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)
Pain in extremity15.03.04.010--
Palpitations02.11.04.012--
Pancreatitis07.18.01.0010.002034%
Pancreatitis acute07.18.01.0020.001356%Not Available
Pancreatitis chronic07.18.01.007--Not Available
Pancytopenia01.03.03.003--Not Available
Paraesthesia23.03.03.094; 17.02.06.005--
Petit mal epilepsy17.12.04.001--Not Available
Pneumothorax22.05.02.003--
Pollakiuria20.02.02.007--
Polydipsia14.05.02.001; 05.03.03.002--Not Available
Polyuria20.02.03.002--Not Available
Progressive multifocal leukoencephalopathy17.16.02.002; 11.05.05.001--Not Available
Proteinuria20.02.01.011--
Prurigo23.03.04.017--Not Available
Pruritus23.03.12.0010.012885%
Rash23.03.13.0010.050183%Not Available
Rash erythematous23.03.13.0290.004611%Not Available
Rash maculo-papular23.03.13.004--
Rash pruritic23.03.13.0300.002984%Not Available
Rectal haemorrhage07.12.03.001; 24.07.02.018--
Renal failure20.01.03.0050.002034%Not Available
Renal tubular necrosis20.01.07.0030.001356%Not Available
Respiratory failure22.02.06.002; 14.01.04.003--
Retching07.01.07.002--Not Available
Rhabdomyolysis15.05.05.002--
Rhinorrhoea22.12.03.021--
Seborrhoeic dermatitis23.03.04.018--Not Available
Seizure17.12.03.001--
Sepsis11.01.11.003--
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