Two medicines, side by side
Gemfibrozil vs rosuvastatin
Gemfibrozil and rosuvastatin are both labeled for heart attack and coronary artery disease and high cholesterol. Drugs@FDA records approvals of gemfibrozil since 1981 and of rosuvastatin since 2003. Pharmacies paid $0.104 per gemfibrozil 600 mg tablet and $0.0692 per rosuvastatin calcium 40 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, gemfibrozil is a peroxisome proliferator receptor alpha agonist and rosuvastatin a hmg-coa reductase inhibitor.
Check it at the source: the gemfibrozil FDA label on DailyMed (effective April 10, 2026); the rosuvastatin FDA label on DailyMed (effective September 4, 2026).
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
Highlights of the rosuvastatin record
Rosuvastatin (Crestor) · label of September 4, 2026
Used for
From the label: indicationsRosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. […]
On the market
- Earliest approval on file
- August 12, 2003
- Generic labelers
- 45 labelers
- Pharmacy cost
- $0.0692 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 13
Source: FDA drug labels via openFDA (Gemfibrozil label of April 10, 2026, Rosuvastatin label of September 4, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do gemfibrozil and rosuvastatin differ on the record?
In FDA's classes, gemfibrozil is a peroxisome proliferator receptor alpha agonist and rosuvastatin a hmg-coa reductase inhibitor.
Half-life, in each label's words: Gemfibrozil, “Peak plasma levels occur in 1 to 2 hours with a plasma half-life of 1.5 hours following multiple doses.”; Rosuvastatin, “The elimination half-life of rosuvastatin is approximately 19 hours.”
Only the gemfibrozil label carries a boxed warning.
Generics: gemfibrozil since 1993; rosuvastatin since 2016 (Drugs@FDA).
| Gemfibrozil | Rosuvastatin | |
|---|---|---|
| Labeled for | High cholesterol, Heart attack and coronary artery disease | Heart attack and coronary artery disease, High cholesterol, High triglycerides, Stroke prevention |
| Pharmacologic class | Peroxisome Proliferator Receptor alpha Agonist | HMG-CoA Reductase Inhibitor |
| How it works (label) | n/a | Rosuvastatin is an inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. |
| Half-life (label) | Peak plasma levels occur in 1 to 2 hours with a plasma half-life of 1.5 hours following multiple doses. | The elimination half-life of rosuvastatin is approximately 19 hours. |
| Earliest approval on file (Drugs@FDA) | December 21, 1981 | August 12, 2003 |
| First generic approved | January 25, 1993 | April 29, 2016 |
| Generic labelers (NDC) | 27 labelers | 45 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.104 per tablet (Gemfibrozil 600 mg tablet) | $0.0692 per tablet (Rosuvastatin calcium 40 mg tablet) |
| 12-month price change | +2% | -7% |
| Boxed warning | Yes | No |
| Shortage now | A presentation being discontinued | No current entry |
| Recalls recorded | 0 | 13 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 15,090 | 110,043 |
| 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?
Gemfibrozil label, drug interactionsAvoid concomitant use of gemfibrozil with rosuvastatin.
Gemfibrozil label, drug interactionsAvoid concomitant use of LOPID with rosuvastatin.
Rosuvastatin label, drug interactionsGemfibrozil Prevention or Management: Avoid concomitant use of gemfibrozil with rosuvastatin.
Rosuvastatin label, warnings and precautionsSteps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis The concomitant use of rosuvastatin with cyclosporine or gemfibrozil is not recommended.
Source: FDA drug labels via openFDA
What next?
- Alternatives to gemfibrozil
- every medicine labeled for the same conditions