Two medicines, side by side
Fluvastatin vs rosuvastatin
Fluvastatin and rosuvastatin are both labeled for high cholesterol. Drugs@FDA records approvals of fluvastatin since 1993 and of rosuvastatin since 2003. Pharmacies paid $2.88 per fluvastatin ER 80 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: Fluvastatin, “Fluvastatin sodium is a competitive inhibitor of HMG-CoA reductase, the rate limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) to mevalonate, a precursor of sterols …”; 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 fluvastatin FDA label on DailyMed (effective April 21, 2025); the rosuvastatin FDA label on DailyMed (effective September 4, 2026).
Highlights of the fluvastatin record
Fluvastatin (Lescol) · label of April 21, 2025
Used for
From the label: indicationsTherapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate. […]
On the market
- Earliest approval on file
- December 31, 1993
- Generic labelers
- 4 labelers
- Pharmacy cost
- $2.88 per tablet
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 2
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 (Fluvastatin label of April 21, 2025, Rosuvastatin label of September 4, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do fluvastatin and rosuvastatin differ on the record?
How each works, in its label's words: Fluvastatin, “Fluvastatin sodium is a competitive inhibitor of HMG-CoA reductase, the rate limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) to mevalonate, a precursor of sterols …”; 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.
Half-life, in each label's words: Fluvastatin, “The elimination half-life (t 1/2 ) of fluvastatin is approximately 3 hours.”; Rosuvastatin, “The elimination half-life of rosuvastatin is approximately 19 hours.”
Generics: fluvastatin since 2012; rosuvastatin since 2016 (Drugs@FDA).
| Fluvastatin | Rosuvastatin | |
|---|---|---|
| Labeled for | High cholesterol | 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) | Fluvastatin sodium is a competitive inhibitor of HMG-CoA reductase, the rate limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) to mevalonate, a precursor of sterols, including cholesterol. | 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) | The elimination half-life (t 1/2 ) of fluvastatin is approximately 3 hours. | The elimination half-life of rosuvastatin is approximately 19 hours. |
| Earliest approval on file (Drugs@FDA) | December 31, 1993 | August 12, 2003 |
| First generic approved | April 11, 2012 | April 29, 2016 |
| Generic labelers (NDC) | 4 labelers | 45 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $2.88 per tablet (Fluvastatin ER 80 mg tablet) | $0.0692 per tablet (Rosuvastatin calcium 40 mg tablet) |
| 12-month price change | +4% | -7% |
| Boxed warning | No | No |
| Shortage now | A presentation being discontinued | No current entry |
| Recalls recorded | 2 | 13 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 7,505 | 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 do the labels say about using others of their kind?
Fluvastatin label, drug interactionsBleeding and/or increased prothrombin times have been reported in patients taking coumarin anticoagulants concomitantly with other HMG-CoA reductase inhibitors.
Source: FDA drug labels via openFDA
What next?
- Alternatives to fluvastatin
- every medicine labeled for the same conditions