Note: This document contains side effect information about bempedoic acid/ezetimibe. Some dosage forms listed on this page may not apply to the brand name Nexlizet.

Applies to bempedoic acid/ezetimibe: oral tablet.

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:

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 in moving
• 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 pain, spasm, or stiffness
• pain or tenderness around the eyes and cheekbones
• 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

Incidence not known

• Black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• chills
• constipation
• dark urine
• diarrhea
• difficulty swallowing
• gaseous stomach pain
• hives, itching, skin rash
• indigestion
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• light-colored stools
• loss of appetite
• muscular tenderness, wasting, or weakness
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• recurrent fever
• red, irritated eyes
• severe nausea or vomiting
• sores, ulcers, or white spots in the mouth or on the lips
• stomach fullness
• upper right stomach pain
• yellow eyes or skin

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

Incidence not known

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• discouragement
• feeling sad or empty
• irritability
• loss of interest or pleasure
• trouble concentrating
• trouble sleeping

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