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)
Thrombocytopenia01.08.01.0020.015956%Not Available
Thrombosis24.01.01.0060.006469%Not Available
Tooth disorder07.09.05.0010.004312%Not Available
Tremor17.01.06.0020.018974%
Vomiting07.01.07.0030.035793%
Peripheral swelling08.01.03.053; 02.05.04.0150.036655%Not Available
Weight fluctuation14.03.02.0020.014662%Not Available
Eye pruritus06.04.05.0060.014662%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.004312%Not Available
Limb discomfort15.03.04.0140.014662%Not Available
Mental disorder19.07.01.0020.024149%Not Available
Parkinson's disease17.01.05.0100.010781%Not Available
Adverse drug reaction08.06.01.0090.016818%Not Available
Drug intolerance08.06.01.0130.014662%Not Available
Type 2 diabetes mellitus14.06.01.003; 05.06.01.0030.006469%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.004--
Graves' disease06.09.04.009; 05.02.02.009; 10.04.08.0140.004312%Not Available
Illness08.01.03.0910.051317%Not Available
Immune thrombocytopenia10.02.01.083; 01.08.01.0130.006469%Not Available
Treatment noncompliance12.09.02.006; 08.06.01.0670.024149%Not Available
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