Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Enasidenib
Drug ID BADD_D02517
Description Enasidenib is an orally available treatment for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with specific mutations in the isocitrate dehydrogenase 2 (IDH2) gene, which is a recurrent mutation detected in 12-20% of adult patients with AML [A20344, A20345]. Patients eligible for this treatment are selected by testing the presence of IDH2 mutations in the blood or bone marrow. This small molecule acts as an allosteric inhibitor of mutant IDH2 enzyme to prevent cell growth, and it also has shown to block several other enzymes that play a role in abnormal cell differentiation. First developed by Agios Pharmaceuticals and licensed to Celgene, enasidenib was approved by U.S. Food and Drug Administration on August 1, 2017.
Indications and Usage Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation.
Marketing Status Not Available
ATC Code L01XX59
DrugBank ID DB13874
KEGG ID D10901
MeSH ID C000605269
PubChem ID 89683805
TTD Drug ID D0K7FT
NDC Product Code Not Available
Synonyms enasidenib | AG-221 | Idhifa
Chemical Information
Molecular Formula C19H17F6N7O
CAS Registry Number 1446502-11-9
SMILES CC(C)(CNC1=NC(=NC(=N1)C2=NC(=CC=C2)C(F)(F)F)NC3=CC(=NC=C3)C(F)(F)F)O
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)
Haemoglobin decreased13.01.05.0030.001865%Not Available
Headache17.14.01.001--
Hypertension24.08.02.001--
Hypoaesthesia17.02.06.023--Not Available
Infection11.01.08.0020.000417%Not Available
Influenza22.07.02.001; 11.05.03.0010.001332%Not Available
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.0040.000533%Not Available
Joint swelling15.01.02.0040.000799%Not Available
Leukaemia16.01.03.001; 01.10.03.0010.000903%
Leukocytosis01.02.01.0020.000533%
Loss of consciousness17.02.04.004--Not Available
Malaise08.01.01.003--
Muscular weakness17.05.03.005; 15.05.06.0010.000799%
Myeloid leukaemia01.10.08.001; 16.01.08.0010.000533%Not Available
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.0010.005861%
Neuropathy peripheral17.09.03.0030.000533%Not Available
Neutropenia01.02.03.004--Not Available
Neutrophil count decreased13.01.06.0100.000533%
Orthostatic hypotension24.06.03.004; 17.05.01.0200.000533%Not Available
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Pancytopenia01.03.03.0030.001598%Not Available
Paraesthesia17.02.06.005--
Platelet count decreased13.01.04.0010.007193%
Pleural effusion22.05.02.0020.000533%
Pneumonia22.07.01.003; 11.01.09.0030.002398%Not Available
Pruritus23.03.12.001--
Pyrexia08.05.02.0030.002931%
Rash23.03.13.001--Not Available
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