Pharmacologic class (EPC) · 3 drug pages

Dietary cholesterol absorption inhibitor: adverse event reports filed with FDA

23,350 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

23,350
reports across the class: 0.1% of all reports; 1,993
reports, 12 months to June 2026: 1,823 in the 12 months before; 69.7%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Dietary cholesterol absorption inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 23,350 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

1,993 reports arrived in the 12 months to June 2026, close to the 1,823 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 69.7% of the class's reports are marked serious, 5% record death among the outcomes and 23.7% record hospitalisation, as reported.

Across the class the reactions recorded most often are myalgia (14.8%), fatigue (5.7%) and arthralgia (5.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Ezetimibe	generic	11,443	1,943	84.3%	Myalgia
ZetiaEzetimibe	brand	8,262	45	45.9%	Myalgia
VytorinEzetimibe and simvastatin	brand	3,645	5	77.7%	Myalgia

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Myalgiamuscle pain14.8%3,450
Fatiguetiredness5.7%1,320
Arthralgiajoint pain5.5%1,283
Drug ineffectivethe medicine did not work as expected4.7%1,109
Rhabdomyolysismuscle breakdown4.7%1,098
Nauseafeeling sick4.7%1,097
Dizzinesslight-headedness or unsteadiness4.7%1,091
Diarrhoealoose or frequent stools4.5%1,053
Muscle spasmsmuscle cramps4.3%1,004
Dyspnoeashortness of breath4.2%972
Pain in extremitypain in an arm or leg4.1%969
Astheniaweakness or lack of energy4%936
Headachehead pain4%935
Blood creatine phosphokinase increased3.6%843
Painpain, site not specified3.3%762
Malaisegeneral feeling of being unwell3.2%754
Muscular weaknessmuscle weakness3.2%741
Drug interactionan interaction between medicines3.1%723
Pruritusitching3%693
Abdominal painstomach or belly pain2.9%684
Myocardial infarctionheart attack2.7%629
Vomitingbeing sick2.4%564
Drug hypersensitivityan allergic-type reaction to a medicine2.4%557
Abdominal pain upperupper stomach pain2.4%550
Falla fall2.3%536

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death5%1,164

Life-threatening5.8%1,353

Hospitalisation (initial or prolonged)23.7%5,538

Disability7.3%1,698

Congenital anomaly0.4%94

Other serious48.4%11,293

Not serious30.3%7,081

Patient age

Under 20.1%20

2 to 110.2%43

12 to 170.1%28

18 to 444.3%1,015

45 to 6425.9%6,048

65 to 7420.6%4,801

75 and over13.6%3,176

Age not given35.2%8,219

Who reported

Physician38.8%9,056

Pharmacist8%1,879

Other health professional20.6%4,808

Lawyer0.6%130

Consumer or non-health professional25.4%5,940

Not given6.6%1,537

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Dietary cholesterol absorption inhibitor reports

Which drugs are in the Dietary cholesterol absorption inhibitor class on this site?

Ezetimibe, Zetia and Vytorin. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

23,350 reports through June 2026, 1,993 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

myalgia (14.8%), fatigue (5.7%), arthralgia (5.5%), drug ineffective (4.7%) and rhabdomyolysis (4.7%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.