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)
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--
Osteonecrosis15.02.04.007; 24.04.05.004--
Pancreatitis acute07.18.01.002--Not Available
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Rhabdomyolysis15.05.05.002--
Stevens-Johnson syndrome12.03.01.014; 11.07.01.005; 23.03.01.007; 10.01.01.045--
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 increased13.03.04.028--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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