Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cobicistat
Drug ID BADD_D00512
Description Cobicistat, marketed under the name Tybost (formerly GS-9350), indicated for treating infection with human immunodeficiency virus (HIV). Although it does not have any anti-HIV activity, cobicistat acts as a pharmacokinetic enhancer by inhibiting cytochrome P450 3A isoforms (CYP3A) and therefore increases the systemic exposure of coadministered agents that are metabolized by CYP3A enzymes. More specifically, cobicistat is indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection. Increasing systemic exposure of anti-retrovirals (ARVs) without increasing dosage allows for better treatment outcomes and a decreased side effect profile.
Indications and Usage Cobicistat is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection. It is not interchangeable with ritonavir to increase systemic exposure of darunavir 600 mg twice daily, fosamprenavir, saquinavir, or tipranavir due to lack of exposure data. The use of cobicistat is not recommended with darunavir 600 mg twice daily, fosamprenavir, saquinavir or tipranavir. Complex or unknown mechanisms of drug interactions preclude extrapolation of ritonavir drug interactions to certain cobicistat interactions. Cobicistat and ritonavir when administered with either atazanavir or darunavir may result in different drug interactions when used with concomitant medications.
Marketing Status approved
ATC Code V03AX03
DrugBank ID DB09065
KEGG ID D09881
MeSH ID D000069547
PubChem ID 25151504
TTD Drug ID D02VJP
NDC Product Code 63285-889; 66721-500; 54014-9350; 57572-0035; 61958-1401
UNII LW2E03M5PG
Synonyms Cobicistat | Tybost | GS 9350 | 9350, GS | GS9350 | GS-9350
Chemical Information
Molecular Formula C40H53N7O5S2
CAS Registry Number 1004316-88-4
SMILES CC(C)C1=NC(=CS1)CN(C)C(=O)NC(CCN2CCOCC2)C(=O)NC(CCC(CC3=CC=CC=C3)NC(=O)OCC4=CN=C S4)CC5=CC=CC=C5
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)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Alanine aminotransferase13.03.04.002--Not Available
Amylase13.05.01.010--Not Available
Aspartate aminotransferase13.03.04.008--Not Available
Asthenia08.01.01.001--Not Available
Blood bilirubin13.03.04.015--Not Available
Blood bilirubin increased13.03.04.018--
Blood creatine phosphokinase13.04.01.009--Not Available
Body temperature increased13.15.01.001--Not Available
Depression19.15.01.001--
Dermatitis23.03.04.002--Not Available
Dermatitis allergic23.03.04.003; 10.01.03.014--Not Available
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Drug hypersensitivity10.01.01.001--Not Available
Dry mouth07.06.01.002--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.001--
Eye disorder06.08.03.001--Not Available
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Gamma-glutamyltransferase13.03.04.022--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Glucose urine present13.13.02.001--Not Available
Haematuria24.07.01.047; 20.02.01.006; 21.10.01.018--
Headache17.14.01.001--
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