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)
Lipase increased13.05.01.003--
Low density lipoprotein13.12.01.011--Not Available
Low density lipoprotein increased13.12.01.005--Not Available
Myalgia15.05.02.001--
Nausea07.01.07.001--
Osteonecrosis24.04.05.004; 15.02.04.007--
Pancreatitis acute07.18.01.002--Not Available
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Rhabdomyolysis15.05.05.002--
Stevens-Johnson syndrome23.03.01.007; 12.03.01.014; 11.07.01.005; 10.01.03.020--
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.006--
Urticaria23.04.02.001; 10.01.06.001--
Vomiting07.01.07.003--
Lipase13.05.01.011--Not Available
Body fat disorder14.08.04.012--Not Available
Hepatic enzyme increased13.03.01.019--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Pancreatic enzymes increased13.05.01.004--Not Available
Immune reconstitution inflammatory syndrome08.06.02.014; 10.02.01.043--Not Available
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