Meta Information
ID:fluvastatin
Name:
Schema Version:2.4_uniform_evidence_2026_06_18
Created
2026-05-21T22:30:00Z
Model
phase-a-upgrade-claude-sonnet-4.6
Interactions
Target id:
/class/fibrates
Target name:
Fibrates
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Combining fluvastatin with fibrates, particularly gemfibrozil, significantly increases the risk of severe muscle damage (myopathy) and a potentially fatal condition called rhabdomyolysis.
Actionable advice:
Fibrates should not be used with fluvastatin; if the combination is essential, fenofibrate should be used only with extreme caution and close medical supervision.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
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.
Label source:
Action type:
avoid
Target id:
/class/cyp2c9-inhibitors
Target name:
Strong CYP2C9 Inhibitors (e.g., Fluconazole)
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
These drugs block the CYP2C9 enzyme, which is the primary pathway for breaking down fluvastatin. This leads to dangerously high levels of fluvastatin in the blood, increasing the risk of severe muscle toxicity.
Actionable advice:
These drugs should not be used together. If a strong CYP2C9 inhibitor is medically necessary, fluvastatin therapy should be temporarily paused.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Exact phrase from label:
Cyclosporine and Fluconazole: Avoid use with LESCOL XL.
Label source:
FDA label: Fluvastatin (LESCOL XL) — Highlights, Drug Interactions
Action type:
avoid
Target id:
/class/immunosuppressants
Target name:
Cyclosporine
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Cyclosporine significantly inhibits the metabolism and transport of fluvastatin, leading to a large increase in its concentration and a very high risk of severe muscle damage.
Actionable advice:
This combination should be avoided. If unavoidable, the dose of fluvastatin must be significantly reduced under strict medical supervision.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
7 DRUG INTERACTIONS Cyclosporine: Combination increases fluvastatin exposure.
Label source:
Action type:
avoid
Target id:
/condition/pregnancy
Target name:
Pregnancy
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Statins are contraindicated in pregnancy as they may cause fetal harm by interfering with cholesterol synthesis, which is critical for normal fetal development.
Actionable advice:
Fluvastatin should not be taken during pregnancy, when trying to conceive, or when pregnancy is possible.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Lipid lowering drugs are contraindicated during pregnancy, because cholesterol and cholesterol derivatives are needed for normal fetal development.
Label source:
Action type:
avoid
Target id:
/condition/lactation
Target name:
Breastfeeding (Lactation)
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Due to the potential for interfering with infant development and causing serious adverse reactions, fluvastatin is contraindicated during breastfeeding.
Actionable advice:
Fluvastatin should not be taken while breastfeeding.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Because of the potential for serious adverse reactions in nursing infants, nursing women should not take fluvastatin sodium [ see Contraindications ( 4 ) ].
Label source:
Action type:
avoid
Target id:
/condition/hepatic-impairment
Target name:
Active Liver Disease
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Fluvastatin is metabolized by the liver and can itself cause liver enzyme elevations; it is contraindicated in patients with active liver disease or unexplained high liver enzymes.
Actionable advice:
Fluvastatin should not be used in active liver disease.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
8.6 Hepatic Impairment Fluvastatin sodium is contraindicated in patients with active liver disease or unexplained, persistent elevations in serum transaminases [ see Clinical Pharmacology ( 12.3 ) ].
Label source:
Action type:
avoid
Target id:
/intervention/red-yeast-rice
Target name:
Red Yeast Rice
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Red yeast rice contains monacolin K, a naturally occurring statin chemically identical to lovastatin. Taking it with fluvastatin constitutes duplicative therapy and greatly increases the risk of muscle and liver toxicity.
Actionable advice:
Red yeast rice supplements should never be taken while on any prescribed statin medication.
Validation status:
validated_via_pubmed
Evidence tier:
tier_b
Evidence basis:
pubmed_abstract_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Red yeast rice contains a fungus (Monascus purpureus), which was utilized in the original production of lovastatin (MEVACOR, Merck & Co, Whitehouse Station, NJ), the first marketed pharmaceutical statin, and is chemically identical to such product.
Label source:
PubMed: The American journal of medicine (2017)
Source url:
Exact phrase from label:
Its main pharmacologically active compound, monakolin K, was isolated from red yeast rice and is used as an inhibitor of cholesterol synthesis under the INN lovastatin. Lovastatin and several other statins are marketed as drugs whereas red yeast rice is offered as a food supplement. As statins can cause severe side effects, such as muscle damage and kidney failure, the dosing and information about interactions with drugs and food is essential for the use of these products.
Label source:
PubMed: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz (2017)
Source url:
Exact phrase from label:
RYR supplements contain monacolin K, which is chemically identical to lovastatin, a licensed drug with a well-known risk profile.
Label source:
PubMed: British journal of clinical pharmacology (2017)
Action type:
avoid
Target id:
/circadian/sleep
Target name:
Going to Sleep
Severity:
moderate
Interaction type:
synergistic
Nature:
temporal
Temporal spacing:
Hours before target:
2
Hours after target:
null
Description:
The body's natural cholesterol production peaks overnight. Taking short-acting statins like fluvastatin in the evening aligns the drug's peak effect with this period, maximizing its cholesterol-lowering efficacy.
Actionable advice:
A daily dose of fluvastatin is best taken in the evening, ideally within a couple of hours of bedtime.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Exact phrase from label:
The recommended dosage for LESCOL XL is 80 mg once daily.
Label source:
FDA label: Fluvastatin (LESCOL XL) — Section 2.2 Recommended Dosage in Adult Patients (extended-release: any time of day)
Action type:
informational_none
Target id:
/intervention/warfarin
Target name:
Warfarin
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Fluvastatin can slightly inhibit the metabolism of warfarin (via CYP2C9), which may increase warfarin's blood-thinning effect and raise the risk of bleeding.
Actionable advice:
Your INR (blood clotting time) must be monitored closely when starting, stopping, or changing the dose of fluvastatin.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
7.8 Warfarin Bleeding and/or increased prothrombin times have been reported in patients taking coumarin anticoagulants concomitantly with other HMG-CoA reductase inhibitors.
Label source:
Action type:
monitor
Target id:
/class/cyp2c9-inducers
Target name:
CYP2C9 Inducers (e.g., Rifampin, Carbamazepine)
Severity:
moderate
Interaction type:
diminishing
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
These drugs accelerate the CYP2C9 enzyme, causing the body to break down fluvastatin much faster. This can significantly reduce fluvastatin's effectiveness at lowering cholesterol.
Actionable advice:
This combination is best avoided, or a higher fluvastatin dose with regular lipid monitoring may be warranted.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Exact phrase from label:
In vitro data indicate that fluvastatin metabolism involves multiple Cytochrome P450 (CYP) isozymes. CYP2C9 isoenzyme is primarily involved in the metabolism of fluvastatin (approximately 75%), while CYP2C8 and CYP3A4
Label source:
FDA label: Fluvastatin (LESCOL XL) — Section 12.3 Pharmacokinetics, Metabolism
Action type:
avoid
Target id:
/intervention/colchicine
Target name:
Colchicine
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Using colchicine (for gout) with fluvastatin increases the risk of developing muscle pain and damage (myopathy), particularly in older adults or those with kidney problems.
Actionable advice:
This combination is best used with caution, and it is important to promptly report any unexplained muscle pain, tenderness, or weakness.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Isolated cases of myopathy have been reported during postmarketing experience with concomitant administration of fluvastatin sodium and colchicine.
Label source:
Action type:
monitor
Target id:
/intervention/niacin
Target name:
Niacin (Vitamin B3)
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Combining fluvastatin with high doses of niacin (typically over 1 gram per day) can increase the risk of developing severe muscle problems (myopathy and rhabdomyolysis).
Actionable advice:
This is best used with caution, especially at niacin doses above 1g/day, and it is a good idea to monitor for any muscle-related symptoms.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Myopathy was not observed in a clinical trial in 74 patients involving patients who were treated with fluvastatin sodium together with niacin.
Label source:
Action type:
monitor
Target id:
/dietary/alcohol-acute
Target name:
Alcohol (Acute Consumption)
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Substantial, regular alcohol consumption can add to the potential for liver stress and damage when combined with statin therapy.
Actionable advice:
Alcohol intake is best limited, and heavy or daily drinking is best avoided while taking fluvastatin.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Caution should be exercised when fluvastatin sodium is administered to patients with a history of liver disease or heavy alcohol ingestion [ see Clinical Pharmacology ( 12.3 ) ].
Label source:
Action type:
avoid
Target id:
/condition/renal-impairment
Target name:
Severe Renal Impairment
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
In severe kidney disease, the body's ability to clear fluvastatin may be reduced, increasing drug levels and the risk of muscle-related side effects.
Actionable advice:
This is best used with caution in severe renal impairment; a lower starting dose and careful monitoring are required.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Fluvastatin has not been studied at doses greater than 40 mg in patients with severe renal impairment; therefore caution should be exercised when treating such patients at higher doses [ see Clinical Pharmacology ( 12.3 ) ].
Label source:
Action type:
monitor
Target id:
/intervention/saint-johns-wort
Target name:
Saint John's Wort
Severity:
moderate
Interaction type:
diminishing
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
St. John's Wort induces metabolic enzymes, including CYP2C9, which can accelerate the breakdown of fluvastatin and significantly reduce its cholesterol-lowering effect.
Actionable advice:
St. John's Wort supplements are best avoided while on fluvastatin therapy.
Validation status:
validated_via_primary_literature
Evidence tier:
tier_b
Evidence basis:
primary_literature_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
The investigation outlines their mechanisms of action, distinguishing between enzyme induction, which can diminish drug efficacy, and inhibition, which may lead to increased drug concentrations and toxicity. It was highlighted that certain medicinal plants and their bioactive compounds may act as inducers or inhibitors across major isoforms, including CYP1A2, CYP2C9, CYP2D6, and CYP3A4. Comprehensive data were compiled for ten plant species with the most extensive scientific information regarding their effects on CYP450, namely St John's wort (Hypericum perforatum L.), Echinacea (Echinacea purpurea (L.) Moench), Ginkgo (Ginkgo biloba L.), Danshen (Salvia miltiorrhiza Bunge), Garlic (Allium sativum L.), Ginger (Zingiber officinale Roscoe), Milk thistle (Silybum marianum L. Gaertn.), Black cohosh (Actaea racemosa L.), Ginseng (Panax ginseng C.A. Mey), and Liquorice (Glycyrrhiza glabra L.).
Label source:
PubMed: Herbal Medicines and Drugs Interactions: Cytochrome P450 Responsibility. (PMID 41764614)
Action type:
avoid
Target id:
/intervention/coenzyme-q10
Target name:
Coenzyme Q10 (CoQ10)
Severity:
minor
Interaction type:
synergistic
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Fluvastatin inhibits the HMG-CoA reductase pathway, which is responsible for producing both cholesterol and CoQ10. This can lower the body's CoQ10 levels, and supplementation may help replenish them.
Actionable advice:
Consider supplementing with CoQ10 to potentially mitigate statin-related side effects like muscle fatigue.
Validation status:
validated_via_primary_literature
Evidence tier:
tier_b
Evidence basis:
primary_literature_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
In conclusion, we have found that fluvastatin, independently of the cholesterol level in the blood, consistently and specifically increased the frequency of calcium sparks in skeletal muscle cells, an effect which could be prevented by the addition of coenzyme Q10 to the diet.
Label source:
PubMed: Effects of fluvastatin and coenzyme Q10 on skeletal muscle in normo- and hypercholesterolaemic rats. (PMID 25920381)
Action type:
informational_none
Target id:
/intervention/glyburide
Target name:
Glyburide (Glibenclamide)
Severity:
minor
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Fluvastatin may increase the concentration of the diabetes medication glyburide, which could raise the risk of experiencing low blood sugar (hypoglycemia).
Actionable advice:
Blood glucose levels are best monitored closely if these two medications are taken together.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
At therapeutic concentrations, the protein binding of fluvastatin is not affected by warfarin, salicylic acid and glyburide.
Label source:
Action type:
monitor
Target id:
/intervention/phenytoin
Target name:
Phenytoin
Severity:
minor
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Fluvastatin may slightly inhibit the metabolism of the anti-seizure medication phenytoin, potentially leading to increased phenytoin levels and side effects.
Actionable advice:
Your doctor may need to monitor phenytoin levels if fluvastatin is started, stopped, or the dose is changed.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
7.7 Phenytoin Concomitant administration of fluvastatin and phenytoin increased phenytoin exposures.
Label source:
Action type:
monitor
Target id:
/class/acid-suppressors
Target name:
Gastric Acid Suppressors (PPIs, H2 Blockers)
Severity:
minor
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Drugs like cimetidine, ranitidine, and omeprazole can increase the absorption and peak concentration of fluvastatin, though the clinical impact on safety or efficacy is generally minimal.
Actionable advice:
This potential interaction is worth keeping in mind, but no specific scheduling or avoidance is typically required.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
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.
Label source:
Action type:
informational_none
Target id:
/dietary/grapefruit-pomelo
Target name:
Grapefruit and Grapefruit Juice
Severity:
minor
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Unlike many other statins (e.g., atorvastatin, simvastatin), fluvastatin is primarily metabolized by CYP2C9, not CYP3A4. Therefore, the interaction with grapefruit is not considered clinically significant.
Actionable advice:
No special precautions are needed regarding grapefruit consumption while taking fluvastatin.
Validation status:
validated_via_primary_literature
Evidence tier:
tier_b
Evidence basis:
primary_literature_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Fluvastatin has a low potential for drug interactions due to its CYP2C9-dependant metabolism.
Label source:
PubMed: [Drug interactions with antilipemics]. (PMID 12822205)
Action type:
informational_none
Target id:
/dietary/meal
Target name:
Food
Severity:
minor
Interaction type:
diminishing
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Taking immediate-release fluvastatin with food can delay its absorption and reduce its peak concentration in the blood, but the overall long-term lipid-lowering effect is not significantly changed.
Actionable advice:
Fluvastatin can be taken with or without food, but try to be consistent from day to day.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Fluvastatin administered as fluvastatin sodium extended-release 80 mg tablets reaches peak concentration in approximately 3 hours under fasting conditions, after a low fat meal, or 2.5 hours after a low fat meal.
Label source:
Action type:
informational_none