Two medicines, side by side
Simvastatin vs rosuvastatin
Simvastatin and rosuvastatin are both labeled for heart attack and coronary artery disease, high cholesterol and high triglycerides. Drugs@FDA records approvals of simvastatin since 1991 and of rosuvastatin since 2003. Pharmacies paid $0.0321 per simvastatin 20 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. 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.”; Rosuvastatin, “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.”
Check it at the source: the simvastatin FDA label on DailyMed (effective March 28, 2025); the rosuvastatin FDA label on DailyMed (effective September 4, 2026).
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 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 (Simvastatin label of March 28, 2025, Rosuvastatin label of September 4, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do simvastatin and rosuvastatin differ on the record?
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.”; Rosuvastatin, “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.”
Both are in FDA's class HMG-CoA reductase inhibitors.
Generics: simvastatin since 2006; rosuvastatin since 2016 (Drugs@FDA).
| Simvastatin | Rosuvastatin | |
|---|---|---|
| Labeled for | Heart attack and coronary artery disease, High cholesterol, High triglycerides | Heart attack and coronary artery disease, High cholesterol, High triglycerides, Stroke prevention |
| Pharmacologic class | HMG-CoA Reductase Inhibitor | HMG-CoA Reductase Inhibitor |
| How it works (label) | Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration. | 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) | n/a | The elimination half-life of rosuvastatin is approximately 19 hours. |
| Earliest approval on file (Drugs@FDA) | December 23, 1991 | August 12, 2003 |
| First generic approved | June 23, 2006 | April 29, 2016 |
| Generic labelers (NDC) | 27 labelers | 45 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0321 per tablet (Simvastatin 20 mg tablet) | $0.0692 per tablet (Rosuvastatin calcium 40 mg tablet) |
| 12-month price change | +5% | -7% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 26 | 13 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 248,728 | 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)
What next?
- Alternatives to simvastatin
- every medicine labeled for the same conditions