Nexletol Side Effects

Generic name: bempedoic acid

Medically reviewed by Philip Thornton, DipPharm. Last updated on Dec 25, 2023.

Note: This document provides detailed information about Nexletol.

Applies to bempedoic acid: oral tablet Side Effects associated with bempedoic acid. Some dosage forms listed on this page may not apply specifically to the brand name Nexletol.

Applies to bempedoic acid: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may increase the uric acid levels in the blood (hyperuricemia), which can lead to gout. This can occur within 4 weeks of using this medicine. Check with your doctor right away if you have joint pain, stiffness, or swelling, lower back, side, or stomach pain, or swelling of the feet or lower legs.

Tendon problems, including swelling, inflammation, or rupture can occur in the shoulder (rotator cuff), upper arm (biceps tendon), or Achilles tendon at the back of the ankle, within days or months after starting treatment with bempedoic acid (the active ingredient contained in Nexletol) If you hear or feel a snap or pop, have bruising right after an injury, or are unable to move or put weight in an affected tendon area, check with your doctor right away. Avoid using and exercising the affected area.

Using this medicine together with simvastatin or pravastatin may increase your risk of developing muscle pain or weakness. Talk to your doctor if you have any concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Nexletol

Along with its needed effects, bempedoic acid may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking bempedoic acid:

Other side effects of Nexletol

Some side effects of bempedoic acid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to bempedoic acid: oral tablet.

General adverse events

The more commonly reported adverse reactions have included upper respiratory tract infections, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, extremity pain, anemia, and elevated liver enzymes.^[Ref]

Metabolic

• Very common (10% or more): Hyperuricemia (26%)
• Common (1% to 10%): Clinically significant hyperuricemia, gout
• Uncommon (0.1% to 1%): Increase in creatine kinase

Gout occurred in 1.5% of patients receiving this drug compared to 0% of placebo-treated patients.

Musculoskeletal

• Common (1% to 10%): Muscle spasms, back pain, extremity pain
• Uncommon (0.1% to 1%): Tendon rupture

Respiratory

• Common (1% to 10%): Upper respiratory tract infection, bronchitis

Hematologic

• Common (1% to 10%): Anemia, decreased leukocytes, increased platelet counts

Approximately 10.1% of patients had an increase in platelet count of 100x10(9)/L or more on 1 or more occasion compared to 4.7% receiving placebo. Platelet count elevations appeared to be asymptomatic as they did not result in an increased risk of thromboembolic events or require medical intervention.

Genitourinary

• Common (1% to 10%): Benign prostatic hyperplasia

Benign prostatic hyperplasia or prostatomegaly was reported in 1.3% of patients receiving this drug versus 0.1% in placebo patients.

Gastrointestinal

• Common (1% to 10%): Abdominal pain or discomfort
• Frequency not reported: Diarrhea

Hepatic

• Common (1% to 10%): Elevated liver enzymes

Renal

• Common (1% to 10%): Increased BUN, increased creatinine values

Cardiovascular

• Common (1% to 10%): Atrial fibrillation

Atrial fibrillation was reported in 1.7% of patients receiving this drug compared with 1.1% of placebo-treated patients.

Dermatologic

• Rare (less than 0.1%): Cellulitis

See also:

Further information

Nexletol side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer