Two medicines, side by side
Simvastatin vs ezetimibe
Simvastatin and ezetimibe are both labeled for high cholesterol. Drugs@FDA records approvals of simvastatin since 1991 and of ezetimibe since 2002. Pharmacies paid $0.0321 per simvastatin 20 mg tablet and $0.0667 per ezetimibe 10 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, simvastatin is a hmg-coa reductase inhibitor and ezetimibe a dietary cholesterol absorption inhibitor.
Check it at the source: the simvastatin FDA label on DailyMed (effective March 28, 2025); the ezetimibe FDA label on DailyMed (effective November 25, 2025).
Highlights of the simvastatin record
Simvastatin (Zocor) · label of March 28, 2025
Used for
From the label: indicationsZOCOR ® is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. […]
On the market
- Earliest approval on file
- December 23, 1991
- Generic labelers
- 27 labelers
- Pharmacy cost
- $0.0321 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 26
Highlights of the ezetimibe record
Ezetimibe (Zetia) · label of November 25, 2025
Used for
From the label: indicationsZETIA ® is indicated: In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). […]
On the market
- Earliest approval on file
- October 25, 2002
- Generic labelers
- 23 labelers
- Pharmacy cost
- $0.0667 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Source: FDA drug labels via openFDA (Simvastatin label of March 28, 2025, Ezetimibe label of November 25, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do simvastatin and ezetimibe differ on the record?
In FDA's classes, simvastatin is a hmg-coa reductase inhibitor and ezetimibe a dietary cholesterol absorption inhibitor.
How each works, in its label's words: Simvastatin, “Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration.”; Ezetimibe, “Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine.”
Generics: simvastatin since 2006; ezetimibe since 2015 (Drugs@FDA).
| Simvastatin | Ezetimibe | |
|---|---|---|
| Labeled for | Heart attack and coronary artery disease, High cholesterol, High triglycerides | High cholesterol |
| Pharmacologic class | HMG-CoA Reductase Inhibitor | Dietary Cholesterol Absorption Inhibitor |
| How it works (label) | Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration. | Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine. |
| Half-life (label) | n/a | Both ezetimibe and ezetimibe-glucuronide are eliminated from plasma with a half-life of approximately 22 hours for both ezetimibe and ezetimibe-glucuronide. |
| Earliest approval on file (Drugs@FDA) | December 23, 1991 | October 25, 2002 |
| First generic approved | June 23, 2006 | June 26, 2015 |
| Generic labelers (NDC) | 27 labelers | 23 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0321 per tablet (Simvastatin 20 mg tablet) | $0.0667 per tablet (Ezetimibe 10 mg tablet) |
| 12-month price change | +5% | -6% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 26 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 248,728 | 74,543 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Simvastatin label, drug interactionsNiacin Clinical Impact: Cases of myopathy and rhabdomyolysis have been observed with concomitant use of lipid modifying dosages of niacin-containing products (≥1 gram/day niacin) with ZOCOR. The risk of myopathy is greater in Chinese patients. … Intervention: Concomitant use of ZOCOR with lipid-modifying dosages of niacin is not recommended in Chinese patients [see ]. For non-Chinese patients, consider if the benefit of using lipid-modifying doses of niacin …
Source: FDA drug labels via openFDA
What next?
- Alternatives to simvastatin
- every medicine labeled for the same conditions