What the label lists and what reports show
Ezetimibe side effects
Ezetimibe's FDA label lists its adverse reactions in its own words. FAERS holds 74,543 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (4,980 reports).
- Generic listed
Check it at the source: the ezetimibe FDA label on DailyMed (effective November 25, 2025, Organon LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ZETIA?ZETIA may cause serious side effects including: increased liver enzymes. An increase in liver enzymes can happen in people taking ZETIA alone or with statins. Your healthcare provider may do blood tests to check your liver before and during treatment. Your healthcare provider may need to change or stop your treatment with ZETIA because of an increase in liver enzymes. muscle pain, tenderness, and weakness (myopathy). Muscle problems, including muscle breakdown (rhabdomyolysis) can happen. Tell your healthcare provider right away if: you have unexplained muscle pain, tenderness, weakness, feel more tired than usual, or fever. you have muscle problems that do not go away even after your healthcare provider has advised you to stop taking ZETIA. Your healthcare provider may do further tests to diagnose the cause of your muscle problems. […]
Source: FDA drug label, Organon LLC, effective November 25, 2025 (SPL set 174e45e0-45bb-48b7-9e60-8f6cfc1d22bb), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following serious adverse reactions are discussed in greater detail in other sections of the label: Liver enzyme abnormalities [see Warnings and Precautions (5.2) ] Rhabdomyolysis and myopathy [see Warnings and Precautions (5.3) ] Common adverse reactions in clinical trials: ZETIA administered alone (incidence ≥2% and greater than placebo): upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza. ( 6.1 ) ZETIA coadministered with a statin (incidence ≥2% and greater than statin alone): nasopharyngitis, myalgia, upper respiratory tract infection, arthralgia, diarrhea, back pain, influenza, pain in extremity, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
TABLE 2: Adverse Reactions Occurring ≥2% in ZETIA-treated Patients Coadministered with a Statin and at an Incidence Greater than Statin
| Adverse Reaction | All Statins All Statins = all doses of all statins (%) n = 9,361 | ZETIA + All Statins (%) n = 11,308 |
|---|---|---|
| Nasopharyngitis | 3.3 | 3.7 |
| Myalgia | 2.7 | 3.2 |
| Upper respiratory tract infection | 2.8 | 2.9 |
| Arthralgia | 2.4 | 2.6 |
| Diarrhea | 2.2 | 2.5 |
| Back pain | 2.3 | 2.4 |
| Influenza | 2.1 | 2.2 |
| Pain in extremity | 1.9 | 2.1 |
| Fatigue | 1.6 | 2.0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Organon LLC, effective November 25, 2025 (SPL set 174e45e0-45bb-48b7-9e60-8f6cfc1d22bb), via openFDA; the full label on DailyMed
What do FAERS reports show?
74,543 reports list ezetimibe among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,305 are coded as a death and 21,966 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ezetimibe: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions