Two medicines, side by side
Pravastatin vs simvastatin
Pravastatin and simvastatin are both labeled for heart attack and coronary artery disease, high cholesterol and high triglycerides. Drugs@FDA records approvals of pravastatin since 1991 and of simvastatin since 1991. Pharmacies paid $0.058 per pravastatin sodium 20 mg tablet and $0.0321 per simvastatin 20 mg tablet (NADAC, October 7, 2026). How each works, in its label's words: Pravastatin, “Pravastatin is a reversible inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of cholesterol.”; Simvastatin, “Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration.”
Check it at the source: the pravastatin FDA label on DailyMed (effective July 31, 2026); the simvastatin FDA label on DailyMed (effective March 28, 2025).
Highlights of the pravastatin record
Pravastatin (Pravachol) · label of July 31, 2026
Used for
From the label: indicationsPravastatin sodium tablets are indicated: To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). […]
On the market
- Earliest approval on file
- October 31, 1991
- Generic labelers
- 37 labelers
- Pharmacy cost
- $0.058 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 17
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
Source: FDA drug labels via openFDA (Pravastatin label of July 31, 2026, Simvastatin label of March 28, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do pravastatin and simvastatin differ on the record?
How each works, in its label's words: Pravastatin, “Pravastatin is a reversible inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of cholesterol.”; Simvastatin, “Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration.”
Both are in FDA's class HMG-CoA reductase inhibitors.
Generics: pravastatin since 2006; simvastatin since 2006 (Drugs@FDA).
| Pravastatin | Simvastatin | |
|---|---|---|
| Labeled for | Heart attack and coronary artery disease, High cholesterol, High triglycerides | Heart attack and coronary artery disease, High cholesterol, High triglycerides |
| Pharmacologic class | HMG-CoA Reductase Inhibitor | HMG-CoA Reductase Inhibitor |
| How it works (label) | Pravastatin is a reversible inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of cholesterol. | Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration. |
| Half-life (label) | Following single dose oral administration of 14 C-pravastatin, the radioactive elimination t ½ for pravastatin is 1.8 hours in humans and the elimination half-life (t ½ ) for total radioactivity (pravastatin plus … | n/a |
| Earliest approval on file (Drugs@FDA) | October 31, 1991 | December 23, 1991 |
| First generic approved | April 24, 2006 | June 23, 2006 |
| Generic labelers (NDC) | 37 labelers | 27 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.058 per tablet (Pravastatin sodium 20 mg tablet) | $0.0321 per tablet (Simvastatin 20 mg tablet) |
| 12-month price change | -18% | +5% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 17 | 26 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 19,683 | 248,728 |
| 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 pravastatin
- every medicine labeled for the same conditions