Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Eliglustat
Drug ID BADD_D00757
Description Eliglustat, marketed by Genzyme as CERDELGA, is a glucosylceramide synthase inhibitor indicated for the long-term treatment of type 1 Gaucher disease. Patients selected for treatment with Eliglustat undergo an FDA approved genotype test to establish if they are CYP2D6 EM (extensive metabolizers), IM (intermediate metabolizers), or PM (poor metabolizers), as the results of this test dictate the dosage of Eliglustat recommended. There are no recommended dosing guidelines for CYP2D6 ultra-rapid or indeterminate metabolizers. Eliglustat was approved for use by the FDA in August 2014.
Indications and Usage Eliglustat is indicated for the long-term treatment of type 1 Gaucher disease in patients who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) in treatment-naive and treatment-experienced adult patients.
Marketing Status Prescription
ATC Code A16AX10
DrugBank ID DB09039
KEGG ID D09893
MeSH ID C522917
PubChem ID 23652731
TTD Drug ID D0J8IJ
NDC Product Code 58468-0220
Synonyms eliglustat | Cerdelga | eliglustat tartrate | Genz-112638
Chemical Information
Molecular Formula C23H36N2O4
CAS Registry Number 491833-29-5
SMILES CCCCCCCC(=O)NC(CN1CCCC1)C(C2=CC3=C(C=C2)OCCO3)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)
Headache17.14.01.0010.074763%
Hypertension24.08.02.0010.021361%
Hypoaesthesia17.02.06.0230.021361%Not Available
Loss of consciousness17.02.04.0040.032041%Not Available
Malaise08.01.01.0030.042722%
Migraine24.03.05.003; 17.14.02.0010.032041%Not Available
Nausea07.01.07.0010.117485%
Nervous system disorder17.02.10.0010.021361%Not Available
Pain08.01.08.0040.053402%
Pain in extremity15.03.04.0100.032041%
Palpitations02.01.02.0030.042722%
Paraesthesia17.02.06.0050.021361%
Rash23.03.13.0010.032041%Not Available
Retching07.01.07.0020.032041%Not Available
Sinusitis22.07.03.007; 11.01.13.0050.021361%
Somnolence19.02.05.003; 17.02.04.0060.021361%
Syncope24.06.02.012; 17.02.04.008; 02.01.02.0080.021361%
Tachycardia02.03.02.0070.021361%Not Available
Thrombocytopenia01.08.01.0020.032041%Not Available
Tremor17.01.06.0020.032041%
Urinary tract infection20.08.02.001; 11.01.14.0040.032041%
Viral infection11.05.04.0010.021361%Not Available
Vomiting07.01.07.0030.032041%
Weight decreased13.15.01.0050.042722%
Peripheral swelling02.05.04.015; 08.01.03.0530.021361%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Helicobacter infection11.02.18.0010.032041%Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.005572%Not Available
Parkinson's disease17.01.05.0100.005572%Not Available
Type 2 diabetes mellitus14.06.01.003; 05.06.01.0030.021361%Not Available
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