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)
Abdominal discomfort07.01.06.0010.018974%-
Abdominal distension07.01.04.0010.038811%
Abdominal pain upper07.01.05.0030.035793%
Anaemia01.03.02.0010.011643%
Anxiety19.06.02.0020.021131%
Arthralgia15.01.02.0010.072448%
Asthenia08.01.01.001---
Atrial fibrillation02.03.03.0020.004312%
Back pain15.03.04.0050.043986%
Bone pain15.02.01.0010.055630%
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.0030.026305%-
Cholelithiasis09.03.01.0020.009487%-
Condition aggravated08.01.03.0040.033636%-
Constipation07.02.02.0010.060804%
Cough22.02.03.0010.097460%
Dehydration14.05.05.0010.016818%
Depression19.15.01.0010.013800%
Dermatitis23.03.04.002---
Diabetes mellitus05.06.01.001; 14.06.01.0010.006469%-
Diarrhoea07.02.01.0010.062961%
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.0070.106947%
Drug interaction08.06.03.0010.004312%-
Dry mouth07.06.01.0020.009487%
Dry skin23.03.03.0010.036655%
Dysarthria17.02.08.001; 19.19.03.0010.009487%
Dyspepsia07.01.02.0010.094441%
Fatigue08.01.01.0020.130234%
Feeling abnormal08.01.09.0140.021993%-
Flatulence07.01.04.0020.021993%
Frequent bowel movements07.02.04.0020.011643%-
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