Applies to bempedoic acid: oral tablet.

Serious side effects of Bempedoic acid

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:

Less common

• Ankle, knee, or great toe joint pain
• arm, back, or leg pain
• bloody urine
• body aches or pain
• chills
• cough
• cough producing mucus
• difficulty breathing
• difficulty urinating
• dizziness
• ear congestion
• fainting
• fast or irregular heartbeat
• fever
• frequent urination
• headache
• joint pain, stiffness, or swelling
• loss of voice
• lower back, side, or stomach pain
• muscle spasms
• pale skin
• runny or stuffy nose
• sneezing
• sore throat
• swelling of the feet or lower legs
• tightness in the chest
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

Rare

• Bone pain

Other side effects of Bempedoic acid

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:

Less common

• Stomach pain or discomfort

For Healthcare Professionals

Applies to bempedoic acid: oral tablet.

General

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