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)
Gastritis07.08.02.001--
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.0010.002984%Not Available
Gastrointestinal pain07.01.05.005--
Generalised tonic-clonic seizure17.12.01.002--Not Available
Gout15.01.06.001; 14.09.01.001--Not Available
Gynaecomastia21.05.04.003; 05.05.02.003--
Haematemesis24.07.02.011; 07.12.02.002--Not Available
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.006--
Haemoglobin13.01.05.018--Not Available
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.001--Not Available
Hepatic failure09.01.03.0020.002034%
Hepatic steatosis09.01.07.003; 14.08.04.005--Not Available
Hepatitis09.01.07.004--Not Available
Hepatitis acute09.01.07.005--Not Available
Hepatitis B11.05.28.003; 09.01.09.003--
Hepatitis C11.05.28.004; 09.01.09.005--Not Available
Hepatitis viral09.01.09.007; 11.05.04.011--
Hepatomegaly09.01.05.001--Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.002984%Not Available
Herpes simplex23.11.05.004; 11.05.02.001--Not Available
Hiccups07.01.06.009; 22.12.01.001--
High density lipoprotein decreased13.12.01.003--Not Available
Hodgkin's disease16.31.01.001; 01.16.01.0010.001356%Not Available
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.003--Not Available
Hypercholesterolaemia14.08.01.001--Not Available
Hyperglycaemia05.06.02.002; 14.06.02.002--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hyperkalaemia14.05.03.001--
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