Two medicines, side by side
Ezetimibe/simvastatin vs gemfibrozil
Ezetimibe/simvastatin and gemfibrozil are both labeled for heart attack and coronary artery disease and high cholesterol. Drugs@FDA records approvals of ezetimibe/simvastatin since 2004 and of gemfibrozil since 1981. Pharmacies paid $0.285 per unit (Ezetimibe-simvastatin 10-80 mg) 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/simvastatin is a dietary cholesterol absorption inhibitor and gemfibrozil a peroxisome proliferator receptor alpha agonist.
Check it at the source: the ezetimibe/simvastatin FDA label on DailyMed (effective January 21, 2026); the gemfibrozil FDA label on DailyMed (effective April 10, 2026).
Highlights of the ezetimibe and simvastatin record
Ezetimibe and simvastatin (Vytorin) · label of January 21, 2026
Used for
From the label: indicationsVYTORIN VYTORIN ® is a combination of simvastatin and ezetimibe indicated: As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). […]
On the market
- Earliest approval on file
- July 23, 2004
- Generic labelers
- 7 labelers
- Pharmacy cost
- $0.285 per unit
Supply and safety
- Shortage
- No current entry
- Recalls
- 10
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/simvastatin label of January 21, 2026, Gemfibrozil label of April 10, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do ezetimibe/simvastatin and gemfibrozil differ on the record?
In FDA's classes, ezetimibe/simvastatin is a dietary cholesterol absorption inhibitor and gemfibrozil a peroxisome proliferator receptor alpha agonist.
Half-life, in each label's words: Ezetimibe/simvastatin, “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/simvastatin since 2017; gemfibrozil since 1993 (Drugs@FDA).
| Ezetimibe/simvastatin | Gemfibrozil | |
|---|---|---|
| Labeled for | High cholesterol, Heart attack and coronary artery disease | High cholesterol, Heart attack and coronary artery disease |
| Pharmacologic class | Dietary Cholesterol Absorption Inhibitor, HMG-CoA Reductase Inhibitor | Peroxisome Proliferator Receptor alpha Agonist |
| How it works (label) | VYTORIN Plasma cholesterol is derived from intestinal absorption and endogenous synthesis. VYTORIN contains ezetimibe and simvastatin, two lipid-lowering compounds with complementary mechanisms of action. | 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) | July 23, 2004 | December 21, 1981 |
| First generic approved | April 26, 2017 | January 25, 1993 |
| Generic labelers (NDC) | 7 labelers | 27 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.285 per unit (Ezetimibe-simvastatin 10-80 mg) | $0.104 per tablet (Gemfibrozil 600 mg tablet) |
| 12-month price change | -35% | +2% |
| Boxed warning | No | Yes |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 10 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 15,110 | 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)
Do their labels mention each other?
Ezetimibe/simvastatin label, contraindicationsConcomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications and nefazodone). ( 4 ) Concomitant use of cyclosporine, danazol or gemfibrozil. ( 4 ) Acute liver failure or decompensated cirrhosis. ( 4 ) Hypersensitivity to simvastatin, ezetimibe or any excipient of VYTORIN.
Ezetimibe/simvastatin label, drug interactionsCyclosporine, Danazol, or Gemfibrozil Clinical Impact: The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine, danazol, or gemfibrozil with VYTORIN. Gemfibrozil may cause myopathy when given alone. Intervention: Concomitant use of cyclosporine, danazol, or gemfibrozil with VYTORIN is contraindicated [see ].
Source: FDA drug labels via openFDA
What next?
- Alternatives to ezetimibe/simvastatin
- every medicine labeled for the same conditions