Prescription medication · Cholesterol Absorption Inhibitor
ezetimibe
Also sold as Zetia.
Data updated 2026-05-15
- 70,203
- FDA reportsOften reported
- 25
- InteractionsSeveral interactions
- 99% less
- Generic vs brandHuge savings
- In shortage
- FDA status
What the data shows
ezetimibe (Zetia) is a prescription Cholesterol Absorption Inhibitor, more reported than most tracked drugs (70,203 FDA reports), whose generic costs a fraction of the brand (about 99% less).
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.
Verify with FDA → · CMS NADAC pricing →
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 →
NADAC price trail: EZETIMIBE 10 MG TABLET
Same CMS presentation as the headline generic unit price above (4 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -8.4% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| March 20, 2024 | $0.1021/EA | - | 1 |
| July 17, 2024 | $0.0786/EA | -22.9% | 3 |
| October 23, 2024 | $0.0820/EA | +4.3% | 2 |
| December 18, 2024 | $0.0752/EA | -8.4% | 39 |
What it does
Information not available.
Common side effects
Headache, Upper respiratory tract infection, Muscle pain
Key warnings
No specific warnings noted. Always follow your prescriber's instructions.
Side Effects (from patient reports)
Based on 70,203 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for ezetimibe, by number of reports
- Fatigue
Fatigue
4,663 reports
- Nausea
Nausea
4,195 reports
- Myalgia
Myalgia
4,191 reports
- Diarrhoea
Diarrhoea
3,662 reports
- Dizziness
Dizziness
3,338 reports
- Dyspnoea
Dyspnoea
3,257 reports
- Headache
Headache
3,149 reports
- Arthralgia
Arthralgia
2,850 reports
- Asthenia
Asthenia
2,785 reports
- Pain
Pain
2,754 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.
Reports over time
Adverse-event reports filed for ezetimibe each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where ezetimibe sits
ezetimibe has more FDA adverse-event reports than 80% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is ezetimibe; the line is the median (50th percentile).
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
Reports Mentioning Death
4,102
5.8% of reports — not proof of cause
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 |
| 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 |
| 16 | MALAISE | 2,188 |
| 17 | PRURITUS | 2,120 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
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 currently in shortage?
Related Medications in Cholesterol Absorption Inhibitor
Other drugs grouped near ezetimibe - same-class peers and common alternatives.
alirocumab
Praluent
Praluent is a medicine that can lower cholesterol.
Compare with ezetimibe →
atorvastatin
Lipitor
Atorvastatin is a drug that lowers cholesterol and reduces the risk of heart problems and stroke.
Compare with ezetimibe →
bempedoic acid
Nexletol
Compare with ezetimibe →
bempedoic acid/ezetimibe
Nexlizet
Nexlizet is a combination medicine that helps lower cholesterol.
Compare with ezetimibe →
cholestyramine
Questran
Cholestyramine is a medicine that helps lower high cholesterol levels in your blood.
Compare with ezetimibe →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for ezetimibe: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 70,203.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 5.84%.
- oxybutynin Δ 0.04 pts · 28,434 reports · Anticholinergic / Antispasmodic 5.80%death share
- ergocalciferol Δ 0.05 pts · 366,491 reports · Vitamin D2 Supplement 5.90%death share
- vortioxetine Δ 0.05 pts · 16,243 reports · Serotonin Modulator 5.90%death share
- selenium Δ 0.06 pts · 4,079 reports · Mineral Supplement 5.79%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
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
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. Regulatory labeling describes its approved uses and the patient populations studied in pre-market trials. 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 70,203 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 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). 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. This registry does not provide medication decisions.
Last updated: April 14, 2024
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