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)
Madarosis06.06.04.010; 23.02.02.0040.000381%Not Available
Malignant neoplasm progression16.16.01.0050.006469%Not Available
Musculoskeletal discomfort15.03.04.0010.000302%Not Available
Pulmonary mass22.02.07.0040.000168%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.000571%Not Available
Paraesthesia oral07.05.05.035; 17.02.06.0080.000112%Not Available
Breast cancer female21.05.01.011; 16.10.01.0040.000246%Not Available
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.000112%Not Available
Bicytopenia01.03.03.0100.000224%Not Available
Metastases to central nervous system17.02.10.013; 16.22.02.0040.000560%Not Available
Skin toxicity23.03.03.032; 12.03.01.0200.000168%Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.0270.003089%
Breast disorder21.05.04.0040.000168%Not Available
Cardiac disorder02.11.01.0030.001019%Not Available
Haematotoxicity01.05.01.007; 12.03.01.0250.000448%Not Available
Infarction24.04.02.0170.000112%Not Available
Inflammation08.01.05.007; 10.02.01.0890.000168%Not Available
Limb discomfort15.03.04.0140.000302%Not Available
Metastatic neoplasm16.16.01.0070.000112%Not Available
Neoplasm progression16.16.02.0050.000638%Not Available
White blood cell disorder01.02.05.0020.000492%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.004958%
Renal injury20.01.03.015; 12.01.05.0010.000112%Not Available
Ill-defined disorder08.01.03.0490.000504%Not Available
Mitral valve disease02.07.01.0030.000112%
Blood disorder01.05.01.0040.000112%Not Available
Immunodeficiency10.03.02.0020.000168%Not Available
Disease progression08.01.03.0380.008887%
Drug intolerance08.06.01.013--Not Available
Hepatic lesion09.01.08.0050.000224%Not Available
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