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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Tricor
Generic Name
Fenofibrate
Active Ingredient
FenofibrateCategory
Peroxisome Proliferator Receptor alpha Agonist [EPC]
Variants
3
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 145 mg/1 | TABLET | ORAL | 0074-3189 |
| 145 mg/1 | TABLET | ORAL | 50090-2899 |
| 145 mg/1 | TABLET | ORAL | 43353-272 |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Tricor, you must consult a qualified healthcare professional.
Detailed information about Tricor
Fenofibrate is a peroxisome proliferator receptor alpha (PPAR-α) agonist used primarily to manage lipid levels, including triglycerides and cholesterol, to reduce the risk of cardiovascular complications in high-risk patients.
Dosage for fenofibrate must be individualized based on the patient's lipid profile, renal function, and response to therapy. Because there are multiple formulations (tablets, micronized capsules, etc.), the milligram strength varies significantly between products.
Fenofibrate is generally not recommended for use in the pediatric population. Its safety and effectiveness in children and adolescents under the age of 18 have not been established. In rare cases of familial hypercholesterolemia, a specialist may consider its use, but this is strictly under expert supervision and is not a standard FDA-approved pediatric indication.
Fenofibrate is primarily excreted by the kidneys, and its accumulation can lead to toxicity.
Fenofibrate has not been adequately studied in patients with hepatic impairment. However, because it can cause elevations in liver enzymes and is contraindicated in patients with active liver disease, it should be used with extreme caution or avoided entirely in those with significant liver dysfunction.
For patients over the age of 65, dosing should be conservative. Since renal function naturally declines with age, many doctors start elderly patients on the lowest available dose and monitor kidney function (creatinine levels) frequently.
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and return to your regular schedule. Do not double the dose to catch up, as this increases the risk of side effects like muscle toxicity.
There is no specific antidote for fenofibrate overdose. Treatment is supportive. Signs of overdose may include severe nausea, vomiting, diarrhea, or muscle pain. If an overdose is suspected, contact a poison control center or seek emergency medical attention immediately. Because fenofibrate is highly protein-bound, hemodialysis is not effective in removing the drug from the system.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking the medication without medical guidance, as this could lead to a rapid increase in triglyceride levels.
While many patients tolerate fenofibrate well, some experience mild to moderate side effects. These often diminish as the body adjusts to the medication:
Fenofibrate is a potent metabolic modifier and requires careful medical supervision. It is not a substitute for a heart-healthy diet and exercise; rather, it is an addition to these lifestyle changes. Patients must be aware that the primary risks involve the liver, muscles, and kidneys.
As of 2024, there are no FDA black box warnings for Fenofibrate. However, it is important to note that the related drug, Clofibrate, showed increased mortality in clinical trials, which led to a class-wide caution for fibrates for many years. Current evidence for fenofibrate does not support a similar mortality risk, but the medication is still used with caution.
Fenofibrate must NEVER be used in the following circumstances:
FDA Pregnancy Category C (under the old system). There are no adequate and well-controlled studies of fenofibrate in pregnant women. Animal studies have shown embryotoxicity at doses several times the human dose. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is generally recommended that lipid-lowering medications be discontinued during pregnancy unless the risk of severe hypertriglyceridemia-induced pancreatitis is very high.
Fenofibrate should not be used by nursing mothers. It is unknown if fenofibrate is excreted in human milk, but animal studies suggest it may be. Because of the potential for serious adverse reactions in the nursing infant (including interference with lipid metabolism), a decision should be made whether to discontinue nursing or discontinue the drug.
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Use in children is considered off-label and is generally reserved for severe genetic lipid disorders under the care of a pediatric lipid specialist.
Fenofibrate is a prodrug of fenofibric acid. Its primary mechanism is the activation of the Peroxisome Proliferator-Activated Receptor alpha (PPAR-α). This activation increases the lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-III. The resulting fall in triglycerides produces an alteration in the size and composition of LDL from small, dense particles to large, buoyant particles. Additionally, PPAR-α activation increases the synthesis of apoproteins A-I and A-II, which leads to an increase in HDL cholesterol.
The onset of action for triglyceride reduction is typically seen within 2 to 4 weeks, with peak effects occurring after 6 to 8 weeks of consistent therapy. The duration of effect lasts for as long as the medication is taken; lipid levels usually return to baseline within 4 to 8 weeks after discontinuation.
| Parameter | Value |
|---|---|
| Bioavailability | 60% - 90% (varies by formulation) |
Common questions about Tricor
Fenofibrate is primarily used to treat high levels of triglycerides (fats) and cholesterol in the blood. By lowering high triglycerides, it helps reduce the risk of developing pancreatitis, a painful and potentially life-threatening inflammation of the pancreas. It is also used to treat mixed dyslipidemia, where it helps lower 'bad' LDL cholesterol and increase 'good' HDL cholesterol. Healthcare providers typically prescribe it alongside a heart-healthy diet and exercise program. It is often used when other lifestyle changes alone are not enough to reach target lipid levels.
The most common side effects reported by patients taking fenofibrate include stomach pain, back pain, headache, and nausea. Some people may also experience a stuffy or runny nose or mild indigestion. In clinical trials, about 7% to 10% of patients showed an increase in liver enzymes, which is why regular blood tests are necessary. Most of these common side effects are mild and tend to go away as the body adjusts to the medication. However, if these symptoms persist or become bothersome, you should consult your healthcare provider.
Drinking alcohol while taking fenofibrate is generally discouraged. Alcohol can significantly raise triglyceride levels, which directly contradicts the purpose of taking the medication. Furthermore, both fenofibrate and alcohol can put stress on the liver; combining them increases the risk of liver irritation or damage. Alcohol is also a known risk factor for pancreatitis, a condition fenofibrate is often used to prevent. If you do choose to drink, it should be in very limited amounts and only after discussing the risks with your doctor.
Fenofibrate is generally not recommended during pregnancy unless the benefits clearly outweigh the risks to the fetus. It is classified as FDA Pregnancy Category C, meaning animal studies have shown potential harm, but there aren't enough human studies to confirm safety. Most doctors recommend stopping lipid-lowering medications during pregnancy because cholesterol is necessary for fetal development. However, in cases of extremely high triglycerides that could cause pancreatitis, a specialist might consider it. Always inform your doctor if you are pregnant or planning to become pregnant before starting this drug.
You will not feel fenofibrate 'working' immediately, as it does not treat acute symptoms. However, it begins to affect your lipid metabolism within the first few days. Significant changes in your triglyceride and cholesterol levels are usually visible in blood tests after 2 to 4 weeks of consistent use. Maximum effectiveness is typically reached after 6 to 8 weeks. Your doctor will likely schedule a follow-up blood test during this window to see if the dose needs to be adjusted based on your body's response.
You should not stop taking fenofibrate suddenly without consulting your healthcare provider. While there are no withdrawal symptoms like those seen with some antidepressants or blood pressure medications, stopping fenofibrate will cause your triglyceride and cholesterol levels to rise back to their previous levels fairly quickly. This increase can raise your risk of cardiovascular problems or a pancreatitis flare-up. If you need to stop the medication due to side effects, your doctor will help you do so safely and may suggest an alternative treatment.
If you miss a dose of fenofibrate, take it as soon as you remember. However, if it is nearly time for your next scheduled dose, skip the missed one and continue with your regular dosing schedule. Do not take two doses at once to make up for the missed one, as this increases the risk of side effects, particularly muscle pain or liver issues. Consistency is key to managing lipid levels effectively, so try to take your medication at the same time every day to help you remember.
Weight gain is not a commonly reported side effect of fenofibrate in clinical trials. In fact, because patients are usually advised to follow a low-fat, low-calorie diet while taking the medication, many patients may actually lose weight. If you experience sudden or unexplained weight gain while taking this drug, it could be a sign of a different issue, such as fluid retention or a thyroid problem, and should be reported to your doctor. It is important to continue monitoring your weight and diet throughout your treatment.
Fenofibrate can interact with several other medications, some of which are very common. The most significant interaction is with statins (like atorvastatin), which can increase the risk of serious muscle breakdown. It also interacts with blood thinners like warfarin, potentially increasing the risk of bleeding, and with certain immunosuppressants like cyclosporine. Because of these risks, it is vital to provide your doctor and pharmacist with a complete list of all medications, supplements, and herbs you are taking so they can monitor for interactions.
Yes, fenofibrate is widely available as a generic medication in several different strengths and formulations. Generic versions are typically much more affordable than brand-name versions like Tricor, Antara, or Lipofen. However, it is important to note that different generic versions may not be directly interchangeable because their absorption rates can vary. You should always stick with the specific formulation your doctor prescribed and check with your pharmacist if the appearance of your medication changes.
Other drugs with the same active ingredient (Fenofibrate)
> Warning: Stop taking Fenofibrate and call your doctor immediately if you experience any of these serious symptoms:
No FDA black box warnings currently exist for Fenofibrate. However, it carries significant 'Warnings and Precautions' regarding liver enzyme elevations and skeletal muscle toxicity, especially when used in combination with HMG-CoA reductase inhibitors (statins). The FDA previously required a warning regarding the risk of coronary heart disease mortality based on older studies of a different fibrate (clofibrate), but subsequent large-scale trials for fenofibrate (like FIELD and ACCORD) did not show an increase in all-cause mortality, though they also failed to show a significant reduction in major cardiovascular events in certain populations.
Report any unusual symptoms to your healthcare provider immediately. Regular blood work is necessary to ensure the medication is working safely.
To ensure safety, the following monitoring schedule is typically recommended:
Fenofibrate generally does not cause drowsiness or impair cognitive function. However, if you experience rare side effects like dizziness or severe headaches, you should avoid driving or operating heavy machinery until you know how the medication affects you.
Alcohol should be consumed with extreme caution, if at all, while taking fenofibrate. Alcohol can significantly increase triglyceride levels, counteracting the drug's effects. Furthermore, both alcohol and fenofibrate can stress the liver, increasing the risk of hepatotoxicity. Chronic heavy drinking also increases the risk of pancreatitis, which fenofibrate is often prescribed to prevent.
There is no 'withdrawal syndrome' associated with stopping fenofibrate. However, if you stop the medication suddenly, your triglyceride and cholesterol levels may rise rapidly, increasing the risk of cardiovascular events or pancreatitis. It is usually not necessary to taper the dose, but discontinuation should only happen under a doctor's guidance.
> Important: Discuss all your medical conditions, especially liver, kidney, or gallbladder disease, with your healthcare provider before starting Fenofibrate.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking. The interaction between fenofibrate and blood thinners or statins is particularly critical and requires active management.
Conditions requiring a careful risk-benefit analysis include:
Patients who have had a photoallergic or phototoxic reaction (severe skin reaction to sunlight) while taking other fibrates (like gemfibrozil) or ketoprofen may be at higher risk for similar reactions with fenofibrate. There is also a potential for cross-sensitivity in patients allergic to other fibric acid derivatives.
> Important: Your healthcare provider will evaluate your complete medical history, including kidney and liver function, before prescribing Fenofibrate.
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects. However, since fenofibrate is excreted by the kidneys, and elderly patients are more likely to have decreased renal function, dose selection should be cautious. Doctors typically monitor renal function more frequently in this age group to avoid drug accumulation and the associated risk of myopathy.
In patients with a GFR of 30 to 59 mL/min, the dose of fenofibrate should be minimized (e.g., 43 to 48 mg/day). If the GFR falls below 30 mL/min, the drug must be discontinued. Regular monitoring of the GFR is essential throughout therapy.
Fenofibrate has not been studied in patients with hepatic impairment. However, since it can cause liver enzyme elevations and is contraindicated in active liver disease, its use in patients with any degree of hepatic dysfunction (Child-Pugh Class A, B, or C) is generally discouraged or must be done with extreme caution.
> Important: Special populations require individualized medical assessment and more frequent laboratory monitoring.
| Protein Binding | 99% (to Albumin) |
| Half-life | ~20 hours (range 10-35 hours) |
| Tmax | 6 - 8 hours |
| Metabolism | Esterase hydrolysis to Fenofibric Acid; Glucuronidation |
| Excretion | Renal 60%, Fecal 25% |
Fenofibrate belongs to the fibric acid derivative (fibrate) class. Other drugs in this class include gemfibrozil and clofibrate (the latter is largely discontinued). It is distinct from statins (HMG-CoA reductase inhibitors), bile acid sequestrants, and PCSK9 inhibitors in its specific potency against triglycerides.