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)
Red blood cell count decreased13.01.05.0070.001332%Not Available
Renal failure20.01.03.005--Not Available
Seizure17.12.03.001--
Sepsis11.01.11.0030.000347%
Septic shock24.06.02.011; 11.01.11.0040.000208%Not Available
Somnolence19.02.05.003; 17.02.04.006--
Syncope17.02.04.008; 02.01.02.008; 24.06.02.012--
Thrombocytopenia01.08.01.0020.001066%Not Available
Thrombosis24.01.01.006--Not Available
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.000799%
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
White blood cell count decreased13.01.06.0120.003996%
White blood cell count increased13.01.06.0130.001066%Not Available
Peripheral swelling02.05.04.015; 08.01.03.0530.001332%Not Available
Cerebral disorder17.02.10.0170.000533%Not Available
Blood test abnormal13.18.01.0030.000533%Not Available
Cardiac disorder02.01.01.003--Not Available
Decreased appetite08.01.09.028; 14.03.01.0050.005062%
Disease progression08.01.03.038--
Unevaluable event08.01.03.0510.000533%Not Available
Acute promyelocytic leukaemia differentiation syndrome22.02.01.023; 12.03.01.0420.005861%
Oropharyngeal pain07.05.05.004; 22.02.05.0220.001066%
Acute kidney injury20.01.03.016--
Bone marrow reticulin fibrosis16.32.03.010; 01.05.01.0090.000533%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000139%
Liver function test increased13.03.01.0440.000533%Not Available
Full blood count decreased13.01.07.0040.002931%Not Available
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