Evigrade
DrugsCosmetic ingredientsCalculatorsInteractionsEvigrade SkinEvigrade Meds ↗
ConditionsJournalMethodologyPro for practitioners
ESRU

Fluvastatin

AEMPS

Statin (HMG-CoA reductase inhibitor)

ATC code: C10AA04

Brand names: Lescol XL, Digaril Prolib, Fluvastatina Cinfa, Fluvastatina Normon

Updated · Methodology

Indications

A

Dyslipidemia

Second line

Primary hypercholesterolemia and mixed dyslipidemia in patients intolerant of more potent statins (myopathy on atorvastatin or simvastatin) or needing to minimize CYP3A4 drug interactions. Per 2019 and SEA 2023 – second-line. Dose: 20–80 mg once daily in the evening (XL form) or 40 mg twice daily. Full effect at 4 weeks. In transplant recipients (especially renal), fluvastatin is often chosen due to minimal interaction with tacrolimus and cyclosporine.

Sources

  1. AEMPS: Ficha técnica de Fluvastatina (2024)
  2. ESC/EAS: 2019 ESC/EAS Guidelines for the management of dyslipidaemias (2019)

ICD-10: E78 · ICD-11: 5C80

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

D

Anti-aging and longevity

Not recommended

Statins, including fluvastatin, are sometimes marketed as a longevity drug for all adults over 40. Per 2019, 2018, and SEA 2023, statin therapy in adults without diagnosed dyslipidemia or familial hypercholesterolemia is not started at ASCVD risk <5%: benefits do not exceed harms (myopathy, transaminitis, raised blood glucose). In the potency race, fluvastatin loses to atorvastatin/rosuvastatin; prescribing it just in case has no rationale. If prescribed without SCORE2 risk calculation or a lipid panel, consider getting a second opinion and a formal risk estimate.

Sources

  1. AEMPS: Ficha técnica de Fluvastatina (2024)
  2. Cochrane: Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases (2012)
How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Fluvastatin reversibly and competitively inhibits hepatic HMG-CoA reductase – hepatocytes synthesize less cholesterol and take up more via apo-B/E receptors. Efficacy below atorvastatin and rosuvastatin: 20–35% LDL-C reduction at 20–80 mg. Minimal CYP3A4 metabolism (mostly CYP2C9), so fewer drug interactions; suitable for patients intolerant of atorvastatin or simvastatin.

Safety

Contraindications

  • Hypersensitivity
  • Active liver disease or unexplained persistent transaminase elevation
  • Pregnancy and breastfeeding
  • Concomitant high-dose fluconazole

Serious adverse effects

  • Rhabdomyolysis (rare)
  • Immune-mediated necrotizing myopathy
  • Acute liver injury
  • Hypersensitivity reactions

Common adverse effects

  • Myalgia
  • GI upset
  • Headache
  • Transaminase elevation
  • Insomnia

Pregnancy: can you take Fluvastatin?

Contraindicated. Effective contraception in women of reproductive age; stop 1–2 months before planned conception.

Breastfeeding: can you take Fluvastatin?

Contraindicated. Defer therapy until breastfeeding ends.

Calculate RIDFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Monitoring

ALT at baseline and on hepatitis symptoms; CK only on muscle pain. Lipids at 4–6 weeks and every 6–12 months. In diabetes – (statins slightly raise glucose).

Drug–drug interactions

1 pair found. Sorted from critical to minor.

MajorCiclosporinImmunosuppressants. Calcineurin inhibitors

Mechanism

Cyclosporine inhibits OATP1B1. Fluvastatin rises 2-fold. recommends dose cap.

Symptoms

Myalgia, weakness, dark urine, rising CK within 5–10 days.

Management

In patients taking cyclosporine, do not exceed fluvastatin capsules 20 mg twice daily ( label). The FDA advises avoiding fluvastatin 80 mg extended-release tablets with cyclosporine. The Spanish fluvastatin SmPC requires the lowest possible starting and maintenance dose with cyclosporine, and the cyclosporine SmPC requires statin dose reduction. If muscle pain, weakness or dark urine appear, check creatine kinase (CK). Stop fluvastatin if CK exceeds 5 times the upper limit of normal (fluvastatin SmPC).

Sources

Pair details →Ciclosporin →

Label mentions42 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • MajorGemfibrozil
    «Gemfibrozil: Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are coadministered with gemfibrozil, concomitant administration of fluvastatin sodium with…»

    FDA, section 7 · Open on DailyMed

  • Moderateanticoagulantesclass named in the label
    «Warfarina y otros derivados cumarínicos: Sin embargo, muy raramente se han notificado casos aislados de hemorragias y/o aumentos del tiempo de protrombina en pacientes tratados con fluvastatina que…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateanticoagulantsclass named in the label
    «Warfarin: Bleeding and/or increased prothrombin times have been reported in patients taking coumarin anticoagulants concomitantly with other HMG-CoA reductase inhibitors. Therefore, patients…»

    FDA, section 7 · Open on DailyMed

  • ModerateColchicine
    «Colchicina: En casos aislados se ha notificado miotoxicidad, incluyendo dolor y debilidad muscular y rabdomiólisis con la administración concomitante de colchicina. El riesgo y el beneficio del…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateColchicine
    «Colchicine: Cases of myopathy, including rhabdomyolysis, have been reported with fluvastatin coadministered with colchicine, and caution should be exercised when prescribing fluvastatin with…»

    FDA, section 7 · Open on DailyMed

  • ModerateErythromycin
    «Durante el tratamiento: Se ha notificado un aumento del riesgo de miopatía en pacientes que reciben agentes inmunosupresores (incluyendo ciclosporina), fibratos, ácido nicotínico o eritromicina junto…»

    AEMPS, section 4.4 · Open on CIMA

  • Moderatefibratesclass named in the label
    «DRUG INTERACTIONS: Concomitant lipid-lowering therapies: Use with fibrates or lipid-modifying doses (≥ 1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used…»

    FDA, section 7 · Open on DailyMed

  • Moderatefibratosclass named in the label
    «Fibratos y niacina: La administración concomitante de fluvastatina con bezafibrato, gemfibrozilo, ciprofibrato o niacina (ácido nicotínico) no ejerce un efecto clínicamente relevante sobre la…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateFluconazole
    «Fluconazol: La administración de fluvastatina a voluntarios sanos tratados previamente con fluconazol (inhibidor de la CYP 2C9) dio lugar a un aumento de la exposición y de la concentración máxima de…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateGemfibrozil
    «Fibratos y niacina: La administración concomitante de fluvastatina con bezafibrato, gemfibrozilo, ciprofibrato o niacina (ácido nicotínico) no ejerce un efecto clínicamente relevante sobre la…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateinmunosupresoresclass named in the label
    «Durante el tratamiento: Se ha notificado un aumento del riesgo de miopatía en pacientes que reciben agentes inmunosupresores (incluyendo ciclosporina), fibratos, ácido nicotínico o eritromicina junto…»

    AEMPS, section 4.4 · Open on CIMA

  • ModeratePhenytoin
    «DRUG INTERACTIONS: Phenytoin: Monitor plasma phenytoin levels when fluvastatin treatment is initiated or when the dosage is changed ( 7 )»

    FDA, section 7 · Open on DailyMed

  • ModerateRifampicin
    «Rifampicina: La administración de fluvastatina a voluntarios sanos previamente tratados con rifampicina (rifampina) dio lugar a una reducción de la biodisponibilidad de fluvastatina en…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateWarfarin
    «Warfarina y otros derivados cumarínicos: Sin embargo, muy raramente se han notificado casos aislados de hemorragias y/o aumentos del tiempo de protrombina en pacientes tratados con fluvastatina que…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateWarfarin
    «DRUG INTERACTIONS: Warfarin and coumarin derivates: Monitor prothrombin times when fluvastatin coadministration is initiated, discontinued, or the dosage changed ( 7 )»

    FDA, section 7 · Open on DailyMed

  • antidiabéticosclass named in the label
    «Agentes antidiabéticos orales: En los pacientes que reciben sulfonilureas por vía oral (glibenclamida [gliburida], tolbutamida) para el tratamiento de la diabetes mellitus no insulinodependiente…»

    AEMPS, section 4.5 · Open on CIMA

  • antidiabéticos oralesclass named in the label
    «Agentes antidiabéticos orales: En los pacientes que reciben sulfonilureas por vía oral (glibenclamida [gliburida], tolbutamida) para el tratamiento de la diabetes mellitus no insulinodependiente…»

    AEMPS, section 4.5 · Open on CIMA

  • Fluconazole
    «DRUG INTERACTIONS: Fluconazole: Combination increases fluvastatin exposure. Limit fluvastatin dose to 20 mg ( 2.5 , 7.2 )»

    FDA, section 7 · Open on DailyMed

  • Glibenclamide
    «Agentes antidiabéticos orales: En los pacientes que reciben sulfonilureas por vía oral (glibenclamida [gliburida], tolbutamida) para el tratamiento de la diabetes mellitus no insulinodependiente…»

    AEMPS, section 4.5 · Open on CIMA

  • inhibidores de la bomba de protonesclass named in the label
    «Antagonistas de los receptores H2 de la histamina e inhibidores de la bomba de protones»

    AEMPS, section 4.5 · Open on CIMA

  • inhibidores del CYP3A4class named in the label
    «Itraconazol y eritromicina: Dada la mínima participación de esta enzima en el metabolismo de fluvastatina, cabe esperar que no sea probable que otros inhibidores de la isoenzima CYP3A4 (p.ej…»

    AEMPS, section 4.5 · Open on CIMA

  • Insulin
    «Agentes antidiabéticos orales: En los pacientes que reciben sulfonilureas por vía oral (glibenclamida [gliburida], tolbutamida) para el tratamiento de la diabetes mellitus no insulinodependiente…»

    AEMPS, section 4.5 · Open on CIMA

  • insulinaclass named in the label
    «Agentes antidiabéticos orales: En los pacientes que reciben sulfonilureas por vía oral (glibenclamida [gliburida], tolbutamida) para el tratamiento de la diabetes mellitus no insulinodependiente…»

    AEMPS, section 4.5 · Open on CIMA

  • Itraconazole
    «Itraconazol y eritromicina: La administración concomitante de fluvastatina con itraconazol y eritromicina, potentes inhibidores del citocromo P450 (CYP) 3A4, tiene efectos mínimos sobre la…»

    AEMPS, section 4.5 · Open on CIMA

  • Ketoconazole
    «Itraconazol y eritromicina: Dada la mínima participación de esta enzima en el metabolismo de fluvastatina, cabe esperar que no sea probable que otros inhibidores de la isoenzima CYP3A4 (p.ej…»

    AEMPS, section 4.5 · Open on CIMA

  • Omeprazole
    «La administración concomitante de fluvastatina con cimetidina, ranitidina u omeprazol produce un aumento en la biodisponibilidad de fluvastatina, que, no obstante, no tiene relevancia clínica.»

    AEMPS, section 4.5 · Open on CIMA

  • Phenytoin
    «Fenitoína: La magnitud total de las variaciones en la farmacocinética de fenitoína durante la administración concomitante con fluvastatina es relativamente reducida y no es clínicamente…»

    AEMPS, section 4.5 · Open on CIMA

  • sulfonilureasclass named in the label
    «Agentes antidiabéticos orales: En los pacientes que reciben sulfonilureas por vía oral (glibenclamida [gliburida], tolbutamida) para el tratamiento de la diabetes mellitus no insulinodependiente…»

    AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

  • ModerateClarithromycin
    «Inhibidores de HMG-CoA reductasa (estatinas): Se debe tener precaución al prescribir claritromicina con estatinas. En situaciones donde el uso concomitante de claritromicina con estatinas no se puede…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateColchicine
    «Table 4. Other Potentially Significant Drug Interactions Concomitant Drug Class or Food Noted or Anticipated Outcome Clinical Comment HMG-Co A Reductase Inhibitors: atorvastatin, fluvastatin…»

    FDA, section 7 · Open on DailyMed

  • ModerateEltrombopag
    «Inhibidores de la HMG CoA reductasa: La administración de 75 mg de eltrombopag una vez al día, durante 5 días, con una dosis única de 10 mg de rosuvastatina, sustrato de OATP1B1 y BCRP, a 39 sujetos…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateEltrombopag
    «Transporters: Use caution when concomitantly administering eltrombopag and drugs that are substrates of OATP1B1 (e.g., atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan…»

    FDA, section 7 · Open on DailyMed

  • ModerateFluconazole
    «Inhibidores de la HMG-CoA reductasa: El riesgo de miopatía y de rabdomiólisis aumenta cuando se administra fluconazol concomitantemente con inhibidores de la HMG-CoA reductasa que se metabolizan por…»

    AEMPS, section 4.5 · Open on CIMA

  • MinorVerapamil
    «Fluvastatina, pravastatina y rosuvastatina no son metabolizadas por CYP3A4 y es menos probable que interactúen con verapamilo.»

    AEMPS, section 4.5 · Open on CIMA

  • Ciclosporin
    «Número de veces que cambia la exposición con ciclosporina: Fluvastatina»

    AEMPS, section 4.5 · Open on CIMA

  • Colchicine
    «El uso concomitante de atorvastatina, simvastatina, pravastatina, fluvastatina, gemfibrozilo, fenofibrato, ácido fenofíbrico o bezafibrato (por ellos mismos asociados a miotoxicidad) puede potenciar…»

    AEMPS, section 4.5 · Open on CIMA

  • Ezetimibe
    «Estatinas: No se observaron interacciones farmacocinéticas clínicamente relevantes cuando ezetimiba se administró junto con atorvastatina, simvastatina, pravastatina, lovastatina, fluvastatina o…»

    AEMPS, section 4.5 · Open on CIMA

  • Losartan
    «Losartán se metaboliza principalmente por el citocromo P450 (CYP) 2C9 dando lugar al metabolito activo carboxiácido. Durante un ensayo clínico, se observó que fluconazol (inhibidor de CYP2C9)…»

    AEMPS, section 4.5 · Open on CIMA

  • Phenytoin
    «Drugs that Affect Phenytoin Concentrations: Other Acute alcohol intake, amiodarone, chloramphenicol, chlordiazepoxide, disulfiram, estrogen, fluvastatin, isoniazid, methylphenidate, phenothiazines…»

    FDA, section 7 · Open on DailyMed

  • Terbinafine
    «Drug-Drug Interactions: In vitro studies with human liver microsomes showed that terbinafine does not inhibit the metabolism of tolbutamide, ethinylestradiol, ethoxycoumarin, cyclosporine, cisapride…»

    FDA, section 7 · Open on DailyMed

Showing 40 of 42, heaviest first

Check interaction with another drug

Opens the checker prefilled with this drug. Pick the second one from your regimen.

Open checker

Summary of a multi-drug list →

Medicine list: everything you take in one place →

Frequently asked

What is Fluvastatin used for?

Fluvastatin is evaluated for the following indications with varying evidence strength: Dyslipidemia (evidence tier A), Anti-aging and longevity (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Fluvastatin?

Common side effects of Fluvastatin (≥ 1 in 100): Myalgia, GI upset, Headache, Transaminase elevation, Insomnia. See the Safety section for uncommon and serious reactions.

Is Fluvastatin safe during pregnancy?

Contraindicated. Effective contraception in women of reproductive age; stop 1–2 months before planned conception.

Is Fluvastatin compatible with breastfeeding?

Contraindicated. Defer therapy until breastfeeding ends.

Who should not take Fluvastatin?

Fluvastatin is contraindicated in: Hypersensitivity; Active liver disease or unexplained persistent transaminase elevation; Pregnancy and breastfeeding; Concomitant high-dose fluconazole. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Gemfibrozil, Krill oil, Lovastatin, Omega-3 triglycerides (EPA and DHA), Pravastatin, Simvastatin, Atorvastatin + Ezetimibe, Pitavastatin