Ezetimibe: Side Effects, Uses & Monitoring
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia.
- Data source
- FDA labeling via NIH DailyMed (label cb18564f…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Upper respiratory tract infection | 4.3% |
| Diarrhea | 4.1% |
| Nasopharyngitis | 3.7% |
| Myalgia | 3.2% |
| Arthralgia | 3% |
| Sinusitis | 2.8% |
| Pain in extremity | 2.7% |
| Fatigue | 2.4% |
| Back pain | 2.4% |
| Influenza | 2% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. 1.1 Primary Hyperlipidemia Monotherapy ZETIA1 , administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. 1 COPYRIGHT © 2001, 2002, 2005, 2007, 2008 Merck/Schering-Plough Pharmaceuticals. All rights reserved. Combination Therapy with HMG-CoA Reductase Inhibitors (Statins) ZETIA, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, and Apo B in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combinati…
Conditions associated with Ezetimibe in labeling
Frequently Asked Questions
What is Ezetimibe used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Ezetimibe?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Ezetimibe. Individual risk varies.
Does Ezetimibe require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Ezetimibe.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.