What the label lists and what reports show
Bempedoic acid and ezetimibe side effects
Bempedoic acid and ezetimibe's FDA label: “The most common reasons for bempedoic acid treatment discontinuation were muscle spasms (0.5% versus 0.3% placebo), diarrhea (0.4% versus 0.1% placebo), and pain in extremity (0.3% versus 0.0% placebo).” FAERS holds 687 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 myalgia (62 reports).
- No generic listed
Check it at the source: the bempedoic acid and ezetimibe FDA label on DailyMed (effective June 25, 2026, Esperion Therapeutics, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of NEXLIZET?NEXLIZET may cause serious side effects, including: increased levels of uric acid in your blood (hyperuricemia). This can happen within 4 weeks of you starting NEXLIZET and continue throughout your treatment. Your healthcare provider may monitor your blood uric acid levels while you are taking NEXLIZET. High levels of blood uric acid may lead to gout. Call your healthcare provider if you have the following symptoms of hyperuricemia and gout: severe foot pain especially in the toe joint warm joints swelling tender joints joint redness tendon rupture or injury. Tendon problems can happen in people who take bempedoic acid, one of the medicines in NEXLIZET. Tendons are tough cords of tissue that connect muscles to bones. […]
Source: FDA drug label, Esperion Therapeutics, Inc., effective June 25, 2026 (SPL set 3fa2108c-0300-47b8-9d34-f762af7c93c6), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common reasons for bempedoic acid treatment discontinuation were muscle spasms (0.5% versus 0.3% placebo), diarrhea (0.4% versus 0.1% placebo), and pain in extremity (0.3% versus 0.0% placebo).
Table 1. Adverse Reactions (≥ 2% and greater than placebo) in Bempedoic Acid-Treated Patients with Primary Hypercholesterolemia and CVD or HeFH (Trials 2 and 3)
| Adverse Reaction | Placebo Background therapy included statin ± other lipid-lowering therapies (N = 999) % | Bempedoic acid (N = 2,009) % |
|---|---|---|
| Upper respiratory tract infection | 4.0 | 4.5 |
| Muscle spasms | 2.3 | 3.6 |
| Hyperuricemia Grouped term that includes other related terms | 1.1 | 3.5 |
| Back pain | 2.2 | 3.3 |
| Abdominal pain or discomfort | 2.2 | 3.1 |
| Bronchitis | 2.5 | 3.0 |
| Pain in extremity | 1.7 | 3.0 |
| Anemia | 1.9 | 2.8 |
| Elevated liver enzymes | 0.8 | 2.1 |
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, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Hyperuricemia [see Warnings and Precautions (5.1) ] Tendon Rupture [see Warnings and Precautions (5.2) ] Common adverse reactions with NEXLIZET in the primary hypercholesterolemia trials (incidence ≥ 2% and more frequently than placebo) were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, elevated liver enzymes, diarrhea, arthralgia, sinusitis, fatigue, and influenza. ( 6.1 ) The common adverse reaction associated with bempedoic acid in the cardiovascular outcomes trial (incidence ≥ 2% and more frequently than placebo) were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Esperion at 833-377-7633 (833 ESPRMED) 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 clinical practice. …
Source: FDA drug label, Esperion Therapeutics, Inc., effective June 25, 2026 (SPL set 3fa2108c-0300-47b8-9d34-f762af7c93c6), via openFDA; the full label on DailyMed
What do FAERS reports show?
687 reports list bempedoic acid and ezetimibe among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 61 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 22 reactions below, 12 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?
- Bempedoic acid and ezetimibe: 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