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)
Shock24.06.02.002--Not Available
Sinus bradycardia02.03.03.009--
Skin disorder23.03.03.007--Not Available
Skin lesion23.03.03.010--Not Available
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Stomatitis07.05.06.005--
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.0180.002984%Not Available
Syncope24.06.02.012; 02.11.04.015; 17.02.04.008--
Tachycardia02.03.02.007--Not Available
Throat irritation22.12.03.029; 07.05.05.037--Not Available
Thrombocytopenia01.08.01.0020.002034%Not Available
Tinnitus04.04.01.002; 17.04.07.0040.001356%
Tongue coated07.14.02.011--Not Available
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.006--
Transient ischaemic attack24.04.06.005; 17.08.04.001--
Urethral disorder20.07.01.002--Not Available
Urinary tract disorder20.08.01.001--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Vasculitis24.12.04.027; 10.02.02.0060.002984%
Vertigo17.02.12.002; 04.04.01.003--
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Xeroderma23.01.02.003--Not Available
Xerosis08.01.03.016--Not Available
Fat redistribution14.08.04.002--Not Available
Acute generalised exanthematous pustulosis11.07.01.018; 10.01.01.034; 23.03.10.002; 12.03.01.005--Not Available
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