Prescription medicine
Fluvastatin Brand names: Lescol
Fluvastatin (Lescol) is a prescription medicine with an FDA approval on record since 1993. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $2.88 per fluvastatin ER 80 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the fluvastatin FDA label on DailyMed (effective April 21, 2025, Teva Pharmaceuticals USA, Inc.); the NDA 20261 record on Drugs@FDA; every fluvastatin label on DailyMed.
Highlights of the record
FDA label of April 21, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTherapy 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.
Forms and strengths
- 20 mg
- 40 mg
- 80 mg
Capsule; extended-release tablet; film-coated extended-release tablet.
On the market
- Earliest approval on file
- December 31, 1993 Lescol, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first April 11, 2012; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 4 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $2.88 per tablet Fluvastatin ER 80 mg tablet
- Shortage (FDA)
- None current 3 past records
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest May 29, 2014; 1 more by firms not listed as its makers
- FAERS reports
- 7,505 through July 30, 2026
What is fluvastatin used for?
From the label: indications and usageTherapy 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. […]
Conditions named in the indications of fluvastatin's FDA labels, with every medicine labeled for each:
From other fluvastatin labelsHigh cholesterol: … indicated as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG) and apolipoprotein B (Apo B) levels, and to increase high-density lipoprotein cholesterol …
FDA pharmacologic class: HMG-CoA Reductase Inhibitor.
Source: FDA drug label (Fluvastatin), Teva Pharmaceuticals USA, Inc., effective April 21, 2025 (SPL set aad8b373-0aec-4efb-8e61-3d8114b31127), via openFDA; the full label on DailyMed
What does the patient leaflet for fluvastatin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking fluvastatin capsules?Talk to your doctor before you start any new medicines. This includes prescription and nonprescription medicines, vitamins and herbal supplements. Fluvastatin capsules and certain other medicines can interact causing serious side effects. Do not get pregnant. If you get pregnant, stop taking fluvastatin capsules right away and call your doctor.
From the patient leaflet: How should I store fluvastatin capsules?Store fluvastatin capsules at room temperature, 20° to 25°C (68° to 77°F). Protect from light. Do not keep medicine that is out of date or that you no longer need. Keep fluvastatin capsules out of the reach of children. Be sure that if you throw medicines away, they are out of the reach of children.
Source: FDA drug label (Fluvastatin), Teva Pharmaceuticals USA, Inc., effective April 21, 2025 (SPL set aad8b373-0aec-4efb-8e61-3d8114b31127), via openFDA; the full label on DailyMed
Is there a generic for fluvastatin (Lescol)?
The FDA approved the first generic fluvastatin on April 11, 2012. 5 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists fluvastatin from 4 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1993 earliest approval on file
- 2012 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fluvastatin (Lescol)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.88 per Fluvastatin ER 80 mg tablet, up 4% from $2.78 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Fluvastatin ER 80 mg tablet (generic)
- Lescol xl 80 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fluvastatin ER 80 mg tablet | Generic | $2.88 per tablet | $86.38 | +4% |
| Fluvastatin sodium 20 mg capsule | Generic | $2.67 per capsule | $80.19 | -17% |
| Fluvastatin sodium 40 mg capsule | Generic | $2.86 per capsule | $85.88 | -2% |
| Lescol xl 80 mg tablet | Brand | $13.06 per tablet | $391.93 | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is fluvastatin in shortage?
No fluvastatin presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 3 records are all marked to be discontinued, the latest updated January 27, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Fluvastatin Sodium, Tablet, Extended Release, 80 mg (NDC 0781-8017-01) | Sandoz Inc. | To Be Discontinued | January 27, 2026 |
| Fluvastatin Sodium, Tablet, Extended Release, 80 mg (NDC 0781-8017-31) | Sandoz Inc. | To Be Discontinued | January 27, 2026 |
| Lescol XL, Tablet, Extended Release, 80 mg (NDC 66758-211-31) | Sandoz Inc. | To Be Discontinued | January 27, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has fluvastatin been recalled?
The FDA's Enforcement Report lists 3 recalls naming fluvastatin since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of fluvastatin and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 29, 2014 | Class II | Teva Pharmaceuticals USA | Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: FLUVASTATIN SODIUM, Capsule, 20 mg may have potentially been mislabeled as the following drug: VALSARTAN, Tablet, 80 mg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: FLUVASTATIN, Capsule, 20 mg may have potentially been mislabeled as the following drug: ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fluvastatin label say about other medicines?
The fluvastatin label names 13 other medicines in its interaction, contraindication or warning sections. The labels of 27 other medicines name fluvastatin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cimetidine | warnings and precautions | Caution should be exercised if a statin or other agent used to lower cholesterol levels is administered to patients receiving other drugs (e.g., ketoconazole, spironolactone, cimetidine) that may decrease the levels of endogenous steroid hormones. |
| Colchicine | drug interactions | Cases of myopathy, including rhabdomyolysis, have been reported with fluvastatin coadministered with colchicine, and caution should be exercised when prescribing fluvastatin with colchicine. |
| Cyclosporine | drug interactions | DRUG INTERACTIONS Cyclosporine: Combination increases fluvastatin exposure. |
| Erythromycin | warnings and precautions | The risk of myopathy and/or rhabdomyolysis with statins is increased with concurrent therapy with cyclosporine, erythromycin, fibrates or niacin. |
| Fluconazole | drug interactions | Limit fluvastatin dose to 20 mg ( 2.4 , 7.1 ) Fluconazole: Combination increases fluvastatin exposure. |
| Gemfibrozil | drug interactions | Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are coadministered with gemfibrozil, concomitant administration of fluvastatin sodium with gemfibrozil should be avoided. |
| Glyburide | drug interactions | Caution should be used when prescribing with fluvastatin ( 5.1 , 7.3 , 7.4 ) Glyburide: Monitor blood glucose levels when fluvastatin dose is changed ( 7 ) Phenytoin: |
| Ketoconazole | warnings and precautions | Caution should be exercised if a statin or other agent used to lower cholesterol levels is administered to patients receiving other drugs (e.g., ketoconazole, spironolactone, cimetidine) that may decrease the levels of endogenous steroid hormones. |
| Niacin | drug interactions | Limit fluvastatin dose to 20 mg ( 2.5 , 7.2 ) Concomitant lipid-lowering therapies: Use with fibrates or lipid-modifying doses (≥ 1 g/day) of niacin increases the risk of adverse skeletal muscle effects. |
| Phenytoin | drug interactions | Caution should be used when prescribing with fluvastatin ( 5.1 , 7.3 , 7.4 ) Glyburide: Monitor blood glucose levels when fluvastatin dose is changed ( 7 ) Phenytoin: |
| Spironolactone | warnings and precautions | Caution should be exercised if a statin or other agent used to lower cholesterol levels is administered to patients receiving other drugs (e.g., ketoconazole, spironolactone, cimetidine) that may decrease the levels of endogenous steroid hormones. |
| Testosterone | warnings and precautions | Small declines in total serum testosterone have been noted in treated groups, but no commensurate elevation in LH occurred, suggesting that the observation was not due to a direct effect upon testosterone production. |
| Warfarin | drug interactions | Monitor plasma phenytoin levels when fluvastatin treatment is initiated or when the dosage is changed ( 7 ) Warfarin and coumarin derivates: |
Other labels that name fluvastatin
- Atazanavir and cobicistat
- Clarithromycin
- Cobicistat and darunavir
- Cobicistat, darunavir, emtricitabine and tenofovir alafenamide
- Elbasvir and grazoprevir
- Eltrombopag
- Etravirine
- Fostemsavir
- Glecaprevir and pibrentasvir
- Letermovir
- Mifepristone
- Nefazodone
- Sofosbuvir and velpatasvir and voxilaprevir
- Terbinafine
- Voclosporin
Source: FDA drug label (Fluvastatin), Teva Pharmaceuticals USA, Inc., effective April 21, 2025 (SPL set aad8b373-0aec-4efb-8e61-3d8114b31127), via openFDA; the full label on DailyMed
What do FAERS reports show for fluvastatin?
The FDA Adverse Event Reporting System holds 7,505 reports that list fluvastatin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 889 are coded as a death and 3,248 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as fluvastatin?
19 other medicines are given the same way (oral) and in the same FDA class as fluvastatin or labeled mainly for the same use (high cholesterol), the same class first. High cholesterol lists all 25 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Atorvastatin | High cholesterol | 61 labelers | $0.0228 per tablet 10 mg tablet | No current entry |
| Rosuvastatin | High cholesterol | 46 labelers | $0.0692 per tablet 40 mg tablet | No current entry |
| Pravastatin | High cholesterol | 37 labelers | $0.058 per tablet 20 mg tablet | No current entry |
| Simvastatin | High cholesterol | 27 labelers | $0.0321 per tablet 20 mg tablet | No current entry |
| Amlodipine and atorvastatin | High cholesterol | 6 labelers | $1.34 per unit 10-40 mg | No current entry |
| Lovastatin | High cholesterol | 19 labelers | $0.0436 per tablet 20 mg tablet | No current entry |
| Pitavastatin | High cholesterol | 12 labelers | $0.954 per tablet 2 mg tablet | No current entry |
| Ezetimibe and simvastatin | High cholesterol | 7 labelers | $0.285 per unit 10-80 mg | No current entry |
Every medicine labeled for the same conditions as fluvastatin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does fluvastatin compare with medicines for the same use?
5 side-by-side pages set fluvastatin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to fluvastatin
- 19 medicines for the same use
- Other statins
- the pharmacologic class, with prices and generics
- Fluvastatin side effects
- the label's list beside FAERS reports
- Fluvastatin shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other