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)
Malaise08.01.01.0030.003212%
Menopausal symptoms21.02.02.0020.000112%Not Available
Metastases to liver16.22.02.001; 09.04.02.0040.001959%Not Available
Metastases to lung22.08.01.005; 16.22.02.0020.000951%Not Available
Metastases to spine16.22.02.007; 15.09.03.0070.000224%Not Available
Mouth ulceration07.05.06.0040.000548%Not Available
Mucosal inflammation08.01.06.0020.000795%Not Available
Musculoskeletal pain15.03.04.0070.000985%
Myocardial infarction24.04.04.009; 02.02.02.0070.000783%
Myocardial ischaemia24.04.04.010; 02.02.02.0080.000112%Not Available
Myocarditis02.04.03.0010.000112%
Nausea07.01.07.0010.020136%
Neck pain15.03.04.0090.000358%
Necrosis24.04.02.006; 08.03.03.0010.000112%Not Available
Neoplasm16.16.02.0010.000112%Not Available
Neoplasm malignant16.16.01.0010.000604%Not Available
Nephropathy toxic12.03.01.010; 20.05.03.0020.000224%Not Available
Nervousness19.06.02.0030.000492%Not Available
Neutropenia01.02.03.0040.009973%Not Available
Neutrophilia01.02.01.0050.000112%Not Available
Night sweats23.02.03.006; 08.01.03.0310.000492%Not Available
Oedema14.05.06.010; 08.01.07.0060.000907%Not Available
Oedema peripheral08.01.07.007; 02.05.04.007; 14.05.06.0110.001410%
Oral mucosal blistering07.05.05.0170.000381%Not Available
Oral pain07.05.05.0340.000683%
Pain in extremity15.03.04.0100.002608%
Pain in jaw15.02.01.0030.000246%Not Available
Pain of skin23.03.03.0030.000112%
Palpitations02.11.04.0120.002160%
Pancreatitis07.18.01.0010.000392%
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