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
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
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)
Abdominal discomfort07.01.06.0010.006216%Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abnormal dreams19.02.03.001; Available
Abortion spontaneous18.01.04.0010.018649%Not Available
Acute myocardial infarction24.04.04.001; Available
Acute respiratory distress syndrome22.01.03.001--
Ageusia17.02.07.001; Available
Alanine aminotransferase increased13.03.01.003--
Altered state of consciousness19.07.01.003; Available
Amylase increased13.05.01.009--
Angina pectoris02.02.02.002;
Angioedema23.04.01.001; Available
Aphthous ulcer07.05.06.002--Not Available
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
B-cell lymphoma16.28.01.001; Available
Basedow's disease10.04.08.004;; Available
Blood bilirubin increased13.03.01.008--
Blood cholesterol increased13.12.01.0020.009324%
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine decreased13.13.01.003--Not Available
Blood creatinine increased13.13.01.004--
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