Vytorinezetimibe + simvastatin
According to the FDA label: VYTORIN VYTORIN ® is a combination of simvastatin and ezetimibe indicated: As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).
15,079 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Vytorin in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Nausea 1,010 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 819 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Fatigue 773 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Dizziness 732 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Pain 703 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Myalgia 672 reports
Dyspnoea 645 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Asthenia 601 reports
Physical weakness or lack of strength.
Full definition in the glossary →Diarrhoea 600 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Headache 563 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Pain in Extremity 548 reports
Pain in an arm or leg.
Full definition in the glossary →Arthralgia 530 reports
Myocardial Infarction 518 reports
The medical term for a heart attack.
Full definition in the glossary →Weight Decreased 502 reports
Fall 476 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 7,816 |
| Male | 6,693 |
| Unknown | 56 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 20 |
| 18-34 | 119 |
| 35-49 | 854 |
| 50-64 | 3,391 |
| 65-74 | 2,660 |
| 75+ | 1,953 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Vytorin. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 5,616 |
| Other Serious | 5,573 |
| Hospitalization | 4,769 |
| Death | 853 |
| Disability | 788 |
| Life-Threatening | 694 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Vytorin. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 40 |
| 2005 | 627 |
| 2006 | 949 |
| 2007 | 1,300 |
| 2008 | 1,554 |
| 2009 | 1,189 |
| 2010 | 1,679 |
| 2011 | 1,131 |
| 2012 | 987 |
| 2013 | 801 |
| 2014 | 830 |
| 2015 | 912 |
| 2016 | 751 |
| 2017 | 563 |
| 2018 | 447 |
| 2019 | 407 |
| 2020 | 250 |
| 2021 | 197 |
| 2022 | 131 |
| 2023 | 97 |
| 2024 | 98 |
| 2025 | 108 |
| 2026 (partial) | 31 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Vytorin
In FDA adverse event reports that mention Vytorin, these medications appeared most often in the same report.
- Aspirin (3,588 reports)
- Furosemide (1,862 reports)
- Levothyroxine (1,695 reports)
- Clopidogrel (1,649 reports)
- Lisinopril (1,625 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026