Prescription medicine
Eliglustat Brand names: Cerdelga
Eliglustat (Cerdelga) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the eliglustat FDA label on DailyMed (effective March 3, 2024, Genzyme Corporation); the NDA 205494 record on Drugs@FDA; every eliglustat label on DailyMed.
Highlights of the record
FDA label of March 3, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCERDELGA is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test [see Dosage and Administration (2.1) ].
Forms and strengths
- 84 mg
Capsule.
On the market
- Earliest approval on file
- August 19, 2014 Cerdelga, Genzyme Corp; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first September 8, 2021; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 13, 2038 Cerdelga capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,599 through July 30, 2026
What is eliglustat used for?
From the label: indications and usageCERDELGA is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test [see Dosage and Administration (2.1) ]. CERDELGA is a glucosylceramide synthase inhibitor indicated for the long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test. ( 1 ) Limitations of Use: CYP2D6 ultra-rapid metabolizers may not achieve adequate concentrations of CERDELGA to achieve a therapeutic effect. […]
FDA pharmacologic class: Glucosylceramide Synthase Inhibitor.
Source: FDA drug label (Cerdelga), Genzyme Corporation, effective March 3, 2024 (SPL set 819f828a-b888-4e46-83fc-94d774a28a83), via openFDA; the full label on DailyMed
What does the patient leaflet for eliglustat say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about CERDELGA?CERDELGA can affect the way other medicines work and other medicines can affect how CERDELGA works. Using CERDELGA with other medicines or herbal supplements may cause an increased risk of side effects. Especially tell your doctor if you take: St. John's Wort (Hypericum perforatum) Medicine for: Fungal infections Tuberculosis Seizures Heart conditions or high blood pressure Depression or other mental health problems If you take any medicines for the conditions listed above, your doctor may need to prescribe a different medicine, change your dose of other medicines, or change your dose of CERDELGA. Tell your doctor about any new medicines before you start taking them.
From the patient leaflet: What should I avoid while taking CERDELGA?Avoid eating or drinking grapefruit products while taking CERDELGA. Grapefruit products can increase the amount of CERDELGA in your body.
From the patient leaflet: How should I store CERDELGA?Store CERDELGA at room temperature between 68°F-77 °F (20°C-25 °C). Keep CERDELGA and all medicines out of reach of children.
Source: FDA drug label (Cerdelga), Genzyme Corporation, effective March 3, 2024 (SPL set 819f828a-b888-4e46-83fc-94d774a28a83), via openFDA; the full label on DailyMed
Is there a generic for eliglustat (Cerdelga)?
The FDA approved the first generic eliglustat on September 8, 2021. 6 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 5 patents for Cerdelga capsules: the compound patent runs to November 24, 2030, and the last listed entry to December 13, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2021 first generic approved
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the eliglustat label say about other medicines?
The eliglustat label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name eliglustat. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | warnings and precautions | … arrhythmia) long QT syndrome in combination with Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications [see Clinical Pharmacology (12.2) ] |
| Digoxin | drug interactions | Prevention or Management; Digoxin; Monitor serum digoxin concentrations before initiating CERDELGA. Reduce digoxin dose by 30% and continue monitoring. |
| Procainamide | warnings and precautions | Avoid use of CERDELGA in patients with: pre-existing cardiac disease (congestive heart failure, recent acute myocardial infarction, bradycardia, heart block, ventricular arrhythmia) long QT syndrome in combination with Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic … |
| Quinidine | warnings and precautions | Avoid use of CERDELGA in patients with: pre-existing cardiac disease (congestive heart failure, recent acute myocardial infarction, bradycardia, heart block, ventricular arrhythmia) long QT syndrome in combination with Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic … |
| Sotalol | warnings and precautions | … long QT syndrome in combination with Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications [see Clinical Pharmacology (12.2) ] |
Source: FDA drug label (Cerdelga), Genzyme Corporation, effective March 3, 2024 (SPL set 819f828a-b888-4e46-83fc-94d774a28a83), via openFDA; the full label on DailyMed
What do FAERS reports show for eliglustat?
The FDA Adverse Event Reporting System holds 1,599 reports that list eliglustat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 21 are coded as a death and 210 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other glucosylceramide synthase inhibitors
- the pharmacologic class, with prices and generics
- Eliglustat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other