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)
Somnolence19.02.05.003; 17.02.04.006--
Stomatitis07.05.06.0050.003197%
Suicidal ideation19.12.01.003--
Swelling08.01.03.015--Not Available
Swelling face23.04.01.018; 10.01.05.0180.001066%Not Available
Syncope24.06.02.012; 17.02.04.008; 02.01.02.008--
Tachycardia02.03.02.007--Not Available
Thrombocytopenia01.08.01.0020.002664%Not Available
Thrombosis24.01.01.006--Not Available
Tooth abscess11.01.04.003; 07.09.01.0030.000533%Not Available
Tremor17.01.06.0020.002131%
Ulcer08.03.06.0010.000799%Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Viral infection11.05.04.0010.000533%Not Available
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.06.0080.001598%Not Available
Vitreous floaters06.09.01.0050.000533%
Vomiting07.01.07.0030.008259%
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
White blood cell count decreased13.01.06.0120.009324%
White blood cell count increased13.01.06.013--Not Available
Cardiotoxicity12.03.01.007; 02.01.01.0020.000533%Not Available
Tooth infection11.01.04.004; 07.09.01.0040.000533%
Onychoclasis23.02.05.0050.000799%Not Available
Peripheral swelling08.01.03.053; 02.05.04.0150.003197%Not Available
Osteopenia15.02.03.003; 14.04.04.0040.000533%Not Available
Neutropenic sepsis11.01.11.006; 01.02.03.0070.000208%Not Available
Contusion24.07.06.001; 23.03.11.002; 15.03.01.008; 12.01.06.001--
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