Common Side Effects of Nexlizet
Nexlizet (bempedoic acid plus ezetimibe) is generally well tolerated with adverse effects similar to placebo, with the most notable side effects being hyperuricemia/gout, mild gastrointestinal symptoms, upper respiratory infections, and tendon-related issues. 1
Most Common Adverse Effects
Hyperuricemia and Gout (Most Clinically Significant)
- Bempedoic acid increases serum uric acid levels by approximately 0.8 mg/dL on average due to competitive renal transportation by OAT 2 transporters 2
- Hyperuricemia occurs four times more frequently than placebo, and acute gout occurs three times more frequently 3
- Monitor serum uric acid before initiation and when clinically indicated; initiate urate-lowering drugs as appropriate if symptoms develop 1
Musculoskeletal Effects
- Upper respiratory tract infection, muscle spasms, back pain, and pain in extremities are reported adverse effects 1
- Importantly, bempedoic acid has significantly lower muscle-related adverse effects compared to statins because it is activated only in the liver and skeletal muscles lack the ACL enzyme 4, 3
- Tendon rupture is a rare but serious adverse effect; discontinue immediately if tendon rupture occurs and consider discontinuing if joint pain, swelling, or inflammation develops 1
Gastrointestinal Effects
- Mild and transient gastrointestinal events, abdominal pain or discomfort, and diarrhea can occur, primarily from the ezetimibe component 1
- These effects are generally similar to placebo in incidence 1
Hepatic Effects
- Elevated liver enzymes can occur with bempedoic acid therapy 1, 5
- Monitor liver enzymes during treatment, though mild elevations do not require discontinuation 5
- The overall incidence remains similar to placebo 1
Other Reported Adverse Effects
- Bronchitis, sinusitis, influenza, and anemia 1
- Headache and fatigue (from ezetimibe component) 1
- Arthralgia 1
Important Clinical Caveats
Muscle Safety Profile
A key advantage of Nexlizet is its muscle-sparing effect, making it particularly valuable for statin-intolerant patients who often discontinue therapy due to muscle symptoms 4. The bempedoic acid component has low rates of muscle-related adverse effects even in statin-intolerant patients 4.
Pregnancy and Lactation
All lipid-lowering drugs, including Nexlizet, should be avoided during pregnancy and nursing or in women who may become pregnant 1. Discontinue when pregnancy is recognized unless benefits outweigh potential fetal risks 1.
Drug Interactions
Avoid concomitant use with cyclosporine and fibrates; avoid simvastatin >20 mg daily or pravastatin >40 mg daily when using bempedoic acid 1.