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.
How to Take It
Take Vytorin once a day in the evening. You can take it with or without food. The usual dose is between 10/10 mg to 10/40 mg daily. Your doctor may adjust your dose based on your cholesterol levels.
This is a plain-language summary of ezetimibe/simvastatin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Do not take Vytorin if you are pregnant. It can harm your unborn baby. Talk to your doctor if you are breastfeeding or plan to breastfeed, as it is not recommended during treatment with Vytorin.
This is a plain-language summary of ezetimibe/simvastatin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. Do not take two doses at the same time.
This is a plain-language summary of ezetimibe/simvastatin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Vytorin at room temperature (68°F to 77°F) in a tightly closed container.
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.
What to do: Your daily dose of ezetimibe and simvastatin should be limited to 10 mg/20 mg to prevent muscle problems.
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.
What to do: Do not take more than 10/10 mg of VYTORIN daily if you are also taking diltiazem.
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.
What to do: Your doctor should limit your VYTORIN dose to 10/10 mg daily while you are on verapamil.
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.
What to do: You should not take these two medications together at the same time.
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.
What to do: Your daily dose of VYTORIN should not exceed 10/20 mg if you are taking amiodarone.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
Is ezetimibe/simvastatin safe during pregnancy?
Related Medications in Cholesterol Absorption Inhibitor / Statin Combination
Other drugs grouped near ezetimibe/simvastatin - same-class peers and common alternatives.
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cholestyramine
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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: January 21, 2026
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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