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) 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 D03656
MeSH ID D000069454
PubChem ID 213039
TTD Drug ID D03IGH
NDC Product Code 70518-1483; 59676-566; 50370-0037; 68554-0035; 59676-562; 65015-880; 59676-564; 59676-563; 68554-0114; 65015-761; 42385-728; 47621-302; 53104-7694; 59676-565
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
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)
Hyperkalaemia14.05.03.001--
Hyperlactacidaemia14.01.01.006--Not Available
Hypernatraemia14.05.04.001--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypertriglyceridaemia14.08.02.001--
Hyperuricaemia14.09.01.003--
Hypoaesthesia17.02.06.023--Not Available
Hypoalbuminaemia14.10.01.002; 09.01.02.003--
Hypocalcaemia14.04.01.004--
Hypoglycaemia14.06.03.001; 05.06.03.001--
Hyponatraemia14.05.04.002--
Hypothyroidism14.11.01.012; 05.02.03.001--
Immune system disorder10.02.01.001--Not Available
Increased appetite08.01.09.027; 14.03.01.003--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Insulin resistance14.06.02.003; 05.06.02.003--Not Available
Irritability19.04.02.013; 08.01.03.011--
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.004--Not Available
Joint stiffness15.01.02.003--Not Available
Lethargy17.02.04.003; 08.01.01.008; 19.04.04.004--
Leukopenia01.02.02.001--Not Available
Libido decreased21.03.02.005; 19.08.03.001--
Lip dry07.06.01.003--Not Available
Lipase increased13.05.01.003--
Lipoatrophy23.07.01.001; 14.08.04.006--
Liver disorder09.01.08.0010.009324%Not Available
Liver function test abnormal13.03.01.0130.009324%Not Available
Loss of consciousness17.02.04.004--Not Available
Low density lipoprotein increased13.12.01.005--Not Available
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