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.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$12.58/unit
Generic Available
No
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
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
- Feeling sick to your stomach
Feeling sick to your stomach
1,008 reports
- Feeling tired
Feeling tired
771 reports
- Feeling lightheaded
Feeling lightheaded
731 reports
- General pain
General pain
702 reports
- Muscle pain
Muscle pain
669 reports
- Shortness of breath
Shortness of breath
644 reports
- Weakness
Weakness
601 reports
- Loose stools
Loose stools
600 reports
- Head pain
Head pain
562 reports
- Pain in arm or leg
Pain in arm or leg
546 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.
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.
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?
What should I avoid while taking Vytorin?
How often will my cholesterol be checked?
What if I have kidney problems?
Can Vytorin cause diabetes?
What are the symptoms of rhabdomyolysis?
Can I stop taking Vytorin if my cholesterol is under control?
Does Vytorin have lactose?
How long will I need to take Vytorin?
What if I forget to refill my prescription?
What are the common side effects of ezetimibe/simvastatin?
Does ezetimibe/simvastatin interact with other medications?
What drug class is ezetimibe/simvastatin?
What pregnancy or breastfeeding source fields are listed for ezetimibe/simvastatin?
Related Medications in Cholesterol Absorption Inhibitor / Statin Combination
Other drugs grouped near ezetimibe/simvastatin - same-class peers and common alternatives.
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bempedoic acid
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bempedoic acid/ezetimibe
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cholestyramine
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Medication Guides
Understanding Drug Interactions
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Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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.
Read our methodology - how this data is sourced, computed, and verified.
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
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages