Fluvastatin: uses, dosing, side effects & brands

Fluvastatin is a hmg-coa reductase inhibitor sold in the U.S. under one brand, for coronary artery disease, hypercholesterolemia and hyperlipoproteinemias. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class: Hmg-Coa Reductase Inhibitor
Treats: Coronary Artery Disease, Hypercholesterolemia and Hyperlipoproteinemias
Available as: Tablet, extended release
Sold as: Lescol XL
Prescription?: Prescription only
Generic available?: Not in our catalog
What the pharmacy pays: about $86 for a 30-count supply — not your price

How fluvastatin is dosed

From the FDA label for Lescol XL (application NDA021192). Other fluvastatin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Fluvastatin sodium extended-release tablets can be taken with or without food and may be taken at any time of the day. ( 2.1 ) • Do not break, crush or chew fluvastatin sodium extended-release tablets prior to administration. ( 2.1 ) • Adults : The recommended starting dose is 80 mg (administered as one 80 mg fluvastatin sodium extended-release tablet once daily). ( 2.2 ) Children : The recommended dose is 80 mg once daily in pediatric patients 10 years of age and older who require 80 mg of fluvastatin. Fluvastatin sodium extended-release tablets are not recommended for dosage initiation in pediatric patients because the recommended starting dosage cannot be achieved with the available strength of 80 mg. ( 2.3 ) 2.1 Important Dosage Information • Take fluvastatin sodium extended-release tablets orally once daily as a single dose, with or without food. • Do not break, crush, or chew fluvastatin sodium extended-release tablets. • Fluvastatin sodium extended-release tablet is only available as an 80 mg tablet. Fluvastatin sodium extended-release tablets cannot be titrated [see Dosage and Administration (2.2, 2.3)] . • For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving fluvastatin sodium extended-release tablets 80 mg daily, prescribe alternative LDL-C-lowering treatment. • Assess LDL-C when clinically appropriate, as early as 4…

Fluvastatin side effects

The following serious adverse reactions are discussed in greater detail in other sections of the label: • Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1 )] • Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions ( 5.2 )] • Hepatic Dysfunction [see Warnings and Precautions ( 5.3 )] • Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions ( 5.4 )] Most frequent adverse reactions occurring in ≥ 2.5% of subjects treated with fluvastatin sodium extended-release tablets and more than placebo are: influenza-like symptoms, sinusitis, dyspepsia, urinary tract infection, bronchitis, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the fluvastatin capsule, clinical trials there were 2326 patients treated with fluvastatin (age range, 18 to 75 years, 44% women, 94% White, 4% Black or African American, 2% other ethnicities) with a median treatment duration of 24 weeks. The most common adverse reactions that led to treatment discontinuation and…

Who shouldn’t take fluvastatin

Fluvastatin sodium extended-release tablets are contraindicated in patients with: • Acute liver failure or decompensated cirrhosis [see Warnings and Precautions ( 5.3 )] . • Hypersensitivity to fluvastatin or any of the excipients in fluvastatin sodium extended-release tablets. Hypersensitivity reactions, including anaphylaxis, angioedema, and Stevens-Johnson syndrome have been reported [see Adverse Reactions ( 6.2 )] . • Acute liver failure or decompensated cirrhosis ( 4 ) • Hypersensitivity to fluvastatin or any excipient in fluvastatin sodium extended-release tablets ( 4 )

Fluvastatin drug interactions

Gemfibrozil : Avoid use with fluvastatin sodium extended-release tablets. ( 7.1 ) • Cyclosporine and Fluconazole : Avoid use with fluvastatin sodium extended-release tablets. ( 7.1 ) • Fibrates, Lipid-modifying doses (≥ 1 g/day) of Niacin, and Colchicine : Consider if the benefit of concomitant use with fluvastatin sodium extended-release tablets outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration. ( 7.1 ) • Warfarin : Obtain an International Normalized Ratio (INR) before starting and frequently enough after initiation or discontinuation to ensure that no significant alteration in INR occurs. Once the INR is stable, monitor INR at regular intervals. ( 7.2 ) • Glyburide : Monitor blood glucose levels when fluvastatin sodium extended-release tablets are initiated. ( 7.2 ) • Phenytoin : Monitor plasma phenytoin levels when fluvastatin sodium extended-release tablets treatment is initiated. ( 7.2 ) 7.1 Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Fluvastatin Sodium Extended-Release Tablets Table 3 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with fluvastatin and instructions for preventing or managing them [see Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.3 )] . Table 3. Drug Interactions That Increase the Risk of Myopathy and Rhabdomyolysis with Fluvastatin Sodium Extended-Release Tablets Gemfibrozil Clinical impact There is an increased risk of myopathy/rhabdomyolysis when fluvastatin sodium extended-release tablets are administered with gemfibrozil Intervention Avoid concomitant use of gemfibrozil with fluvastatin sodium extended-release tablets. Cyclosporine Clinical impact Cyclosporine coadministration increases fluvastatin exposure. The risk of myopathy and rhabdomyolysis may be increased with concomitant use of cyclosporine with fluvastatin sodium extended-release tablets. Intervention Avoid concomitant use of cyclosporine with fluvastatin sodium extended-release tablets. Fluconazole Clinical impact Fluconazole coadministration increases fluvastatin exposure. The risk of myopathy and rhabdomyolysis may be increased with concomitant use of fluconazole with fluvastatin sodium extended-release tablets. Intervention Avoid concomitant use of fluconazole with fluvastatin sodium extended-release tablets. Niacin Clinical impact Risk of myopathy and rhabdomyolysis may be enhanced with concomitant use with lipid-modifying doses (≥ 1 g/day) of niacin with fluvastatin sodium extended-release tablets. Intervention Consider if the benefit of using lipid-modifying doses (≥ 1 g/day) of niacin concomitantly with fluvastatin sodium extended-release tablets outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration. Fibrates Clinical impact Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis may be increased with concomitant use of fibrates with fluvastatin sodium extended-release tablets. Intervention Consider if the benefit of using fibrates concomitantly with fluvastatin sodium extended-release tablets outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration. Colchicine Clinical impact Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with fluvastatin. Intervention Consider if the benefit of using colchicine concomitantly with fluvastatin sodium extended-release tablets outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration. 7.2 Fluvastatin Sodium Extended-Release Tablets Effects on Other Drugs Table 4 presents fluvastatin sodium extended-release tablets’ effects on other drugs and instructions for preventing or managing them. Table 4. Fluvastatin Sodium Extended-Release Tablets’ Effects on Other Drugs Warfarin Clinical impact There are postmarketing reports of clinically evident bleeding and/or increased INR in patients taking concomitant statins and warfarin. Intervention In patients taking warfarin, obtain an INR before starting fluvastatin sodium extended-release tablets and frequently enough after initiation or discontinuation to ensure that no significant alteration in INR occurs. Once the INR is stable, monitor INR at regularly recommended intervals. Glyburide Clinical impact Concomitant administration of fluvastatin and glyburide increased glyburide exposures [see Clinical Pharmacology ( 12.3 )] . Intervention Monitor blood glucose levels when fluvastatin sodium extended-release tablets are initiated. Phenytoin Clinical impact Concomitant administration of fluvastatin and phenytoin increased phenytoin exposures [see Clinical Pharmacology ( 12.3 )] . Intervention Monitor plasma phenytoin levels when fluvastatin sodium extended-release tablets are initiated.

Every fluvastatin product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Lescol XL.

What fluvastatin pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Fluvastatin pill imprints
Imprint	Strength	Colour	Shape	Maker
BS08;80	80 mg	yellow	round	—
MYLAN;8020	20 mg	pink, white	capsule	—
MYLAN;8021	40 mg	pink, orange	capsule	—
Lescol;XL;80	80 mg	yellow	round	—
TV;7446	80 mg	white	round	—
Lescol;XL;80	80 mg	yellow	round	—

Can you crush or split fluvastatin?

At least one fluvastatinproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.

What each fluvastatin label says about crushing, splitting and chewing

How long fluvastatin keeps

No fluvastatin label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.

Does fluvastatin expire? The in-use limits and storage rules from its labels

Fluvastatin and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

No relevant published information exists on the use of fluvastatin during breastfeeding. Because of a concern with disruption of infant lipid metabolism, the consensus is that fluvastatin should not be used during breastfeeding. However, others have argued that children homozygous for familial hypercholesterolemia are treated with statins beginning at 1 year of age, that statins have low oral bioavailability, and risks to the breastfed infant are low, especially with rosuvastatin and pravastatin. Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Full LactMed record for fluvastatin: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised July 15, 2026. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about fluvastatin

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,172 reports naming fluvastatin, and the FDA flagged 92% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

myalgia120 reports
dizziness108 reports
nausea108 reports
diarrhoea100 reports
fatigue92 reports
pruritus92 reports
dyspnoea90 reports
pyrexia85 reports

Read these as a signal, not a rate. A report does not mean fluvastatin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

Related calculators

How long it stays in your system →

Frequently asked questions

What is fluvastatin?

Lescol XL (Fluvastatin Sodium) is a HMG-CoA reductase inhibitor used to treat Coronary Artery Disease, Hypercholesterolemia, Hyperlipoproteinemias, Hypertriglyceridemia.

What kind of drug is fluvastatin?

The FDA classifies fluvastatin as a hmg-coa reductase inhibitor. Statins block HMG-CoA reductase, the key enzyme the liver uses to make cholesterol. With less cholesterol being produced, the liver pulls more LDL ("bad") cholesterol out of the blood, lowering overall blood cholesterol levels. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take fluvastatin with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run fluvastatin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does fluvastatin come in?

Across the brands we track, fluvastatin is currently marketed as tablet, extended release, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic fluvastatin?

We do not currently list a generic-labelled fluvastatin product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Cite this page

APA: pharmaranks. (2026, July 24). Fluvastatin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/fluvastatin
MLA: “Fluvastatin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/fluvastatin.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for fluvastatin on DailyMed (NIH) ↗.