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fenofibrate

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Brand names: TriCor, Antara

Fibrate Rx

Fenofibrate is a medicine that helps lower bad cholesterol and fats (triglycerides) in your blood, while raising good cholesterol.

Drug Pricing (NADAC)

Brand Price

$0.99/unit

Generic Price

$18.90/unit

Generic Available

Yes (39 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

This medicine is used with a diet to treat high cholesterol and high levels of triglycerides (fats) in the blood.

Common side effects

Abnormal liver function tests, Increased ALT (a liver enzyme), Increased AST (a liver enzyme)

Key warnings

Fenofibrate can cause liver problems.

How It Works

Fenofibrate is a type of drug called a PPAR alpha agonist. It works by activating a protein in your body that helps break down fats and cholesterol. This leads to lower levels of bad cholesterol and triglycerides, and higher levels of good cholesterol.

How to Take It

Take fenofibrate tablets with meals to help your body absorb the medicine better. The usual starting dose is 160 mg once a day for high cholesterol. For very high triglycerides, the starting dose is between 54 mg to 160 mg once a day. Your doctor may adjust your dose based on how well the medicine is working for you.

Pregnancy & Breastfeeding

It is not known if fenofibrate will harm an unborn baby. You should only use fenofibrate during pregnancy if your doctor decides that the benefit outweighs the risk. You should not breastfeed while taking fenofibrate.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and take your next dose at the regular time.

Storage

Store fenofibrate tablets at room temperature, away from moisture and heat.

Side Effects (from patient reports)

Based on 22,480 FDA adverse event reports.

Feeling sick to your stomach
2,914
Feeling tired
2,842
Loose or watery stools
2,681
The medicine is not working
2,450
Difficulty breathing
2,100
Pain in your head
2,059
Feeling lightheaded or unsteady
1,962
Aching or soreness
1,954
Weakness
1,826
Accidentally losing your balance
1,692

FDA Adverse Event Report Analysis

Detailed analysis of 48,091 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

48,091

Death-Related Reports

3,471

Hospitalization Reports

16,065

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 21,713 (48%)
Male 23,048 (51%)

Age Distribution

0–17 429
18–44 3,031
45–64 13,365
65–74 8,336
75+ 5,320

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 NAUSEA 2,912
2 FATIGUE 2,840
3 DIARRHOEA 2,681
4 DRUG INEFFECTIVE 2,453
5 DYSPNOEA 2,099
6 HEADACHE 2,058
7 DIZZINESS 1,962
8 PAIN 1,955
9 ASTHENIA 1,826
10 FALL 1,692
11 VOMITING 1,633
12 ARTHRALGIA 1,583
13 OFF LABEL USE 1,541
14 PRURITUS 1,516
15 ACUTE KIDNEY INJURY 1,468

Reactions in Death Reports

DEATH 1,051
DYSPNOEA 355
SEPSIS 342
FALL 335
DIARRHOEA 324
ASTHENIA 315
CARDIO-RESPIRATORY ARREST 308
FATIGUE 284
NAUSEA 277
DECREASED APPETITE 266

Reactions in Hospitalization Reports

DYSPNOEA 972
FALL 956
NAUSEA 895
ACUTE KIDNEY INJURY 865
DIARRHOEA 855
PNEUMONIA 822
FATIGUE 792
ASTHENIA 790
RENAL FAILURE 727
PAIN 717

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Fenofibrate can cause liver problems. Your doctor should check your liver function with blood tests before you start taking it and regularly while you are taking it. Stop taking fenofibrate and tell your doctor right away if you have signs of liver problems, such as yellowing of your skin or eyes, dark urine, or stomach pain. Fenofibrate can also cause muscle pain or weakness, especially if you are also taking a statin medicine. Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness.

Known Drug Interactions

7.2 Immunosuppressants Immunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including fenofibrate, there is a risk that an interaction will lead to deterioration of renal function.

Mechanism: Cyclosporine can damage the kidneys, and because the body uses the kidneys to get rid of fenofibrate, taking both together can cause kidney function to drop.

What to do: Your doctor should monitor your kidney function tests closely if you are taking both of these medications.

moderate colchicine

7.4 Colchicine Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates co administered with colchicine, and caution should be exercised when prescribing fenofibrate with colchicine.

Mechanism: Combining these drugs can lead to a higher risk of severe muscle pain and muscle breakdown.

What to do: Use caution when taking these together and tell your doctor immediately if you have unexplained muscle pain or weakness.

Fibrates Clinical Impact: Both fenofibrate and ezetimibe (a component of NEXLIZET) may increase cholesterol excretion into the bile, leading to cholelithiasis. Coadministration of NEXLIZET with fibrates other than fenofibrate is not recommended [see Adverse Reactions (6.1) ] . Intervention: If cholelithiasis is suspected in a patient receiving NEXLIZET and fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered.

Mechanism: Both of these medicines can increase the amount of cholesterol that moves into the bile, which may cause gallstones to form.

What to do: If you have symptoms of gallstones, your doctor should check your gallbladder and may switch your medicine.

Fibrates Clinical Impact: Both fenofibrate and ezetimibe (a component of NEXLIZET) may increase cholesterol excretion into the bile, leading to cholelithiasis. Coadministration of NEXLIZET with fibrates other than fenofibrate is not recommended [see Adverse Reactions (6.1) ] . Intervention: If cholelithiasis is suspected in a patient receiving NEXLIZET and fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered.

Mechanism: Both of these medicines can increase the amount of cholesterol that moves into the bile, which may cause gallstones to form.

What to do: If you suspect you have gallstones, your doctor should perform tests and may consider a different treatment.

( 7.3 ) Fenofibrates : Combination increases exposure of ezetimibe. If cholelithiasis is suspected in a patient receiving ezetimibe and a fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered. Fenofibrates Clinical Impact: Both ezetimibe and fenofibrates may increase cholesterol excretion into the bile, leading to cholelithiasis.

Mechanism: Both drugs increase the amount of cholesterol in your bile, which can lead to the formation of gallstones.

What to do: If you have stomach pain or signs of gallbladder issues, your doctor may need to check your gallbladder or change your medicine.

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Common Questions

Can I drink alcohol while taking fenofibrate?
Talk to your doctor about drinking alcohol while taking fenofibrate, as alcohol can raise triglyceride levels.
How long does it take for fenofibrate to work?
It may take several weeks to months to see the full effect of fenofibrate on your cholesterol and triglyceride levels. Your doctor will check your levels regularly.
Can I stop taking fenofibrate if my cholesterol levels are normal?
Do not stop taking fenofibrate without talking to your doctor first. Your cholesterol levels may go back up if you stop taking the medicine.
Does fenofibrate interact with other medications?
Yes, fenofibrate can interact with other medications, including blood thinners and some immunosuppressants. Tell your doctor about all the medicines you take.
What should I do if I experience side effects?
If you experience any bothersome or severe side effects, talk to your doctor. They may be able to adjust your dose or recommend other ways to manage the side effects.
Can fenofibrate cause weight gain?
Weight gain is not a common side effect of fenofibrate. Some people may experience weight loss.
Is fenofibrate a statin?
No, fenofibrate is not a statin. It belongs to a different class of drugs called fibrates.
Can I take fenofibrate if I have kidney problems?
If you have kidney problems, your doctor may need to adjust your dose of fenofibrate or avoid using it altogether.
Will I need regular blood tests while taking fenofibrate?
Yes, your doctor will likely order regular blood tests to monitor your liver function, kidney function, and cholesterol levels.
Can fenofibrate cause hair loss?
Hair loss is a rare side effect of fenofibrate.
What are the common side effects of fenofibrate?
The most commonly reported side effects of fenofibrate include Abnormal liver function tests, Increased ALT (a liver enzyme), Increased AST (a liver enzyme), Increased CPK (a muscle enzyme), Runny nose. Based on 22,480 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does fenofibrate interact with other medications?
Yes, fenofibrate has 9 known drug interactions. Notable interactions include cyclosporine, colchicine, bempedoic acid. Always inform your doctor about all medications you are taking.
What drug class is fenofibrate?
fenofibrate belongs to the Fibrate drug class. It requires a prescription (Rx). This medicine is used with a diet to treat high cholesterol and high levels of triglycerides (fats) in the blood.
Is fenofibrate safe during pregnancy?
It is not known if fenofibrate will harm an unborn baby. You should only use fenofibrate during pregnancy if your doctor decides that the benefit outweighs the risk. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has fenofibrate been recalled?
There is 1 recall associated with fenofibrate products. CGMP Deviations. Check the recalls section below for full details and affected products.

Active Recalls

Class II March 13, 2025

CGMP Deviations

Glenmark Pharmaceuticals Inc., USA

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What the FDA Data Shows for fenofibrate

The FDA label for fenofibrate (sold under brand names such as TriCor, Antara) classifies it as a prescription-only medication in the Fibrate class. This medicine is used with a diet to treat high cholesterol and high levels of triglycerides (fats) in the blood. Official labeling lists 10 commonly reported side effects, including Abnormal liver function tests, Increased ALT (a liver enzyme), Increased AST (a liver enzyme).

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 22,480 voluntary reports. The database also lists 9 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $18.90 versus $0.99 for the brand.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: April 29, 2024

All federal data sources used on this page