What are the side effects of Lipantil (fenofibrate)?

Side Effects of Lipantil (Fenofibrate)

Fenofibrate (Lipantil) can cause serious side effects including liver injury, myopathy (especially when combined with statins), and increased risk of gallstones, requiring careful monitoring and appropriate dose adjustments in certain populations. 1

Common Side Effects

• Gastrointestinal effects: Dyspepsia, nausea, abdominal pain 2, 3
• Skin reactions: Rash, pruritus 3, 4
• Neurological effects: Headache, dizziness 3, 4
• Musculoskeletal effects: Muscle pain, tenderness, weakness 1, 3

Serious Side Effects

Hepatotoxicity

• Serious drug-induced liver injury, including cases requiring liver transplantation and some resulting in death 1
• Transient elevations in liver enzymes (ALT, AST) are common 1, 4
• Regular monitoring of liver function tests is essential throughout treatment 1

Myopathy and Rhabdomyolysis

• Risk significantly increases when combined with statins 2, 1
• Higher risk in elderly patients, patients with diabetes, renal failure, or hypothyroidism 1
• Gemfibrozil has approximately 10 times higher risk of rhabdomyolysis compared to fenofibrate when combined with statins 2

Renal Effects

• Can reversibly increase serum creatinine levels 1
• Dose reduction required in mild to moderate renal impairment (48 mg vs standard 96 mg) 2
• Should be avoided in severe renal dysfunction (eGFR <30 mL/min/1.73m²) 2, 1

Gallbladder Disease

• Increases cholesterol excretion into bile, leading to risk of gallstones 1, 5
• Contraindicated in patients with existing gallbladder disease 1

Special Population Considerations

Renal Impairment

• Avoid use in severe renal impairment 2, 1
• Dose reduction to 48 mg daily in mild to moderate renal impairment 2

Elderly Patients

• Dose selection should be based on renal function 1
• Higher risk of side effects, particularly myopathy 1

Pregnant Women

• Contraindicated during breastfeeding 1

Drug Interactions

Statins

• Increased risk of myopathy and rhabdomyolysis when combined 2
• Risk is lower with fenofibrate compared to gemfibrozil 2
• Combination therapy has not been shown to improve cardiovascular outcomes 2

Anticoagulants

• May increase the effect of oral coumarin anticoagulants 1
• Requires careful monitoring of prothrombin time/INR 1

Other Medications

• Bile acid sequestrants: Take fenofibrate at least 2 hours before or 4 hours after bile acid sequestrants 2
• Immunosuppressants: Potential interactions require monitoring 1

Monitoring Recommendations

1. Liver function: Monitor ALT, AST, and total bilirubin at baseline and periodically throughout treatment 1
2. Renal function: Regular assessment of serum creatinine, especially in patients with renal impairment 1
3. Muscle symptoms: Patients should report any unexplained muscle pain, tenderness, or weakness 1
4. Signs of gallbladder disease: Monitor for abdominal pain that could indicate gallstone formation 1

Clinical Efficacy Context

While fenofibrate effectively reduces triglycerides (by approximately 46-54%) and increases HDL cholesterol (by approximately 20%) 1, it's important to note that it was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus 1. However, it may provide benefits in specific subgroups with marked hypertriglyceridemia or dyslipidemia 2, 6.

Practical Considerations

• Should be taken once daily with meals 1
• Discontinue if signs of liver injury, severe muscle pain, or hypersensitivity reactions develop 1
• Patients should inform their physician of all medications, supplements, and herbal preparations they are taking 1