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)
Blood thyroid stimulating hormone increased13.10.03.006--
Blood triglycerides increased13.12.03.001--Not Available
Blood uric acid increased13.02.04.001--Not Available
Body temperature increased13.15.01.001--Not Available
Bradycardia02.03.02.002--Not Available
Breast enlargement21.05.04.001--Not Available
Calculus urinary20.04.02.0010.006216%Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Cheilitis23.03.03.025; 07.05.01.001--
Chest pain02.02.02.011; 22.02.08.003; 08.01.08.002--Not Available
Chills15.05.03.016; 08.01.09.001--
Cholelithiasis09.03.01.0020.006216%Not Available
Cholestasis09.01.01.001--Not Available
Chronic hepatitis B11.05.06.005; 09.01.09.008--Not Available
Coma17.02.09.0010.006216%Not Available
Completed suicide08.04.01.010; 19.12.01.001--Not Available
Confusional state19.13.01.001; 17.02.03.005--
Constipation07.02.02.001--
Cough22.02.03.001--
Cryptosporidiosis infection11.06.02.001; 07.19.03.002--Not Available
Death08.04.01.001--
Dermatitis23.03.04.002--Not Available
Dermatitis atopic10.01.04.004; 23.03.04.016--Not Available
Diabetes mellitus14.06.01.001; 05.06.01.0010.006216%Not Available
Diarrhoea07.02.01.0010.037298%
Discomfort08.01.08.003--Not Available
Disorientation19.13.01.002; 17.02.05.015--Not Available
Disturbance in attention17.03.03.001; 19.21.02.002--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Drug eruption23.03.05.001; 10.01.01.005; 08.01.06.015--Not Available
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