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)
Liver disorder09.01.08.0010.000470%Not Available
Lung disorder22.02.07.0010.000112%Not Available
Muscular weakness17.05.03.005; 15.05.06.0010.000604%
Musculoskeletal pain15.03.04.0070.000246%
Myeloid leukaemia16.01.08.001; 01.10.08.0010.000246%Not Available
Nausea07.01.07.0010.006626%
Neuropathy peripheral17.09.03.0030.000470%Not Available
Neutropenia01.02.03.004--Not Available
Orthostatic hypotension17.05.01.020; 24.06.03.0040.000112%Not Available
Pain in extremity15.03.04.0100.001444%
Pancytopenia01.03.03.0030.000616%Not Available
Platelet disorder01.08.03.0010.000112%Not Available
Pleural effusion22.05.02.0020.000224%
Pollakiuria20.02.02.0070.000381%
Pruritus23.03.12.0010.002474%
Pulmonary oedema22.01.03.003; 02.05.02.0030.000112%
Pyrexia08.05.02.0030.001601%
Renal disorder20.01.02.0020.000414%Not Available
Skin lesion23.03.03.0100.000246%Not Available
Thrombocytopenia01.08.01.0020.000392%Not Available
Tinnitus17.04.07.004; 04.04.01.0020.000571%
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.000224%
Peripheral swelling08.01.03.053; 02.05.04.0150.001768%Not Available
General physical health deterioration08.01.03.0180.000224%Not Available
Cerebral disorder17.02.10.0170.000246%Not Available
Pulmonary mass22.02.07.0040.000112%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.000246%Not Available
Appetite disorder19.09.01.002; 14.03.01.0040.000381%Not Available
Haematotoxicity12.03.01.025; 01.05.01.0070.000168%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.004018%
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