Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ribociclib
Drug ID BADD_D02483
Description Ribociclib is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably. Ribociclib was approved by the U.S. FDA in March, 2017 as Kisqali.
Indications and Usage Kisqali (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.
Marketing Status approved; investigational
ATC Code L01EF02
DrugBank ID DB11730
KEGG ID D10883
MeSH ID C000589651
PubChem ID 44631912
TTD Drug ID D08MXP
NDC Product Code 0078-0860; 0078-0874; 0078-0867
UNII TK8ERE8P56
Synonyms ribociclib | LEE011 | Kisqali
Chemical Information
Molecular Formula C23H30N8O
CAS Registry Number 1211441-98-3
SMILES CN(C)C(=O)C1=CC2=CN=C(N=C2N1C3CCCC3)NC4=NC=C(C=C4)N5CCNCC5
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 discomfort07.01.06.001---
Abdominal distension07.01.04.0010.001377%
Abdominal pain07.01.05.0020.002183%
Acute hepatic failure09.01.03.0010.000168%-
Acute myeloid leukaemia16.01.05.001; 01.10.05.0010.000224%-
Acute respiratory distress syndrome10.02.01.067; 22.01.03.001; 24.03.02.0340.000168%
Acute respiratory failure22.02.06.001; 14.01.04.0040.000168%-
Alopecia23.02.02.0010.007107%
Anaemia01.03.02.0010.002183%
Angina pectoris24.04.04.002; 02.02.02.0020.000280%
Anisocytosis01.07.02.0080.000168%-
Aortic valve incompetence02.07.03.0010.000112%-
Arrhythmia02.03.02.0010.000862%-
Arrhythmia supraventricular02.03.03.0010.000112%-
Arterial thrombosis24.01.01.0020.000112%-
Arthralgia15.01.02.0010.003839%
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.000839%
Asthenia08.01.01.0010.004287%-
Atrial fibrillation02.03.03.0020.001119%
Atrial flutter02.03.03.0030.000168%
Autoimmune hepatitis10.04.09.001; 09.01.07.0190.000112%-
Back pain15.03.04.0050.003324%
Benign breast neoplasm16.14.01.005; 21.05.01.0090.000112%-
Blister23.03.01.001; 12.01.06.0020.001175%-
Bone disorder15.02.04.0040.000112%-
Bone pain15.02.01.0010.001019%
Breast cancer21.05.01.003; 16.10.01.0010.002518%-
Breast mass21.05.04.0020.000168%-
Breast neoplasm16.10.02.001; 21.05.01.0040.000112%-
Breast pain21.05.05.0030.000112%
The 1th Page    1 2 3 4 5    Next   Last    Total 10 Pages