Two medicines, side by side
Ezetimibe vs gemfibrozil
Ezetimibe and gemfibrozil are both labeled for high cholesterol. Drugs@FDA records approvals of ezetimibe since 2002 and of gemfibrozil since 1981. Pharmacies paid $0.0667 per ezetimibe 10 mg tablet and $0.104 per gemfibrozil 600 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, ezetimibe is a dietary cholesterol absorption inhibitor and gemfibrozil a peroxisome proliferator receptor alpha agonist.
Check it at the source: the ezetimibe FDA label on DailyMed (effective November 25, 2025); the gemfibrozil FDA label on DailyMed (effective April 10, 2026).
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
Highlights of the gemfibrozil record
Gemfibrozil (Lopid) · label of April 10, 2026
Used for
From the label: indicationsGemfibrozil Tablets are indicated as adjunctive therapy to diet for: Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. […]
On the market
- Earliest approval on file
- December 21, 1981
- Generic labelers
- 27 labelers
- Pharmacy cost
- $0.104 per tablet
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 0
Source: FDA drug labels via openFDA (Ezetimibe label of November 25, 2025, Gemfibrozil label of April 10, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do ezetimibe and gemfibrozil differ on the record?
In FDA's classes, ezetimibe is a dietary cholesterol absorption inhibitor and gemfibrozil a peroxisome proliferator receptor alpha agonist.
Half-life, in each label's words: Ezetimibe, “Both ezetimibe and ezetimibe-glucuronide are eliminated from plasma with a half-life of approximately 22 hours for both …”; Gemfibrozil, “Peak plasma levels occur in 1 to 2 hours with a plasma half-life of 1.5 hours following multiple doses.”
Only the gemfibrozil label carries a boxed warning.
Generics: ezetimibe since 2015; gemfibrozil since 1993 (Drugs@FDA).
| Ezetimibe | Gemfibrozil | |
|---|---|---|
| Labeled for | High cholesterol | High cholesterol, Heart attack and coronary artery disease |
| Pharmacologic class | Dietary Cholesterol Absorption Inhibitor | Peroxisome Proliferator Receptor alpha Agonist |
| How it works (label) | Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine. | n/a |
| Half-life (label) | Both ezetimibe and ezetimibe-glucuronide are eliminated from plasma with a half-life of approximately 22 hours for both ezetimibe and ezetimibe-glucuronide. | Peak plasma levels occur in 1 to 2 hours with a plasma half-life of 1.5 hours following multiple doses. |
| Earliest approval on file (Drugs@FDA) | October 25, 2002 | December 21, 1981 |
| First generic approved | June 26, 2015 | January 25, 1993 |
| Generic labelers (NDC) | 23 labelers | 27 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0667 per tablet (Ezetimibe 10 mg tablet) | $0.104 per tablet (Gemfibrozil 600 mg tablet) |
| 12-month price change | -6% | +2% |
| Boxed warning | No | Yes |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 0 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 74,543 | 15,090 |
| 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)
What next?
- Alternatives to ezetimibe
- every medicine labeled for the same conditions