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fluvastatin

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Brand names: Lescol

HMG-CoA Reductase Inhibitor (Statin) Rx

Fluvastatin (Lescol) is a medicine that helps lower cholesterol levels in your blood. It belongs to a group of drugs called statins.

Drug Shortage Alert

fluvastatin is currently listed as to be discontinued by the FDA. Affected manufacturer: Sandoz Inc..

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Drug Pricing (NADAC)

Generic Price

$2.68/unit

Generic Available

Yes (4 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

This medicine is used to lower high cholesterol and triglycerides (fats) in adults and children (10-16 years old) with certain inherited cholesterol problems.

Common side effects

Headache, Upset stomach, Muscle pain

Key warnings

This medicine can sometimes cause muscle problems, including rhabdomyolysis (a serious muscle breakdown that can lead to kidney damage).

How It Works

Fluvastatin works by blocking a substance your body needs to make cholesterol. This helps to lower bad cholesterol (LDL) and triglycerides while raising good cholesterol (HDL). By lowering cholesterol, it helps prevent heart disease and stroke.

How to Take It

Take fluvastatin capsules once or twice a day, as directed by your doctor. You can take it with or without food. Swallow the capsules whole; do not open them. Your doctor may adjust your dose every 4 weeks based on your cholesterol levels.

Pregnancy & Breastfeeding

You should not take fluvastatin if you are pregnant or breastfeeding. This medicine can harm an unborn baby. If you are a woman who could become pregnant, use effective birth control while taking fluvastatin.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time.

Storage

Store fluvastatin capsules at room temperature, away from light and moisture.

Side Effects (from patient reports)

Based on 3,645 FDA adverse event reports.

Muscle pain
669
Diarrhea
371
Feeling lightheaded
361
Shortness of breath
340
Feeling sick to your stomach
337
Joint pain
317
Falling down
315
Head pain
315
Feeling tired
310
Itchy skin
310

FDA Adverse Event Report Analysis

Detailed analysis of 3,948 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

3,948

Death-Related Reports

573

Hospitalization Reports

1,782

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 1,606 (47%)
Male 1,769 (52%)

Age Distribution

0–17 31
18–44 185
45–64 900
65–74 814
75+ 757

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 MYALGIA 669
2 DIARRHOEA 371
3 DIZZINESS 361
4 DYSPNOEA 340
5 NAUSEA 337
6 ARTHRALGIA 316
7 FALL 315
8 HEADACHE 314
9 FATIGUE 310
10 PRURITUS 309
11 PYREXIA 304
12 VOMITING 284
13 ASTHENIA 278
14 MALAISE 272
15 DECREASED APPETITE 268

Reactions in Death Reports

SEPSIS 248
FALL 241
HAEMORRHAGIC STROKE 235
TACHYCARDIA 231
DIARRHOEA 225
CARDIO-RESPIRATORY ARREST 223
DYSPNOEA 223
ALTERED STATE OF CONSCIOUSNESS 219
HAEMATEMESIS 218
OCULAR DISCOMFORT 218

Reactions in Hospitalization Reports

PYREXIA 110
GENERAL PHYSICAL HEALTH DETERIORATION 102
NAUSEA 102
DIARRHOEA 99
DRUG INEFFECTIVE 97
MYALGIA 93
DIZZINESS 88
ATRIAL FIBRILLATION 87
ACUTE KIDNEY INJURY 84
DRUG INTERACTION 82

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

This medicine can sometimes cause muscle problems, including rhabdomyolysis (a serious muscle breakdown that can lead to kidney damage). Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel sick. This medicine can also cause liver problems. Your doctor should do blood tests to check your liver before you start taking fluvastatin and while you are taking it.

Known Drug Interactions

Gastroprokinetic Agents: Cisapride Contraindicated Cisapride: [See Contraindications ( 4.2 )] Lipid-lowering agents: Lomitapide Lovastatin Simvastatin Contraindicated Lomitapide, Lovastatin, Simvastatin: Clarithromycin may increase the exposure of these drugs by inhibition of CYP3A metabolism, thereby increasing the risk of toxicities from these drugs [see Contraindications ( 4.5 ) and Warnings and Precautions ( 5.4 )] Atorvastatin, Pravastatin, Fluvastatin: [See Warnings and Precautions ( 5.4 )] Atorvastatin Pravastatin Use With Caution Fluvastatin No Dose Adjustment Hypoglycemic Agents: N...

Mechanism: Clarithromycin can affect how your body handles cholesterol medications, though it does not significantly change the levels of fluvastatin.

What to do: No dose adjustment is required for fluvastatin, but you should report any new muscle pain to your doctor.

7 DRUG INTERACTIONS Cyclosporine: Combination increases fluvastatin exposure. 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: Monitor plasma phenytoin levels when fluvastatin treatment is initiated or when the dosage is changed ( 7 ) Warfarin and coumarin derivates: Monitor prothrombin times when fluvastatin coadministration is initiated, discontinued, or the dosage changed ( 7 ) 7.1 Cyclosporine Cyclosporine coadministration increases fluvastatin exposure. Therefore, in pa...

Mechanism: Cyclosporine makes it harder for your body to get rid of fluvastatin, leading to higher levels of the cholesterol medicine in your blood.

What to do: Use this combination with caution. Your doctor may need to adjust your dose or check for muscle pain and other side effects.

moderate glyburide

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: Monitor plasma phenytoin levels when fluvastatin treatment is initiated or when the dosage is changed ( 7 ) Warfarin and coumarin derivates: Monitor prothrombin times when fluvastatin coadministration is initiated, discontinued, or the dosage changed ( 7 ) 7.1 Cyclosporine Cyclosporine coadministration increases fluvastatin exposure. 7.6 Glyburide Concomitant administration of fluvastatin and glyburide increased glyburide expo...

Mechanism: Fluvastatin can increase the amount of glyburide in your system, which may cause your blood sugar to drop too low.

What to do: You should monitor your blood sugar levels closely. Your doctor may need to adjust your medications if your fluvastatin dose changes.

moderate gemfibrozil

7.3 Gemfibrozil 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.

Mechanism: Taking these two cholesterol medicines together can cause a dangerous breakdown of muscle tissue.

What to do: You should avoid taking these two medications together.

moderate niacin

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. 7.5 Niacin The risk of skeletal muscle effects may be enhanced when fluvastatin sodium is used in combination with lipid-modifying doses (≥ 1 g/day) of niacin; a reduction in fluvastatin sodium dosage should be considered in this setting [see Warnings and Precautions ( 5.1 )].

Mechanism: Combining these drugs increases the chance of experiencing muscle pain or damage.

What to do: Your doctor may need to lower your dose of fluvastatin if you are taking high doses of niacin.

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Common Questions

Can I take fluvastatin with other medications?
Tell your doctor about all the medicines you take, including prescription and over-the-counter drugs, vitamins, and herbal supplements. Some medicines can interact with fluvastatin and increase your risk of side effects.
How long will I need to take fluvastatin?
You will likely need to take fluvastatin for a long time to manage your cholesterol levels and reduce your risk of heart disease.
Will I still need to follow a diet if I take fluvastatin?
Yes, you should continue to follow a healthy diet low in saturated fat and cholesterol while taking fluvastatin.
Can I drink alcohol while taking fluvastatin?
Talk to your doctor about whether it is safe for you to drink alcohol while taking fluvastatin. Alcohol can increase your risk of liver problems.
What should I do if I experience side effects?
Tell your doctor about any side effects you experience while taking fluvastatin. They may be able to adjust your dose or recommend other ways to manage the side effects.
How often will I need blood tests?
Your doctor will likely want to check your cholesterol levels and liver function regularly with blood tests.
Can children take fluvastatin?
Fluvastatin can be used in children ages 10-16 with certain inherited high cholesterol conditions.
What happens if I stop taking fluvastatin?
If you stop taking fluvastatin, your cholesterol levels may increase, and your risk of heart disease may also increase.
Is there a generic version of fluvastatin?
Yes, fluvastatin is available as a generic medication.
Does fluvastatin interact with grapefruit?
Grapefruit and grapefruit juice may interact with fluvastatin and should be avoided.
What are the common side effects of fluvastatin?
The most commonly reported side effects of fluvastatin include Headache, Upset stomach, Muscle pain, Abdominal pain, Nausea. Based on 3,645 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does fluvastatin interact with other medications?
Yes, fluvastatin has 12 known drug interactions. Notable interactions include clarithromycin, cyclosporine, glyburide. Always inform your doctor about all medications you are taking.
What drug class is fluvastatin?
fluvastatin belongs to the HMG-CoA Reductase Inhibitor (Statin) drug class. It requires a prescription (Rx). This medicine is used to lower high cholesterol and triglycerides (fats) in adults and children (10-16 years old) with certain inherited cholesterol problems.
Is fluvastatin safe during pregnancy?
You should not take fluvastatin if you are pregnant or breastfeeding. This medicine can harm an unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Is fluvastatin currently in shortage?
Yes, fluvastatin is currently listed as to be discontinued by the FDA. Affected manufacturer: Sandoz Inc.. Visit the FDA Drug Shortages database for the latest updates.

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What the FDA Data Shows for fluvastatin

The FDA label for fluvastatin (sold under brand names such as Lescol) classifies it as a prescription-only medication in the HMG-CoA Reductase Inhibitor (Statin) class. This medicine is used to lower high cholesterol and triglycerides (fats) in adults and children (10-16 years old) with certain inherited cholesterol problems. Official labeling lists 5 commonly reported side effects, including Headache, Upset stomach, Muscle pain.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 3,645 voluntary reports. The database also lists 12 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $2.68.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: October 21, 2025

All federal data sources used on this page