Eliglustat
Eliglustat is a once- or twice-daily capsule medicine that treats Gaucher disease type 1 in adults whose CYP2D6 genetic status fits the label.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Eliglustat (Cerdelga) is a specialist capsule for Gaucher disease type 1 in adults, on the market since about 2014 and a by-mouth alternative to the usual enzyme replacement infusions; it blocks the enzyme that makes glucosylceramide, so less of this fatty substance builds up in organs. Most people tolerate it well, with mild nausea, diarrhea, upper belly pain or headache the side effects most often noticed. The one thing to watch is heart rhythm, because high levels can disturb it, so report a racing or irregular heartbeat or dizziness promptly. Those levels hinge on your CYP2D6 type (how fast your body clears it), liver and kidney health and other medicines, so every new prescription needs checking first.
Clinical pearls
- Swallow capsules whole with water, never opened or crushed, and skip grapefruit and grapefruit juice, which raise eliglustat levels.
- The antidepressant paroxetine and the antifungals terbinafine and ketoconazole can push levels up, so flag eliglustat whenever one is suggested.
- If you take digoxin, expect its blood level to be checked or its dose lowered, because eliglustat can raise it.
- It is not recommended with existing heart disease or long QT syndrome, so mention any heart history before starting.
Patient information guide A plain-language walkthrough of Eliglustat, written from its FDA label.
What Eliglustat is used for
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Eliglustat is used for one condition, based on the Cerdelga label.
- Cerdelga is for long-term treatment of adults with Gaucher disease type 1.
- It is for people who are CYP2D6 extensive, intermediate or poor metabolizers, as shown by an FDA-cleared test.
- It may not work well in ultra-rapid metabolizers.
- No specific dose can be recommended if the CYP2D6 type can't be determined.
How Eliglustat works
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Gaucher disease happens when the body lacks an enzyme needed to break down a fatty substance, glucosylceramide. It builds up in cells of the liver, spleen and bone marrow. This can cause enlarged organs, bone problems, anemia and low platelets.
Eliglustat blocks glucosylceramide synthase, the enzyme that makes this substance. Less is produced, so less builds up in the organs.
Eliglustat dosage
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Cerdelga is a capsule taken by mouth. Your dose schedule (once or twice daily) depends on your CYP2D6 type and on other medicines you take.
- Swallow capsules whole, preferably with water. Do not crush, dissolve or open them.
- Take with or without food.
- Avoid grapefruit and grapefruit juice.
- If you miss a dose, take the next one at the usual time. Do not double up.
- If you are switching from certain enzyme replacement therapies (imiglucerase, velaglucerase alfa or taliglucerase alfa), Cerdelga may be started 24 hours after the last dose.
Dosing details from the FDA-approved label
From the Eliglustat prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- CYP2D6 extensive metabolizers (EMs) and intermediate metabolizers (IMs)
- 84 mg orally twice daily
- Swallow capsules whole, preferably with water; do not crush, dissolve or open; can be taken with or without food; avoid grapefruit or grapefruit juice
- CYP2D6 poor metabolizers (PMs)
- 84 mg orally once daily
- Swallow capsules whole, preferably with water; do not crush, dissolve or open; can be taken with or without food; avoid grapefruit or grapefruit juice
- EMs and IMs with or without hepatic impairment taking CYP2D6 or CYP3A inhibitors (EMs without hepatic impairment taking a strong or moderate CYP2D6 inhibitor or a strong or moderate CYP3A inhibitor; EMs with mild (Child-Pugh Class A) hepatic impairment taking a weak CYP2D6 inhibitor or a strong, moderate, or weak CYP3A inhibitor; IMs without hepatic impairme
- Reduce dosage frequency of CERDELGA 84 mg to once daily
- If a dose is missed, take the prescribed dose at the next scheduled time; do not double the next dose
- Patients currently treated with imiglucerase, velaglucerase alfa, or taliglucerase alfa
- CERDELGA may be administered 24 hours after the last dose of the previous enzyme replacement therapy (ERT)
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Patient Selection ( 2.1 ) : Select patients using an FDA-cleared test for determining CYP2D6 genotype. Recommended Dosage Based on CYP2D6 Metabolizer Status ( 2.2 ) : EMs and IMs: 84 mg orally twice daily. PMs: 84 mg orally once daily. See the Full Prescribing Information for dosing recommendations in patients receiving CYP2D6 and/or CYP3A inhibitors, or with renal or hepatic impairment. ( 2.2 , 4 , 7.1 , 8.6 , 8.7 ) Administration ( 2.4 ) : Swallow capsules whole, do not crush, dissolve or open capsules. ( 2.4 ) Avoid eating grapefruit or drinking grapefruit juice. ( 2.4 ) 2.1 Patient Selection Select patients with Gaucher disease type 1 based on their CYP2D6 metabolizer status. It is recommended patient genotypes be established using an FDA-cleared test for determining CYP2D6 genotype [see Indications and Usage (1) ] . 2.2 Recommended Adult Dosage The recommended dosage of CERDELGA in adults is based on the patient's CYP2D6 metabolizer status. Table 1: Recommended Dosage Regimen by CYP2D6 Metabolizer Status CYP2D6 Metabolizer Status CERDELGA Dosage EMs 84 mg twice daily IMs PMs 84 mg once daily 2.3 Dosage Adjustment in EMs and IMs With or Without Hepatic Impairment and Concomitant Use of CYP2D6 or CYP3A Inhibitors Reduce dosage frequency of CERDELGA 84 mg to once daily in CYP2D6 EMs and IMs with or without hepatic impairment taking CYP2D6 or CYP3A inhibitors, as shown in Table 2 [see Warnings and Precautions (5.1) , Drug Interactions (7.1) , Use in Specific Populations (8.7) ] . Table 2: Recommended Dosage of CERDELGA 84 mg Once Daily based on CYP2D6 Metabolizer, Hepatic Impairment Status, and Concomitant CYP Inhibitors CYP2D6 Metabolizer Status Hepatic Impairment Status Concomitant CYP Inhibitor EMs Without Hepatic Impairment Taking a strong or moderate CYP2D6 inhibitor Taking a strong or moderate CYP3A inhibitor Mild (Child-Pugh Class A) Hepatic Impairment Taking a weak CYP2D6 inhibitor Taking a strong, moderate, or weak CYP3A inhibitor IMs Without Hepatic Impairment Taking a strong or moderate CYP2D6 inhibitor 2.4 Important Administration Instructions Swallow capsules whole, preferably with water, and do not crush, dissolve, or open the capsules. CERDELGA can be taken with or without food. Avoid the consumption of grapefruit or grapefruit juice (strong CYP3A inhibitors) with CERDELGA [see Drug Interactions (7.1) ] .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Eliglustat side effects
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The most common side effects reported in studies were:
Common side effects
- Fatigue
- Headache
- Nausea
- Diarrhea
- Back pain
- Pain in arms or legs
- Upper belly pain
- Joint pain
When to get medical help
- Call your doctor if you notice a racing, pounding or irregular heartbeat, palpitations or dizziness. Eliglustat may affect heart rhythm.
- Get medical help right away if you take too much. Overdose has caused dizziness, low blood pressure, slow heart rate, nausea and vomiting.
- Tell your doctor before starting any new medicine, since some can raise eliglustat levels and raise the risk of heart rhythm problems.
- Tell your doctor if you develop a rash or any side effect that bothers you or does not go away.
Other reported effects included joint pain, dizziness, weakness, heartburn or reflux, constipation, rash and palpitations. Call your doctor about heart rhythm symptoms or anything severe or persistent.
Eliglustat warnings and precautions
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Heart rhythm risk is the main concern. Eliglustat can lengthen the PR, QTc and QRS intervals on an ECG at high blood levels, which may lead to abnormal heart rhythms.
- Avoid it with existing heart disease (heart failure, recent heart attack, slow heart rate, heart block, ventricular arrhythmia).
- Avoid it in long QT syndrome and with Class IA or Class III heart rhythm drugs.
- Heart disease was not studied in clinical trials.
- Some CYP2D6 types, liver problems and interacting drugs raise levels and may make it contraindicated.
Eliglustat interactions
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Many interactions work by raising or lowering eliglustat levels.
- CYP2D6 inhibitors (such as paroxetine, terbinafine) can raise levels, which raises heart rhythm risk.
- CYP3A inhibitors (such as ketoconazole) can raise levels. Some combinations are contraindicated.
- Grapefruit and grapefruit juice act as CYP3A inhibitors, so avoid them.
- Strong CYP3A inducers can lower levels and reduce effectiveness. Avoid them.
- Digoxin levels may rise. Your doctor may check levels and lower the digoxin dose.
- Other P-gp or CYP2D6 drugs may also rise and may need monitoring or dose changes.
Interactions listed in the FDA-approved label
From the Eliglustat prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- CYP2D6 inhibitors (strong, moderate, weak): May increase eliglustat concentrations, which may increase the risk of cardiac arrhythmias from prolongation of the PR, QTc, and/or QRS cardiac interval. EMs with strong or moderate inhibitor: reduce CERDELGA 84 mg to once daily; IMs: continue 84 mg once daily with strong or moderate inhibitor; weak inhibitor: continue 84 mg twice daily. No effect in PMs due to little or no CYP2D6 activity.
- CYP3A inhibitors (strong, moderate, weak): May increase eliglustat concentrations, which may increase the risk of cardiac arrhythmias from prolongation of the PR, QTc, and/or QRS cardiac interval. EMs: strong inhibitor, reduce CERDELGA 84 mg to once daily; moderate, avoid coadministration; weak, continue 84 mg twice daily. IMs: strong, contraindicated. Weak: avoid coadministration.
- Grapefruit or grapefruit juice (strong CYP3A inhibitors): Classed as strong CYP3A inhibitors. Avoid the consumption of grapefruit or grapefruit juice with CERDELGA.
- CYP2D6 inhibitor taken concomitantly with a strong CYP3A inhibitor: May increase eliglustat concentrations and the risk of cardiac arrhythmias. Strong CYP2D6 inhibitor: contraindicated. Moderate CYP2D6 inhibitor: contraindicated.
- CYP2D6 inhibitor taken concomitantly with a moderate CYP3A inhibitor: May increase eliglustat concentrations and the risk of cardiac arrhythmias. Strong CYP2D6 inhibitor: contraindicated. Moderate CYP2D6 inhibitor: avoid coadministration.
- Strong CYP3A inducers: Decrease eliglustat concentrations, which may reduce CERDELGA efficacy. Avoid coadministration.
- Digoxin: CERDELGA may increase concentrations of digoxin (a P-gp substrate) and may increase the risk of its toxicity. Monitor serum digoxin concentrations before initiating CERDELGA. Reduce digoxin dose by 30% and continue monitoring.
- Other P-gp substrates or CYP2D6 substrates: CERDELGA may increase concentrations of these drugs and may increase the risk of their toxicity. Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the concomitant drug and titrate to clinical effect.
Read the label’s full interactions text
7 DRUG INTERACTIONS See Full Prescribing Information for a list of clinically significant drug interactions. ( 7.1 , 7.2 ) 7.1 Effect of Other Drugs on CERDELGA Coadministration of CERDELGA with: CYP2D6 or CYP3A inhibitors may increase eliglustat concentrations which may increase the risk of cardiac arrhythmias from prolongation of the PR, QTc, and/or QRS cardiac interval [see Warnings and Precautions (5.1) , Clinical Pharmacology (12.3) ] . strong CYP3A inducers decrease eliglustat concentrations which may reduce CERDELGA efficacy [see Clinical Pharmacology (12.3) ] . See Table 5 for prevention and management of interactions with drugs affecting CERDELGA. Use of CERDELGA is contraindicated, to be avoided, or may require dosage adjustment depending on the concomitant drug and CYP2D6 metabolizer status [see Dosage and Administration (2.2 , 2.3) , Contraindications (4) , Drug Interactions (7.1) ] . Table 5: Prevention and Management Strategies of Drug Interactions Affecting CERDELGA Based on CYP2D6 Metabolizer Status and Concomitant Interacting Drug Concomitant Drug(s) CYP2D6 Metabolizer Status EMs IMs PMs CYP2D6 Inhibitor Strong Reduce frequency of CERDELGA 84 mg to once daily Continue CERDELGA 84 mg once daily No effect of CYP2D6 inhibitor due to little or no CYP2D6 activity in CYP2D6 PMs. Moderate Weak Continue CERDELGA 84 mg twice daily CYP3A Inhibitor Strong Reduce frequency of CERDELGA 84 mg to once daily Contraindicated Moderate Avoid coadministration Weak Continue CERDELGA 84 mg twice daily Avoid coadministration CYP2D6 Inhibitor Concomitantly with a strong CYP3A Inhibitor Strong Contraindicated Moderate CYP2D6 Inhibitor Concomitantly with a moderate CYP3A Inhibitor Strong Contraindicated Avoid coadministration Moderate CYP3A Inducer Strong Avoid coadministration 7.2 Effect of CERDELGA on Other Drugs See Table 6 for clinically relevant interactions affecting P-gp or CYP2D6 substrates when coadministered with CERDELGA.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Eliglustat
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- You need a CYP2D6 genetic test before starting.
- Do not use it if you have liver impairment in certain groups: moderate or severe in extensive metabolizers, and any degree in intermediate or poor metabolizers.
- Mild liver impairment with some interacting drugs is also contraindicated.
- Avoid it in intermediate and poor metabolizers with any kidney impairment, and in extensive metabolizers with end-stage kidney disease.
- Tell your doctor about heart conditions and long QT syndrome.
- Pregnancy: human data are insufficient, and animal studies showed harm at high doses. Untreated Gaucher disease also carries pregnancy risks.
- Breastfeeding: no human data. Eliglustat was found in rat milk.
- Not established for children.
- Not enough people 65 and over were studied to know whether they respond differently.
Eliglustat overdose
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In one healthy volunteer given about 21 times the recommended dose, effects included dizziness with loss of balance, low blood pressure, slow heart rate, nausea and vomiting. In an overdose, the person should be watched closely and given supportive treatment. Hemodialysis is unlikely to help.
What Eliglustat does in the body
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In people not previously treated, improvements in spleen and liver size, hemoglobin and platelets increased as eliglustat levels rose. At very high levels, ECG intervals (PR, QRS, QTc) lengthen. At eight times the recommended dose, no clinically relevant QT prolongation was seen. Modeling predicts greater increases at very high blood levels.
How your body processes Eliglustat
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Only a small fraction of an oral dose reaches the bloodstream (under 5% in extensive metabolizers). Food does not meaningfully change how much is absorbed. The body breaks eliglustat down mainly through CYP2D6, and to a lesser extent CYP3A4. Poor metabolizers have 7- to 9-fold higher exposure than extensive metabolizers. Half-life is about 6.5 hours in extensive metabolizers and 8.9 hours in poor metabolizers. Most of the dose leaves as metabolites in urine and feces.
How to store Eliglustat
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Store at 68°F–77°F (20°C–25°C) with excursions permitted between 59°F and 86°F (15°C to 30°C) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Eliglustat
146 supplements and herbal products have documented interactions with Eliglustat in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 8
- Moderate · 98
- Minor · 40
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Eliglustat: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Eliglustat — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How should I take my capsules?
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Can I eat grapefruit?
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What side effects should I expect?
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Do I need to worry about my other medicines?
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Is it safe in pregnancy?
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Is Eliglustat available over the counter?
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When was Eliglustat first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Eliglustat on HelloPharmacist
Eliglustat forms and strengths (how it comes)
Eliglustat is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Cerdelga is used for long-term treatment of adults with Gaucher disease type 1 who are CYP2D6 extensive, intermediate or poor metabolizers.
- Cerdelga capsules should be swallowed whole, preferably with water. Do not crush, dissolve or open them.
- Cerdelga can be taken with or without food.
- Avoid grapefruit and grapefruit juice while taking Cerdelga.
- If you miss a Cerdelga dose, take the next dose at the scheduled time. Do not double it.
Eliglustat on the U.S. market: products, makers and brands
How Eliglustat appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Eliglustat product record with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2014. Brand names on the directory include Cerdelga; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Eliglustat is used (Medicaid data)
A general measure of how commonly Eliglustat is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Eliglustat is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Eliglustat prescribed? Of the 1,601 medications we measure, Eliglustat ranks #1,372 by Medicaid prescriptions — more than 14% of them.
Utilization by Eliglustat product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
eliglustat 84 MG Oral Capsule
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1547225
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Eliglustat, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Eliglustat NDCs with Medicaid activity.
Compare Eliglustat products
A representative set of FDA-listed product records for Eliglustat — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 84 mg | Oral | Genzyme Corporation | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Eliglustat NDCs →
Eliglustat side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Eliglustat — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Eliglustat in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Eliglustat FDA approval history
How Eliglustat went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Eliglustat recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Eliglustat recalls since July 2021.
✅No Eliglustat recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1547220 1 dose form · 1 strength
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Dose form (SCDF) Oral Capsule RxCUI 1547224In current FDA listingsClinical drug / strength (SCD) 84 MGRxCUI 1547225
Look up RxCUI 1547220 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Eliglustat supply and shortage status
Whether Eliglustat is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Eliglustat brand names
Eliglustat is sold under one brand name in the FDA directory — Cerdelga. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Eliglustat: manufacturers and labelers
One company lists Eliglustat products with the FDA. By number of product records, the largest are Genzyme Corporation. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Eliglustat drug class (RxNorm)
Eliglustat belongs to the Glucosylceramide Synthase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Eliglustat page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Genzyme Corporation is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →