Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Atazanavir
Drug ID BADD_D00176
Description Atazanavir (formerly known as BMS-232632) is an antiretroviral drug of the protease inhibitor (PI) class. Like other antiretrovirals, it is used to treat infection of human immunodeficiency virus (HIV). Atazanavir is distinguished from other PIs in that it can be given once-daily (rather than requiring multiple doses per day) and has lesser effects on the patient's lipid profile (the amounts of cholesterol and other fatty substances in the blood). Like other protease inhibitors, it is used only in combination with other HIV medications. The U.S. Food and Drug Administration (FDA) approved atazanavir on June 20, 2003.
Indications and Usage Atazanavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 3 months of age and older weighing at least 5kg.[L37604] Atazanavir is also indicated in combination with [cobicistat] and other antiretrovirals for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35kg.[L37599]
Marketing Status approved; investigational
ATC Code J05AE08
DrugBank ID DB01072
KEGG ID D07471
MeSH ID D000069446
PubChem ID 148192
TTD Drug ID D07IQS
NDC Product Code 65862-711; 65862-713; 65862-712; 69097-443; 69097-444; 69097-446; 31722-654; 65862-710; 42385-922; 69238-1138; 70710-1051; 70710-1052; 70771-1591; 70771-1592; 0003-3622; 42385-921; 0003-3631; 16714-860; 16714-861; 70710-1050; 31722-653; 70771-1593; 69238-1136; 11014-0175; 16714-862; 31722-655; 69097-445; 69238-1135; 69238-1137; 0003-3638; 42385-920
UNII QZU4H47A3S
Synonyms Atazanavir Sulfate | Reyataz | Atazanavir | 3,12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-((4-(2-pyridinyl)phenyl)methyl)-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester | CGP 75176 | CGP75176 | CGP-75176 | CGP 73547 | CGP-73547 | CGP73547 | CGP 75355 | CGP75355 | CGP-75355 | CGP 75136 | CGP75136 | CGP-75136 | BMS-232632-05 | BMS 232632 05 | BMS23263205 | BMS 232632 | 232632, BMS | BMS-232632 | BMS232632
Chemical Information
Molecular Formula C38H52N6O7
CAS Registry Number 198904-31-3
SMILES CC(C)(C)C(C(=O)NC(CC1=CC=CC=C1)C(CN(CC2=CC=C(C=C2)C3=CC=CC=N3)NC(=O)C(C(C)(C)C)N C(=O)OC)O)NC(=O)OC
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)
Dry skin23.03.03.001--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspepsia07.01.02.001--
Dysphagia07.01.06.0030.031508%
Dyspnoea02.11.05.003; 22.02.01.004--
Ear infection04.03.01.006; 11.01.05.001---
Ecchymosis01.01.03.001; 23.06.01.001; 24.07.06.002---
Eczema23.03.04.006--
Electrocardiogram QT prolonged13.14.05.004--
Eosinophilia01.02.04.001--
Erythema multiforme10.01.03.015; 23.03.01.003--
Eye disorder06.08.03.001---
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014---
Flatulence07.01.04.002--
Fluid retention14.05.06.002; 20.01.02.003---
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.016--
Gastritis07.08.02.001--
Gastroenteritis07.19.03.001; 11.01.07.004---
Gastrointestinal disorder07.11.01.0010.001804%-
Gastrointestinal pain07.01.05.005--
Generalised oedema08.01.07.004; 14.05.06.007--
Gout14.09.01.001; 15.01.06.001---
Gynaecomastia05.05.02.003; 21.05.04.003--
Haematuria20.02.01.006; 21.10.01.018; 24.07.01.0470.002405%
Haemoglobin decreased13.01.05.003---
Hallucination19.10.04.003--
Headache17.14.01.001--
Hepatic function abnormal09.01.02.001---
Hepatic pain09.01.05.0050.001804%
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