What the label lists and what reports show
Ezetimibe and simvastatin side effects
Ezetimibe and simvastatin's FDA label: “The most commonly reported adverse reactions (incidence ≥2% and greater than placebo) in controlled clinical trials were: headache (5.8%), increased ALT (3.7%), myalgia (3.6%), upper respiratory tract infection (3.6%), and diarrhea (2.8%).” FAERS holds 15,110 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 nausea (1,010 reports).
- Generic listed
Check it at the source: the ezetimibe and simvastatin FDA label on DailyMed (effective January 21, 2026, 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 VYTORIN?VYTORIN may cause serious side effects including: Muscle pain, tenderness, and weakness (myopathy). Muscle problems, including muscle breakdown, can be serious in some people and rarely cause kidney damage that can lead to death. Tell your healthcare provider right away if: you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take VYTORIN. you have muscle problems that do not go away even after your healthcare provider has advised you to stop taking VYTORIN. Your healthcare provider may do further tests to diagnose the cause of your muscle problems. […]
Source: FDA drug label, Organon LLC, effective January 21, 2026 (SPL set 89b860d2-de83-468e-b7e8-76aeec2edca2), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most commonly reported adverse reactions (incidence ≥2% and greater than placebo) in controlled clinical trials were: headache (5.8%), increased ALT (3.7%), myalgia (3.6%), upper respiratory tract infection (3.6%), and diarrhea (2.8%).
Table 1 Includes two placebo-controlled combination studies in which the active ingredients equivalent to VYTORIN were coadministered and two placebo-controlled studies in which VYTORIN was administered. : Adverse…
| Reaction | % Placebo N = 371 | % Ezetimibe 10 mg N = 302 | % Simvastatin All doses. N = 1234 | % VYTORIN N = 1420 |
|---|---|---|---|---|
| Headache | 5.4 | 6.0 | 5.9 | 5.8 |
| Upper respiratory tract infection | 2.7 | 5.0 | 5.0 | 3.6 |
| Myalgia | 2.4 | 2.3 | 2.6 | 3.6 |
| Diarrhea | 2.2 | 5.0 | 3.7 | 2.8 |
| Pain in extremity | 1.3 | 3.0 | 2.0 | 2.3 |
| Influenza | 0.8 | 1.0 | 1.9 | 2.3 |
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.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed in greater detail in other sections of the label: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] Hepatic Dysfunction [see Warnings and Precautions (5.3) ] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4) ] Common (incidence ≥2% and greater than placebo) adverse reactions in clinical trials: headache, increased ALT, myalgia, upper respiratory tract infection, and diarrhea. ( 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, Organon LLC, effective January 21, 2026 (SPL set 89b860d2-de83-468e-b7e8-76aeec2edca2), via openFDA; the full label on DailyMed
What do FAERS reports show?
15,110 reports list ezetimibe and simvastatin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 856 are coded as a death and 4,779 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, 16 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 and simvastatin: 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