What are the listed side effects of fenofibrate (Fibric Acid Derivative) tablets?

From the Guidelines

Fenofibrate tablets can cause a range of side effects, including digestive issues, respiratory symptoms, muscle pain, and less common but serious effects like liver problems and allergic reactions, as indicated in the guidelines for the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults 1.

Common Side Effects

• Digestive issues such as stomach pain, nausea, constipation, and diarrhea
• Respiratory symptoms like cough, runny nose, or sore throat
• Muscle pain, weakness, or tenderness, which should be reported to a healthcare provider immediately due to the risk of rhabdomyolysis
• Headaches, dizziness, and fatigue

Less Common but Serious Side Effects

• Liver problems, indicated by yellowing of skin/eyes, dark urine, upper abdominal pain
• Allergic reactions, such as rash, itching, swelling, severe dizziness
• Pancreatitis, characterized by severe stomach/back pain

Monitoring and Precautions

• Regular blood tests are recommended to monitor liver function and lipid levels during treatment
• Patients should inform their doctor if they experience any unusual symptoms while taking fenofibrate, particularly persistent or severe side effects
• Renal status should be evaluated before fenofibrate initiation, within 3 months after initiation, and every 6 months thereafter, with assessment of renal safety using both serum creatinine level and eGFR based on creatinine 1
• Fenofibrate should not be used if moderate or severe renal impairment is present, and the dose should not exceed 54 mg/day if eGFR is between 30 and 59 mL/min per 1.73 m2 1

From the FDA Drug Label

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 to inform their physician of symptoms of liver injury (e.g., jaundice, abnormal pain, nausea, malaise, dark urine, abnormal stool, pruritus); any muscle pain, tenderness, or weakness; onset of abdominal pain; or any other new symptoms.

The listed side effects of fenofibrate tablets include:

• Liver injury symptoms such as jaundice, abnormal pain, nausea, malaise, dark urine, abnormal stool, pruritus
• Muscle pain, tenderness, or weakness
• Onset of abdominal pain
• Any other new symptoms 2 2

From the Research

Listed Side Effects of Fenofibrate Tablets

The listed side effects of fenofibrate tablets include:

• Gastrointestinal disturbances, such as abdominal discomfort, diarrhea, and constipation 3, 4
• Headache 3, 4
• Muscle cramps 3 and muscle tenderness 4
• Fatigue, loss of libido, impotence, dizziness, and insomnia 4
• Skin rash 4
• Transient elevations in transaminase and creatine phosphokinase levels 3
• Isolated cases of hepatitis with substantially elevated transaminase levels 3
• Increased risk of cholelithiasis (gallstones) due to increased biliary lithogenic index 3, 4
• Pancreatitis, although rare, has been reported in association with fenofibrate use, particularly when combined with other medications like simvastatin 5

Less Common Side Effects

Less common side effects of fenofibrate tablets may include:

• Uricosuric effects, which can be beneficial in some cases 6
• Alterations in LDL structure and hemostatic parameters, which can help protect against coronary heart disease 6
• Increased risk of adverse effects beyond muscle and liver toxicity, although these are less well known and clinically relevant 7