From the Guidelines
Severe side effects of fenofibrate tablets include liver damage, severe muscle pain or weakness, pancreatitis, serious allergic reactions, and gallbladder problems, and patients should seek immediate medical attention if they experience any of these symptoms. These side effects can be life-threatening and require prompt medical intervention. According to the most recent evidence 1, fenofibrate is contraindicated in individuals with eGFR < 30 mL/min/1.73 m2, and there are limited data about the safety of gemfibrozil in patients with advanced CKD. Some key points to consider when prescribing fenofibrate include:
- Monitoring renal status before initiation, within 3 months after initiation, and every 6 months thereafter, as fenofibrate should not be used if moderate or severe renal impairment is present 1
- Being cautious when using fenofibrate with statins, as the combination raises the risk for rhabdomyolysis 1
- Regular blood tests to monitor liver function and muscle enzymes, as fenofibrate can cause liver damage and muscle pain 1 It is essential to weigh the benefits and risks of fenofibrate therapy, particularly in patients with pre-existing liver or kidney conditions, and to closely monitor patients for any signs of severe side effects.
From the FDA Drug Label
5.7 Pancreatitis Pancreatitis has been reported in patients taking fenofibrate, gemfibrozil and clofibrate. 5.9 Hypersensitivity Reactions Acute Hypersensitivity Anaphylaxis and angioedema have been reported post-marketing with fenofibrate. 5.9 Hypersensitivity Reactions Delayed Hypersensitivity Severe cutaneous adverse drug reactions (SCAR), including Stevens-Johnson syndrome, toxic epidermal necrolysis, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported post-marketing, occurring days to weeks after initiation of fenofibrate 5.10 Venothromboembolic Disease In the FIELD trial, pulmonary embolus (PE) and deep vein thrombosis (DVT) were observed at higher rates in the fenofibrate- than the placebo-treated group. 5.11 Paradoxical Decreases in HDL Cholesterol Levels There have been post-marketing and clinical trial reports of severe decreases in HDL cholesterol levels (as low as 2 mg/dL) occurring in diabetic and non-diabetic patients initiated on fibrate therapy.
The severe side effects of fenofibrate tablets include:
- Pancreatitis
- Hypersensitivity reactions, such as anaphylaxis, angioedema, and severe cutaneous adverse reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS)
- Venothromboembolic disease, including pulmonary embolus and deep vein thrombosis
- Paradoxical decreases in HDL cholesterol levels 2
From the Research
Severe Side Effects of Fenofibrate Tablets
- Rhabdomyolysis: a rare but severe side effect of fenofibrate, which can lead to acute renal failure (ARF) 3, 4, 5
- Acute renal failure (ARF): a potential side effect of fenofibrate, especially in patients with chronic renal failure or hypothyroidism 3, 4, 5
- Polymyositis: a rare side effect of fenofibrate, characterized by proximal muscular weakness and increased muscle enzyme levels 6
- Myositis: a rare side effect of fenofibrate, which can be dose-related 6
- Secondary acute renal failure (ARF): a potential side effect of fenofibrate, especially in patients with chronic renal failure or hypothyroidism 3, 4, 5
- Hypertriglyceridemia: a potential side effect of fenofibrate, especially in patients with advanced fibrosis due to metabolic-associated fatty liver disease (MAFLD) 7
Patient Risk Factors
- Chronic renal failure: a risk factor for rhabdomyolysis associated with fenofibrate therapy 4, 5
- Hypothyroidism: a risk factor for rhabdomyolysis associated with fenofibrate therapy 5
- Nephrotic syndrome: a risk factor for rhabdomyolysis associated with fenofibrate therapy 4
- Advanced fibrosis due to MAFLD: a risk factor for hypertriglyceridemia associated with fenofibrate therapy 7
Treatment and Management
- Discontinuation of fenofibrate therapy: the primary treatment for rhabdomyolysis and other severe side effects associated with fenofibrate 3, 4, 5
- Intravenous fluid replacement: a treatment for rhabdomyolysis associated with fenofibrate therapy 3, 4
- Urine alkalization: a treatment for rhabdomyolysis associated with fenofibrate therapy 3, 4
- Corticosteroid therapy: a treatment for polymyositis associated with fenofibrate therapy 6