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)
Skin hypopigmentation23.05.02.0030.000381%
Skin irritation23.03.04.0090.000246%Not Available
Skin reaction23.03.03.013; 10.01.03.0190.000492%Not Available
Stomatitis07.05.06.0050.002697%
Supraventricular tachycardia02.03.03.0120.000246%
Swelling face10.01.05.018; 08.01.03.100; 23.04.01.0180.000604%Not Available
Tendonitis15.07.01.003; 12.01.07.0070.000246%Not Available
Thrombocytopenia01.08.01.0020.001231%Not Available
Tooth disorder07.09.05.0010.000246%Not Available
Toothache07.09.06.0010.000112%
Torsade de pointes02.03.04.0050.000112%Not Available
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.000168%
Tumour pain16.32.03.0030.000112%
Ulcer08.03.06.0010.000414%Not Available
Vena cava thrombosis24.01.10.0010.000112%Not Available
Ventricular arrhythmia02.03.04.0060.000112%
Ventricular tachycardia02.03.04.0100.000112%
Vitreous floaters06.09.01.0050.000381%
Vomiting07.01.07.0030.009033%
Vulvovaginal discomfort21.08.02.0050.000246%Not Available
Mobility decreased15.03.05.023; 17.02.05.018; 08.01.03.0300.000358%Not Available
Cardiotoxicity02.11.01.009; 12.03.01.0070.000582%Not Available
Onychoclasis23.02.05.0050.000168%Not Available
Peripheral swelling08.01.03.053; 02.05.04.0150.002171%Not Available
Brain oedema17.07.02.003; 12.01.10.0100.000112%
Osteopenia15.02.03.003; 14.04.04.0040.000112%Not Available
General physical health deterioration08.01.03.0180.001254%Not Available
Left ventricular hypertrophy02.04.02.0140.000168%Not Available
Dysstasia15.03.05.011; 08.01.03.089; 17.02.02.0120.000112%Not Available
Musculoskeletal chest pain22.09.01.001; 15.03.04.0120.000358%
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