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)
Memory impairment19.20.01.003; 17.03.02.003--
Metastases to liver16.22.02.001; 09.04.02.0040.000347%Not Available
Metastases to lung22.08.01.005; 16.22.02.0020.000556%Not Available
Mouth ulceration07.05.06.0040.000799%Not Available
Muscle spasms15.05.03.004--
Musculoskeletal pain15.03.04.0070.001332%
Myalgia15.05.02.001--
Myocardial infarction24.04.04.009; 02.02.02.007--
Myocarditis02.04.03.0010.000533%
Nasopharyngitis11.01.13.002; 22.07.03.0020.002131%Not Available
Nausea07.01.07.0010.021313%
Neoplasm malignant16.16.01.0010.000278%Not Available
Nephropathy toxic20.05.03.002; 12.03.01.0100.000533%Not Available
Neuropathy peripheral17.09.03.003--Not Available
Neutropenia01.02.03.0040.025309%Not Available
Neutrophil count decreased13.01.06.0100.001598%
Night sweats08.01.03.031; 23.02.03.0060.000533%Not Available
Oedema14.05.06.010; 08.01.07.0060.001066%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Oral candidiasis11.03.03.004; 07.05.07.0010.000799%Not Available
Oral mucosal blistering07.05.05.0170.000799%Not Available
Oral pain07.05.03.0020.000799%
Pain08.01.08.004--
Pain in extremity15.03.04.0100.003730%
Palmar-plantar erythrodysaesthesia syndrome23.07.04.001; 17.02.07.0090.000799%
Palpitations02.01.02.0030.002398%
Pancreatitis07.18.01.0010.001332%
Pancytopenia01.03.03.003--Not Available
Paraesthesia17.02.06.005--
Platelet count decreased13.01.04.0010.002664%
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