65/100 · Elevated
Manufactured by Organon LLC
EZETIMIBE Adverse Events: Moderate Safety Concerns
133,800 FDA adverse event reports analyzed
Last updated: 2026-05-12
EZETIMIBE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Organon LLC. Based on analysis of 133,800 FDA adverse event reports, EZETIMIBE has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for EZETIMIBE include FATIGUE, NAUSEA, MYALGIA, DIARRHOEA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for EZETIMIBE.
Ezetimibe has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 133,800 adverse event reports for this medication, which is primarily manufactured by Organon Llc.
The most commonly reported adverse events include Fatigue, Nausea, Myalgia. Of classified reports, 65.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue, nausea, and myalgia are the most common adverse reactions.
Serious adverse events, such as acute kidney injury and myocardial infarction, are reported but less frequent. Drug interactions and falls are notable safety signals. Weight changes and respiratory issues are also commonly reported.
Patients taking Ezetimibe should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. EZETIMIBE can cause drug interactions and falls, so it is important to monitor patients for these issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ezetimibe received a safety concern score of 65/100 (elevated concern). This is based on a 65.2% serious event ratio across 70,172 classified reports. The score accounts for 133,800 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 34,206, Male: 30,018, Unknown: 355. The most frequently reported age groups are age 70 (1,731 reports), age 65 (1,664 reports), age 71 (1,646 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 70,172 classified reports for EZETIMIBE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
EZETIMIBE can cause drug interactions and falls, so it is important to monitor patients for these issues.
If you are taking Ezetimibe, here are important things to know. The most commonly reported side effects include fatigue, nausea, myalgia, diarrhoea, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Inform your healthcare provider about any pre-existing conditions or other medications you are taking. Report any unusual symptoms to your healthcare provider promptly. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory bodies continue to monitor EZETIMIBE for safety, with no major changes in warnings or recommendations.
The FDA has received approximately 133,800 adverse event reports associated with Ezetimibe. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Ezetimibe include Fatigue, Nausea, Myalgia, Diarrhoea, Drug Ineffective. By volume, the top reported reactions are: Fatigue (4,663 reports), Nausea (4,194 reports), Myalgia (4,191 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ezetimibe.
Out of 70,172 classified reports, 45,783 (65.2%) were classified as serious and 24,389 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Ezetimibe break down by patient sex as follows: Female: 34,206, Male: 30,018, Unknown: 355. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Ezetimibe adverse events are: age 70: 1,731 reports, age 65: 1,664 reports, age 71: 1,646 reports, age 73: 1,598 reports, age 72: 1,588 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Ezetimibe adverse event reports is Organon Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Ezetimibe include: Dizziness, Dyspnoea, Headache, Arthralgia, Asthenia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Ezetimibe to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Ezetimibe has a safety concern score of 65 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Fatigue, nausea, and myalgia are the most common adverse reactions.
Key safety signals identified in Ezetimibe's adverse event data include: Acute kidney injury and myocardial infarction are serious adverse events.. Drug interactions and falls are key safety signals.. Weight changes and respiratory issues are frequently reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
EZETIMIBE can cause drug interactions and falls, so it is important to monitor patients for these issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ezetimibe.
Inform your healthcare provider about any pre-existing conditions or other medications you are taking. Report any unusual symptoms to your healthcare provider promptly.
Ezetimibe has 133,800 adverse event reports on file with the FDA. Serious adverse events, such as acute kidney injury and myocardial infarction, are reported but less frequent. The volume of reports for Ezetimibe reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory bodies continue to monitor EZETIMIBE for safety, with no major changes in warnings or recommendations. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Organon LLC and compare their safety profiles:
The following drugs share commonly reported adverse reactions with EZETIMIBE:
Drugs related to EZETIMIBE based on therapeutic use, drug class, or shared indications: