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 approved; investigational
ATC Code L01XX59
DrugBank ID DB13874
KEGG ID D10901
MeSH ID C000605269
PubChem ID 89683805
TTD Drug ID D0K7FT
NDC Product Code Not Available
UNII 3T1SS4E7AG
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.0010.000761%
Abdominal pain upper07.01.05.0030.000795%
Acute myeloid leukaemia16.01.05.001; 01.10.05.0010.007488%-
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.0010.000112%
Ageusia17.02.07.001; 07.14.03.0030.000437%-
Arthritis15.01.01.0010.000246%
Asthenia08.01.01.0010.001242%-
Bone pain15.02.01.0010.000358%
Cerebral haemorrhage24.07.04.001; 17.08.01.0030.000280%-
Cholangiocarcinoma16.07.01.002; 09.04.02.0090.000246%-
Cholestasis09.01.01.0010.000112%-
Constipation07.02.02.0010.002283%
Death08.04.01.0010.012928%
Dementia19.20.02.001; 17.03.01.0010.000112%-
Diarrhoea07.02.01.0010.006604%
Dry skin23.03.03.0010.000571%
Dysgeusia17.02.07.003; 07.14.03.0010.001332%
Dyspnoea02.11.05.003; 22.02.01.004--
Eating disorder19.09.01.008; 14.03.01.0080.000246%-
Fatigue08.01.01.0020.007253%
Febrile neutropenia08.05.02.004; 01.02.03.0020.000448%
Fluid retention20.01.02.003; 14.05.06.0020.000381%-
Frequent bowel movements07.02.04.0020.000246%-
Gout15.01.06.001; 14.09.01.0010.000246%-
Hepatitis09.01.07.0040.000112%-
Hypervolaemia02.05.04.019; 14.05.06.0030.000112%-
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.0040.000548%-
Joint swelling15.01.02.0040.001522%-
Leukaemia01.10.03.001; 16.01.03.0010.001298%
Leukocytosis01.02.01.0020.000437%
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