Nexlizet Side Effects

Generic name: bempedoic acid/ezetimibe

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jul 11, 2023.

Note: This document provides detailed information about Nexlizet.

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

Applies to bempedoic acid/ezetimibe: 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.

Ezetimibe may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after using this medicine.

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 and ezetimibe combination. 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 Nexlizet

Along with its needed effects, bempedoic acid/ezetimibe 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/ezetimibe:

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

For healthcare professionals

Applies to bempedoic acid/ezetimibe: oral tablet.

General adverse events

The most commonly reported adverse reactions have included 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^[Ref]

Hematologic

Bempedoic Acid:

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

Ezetimibe:

• Postmarketing reports: Thrombocytopenia

Approximately 10.1% of patients had an increase in platelet count of 100x10(9)/L or more on 1 or more occasion of receiving bempedoic acid 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.

Metabolic

Bempedoic Acid:

• 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.

Respiratory

Bempedoic Acid:

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

Ezetimibe:

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

Musculoskeletal

Bempedoic Acid:

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

Ezetimibe

• Postmarketing reports: Myalgia, elevated creatine phosphokinase, myopathy/rhabdomyolysis

Hepatic

Bempedoic Acid:

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

Ezetimibe:

• Postmarketing reports: Hepatic transaminase elevations, hepatitis, cholelithiasis, cholecystitis

Gastrointestinal

Bempedoic acid-ezetimibe:

• Common (1% to 10%): Constipation

Bempedoic Acid:

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

Ezetimibe:

• Common (1% to 10%): Diarrhea
• Postmarketing reports: Abdominal pain, pancreatitis, nausea

Genitourinary

Bempedoic acid-ezetimibe:

• Common (1% to 10%): Urinary tract infection

Bempedoic Acid:

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

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

Immunologic

Bempedoic acid-ezetimibe:

• Common (1% to 10%): Influenza

Hypersensitivity

Ezetimibe:

• Postmarketing reports: Anaphylaxis, angioedema, rash, and urticaria

Psychiatric

Ezetimibe:

• Postmarketing reports: Depression

Cardiovascular

Bempedoic Acid:

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

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

Dermatologic

Bempedoic Acid:

• Rare (less than 0.1%): Cellulitis

Ezetimibe:

• Postmarketing reports: Rash, erythema multiforme

Nervous system

Ezetimibe:

• Postmarketing reports: Headache, dizziness, paresthesia

Other

Bempedoic acid-ezetimibe:

• Frequency not reported: Oral discomfort

Ezetimibe:

• Common (1% to 10%): Fatigue

Renal

Bempedoic Acid:

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

See also:

Frequently asked questions

• Does Nexlizet cause weight loss or weight gain?
• Is Nexlizet a statin?

Further information

Nexlizet 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