Prescription medication · Cholesterol Absorption Inhibitor / Statin Combination

ezetimibe/simvastatin

Also sold as Vytorin. Vytorin is used along with a healthy diet to lower high LDL cholesterol.

Data updated 2026-05-15

6,834
FDA reports
23
InteractionsSeveral interactions
$12.58
Brand price (NADAC)

What the data shows

ezetimibe/simvastatin (Vytorin) is a prescription Cholesterol Absorption Inhibitor / Statin Combination, with 6,834 FDA adverse-event reports on file, with 23 documented drug interactions.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

ezetimibe/simvastatin (Vytorin) is a prescription Cholesterol Absorption Inhibitor / Statin Combination. Vytorin is used along with a healthy diet to lower high LDL cholesterol.

Vytorin is a combination medicine that contains ezetimibe and simvastatin. It helps lower bad cholesterol (LDL-C) in your blood.

Drug Pricing (NADAC)

Brand Price

$12.58/unit

Generic Available

No

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

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What it does

Vytorin is used along with a healthy diet to lower high LDL cholesterol.

Common side effects

Headache, Increased liver enzyme (ALT), Muscle pain

Key warnings

Vytorin can cause muscle problems, including myopathy and rhabdomyolysis.

The sections below are summarized in plain English from ezetimibe/simvastatin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Ezetimibe reduces the amount of cholesterol your body absorbs from food. Simvastatin belongs to a class of drugs called statins. Statins lower cholesterol by blocking a substance your body needs to make cholesterol.

Side Effects (from patient reports)

Based on 6,834 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for ezetimibe/simvastatin, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS)

Serious Warnings

Vytorin can cause muscle problems, including myopathy and rhabdomyolysis. Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel sick. Vytorin can also cause liver problems. Your doctor may do blood tests to check your liver before you start taking Vytorin and while you take it.

Known Drug Interactions

For patients taking amiodarone, amlodipine, or ranolazine, do not exceed VYTORIN 10/20 mg daily [see Dosage and Administration (2.3) ] .

Mechanism: Amlodipine can cause the cholesterol medication to stay in your system longer, which increases the chance of muscle pain or weakness.

Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed VYTORIN 10/10 mg daily.

Mechanism: Diltiazem slows down the breakdown of simvastatin in your body, which can lead to higher levels of the drug in your blood. This increases the risk of serious muscle damage.

Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed VYTORIN 10/10 mg daily.

Mechanism: Verapamil prevents your body from processing simvastatin correctly, causing the drug to build up to high levels. This can lead to severe muscle pain or weakness.

Cyclosporine, Danazol, or Gemfibrozil Clinical Impact: The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine, danazol, or gemfibrozil with VYTORIN. Intervention: Concomitant use of cyclosporine, danazol, or gemfibrozil with VYTORIN is contraindicated [see Contraindications (4) ] .

Mechanism: Cyclosporine causes a large increase in simvastatin levels in your blood, which can lead to a dangerous condition where muscle tissue breaks down.

Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with VYTORIN. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed VYTORIN 10/20 mg daily [see Dosage and Administration (2.3) ] .

Mechanism: Amiodarone slows the removal of simvastatin from your system, which increases the risk of muscle injury.

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This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I take Vytorin with other medications?
Some medicines can interact with Vytorin. Tell your doctor about all the medicines you take, including prescription and over-the-counter drugs, vitamins, and herbal supplements.
What should I avoid while taking Vytorin?
Avoid drinking large amounts of grapefruit juice, as it can increase the level of simvastatin in your blood.
How often will my cholesterol be checked?
Your doctor will check your cholesterol levels regularly, usually within 2 to 4 weeks after starting Vytorin or changing your dose.
What if I have kidney problems?
Tell your doctor if you have kidney problems. Doses higher than 10/20 mg should be used carefully if you have moderate to severe kidney problems.
Can Vytorin cause diabetes?
Vytorin may slightly increase your blood sugar levels. Your doctor may monitor your blood sugar, especially if you have diabetes or are at risk for diabetes.
What are the symptoms of rhabdomyolysis?
Symptoms include muscle pain, tenderness, or weakness, along with fever or feeling sick. Contact your doctor immediately if you experience these symptoms.
Can I stop taking Vytorin if my cholesterol is under control?
Do not stop taking Vytorin without talking to your doctor first. Your cholesterol levels may increase if you stop taking it.
Does Vytorin have lactose?
Yes, Vytorin contains lactose monohydrate.
How long will I need to take Vytorin?
Your doctor will determine how long you need to take Vytorin. It is often a long-term treatment.
What if I forget to refill my prescription?
Try to refill your prescription before you run out of medicine. If you miss a dose, take it as soon as you remember. Do not double your next dose.
What are the common side effects of ezetimibe/simvastatin?
The registry lists Headache, Increased liver enzyme (ALT), Muscle pain, Upper respiratory tract infection, Diarrhea among the most-reported FAERS reaction terms for ezetimibe/simvastatin. The compiled record contains 6,834 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does ezetimibe/simvastatin interact with other medications?
The registry has 23 documented interaction rows for ezetimibe/simvastatin. Notable source-record pairings include amlodipine, diltiazem, verapamil. These rows are not a complete medication review.
What drug class is ezetimibe/simvastatin?
ezetimibe/simvastatin belongs to the Cholesterol Absorption Inhibitor / Statin Combination drug class. It requires a prescription (Rx). Vytorin is used along with a healthy diet to lower high LDL cholesterol.
What pregnancy or breastfeeding source fields are listed for ezetimibe/simvastatin?
The FDA label for ezetimibe/simvastatin contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

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What the FDA Data Shows for ezetimibe/simvastatin

The FDA label for ezetimibe/simvastatin (sold under brand names such as Vytorin) classifies it as a prescription-only medication in the Cholesterol Absorption Inhibitor / Statin Combination class. Vytorin is used along with a healthy diet to lower high LDL cholesterol. Official labeling lists 5 commonly reported side effects, including Headache, Increased liver enzyme (ALT), Muscle pain.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 6,834 voluntary reports. The database also lists 23 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: January 21, 2026

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page