Prescription medication · Fibrate
fenofibrate
Also sold as TriCor, Antara. This medicine is used with a diet to treat high cholesterol and high levels of triglycerides (fats) in the blood.
Data updated 2026-05-15
- 48,091
- FDA reportsOften reported
- 9
- InteractionsFew interactions
- 1
- Recall record
What the data shows
fenofibrate (TriCor) is a prescription Fibrate, reported at a middle-of-the-pack volume (48,091 FDA reports), with 9 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
fenofibrate (TriCor) is a prescription Fibrate. This medicine is used with a diet to treat high cholesterol and high levels of triglycerides (fats) in the blood.
Fenofibrate is a medicine that helps lower bad cholesterol and fats (triglycerides) in your blood, while raising good cholesterol.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from fenofibrate's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of fenofibrate's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of fenofibrate's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of fenofibrate's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store fenofibrate tablets at room temperature, away from moisture and heat.
Side Effects (from patient reports)
Based on 48,091 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for fenofibrate, by number of reports
- Feeling sick to your stomach
Feeling sick to your stomach
2,914 reports
- Feeling tired
Feeling tired
2,842 reports
- Loose or watery stools
Loose or watery stools
2,681 reports
- Difficulty breathing
Difficulty breathing
2,100 reports
- Pain in your head
Pain in your head
2,059 reports
- Feeling lightheaded or unsteady
Feeling lightheaded or unsteady
1,962 reports
- Aching or soreness
Aching or soreness
1,954 reports
- Weakness
Weakness
1,826 reports
- Accidentally losing your balance
Accidentally losing your balance
1,692 reports
- Throwing up
Throwing up
1,633 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for fenofibrate each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where fenofibrate sits
fenofibrate has more FDA adverse-event reports than 73% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is fenofibrate; the line is the median (50th percentile).
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
Reports Mentioning Death
3,471
7.2% of reports — not proof of cause
Hospitalization Reports
16,065
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | NAUSEA | 2,912 |
| 2 | FATIGUE | 2,840 |
| 3 | DIARRHOEA | 2,681 |
| 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 |
| 14 | PRURITUS | 1,516 |
| 15 | ACUTE KIDNEY INJURY | 1,468 |
| 16 | RENAL FAILURE | 1,463 |
| 17 | WEIGHT DECREASED | 1,444 |
Reactions in Death Reports
Reactions in Hospitalization Reports
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.
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I drink alcohol while taking fenofibrate?
How long does it take for fenofibrate to work?
Can I stop taking fenofibrate if my cholesterol levels are normal?
Does fenofibrate interact with other medications?
What should I do if I experience side effects?
Can fenofibrate cause weight gain?
Is fenofibrate a statin?
Can I take fenofibrate if I have kidney problems?
Will I need regular blood tests while taking fenofibrate?
Can fenofibrate cause hair loss?
What are the common side effects of fenofibrate?
Does fenofibrate interact with other medications?
What drug class is fenofibrate?
Is fenofibrate safe during pregnancy?
Has fenofibrate been recalled?
Active Recalls
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
Related Medications in Fibrate
Other drugs grouped near fenofibrate - same-class peers and common alternatives.
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atorvastatin
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bempedoic acid
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bempedoic acid/ezetimibe
Nexlizet
Nexlizet is a combination medicine that helps lower cholesterol.
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cholestyramine
Questran
Cholestyramine is a medicine that helps lower high cholesterol levels in your blood.
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 48,091 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
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages