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What the FDA labels say about taking them together

Ezetimibe and fenofibrate

Ezetimibe's FDA label of November 25, 2025 names fenofibrate in its contraindications section; the fenofibrate labels PlainMeds reads (3) do not name ezetimibe. The ezetimibe label: “Both fenofibrate and ezetimibe may increase cholesterol excretion into the bile, leading to cholelithiasis. Co-administration of ZETIA with fibrates other than fenofibrate is not recommended.”

Check it at the source: the ezetimibe FDA label on DailyMed (effective November 25, 2025, Organon LLC); the fenofibrate FDA label on DailyMed (effective April 29, 2024, A-S Medication Solutions).

What does the ezetimibe label say about fenofibrate?

Ezetimibe label, contraindications

When used in combination with a statin, fenofibrate, or other LDL-C lowering therapy, ZETIA is contraindicated in patients for whom a statin, fenofibrate, or other LDL-C lowering therapy are contraindicated.

Ezetimibe label, drug interactions

Clinical Impact: Both fenofibrate and ezetimibe may increase cholesterol excretion into the bile, leading to cholelithiasis. Co-administration of ZETIA with fibrates other than fenofibrate is not recommended. Intervention: If cholelithiasis is suspected in a patient receiving ZETIA and fenofibrate, gallbladder studies are indicated, and alternative lipid-lowering therapy should be considered.

Ezetimibe label, warnings and precautions

WARNINGS AND PRECAUTIONS Risks Associated with Combination Treatment with a Statin, Fenofibrate, or Other LDL-C Lowering Therapies:

Source: FDA drug label (Zetia), Organon LLC, effective November 25, 2025 (SPL set 174e45e0-45bb-48b7-9e60-8f6cfc1d22bb), via openFDA; the full label on DailyMed

What does the fenofibrate label say about ezetimibe?

Fenofibrate's label (effective April 29, 2024) and its 2 other brand-application labels do not name ezetimibe in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Tricor), NDA021656 (Abbvie), as published by A-S Medication Solutions, effective April 29, 2024 (SPL set 84b2af1b-365e-4723-ac5f-bc826ec47772), via openFDA; the full label on DailyMed

These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.

Both medicines on the record

23Ezetimibe generic labelers
54Fenofibrate generic labelers
EzetimibeFenofibrate
Labeled forHigh cholesterolHigh cholesterol, High triglycerides
Boxed warningNoNo
Pharmacy cost (NADAC)$0.0667 per tablet 10 mg tablet$0.103 per tablet 160 mg tablet
Shortage nowNo current entryNo current entry

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?