaemia05.06.02.002; 14.06.02.002--
Hypersensitivity10.01.03.003--
Hypertriglyceridaemia14.08.02.001--
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