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)
Osteopenia15.02.03.003; 14.04.04.004--Not Available
Lipodystrophy acquired23.07.01.003; 14.08.04.0080.001356%Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Conjunctival hyperaemia06.04.01.004--Not Available
Lymphatic disorder01.09.01.003--Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Protein urine present13.13.02.006--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Affect lability19.04.01.001--Not Available
Pharyngeal lesion22.04.05.011--Not Available
Body fat disorder14.08.04.012--Not Available
Haemorrhage24.07.01.002--Not Available
Toxic skin eruption23.03.05.003; 10.01.01.008; 12.03.01.073--Not Available
Dyslipidaemia14.08.04.0150.002713%Not Available
Nail pigmentation23.02.05.007--Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Angiopathy24.03.02.007--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Drug resistance08.06.01.0050.009223%Not Available
Urine output increased13.13.03.002--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Ischaemic cerebral infarction24.04.06.013; 17.08.01.022--Not Available
Adverse event08.06.01.0100.015326%Not Available
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.003--Not Available
Clostridial infection11.02.02.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Inflammation08.01.05.007; 10.02.01.089--Not Available
Malnutrition14.03.02.004--Not Available
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