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Bempedoic acid / ezetimibe Side Effects

For the Consumer

Applies to bempedoic acid/ezetimibe: oral tablet

Warning

Some cholesterol medications should not be taken at the same time. If you take ezetimibe with another cholesterol medicine, follow your doctor's dosing instructions very carefully.

Get emergency medical help if you have signs of an allergic reaction: hives, rash, severe itching, skin redness or swelling; wheezing, difficult breathing, feeling light-headed; fast or pounding heartbeats; swelling of your face, lips, tongue, or throat.

Some side effects of bempedoic acid and ezetimibe can occur weeks or months after you have started taking this medicine.

Stop taking this medicine and get medical help right away if you have signs of tendon rupture--sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).

Call your doctor at once if you have:

  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or

  • symptoms of gout--joint pain or swelling, warmth or redness around your joints, severe foot or toe pain.

Common side effects may include:

  • stomach pain, diarrhea;

  • anemia;

  • cough, chest tightness, shortness of breath;

  • muscle spasm, back pain, joint pain;

  • pain in your shoulder, arms, or legs;

  • abnormal liver function tests;

  • tiredness; or

  • cold or flu symptoms such as fever, chills, body aches, stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to bempedoic acid / ezetimibe: oral tablet

General

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

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.

Bempedoic Acid:

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

Ezetimibe:

Postmarketing reports: Thrombocytopenia

Metabolic

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

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

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

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

Bempedoic Acid:

Common (1% to 10%): Atrial fibrillation

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

References

1. "Product Information. Nexlizet (bempedoic acid-ezetimibe)." Esperion Therapeutics, Ann Arbor, MI.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.