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)
Pigmentation disorder23.05.03.0010.000168%Not Available
Metastasis16.22.01.0010.000336%Not Available
Renal impairment20.01.03.0100.001869%Not Available
Poor quality sleep19.02.05.005; 17.15.04.0020.000112%Not Available
Pelvic discomfort20.02.03.012; 07.01.06.020; 21.10.01.0120.000112%Not Available
Chronic kidney disease20.01.03.0170.000224%
Cytopenia01.03.03.0120.000548%Not Available
Treatment failure08.06.01.017--Not Available
Liver injury09.01.07.022; 12.01.17.0120.000168%Not Available
Type 2 diabetes mellitus14.06.01.003; 05.06.01.003--Not Available
Hypertransaminasaemia09.01.02.0050.000392%Not Available
Hepatic cancer16.07.02.004; 09.04.02.0080.000280%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000280%
Bone cancer16.29.02.002; 15.09.03.0120.000112%Not Available
Breast cancer recurrent21.05.01.017; 16.10.01.0090.000112%Not Available
Dermatitis exfoliative generalised23.03.07.002; 10.01.01.0290.000112%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.001175%Not Available
Metastases to lymph nodes16.22.02.006; 01.09.01.0150.000168%Not Available
Metastases to pleura22.05.04.002; 16.22.02.0220.000168%Not Available
Recurrent cancer16.16.01.0150.000168%Not Available
Metastases to bone marrow16.22.02.013; 01.05.01.0220.000112%Not Available
Metastases to meninges16.22.02.003; 17.02.10.0120.000112%Not Available
Breast cancer metastatic21.05.01.016; 16.10.01.0080.002854%Not Available
Cell death14.11.02.005; 08.03.03.0030.000112%Not Available
Negative thoughts19.15.02.0120.000112%Not Available
Bone marrow infiltration01.05.01.0180.000168%Not Available
Cardiac dysfunction02.11.01.0040.000112%Not Available
Elliptocytosis01.07.02.0140.000112%Not Available
Hepatic cytolysis09.01.07.0360.000168%Not Available
Illness08.01.03.0910.000660%Not Available
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