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 adult patients who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.[label]
Marketing Status approved
ATC Code A16AX10
DrugBank ID DB09039
KEGG ID D09893
MeSH ID C522917
PubChem ID 23652731
TTD Drug ID D0J8IJ
NDC Product Code 58468-0220
UNII DR40J4WA67
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
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)
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.0020.009487%
Gastrooesophageal reflux disease07.02.02.0030.040968%
Gastrointestinal disorder07.11.01.0010.052611%Not Available
Headache17.14.01.0010.097460%
Hepatomegaly09.01.05.0010.014662%Not Available
Hiatus hernia22.09.02.004; 07.16.01.0010.004312%Not Available
Hypertension24.08.02.0010.014662%
Hypoaesthesia23.03.03.081; 17.02.06.0230.009487%Not Available
Insomnia19.02.01.002; 17.15.03.0020.028462%
Joint swelling15.01.02.0040.014662%Not Available
Lacrimation increased06.08.02.0040.021993%
Loss of consciousness17.02.04.0040.021131%Not Available
Lymphadenopathy01.09.01.0020.004312%Not Available
Malaise08.01.01.0030.037949%
Memory impairment19.20.01.003; 17.03.02.0030.031480%
Menstruation irregular21.01.01.005; 05.05.01.0080.014662%
Migraine24.03.05.003; 17.14.02.0010.036655%Not Available
Nausea07.01.07.0010.106947%
Nervous system disorder17.02.10.0010.004312%Not Available
Pain08.01.08.0040.040105%
Pain in extremity15.03.04.0100.031480%
Palpitations02.11.04.0120.028462%
Plasma cell myeloma16.23.02.004; 01.14.02.0040.004312%Not Available
Rash23.03.13.001--Not Available
Respiratory disorder22.02.07.0020.016818%Not Available
Retching07.01.07.0020.021993%Not Available
Seizure17.12.03.0010.013800%
Somnolence19.02.05.003; 17.02.04.0060.016818%
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.011643%
Tachycardia02.03.02.0070.014662%Not Available
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