Note: This document contains side effect information about bempedoic acid. Some dosage forms listed on this page may not apply to the brand name Nexletol.
Applies to bempedoic acid: oral tablet.
Serious side effects of Nexletol
Along with its needed effects, bempedoic acid (the active ingredient contained in Nexletol) 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 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:
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
