Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Darunavir
Drug ID BADD_D00586
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 D03656
MeSH ID D000069454
PubChem ID 213039
TTD Drug ID D03IGH
NDC Product Code 59676-562; 59676-566; 50370-0037; 68180-345; 47621-302; 53104-7694; 59676-565; 68180-346; 59676-564; 68554-0035; 0480-7736; 69037-0073; 42385-728; 65015-880; 65015-761; 68554-0114; 59676-563
UNII YO603Y8113
Synonyms Darunavir | Prezista | UIC-94017 | UIC 94017 | UIC94017 | Darunavir Ethanolate | Ethanolate, Darunavir | TMC 114 | 114, TMC | TMC114 | TMC-114
Chemical Information
Molecular Formula C27H37N3O7S
CAS Registry Number 206361-99-1
SMILES 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)
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Decreased appetite08.01.09.028; 14.03.01.005--
Erectile dysfunction21.03.01.007; 19.08.04.001--
Ill-defined disorder08.01.03.049--Not Available
Inner ear disorder04.04.02.002--Not Available
Blood disorder01.05.01.004--Not Available
Adverse drug reaction08.06.01.0090.002034%Not Available
Autoimmune disorder10.04.04.003--
Drug intolerance08.06.01.0130.004747%Not Available
Pancreatic enzymes increased13.05.01.004--Not Available
Hepatobiliary disease09.01.08.003--Not Available
Hyperlipidaemia14.08.03.001--
Renal impairment20.01.03.010--Not Available
Lipohypertrophy23.07.01.005; 14.08.04.009--
Immune reconstitution inflammatory syndrome08.06.02.014; 10.02.01.043--Not Available
Treatment failure08.06.01.0170.005290%Not Available
Burning mouth syndrome17.02.06.016; 07.05.05.013--Not Available
Acute kidney injury20.01.03.016--
Drug-induced liver injury12.03.01.044; 09.01.07.0230.001356%Not Available
Hepatic cancer16.07.02.004; 09.04.02.008--Not Available
Drug reaction with eosinophilia and systemic symptoms12.03.01.064; 10.01.01.021; 23.03.05.0050.001356%Not Available
Throat cancer22.08.02.008; 16.19.02.0070.001356%Not Available
Congenital musculoskeletal disorder15.11.06.010; 03.11.06.010--Not Available
Graves' disease10.04.08.014; 06.09.04.009; 05.02.02.009--Not Available
Irregular sleep wake rhythm disorder19.02.06.005; 17.15.06.005--Not Available
Treatment noncompliance12.09.02.006; 08.06.01.0670.017496%Not Available
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