Fenofibrate 160mg Tablets
It is used to lower bad cholesterol, lower triglycerides, and raise good cholesterol (HDL).
Drug Class
Antilipemic Agents, Fibrates
Pharmacologic Class
Peroxisome Proliferator-Activated Receptor Alpha (PPARΞ±) Agonists
Pregnancy Category
Category C
FDA Approved
Dec 1993
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fenofibrate is a medication used to help lower high levels of triglycerides (a type of fat) in your blood and to increase 'good' cholesterol (HDL). It works by helping your body process fats more efficiently. It's often used along with a healthy diet and exercise.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
Check with your pharmacist to see if your specific brand of medication should be taken with food or if it can be taken with or without food.
If you have difficulty swallowing, consult with your doctor for guidance.
Take your medication with a full glass of water.
If you are taking cholestyramine or colestipol, be sure to take them at least 4 hours before or 1 hour after your medication.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Swallow your medication whole; do not chew, break, or crush it.
Do not take any tablets that are chipped or broken.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature with the lid tightly closed.
Some brands of this medication require storage in the original container. Do not remove the anti-moisture cube or packet. If you are unsure, consult with your doctor or pharmacist.
What to Do if You Miss a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take more than one dose in a 24-hour period unless your doctor instructs you to do so.
To ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
Check with your pharmacist to see if your specific brand of medication should be taken with food or if it can be taken with or without food.
If you have difficulty swallowing, consult with your doctor for guidance.
Take your medication with a full glass of water.
If you are taking cholestyramine or colestipol, be sure to take them at least 4 hours before or 1 hour after your medication.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Swallow your medication whole; do not chew, break, or crush it.
Do not take any tablets that are chipped or broken.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature with the lid tightly closed.
Some brands of this medication require storage in the original container. Do not remove the anti-moisture cube or packet. If you are unsure, consult with your doctor or pharmacist.
What to Do if You Miss a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take more than one dose in a 24-hour period unless your doctor instructs you to do so.
Lifestyle & Tips
- Continue to follow a low-fat, low-cholesterol diet as recommended by your doctor or dietitian.
- Engage in regular physical activity.
- Limit or avoid excessive alcohol intake, as it can increase triglyceride levels.
- Maintain a healthy weight.
Available Forms & Alternatives
Available Strengths:
- Fenofibrate 43mg Capsules
- Fenofibrate 130mg Capsules
- Fenofibrate 130mg Capsules
- Fenofibrate 43mg Capsules
- Fenofibrate 120mg Tablets
- Fenofibrate 40mg Tablets
- Fenofibrate 50mg Capsules
- Fenofibrate 120mg Tablets
- Fenofibrate 150mg Capsules
- Fenofibrate 40mg Tablets
- Fenofibrate 145mg Tablets
- Fenofibrate 48mg Tablets
- Fenofibrate 134mg Capsules
- Fenofibrate 200mg Capsules
- Fenofibrate 67mg Capsules
- Fenofibrate 160mg Tablets
- Fenofibrate 145mg Tablets
- Fenofibrate 134mg Capsules
- Fenofibrate 54mg Tablets
- Fenofibrate 200mg Capsules
- Fenofibrate 67mg Capsules
- Fenofibrate Micro 90mg Capsules
Dosing & Administration
Adult Dosing
Standard Dose:
160 mg orally once daily with meals
Dose Range:
160 - 160 mg
Condition-Specific Dosing:
hypertriglyceridemia:
160 mg orally once daily with meals
mixedDyslipidemia:
160 mg orally once daily with meals
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment for 160mg formulation, but monitor renal function.
Moderate:
Reduce dose to 54 mg or 48 mg once daily (depending on formulation).
Severe:
Contraindicated (CrCl < 30 mL/min).
Dialysis:
Contraindicated.
Hepatic Impairment:
Mild:
Use with caution, monitor LFTs.
Moderate:
Use with caution, monitor LFTs.
Severe:
Contraindicated.
Pharmacology
Mechanism of Action
Fenofibrate is a prodrug that is rapidly hydrolyzed to its active metabolite, fenofibric acid. Fenofibric acid activates peroxisome proliferator-activated receptor alpha (PPARΞ±). This activation leads to increased lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing the production of apolipoprotein C-III (an inhibitor of lipoprotein lipase). It also increases the synthesis of apolipoproteins A-I and A-II, leading to increased HDL-C levels.
Pharmacokinetics
Absorption:
Bioavailability:
81% (fenofibric acid from micronized fenofibrate)
Tmax:
6-8 hours
FoodEffect:
Absorption is increased by approximately 35% when taken with food.
Distribution:
Vd:
Approximately 30 L
ProteinBinding:
>99% (to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 20-23 hours (fenofibric acid)
Clearance:
Not available
ExcretionRoute:
Primarily renal (60-70% as fenofibric acid and its glucuronide conjugate), approximately 25% in feces.
Unchanged:
<2% in urine
Pharmacodynamics
OnsetOfAction:
Lipid-lowering effects begin within days.
PeakEffect:
Maximum effects on lipids typically seen within 2-4 weeks.
DurationOfAction:
Effects persist as long as drug is taken.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be life-threatening.
Liver problems: Dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Pancreatitis: Severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Gallstones: Sudden pain in the upper right belly area, right shoulder area, or between the shoulder blades, yellow skin and eyes, or fever with chills.
Severe joint pain or swelling: Contact your doctor if you experience intense joint pain or swelling.
Blood clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color change, or pain in a leg or arm, or difficulty speaking or swallowing.
Muscle problems: Muscle pain or weakness, especially if accompanied by extreme fatigue, weakness, or fever. Inform your doctor if you experience difficulty urinating or notice changes in urine output.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek medical help immediately if you notice red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.
Low blood cell counts: If blood cell counts drop significantly, it can lead to bleeding problems, infections, or anemia. Contact your doctor if you experience signs of infection, such as fever, chills, or sore throat; unexplained bruising or bleeding; or extreme fatigue or weakness.
Other Side Effects
Most medications can cause side effects, but many people experience none or only mild side effects. If you encounter any of the following side effects or any other symptoms that concern you or persist, contact your doctor or seek medical attention:
Headache
Back pain
Stomach pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be life-threatening.
Liver problems: Dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Pancreatitis: Severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Gallstones: Sudden pain in the upper right belly area, right shoulder area, or between the shoulder blades, yellow skin and eyes, or fever with chills.
Severe joint pain or swelling: Contact your doctor if you experience intense joint pain or swelling.
Blood clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color change, or pain in a leg or arm, or difficulty speaking or swallowing.
Muscle problems: Muscle pain or weakness, especially if accompanied by extreme fatigue, weakness, or fever. Inform your doctor if you experience difficulty urinating or notice changes in urine output.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek medical help immediately if you notice red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.
Low blood cell counts: If blood cell counts drop significantly, it can lead to bleeding problems, infections, or anemia. Contact your doctor if you experience signs of infection, such as fever, chills, or sore throat; unexplained bruising or bleeding; or extreme fatigue or weakness.
Other Side Effects
Most medications can cause side effects, but many people experience none or only mild side effects. If you encounter any of the following side effects or any other symptoms that concern you or persist, contact your doctor or seek medical attention:
Headache
Back pain
Stomach pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine (signs of muscle breakdown).
- Severe abdominal pain, nausea, or vomiting (could indicate gallstones or pancreatitis).
- Yellowing of the skin or eyes (jaundice), dark urine, or unusual fatigue (signs of liver problems).
- Swelling in the hands or feet, or decreased urination (signs of kidney problems).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Gallbladder disease
+ Kidney disease
+ Liver disease
+ Elevated liver enzymes
If you are taking any of the following medications:
+ Atorvastatin
+ Fluvastatin
+ Lovastatin
+ Pitavastatin
+ Pravastatin
+ Rosuvastatin
+ Simvastatin
If you are breastfeeding or plan to breastfeed. Note that you should not breastfeed while taking this medication, and you may need to avoid breastfeeding for 5 days after your last dose. Consult your doctor to determine the best course of action.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your complete medical history
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Gallbladder disease
+ Kidney disease
+ Liver disease
+ Elevated liver enzymes
If you are taking any of the following medications:
+ Atorvastatin
+ Fluvastatin
+ Lovastatin
+ Pitavastatin
+ Pravastatin
+ Rosuvastatin
+ Simvastatin
If you are breastfeeding or plan to breastfeed. Note that you should not breastfeed while taking this medication, and you may need to avoid breastfeeding for 5 days after your last dose. Consult your doctor to determine the best course of action.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your complete medical history
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regularly undergo blood work and other laboratory tests as directed by your doctor to monitor your condition. Adhere to the diet and exercise plan recommended by your doctor to ensure optimal management of your health.
Be aware that this medication can cause liver problems, which may be severe and potentially life-threatening, requiring a liver transplant or resulting in death. If you have any concerns or questions, discuss them with your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to experiencing side effects.
If you are pregnant or planning to become pregnant, consult your doctor to discuss the potential benefits and risks associated with using this medication during pregnancy.
Be aware that this medication can cause liver problems, which may be severe and potentially life-threatening, requiring a liver transplant or resulting in death. If you have any concerns or questions, discuss them with your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to experiencing side effects.
If you are pregnant or planning to become pregnant, consult your doctor to discuss the potential benefits and risks associated with using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported, but potential effects could include exacerbation of known side effects such as muscle pain, liver enzyme elevations, or gastrointestinal upset.
What to Do:
There is no specific antidote for fenofibrate overdose. Management should be supportive and symptomatic. Gastric lavage may be considered if ingestion is recent. Monitor vital signs and organ function (especially liver and kidney function). Fenofibric acid is not dialyzable. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Severe renal impairment
- Severe hepatic impairment
- Pre-existing gallbladder disease
- Cyclosporine (increased nephrotoxicity)
Major Interactions
- Statins (HMG-CoA reductase inhibitors): Increased risk of myopathy/rhabdomyolysis. Use with caution, especially with high-dose statins or in patients with renal impairment.
- Warfarin: Potentiates anticoagulant effect (displaces from protein binding sites). Requires INR monitoring and dose adjustment.
- Bile Acid Sequestrants (e.g., cholestyramine, colestipol): Can significantly reduce fenofibrate absorption. Administer fenofibrate at least 1 hour before or 4-6 hours after bile acid sequestrants.
Moderate Interactions
- Ezetimibe: Increased risk of cholelithiasis.
- Colchicine: Increased risk of myopathy/rhabdomyolysis.
Monitoring
Baseline Monitoring
Lipid panel (TC, LDL-C, HDL-C, TG)
Rationale: To establish baseline lipid levels and assess treatment efficacy.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST)
Rationale: To establish baseline liver function and monitor for hepatotoxicity.
Timing: Prior to initiation of therapy.
Renal function (SCr, eGFR)
Rationale: To establish baseline renal function and guide dosing, as fenofibrate is renally eliminated.
Timing: Prior to initiation of therapy.
Creatine Kinase (CK)
Rationale: Consider if patient has risk factors for myopathy (e.g., renal impairment, hypothyroidism, history of muscle toxicity with other lipid-lowering agents).
Timing: Prior to initiation of therapy.
Routine Monitoring
Lipid panel (TC, LDL-C, HDL-C, TG)
Frequency: Every 4-8 weeks initially, then every 6-12 months once stable.
Target: Individualized based on patient risk factors and treatment goals.
Action Threshold: Re-evaluate therapy if lipid goals are not met or if adverse effects occur.
Liver function tests (ALT, AST)
Frequency: Every 3 months during the first year of treatment, then periodically (e.g., every 6-12 months).
Target: Within normal limits.
Action Threshold: Discontinue if ALT or AST levels persist at >3 times the upper limit of normal (ULN).
Renal function (SCr, eGFR)
Frequency: Periodically, especially in elderly or those with risk factors for renal impairment.
Target: Within normal limits or stable for patient's baseline.
Action Threshold: Consider dose reduction or discontinuation if significant decline in renal function occurs.
Creatine Kinase (CK)
Frequency: As needed, if muscle symptoms (pain, tenderness, weakness) develop.
Target: Within normal limits.
Action Threshold: Discontinue if CK levels are significantly elevated or if myopathy/rhabdomyolysis is diagnosed.
Symptom Monitoring
- Unexplained muscle pain, tenderness, or weakness (especially if accompanied by fever or malaise)
- Dark urine
- Severe abdominal pain
- Nausea and vomiting
- Yellowing of the skin or eyes (jaundice)
- Unusual fatigue or weakness
- Loss of appetite
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data, animal studies show some adverse effects at high doses.
Second Trimester:
Limited human data.
Third Trimester:
Limited human data.
Lactation
L3 (Moderately Safe - limited data, potential risk). It is unknown whether fenofibric acid is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Potential for serious adverse reactions in nursing infants is unknown but possible.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.
Geriatric Use
Use with caution in elderly patients due to a higher incidence of decreased renal function. Renal function should be monitored closely, and dose adjustments may be necessary based on creatinine clearance.
Clinical Information
Clinical Pearls
- Always take fenofibrate with food to ensure optimal absorption and efficacy.
- Regular monitoring of liver function tests (LFTs) and renal function is crucial, especially during the first year of treatment and in patients with pre-existing renal impairment.
- Educate patients thoroughly on the symptoms of myopathy/rhabdomyolysis (muscle pain, weakness, dark urine) and gallstones/pancreatitis (severe abdominal pain, nausea, vomiting) and instruct them to report these immediately.
- Fenofibrate is not a substitute for lifestyle modifications (diet, exercise) but rather an adjunct to them.
- When co-prescribed with statins, carefully weigh the benefits against the increased risk of muscle-related side effects and monitor patients closely.
Alternative Therapies
- Statins (HMG-CoA reductase inhibitors) for primary LDL-C lowering and some triglyceride reduction.
- Omega-3 Fatty Acids (e.g., icosapent ethyl, omega-3-acid ethyl esters) for severe hypertriglyceridemia.
- Niacin (nicotinic acid) for increasing HDL-C and lowering triglycerides, though less commonly used due to side effects.
- PCSK9 inhibitors (e.g., evolocumab, alirocumab) for severe hypercholesterolemia, not typically for primary hypertriglyceridemia.
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.