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)
Abdominal pain upper07.01.05.0030.001332%
Acute myeloid leukaemia16.01.05.001; 01.10.05.0010.002780%Not Available
Acute respiratory distress syndrome22.01.03.0010.000139%
Ageusia17.02.07.001; 07.14.03.0030.000533%Not Available
Anaemia01.03.02.001--
Anxiety19.06.02.002--
Arthralgia15.01.02.0010.001332%
Asthenia08.01.01.0010.002131%Not Available
Atrial fibrillation02.03.03.0020.000799%
Back pain15.03.04.005--
Blood bilirubin increased13.03.01.0080.001598%
Blood potassium decreased13.11.01.0100.000533%Not Available
Blood pressure decreased13.14.03.0020.001066%Not Available
Bone pain15.02.01.0010.000799%
Cerebral haemorrhage17.08.01.003; 24.07.04.0010.000208%Not Available
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Constipation07.02.02.0010.002131%
Cough22.02.03.001--
Death08.04.01.0010.008687%
Dehydration14.05.05.001--
Depression19.15.01.001--
Diarrhoea07.02.01.0010.005861%
Dizziness17.02.05.003; 02.01.02.004; 24.06.02.007--
Dry skin23.03.03.0010.000533%
Dysgeusia17.02.07.003; 07.14.03.0010.001865%
Dysphagia07.01.06.003--
Dyspnoea22.02.01.004; 02.01.03.002--
Epistaxis22.04.03.001; 24.07.01.0050.000799%
Fatigue08.01.01.0020.007193%
Febrile neutropenia08.05.02.004; 01.02.03.0020.001066%
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