What the label lists and what reports show
Bempedoic acid side effects
Bempedoic acid's FDA label: “The most common reasons for NEXLETOL 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 2,565 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 (400 reports).
- No generic listed
Check it at the source: the bempedoic acid 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 NEXLETOL?NEXLETOL may cause serious side effects, including: increased levels of uric acid in your blood (hyperuricemia). This can happen within 4 weeks of you starting NEXLETOL and continue throughout your treatment. Your healthcare provider may monitor your blood uric acid levels while you are taking NEXLETOL. 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 NEXLETOL. Tendons are tough cords of tissue that connect muscles to bones. […]
Source: FDA drug label, Esperion Therapeutics, Inc., effective June 25, 2026 (SPL set 88d06d89-a3da-40b4-b273-8f4f7d56c4c9), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common reasons for NEXLETOL 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 NEXLETOL-Treated Patients with Primary Hypercholesterolemia and CVD or HeFH (Trials 2 and 3)
| Adverse Reaction | Placebo Background therapy included statin and ± other lipid-lowering therapies (N = 999)… | NEXLETOL (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 in the ( 6.1 ): Primary hypercholesterolemia trials (incidence ≥ 2% and more frequent than placebo) were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes. Cardiovascular outcomes trial (incidence ≥ 2% and 0.5% greater than placebo) were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis. 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. The data in Table 1 reflect exposure to NEXLETOL in two placebo-controlled primary hypercholesterolemia trials that included 2,009 patients treated with NEXLETOL for 52 weeks (median treatment duration of 52 weeks) [see Clinical Studies (14.2) ]. …
Source: FDA drug label, Esperion Therapeutics, Inc., effective June 25, 2026 (SPL set 88d06d89-a3da-40b4-b273-8f4f7d56c4c9), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,565 reports list bempedoic acid among the medicines taken, each a report of something that happened, not proof the medicine caused it; 22 are coded as a death and 240 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 23 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?
- Bempedoic acid: 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