What the label lists and what reports show
Eliglustat side effects
Eliglustat's FDA label: “Most common adverse reactions (≥10%) are: fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain.” FAERS holds 1,599 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is weight increased (167 reports).
- No generic listed
Check it at the source: the eliglustat FDA label on DailyMed (effective March 3, 2024, Genzyme Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of CERDELGA?See " What is the most important information I should know about CERDELGA? " CERDELGA, used with certain other medicines, may cause changes in the electrical activity of your heart (ECG changes) and irregular heart beat (arrhythmias). Tell your doctor if you have new symptoms such as palpitations, fainting, or dizziness. The most common side effects of CERDELGA include: tiredness, headache, nausea, diarrhea, and pain in the arms, legs, back, or stomach (abdomen). Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CERDELGA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Genzyme Corporation, effective March 3, 2024 (SPL set 819f828a-b888-4e46-83fc-94d774a28a83), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥10%) are: fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain.
Table 4: Adverse Reactions Occurring in ≥5% of GD1 Patients Switching from Enzyme Replacement Therapy to CERDELGA and More Frequently than Imiglucerase (Trial 2) Trial 2 was not designed to support comparative claims…
| Adverse Reaction | CERDELGA (N=106) Patients n (%) | Imiglucerase (N=53) Patients n (%) |
|---|---|---|
| Fatigue | 15 (14) | 1 (2) |
| Headache | 14 (13) | 1 (2) |
| Nausea | 13 (12) | 0 (0) |
| Diarrhea | 13 (12) | 2 (4) |
| Back pain | 13 (12) | 3 (6) |
| Pain in extremity | 12 (11) | 1 (2) |
| Upper abdominal pain | 11 (10) | 0 (0) |
| Dizziness | 9 (8) | 0 (0) |
| Asthenia | 9 (8) | 0 (0) |
| Cough | 7 (7) | 2 (4) |
| Dyspepsia | 7 (7) | 1 (2) |
| Gastroesophageal reflux disease | 7 (7) | 0 (0) |
| Constipation | 5 (5) | 0 (0) |
| Palpitations | 5 (5) | 0 (0) |
| Rash | 5 (5) | 0 (0) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost common adverse reactions (≥10%) are: fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-745-4447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions to CERDELGA (occurring in ≥10% of the 126 GD1 patients treated with CERDELGA across Trials 1 and 2) were fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain. The adverse reaction profile of CERDELGA is based on two controlled studies, Trials 1 and 2 [see Clinical Studies (14.1 , 14.2) ]. Table 3 presents the profile from the 9-month double-blind, randomized, placebo-controlled trial of 40 treatment-naive patients (Trial 1). Patients were between the ages of 16 and 63 on the date of the first dose of study drug, and included 20 males and 20 females.
Source: FDA drug label, 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?
1,599 reports list eliglustat among the medicines taken, 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. Of the 18 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Eliglustat: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions