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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Abortion spontaneous18.01.04.0010.002713%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.001--
Ageusia17.02.07.001; 07.14.03.003--Not Available
Agitation19.06.02.001; 17.02.05.012--
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.001--
Altered state of consciousness19.07.01.003; 17.02.04.001--Not Available
Amnesia17.03.02.001; 19.20.01.0010.003662%
Amylase increased13.05.01.009--
Anaemia01.03.02.001--
Angina pectoris02.02.02.002; 24.04.04.002--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.0020.006917%
Aphthous ulcer07.05.06.002--Not Available
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
B-cell lymphoma16.28.01.001; 01.15.01.001--Not Available
Blood bilirubin increased13.03.04.018--
Blood cholesterol increased13.12.01.002--
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine decreased13.13.01.003--Not Available
Blood creatinine increased13.13.01.004--
Blood thyroid stimulating hormone increased13.10.03.006--
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