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%-
Metastasis16.22.01.0010.000336%-
Renal impairment20.01.03.0100.001869%-
Poor quality sleep17.15.04.002; 19.02.05.0050.000112%-
Pelvic discomfort07.01.06.020; 20.02.03.012; 21.10.01.0120.000112%-
Chronic kidney disease20.01.03.0170.000224%
Cytopenia01.03.03.0120.000548%-
Treatment failure08.06.01.017---
Liver injury09.01.07.022; 12.01.17.0120.000168%-
Type 2 diabetes mellitus05.06.01.003; 14.06.01.003---
Hypertransaminasaemia09.01.02.0050.000392%-
Hepatic cancer09.04.02.008; 16.07.02.0040.000280%-
Multiple organ dysfunction syndrome08.01.03.0570.000280%
Bone cancer15.09.03.012; 16.29.02.0020.000112%-
Breast cancer recurrent16.10.01.009; 21.05.01.0170.000112%-
Dermatitis exfoliative generalised10.01.01.029; 23.03.07.0020.000112%-
Metastases to bone15.09.03.006; 16.22.02.0050.001175%-
Metastases to lymph nodes01.09.01.015; 16.22.02.0060.000168%-
Metastases to pleura16.22.02.022; 22.05.04.0020.000168%-
Recurrent cancer16.16.01.0150.000168%-
Metastases to bone marrow01.05.01.022; 16.22.02.0130.000112%-
Metastases to meninges16.22.02.003; 17.02.10.0120.000112%-
Breast cancer metastatic16.10.01.008; 21.05.01.0160.002854%-
Cell death08.03.03.003; 14.11.02.0050.000112%-
Negative thoughts19.15.02.0120.000112%-
Bone marrow infiltration01.05.01.0180.000168%-
Cardiac dysfunction02.11.01.0040.000112%-
Elliptocytosis01.07.02.0140.000112%-
Hepatic cytolysis09.01.07.0360.000168%-
Illness08.01.03.0910.000660%-
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