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 Not Available
ATC Code L01EF02
DrugBank ID DB11730
KEGG ID D10883
MeSH ID C000589651
PubChem ID 44631912
TTD Drug ID D08MXP
NDC Product Code 0078-0874; 0078-0867; 0078-0860
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Hepatitis acute09.01.07.0050.000533%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.002398%Not Available
Herpes zoster11.05.02.003; 23.09.03.002--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hyperkalaemia14.05.03.0010.000799%
Hypersensitivity10.01.03.003--
Hypersomnia19.02.05.001; 17.15.01.0010.000799%
Hypertension24.08.02.0010.002664%
Hypoaesthesia17.02.06.023--Not Available
Hypokalaemia14.05.03.0020.001598%
Hyponatraemia14.05.04.002--
Hypotension24.06.03.002--
Hypoxia22.02.02.0030.000799%
Increased appetite14.03.01.003; 08.01.09.0270.000533%Not Available
Infection11.01.08.0020.000903%Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Insomnia17.15.03.002; 19.02.01.002--
Interstitial lung disease22.01.02.003; 10.02.01.033--Not Available
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.0040.000799%Not Available
Joint swelling15.01.02.004--Not Available
Laboratory test abnormal13.18.01.001--Not Available
Lacrimation increased06.08.02.0040.001066%
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.0080.001332%
Leukopenia01.02.02.0010.003463%Not Available
Liver disorder09.01.08.0010.001598%Not Available
Liver function test abnormal13.03.01.0130.002131%Not Available
Loss of consciousness17.02.04.004--Not Available
Lung disorder22.02.07.001--Not Available
Lymphadenopathy01.09.01.0020.000533%Not Available
Malaise08.01.01.0030.007193%
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