Prescription medication · HMG-CoA Reductase Inhibitor (Statin)
fluvastatin
Also sold as Lescol. This medicine is used to lower high cholesterol and triglycerides (fats) in adults and children (10-16 years old) with certain inherited cholesterol problems.
Data updated 2026-05-15
- 3,948
- FDA reportsLightly reported
- 12
- InteractionsSeveral interactions
- In shortage
- FDA status
What the data shows
fluvastatin (Lescol) is a prescription HMG-CoA Reductase Inhibitor (Statin), among the least-reported drugs the FDA tracks (3,948 FDA reports), with 12 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
fluvastatin (Lescol) is a prescription HMG-CoA Reductase Inhibitor (Statin). This medicine is used to lower high cholesterol and triglycerides (fats) in adults and children (10-16 years old) with certain inherited cholesterol problems.
Fluvastatin (Lescol) is a medicine that helps lower cholesterol levels in your blood. It belongs to a group of drugs called statins.
Verify with FDA → · CMS NADAC pricing →
Drug Shortage Alert
fluvastatin is currently listed as to be discontinued by the FDA. Affected manufacturer: Sandoz Inc..
View all drug shortages →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).
The sections below are summarized in plain English from fluvastatin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of fluvastatin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of fluvastatin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of fluvastatin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store fluvastatin capsules at room temperature, away from light and moisture.
Side Effects (from patient reports)
Based on 3,948 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for fluvastatin, by number of reports
- Muscle pain
Muscle pain
669 reports
- Diarrhea
Diarrhea
371 reports
- Feeling lightheaded
Feeling lightheaded
361 reports
- Shortness of breath
Shortness of breath
340 reports
- Feeling sick to your stomach
Feeling sick to your stomach
337 reports
- Joint pain
Joint pain
317 reports
- Falling down
Falling down
315 reports
- Head pain
Head pain
315 reports
- Feeling tired
Feeling tired
310 reports
- Itchy skin
Itchy skin
310 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for fluvastatin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where fluvastatin sits
fluvastatin has more FDA adverse-event reports than 22% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is fluvastatin; the line is the median (50th percentile).
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
Reports Mentioning Death
573
14.5% of reports — not proof of cause
Hospitalization Reports
1,782
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
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
Reactions in Hospitalization Reports
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:...
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...
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.
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...
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.
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.
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take fluvastatin with other medications?
How long will I need to take fluvastatin?
Will I still need to follow a diet if I take fluvastatin?
Can I drink alcohol while taking fluvastatin?
What should I do if I experience side effects?
How often will I need blood tests?
Can children take fluvastatin?
What happens if I stop taking fluvastatin?
Is there a generic version of fluvastatin?
Does fluvastatin interact with grapefruit?
What are the common side effects of fluvastatin?
Does fluvastatin interact with other medications?
What drug class is fluvastatin?
Is fluvastatin safe during pregnancy?
Is fluvastatin currently in shortage?
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 3,948 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
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages