ezetimibe
Brand names: Zetia
Ezetimibe and simvastatin is a combination medicine that helps lower cholesterol levels in your blood. It contains two drugs: ezetimibe and simvastatin.
Drug Shortage Alert
ezetimibe is currently listed as to be discontinued by the FDA. Affected manufacturer: Actavis Pharma, Inc..
View all drug shortages →Drug Pricing (NADAC)
Brand Price
$12.66/unit
Generic Price
$0.08/unit
Generic Savings
99%
Generic Available
Yes (18 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine is used to lower high LDL cholesterol ('bad' cholesterol).
Common side effects
Headache, Upper respiratory tract infection, Muscle pain
Key warnings
This medicine can cause muscle problems, including rhabdomyolysis, which can lead to kidney damage and death.
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 ezetimibe and simvastatin once a day in the evening. You can take it with or without food. The usual dose is 10 mg/10 mg to 10 mg/40 mg daily. Your doctor may adjust your dose based on your cholesterol levels.
Pregnancy & Breastfeeding
Do not take ezetimibe and simvastatin if you are pregnant. It can harm your unborn baby. Talk to your doctor about other ways to lower your cholesterol if you are pregnant or planning to become pregnant. Breastfeeding is not recommended while taking this medicine.
Missed Dose
If you miss a dose, take it as soon as you remember. Do not double your next dose.
Storage
Store at room temperature, away from light and moisture. Keep the container tightly closed.
Side Effects (from patient reports)
Based on 35,601 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 70,203 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
70,203
Death-Related Reports
4,102
Hospitalization Reports
20,751
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 4,663 |
| 2 | NAUSEA | 4,195 |
| 3 | MYALGIA | 4,191 |
| 4 | DIARRHOEA | 3,662 |
| 5 | DRUG INEFFECTIVE | 3,517 |
| 6 | DIZZINESS | 3,338 |
| 7 | DYSPNOEA | 3,257 |
| 8 | HEADACHE | 3,149 |
| 9 | ARTHRALGIA | 2,850 |
| 10 | ASTHENIA | 2,785 |
| 11 | PAIN | 2,754 |
| 12 | PAIN IN EXTREMITY | 2,318 |
| 13 | FALL | 2,309 |
| 14 | VOMITING | 2,245 |
| 15 | OFF LABEL USE | 2,213 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This medicine can cause muscle problems, including rhabdomyolysis, which can lead to kidney damage and death. The risk is higher if you are over 65, have kidney problems, have thyroid problems, or take certain other medicines. Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel sick. This medicine can also cause liver problems. Your doctor may do blood tests to check your liver before and during treatment.
Known Drug Interactions
For patients taking amiodarone, amlodipine, or ranolazine, do not exceed ezetimibe and simvastatin 10 mg/20 mg daily [see Dosage and Administration ( 2.3 )].
Mechanism: Amlodipine can increase the levels of the cholesterol medicine in your blood, which may lead to side effects.
What to do: Your doctor should limit your dose of the combination medicine to 10 mg/20 mg daily.
Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed ezetimibe and simvastatin 10 mg/10 mg daily.
Mechanism: Diltiazem can increase the levels of the cholesterol medicine in your blood, which may lead to muscle problems.
What to do: Your doctor should limit your dose of the combination medicine to 10 mg/10 mg daily.
Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed ezetimibe and simvastatin 10 mg/10 mg daily.
Mechanism: Verapamil can cause the levels of the cholesterol medicine to build up in your body, which may lead to muscle damage.
What to do: Your doctor should limit your dose of the combination medicine to 10 mg/10 mg daily.
Cyclosporine, Danazol, or Gemfibrozil Clinical Impact: The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine, danazol, or gemfibrozil with ezetimibe and simvastatin. Intervention: Concomitant use of cyclosporine, danazol, or gemfibrozil with ezetimibe and simvastatin is contraindicated [see Contraindications ( 4 )].
Mechanism: Taking these medicines together greatly increases the risk of serious muscle breakdown and damage.
What to do: Do not use these medications together.
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 ezetimibe and simvastatin. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed ezetimibe and simvastatin 10 mg/20 mg daily [see Dosage and Administration ( 2.3 )].
Mechanism: Taking these drugs together can cause the cholesterol medicine to build up in your body, which increases the risk of serious muscle damage.
What to do: Your doctor should limit your dose of ezetimibe and simvastatin to no more than 10 mg/20 mg daily.
Common Questions
Can I take this medicine if I have liver problems?
What should I do if I experience muscle pain while taking this medicine?
Can I drink grapefruit juice while taking this medicine?
Are there any medicines I should not take with ezetimibe and simvastatin?
How often will my doctor check my cholesterol levels?
Can children take ezetimibe and simvastatin?
What is the highest dose of ezetimibe and simvastatin I can take?
What if I need a high-intensity statin?
What should I do before starting ezetimibe and simvastatin?
What if I have kidney problems?
What are the common side effects of ezetimibe?
Does ezetimibe interact with other medications?
What drug class is ezetimibe?
Is there a generic version of ezetimibe?
Is ezetimibe safe during pregnancy?
Is ezetimibe currently in shortage?
Related Medications in Cholesterol Absorption Inhibitor
Other drugs grouped near ezetimibe — 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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What the FDA Data Shows for ezetimibe
The FDA label for ezetimibe (sold under brand names such as Zetia) classifies it as a prescription-only medication in the Cholesterol Absorption Inhibitor class. This medicine is used to lower high LDL cholesterol ('bad' cholesterol). Official labeling lists 4 commonly reported side effects, including Headache, Upper respiratory tract infection, Muscle pain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 35,601 voluntary reports. The database also lists 25 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.08 versus $12.66 for the brand — a 99% generic savings.
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). Shortage status: FDA Drug Shortages Database.
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: April 14, 2024
Read our methodology — how this data is sourced, computed, and verified.
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