Pravastatin

Statin (HMG-CoA reductase inhibitor)

ATC code: C10AA03

Updated 26 May 2026 · Methodology

Indications

Primary hypercholesterolemia

Second line

Second-line for hypercholesterolemia per 2019 after high-intensity statins (atorvastatin, rosuvastatin). Dose 20–40 mg once daily at bedtime reduces by 30–40%. Preferred in patients on multiple CYP3A4-metabolized drugs (cyclosporine post-transplant, antiretrovirals, antifungals) – pravastatin has no significant interactions. Also in statin intolerance from muscle side effects.

Sources

ICD-10: E78.0 · ICD-11: 5C80.00

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.

Anti-aging and longevity

Not recommended

Pravastatin is a weak-to-moderate hydrophilic statin with minimal CNS penetration. It is prescribed for hyperlipidemia and for primary/secondary CV prevention in high-risk patients ( 2019). In anti-aging practice, pravastatin is positioned as a mild statin for continuous vessel protection in people with normal lipids. In people with normal lipid profile, no clinical studies of prophylactic use exist. The drug causes myalgia, elevated liver enzymes, and new-onset diabetes risk. If pravastatin was prescribed at normal lipid levels, consider seeking a second opinion.

Sources

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

A competitive HMG-CoA reductase inhibitor – the key enzyme in hepatic cholesterol synthesis. Unlike other statins, hydrophilic – not CYP-metabolized (renally excreted unchanged). This gives minimal drug interactions and is advantageous in patients on polytherapy. Intensity class: moderate ( reduction 30–40% at 40–80 mg).

Safety

Contraindications

Hypersensitivity to pravastatin or other statins
Active liver disease or transaminase elevation over 3× upper limit
Pregnancy and lactation
Age under 8

Serious adverse effects

Rhabdomyolysis (rare, higher risk with gemfibrozil, cyclosporine, azole antifungals)
Hepatotoxicity (rare)
Immune-mediated necrotizing myopathy
Type 2 diabetes (modest risk increase with long-term high doses)
Cognitive changes (rare, reversible)

Common adverse effects

Myalgia (1–5%)
Headache
Nausea
Diarrhea or constipation
ALT elevation (modest, reversible)

Pregnancy: can you take Pravastatin?

AEMPS summary of product characteristics (section 4.6): pravastatin is contraindicated during pregnancy. Women of childbearing potential receive it only when pregnancy is unlikely and they have been told about the possible risk; with adolescent girls of childbearing potential, special care is taken to make sure they understand this risk. If a patient plans a pregnancy or becomes pregnant, pravastatin is stopped immediately because of the possible risk to the fetus.

Breastfeeding: can you take Pravastatin?

Contraindicated during lactation.

Calculate RID Full profile on NIH LactMed ↗

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

Practical notes

Timing and administration

Take once daily at bedtime – cholesterol synthesis peaks at night. Before start and at 6–8 weeks check lipid profile, ALT, CK. Adequate hydration and physical activity reduce myalgia risk. In hypothyroidism and vitamin D deficiency, muscle side effects are more marked – correct before starting a statin.

Label mentions46 mentions

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

From this drug’s label

MajorClarithromycin
«DRUG INTERACTIONS: Intervention: For patients taking erythromycin or clarithromycin, do not exceed 40 mg pravastatin sodium once daily [see Dosage and Administration ( Error! Hyperlink reference not…»
FDA, section 7 · Open on DailyMed
MajorErythromycin
«DRUG INTERACTIONS: Intervention: For patients taking erythromycin or clarithromycin, do not exceed 40 mg pravastatin sodium once daily [see Dosage and Administration ( Error! Hyperlink reference not…»
FDA, section 7 · Open on DailyMed
Majorfibratosclass named in the label
«Fibratos: El uso de fibratos solos se asocia ocasionalmente con la aparición de miopatía. Se ha notificado un aumento del riesgo de reacciones adversas musculares, incluyendo rabdomiolisis, cuando…»
AEMPS, section 4.5 · Open on CIMA
MajorGemfibrozil
«Fibratos: El uso de fibratos solos se asocia ocasionalmente con la aparición de miopatía. Se ha notificado un aumento del riesgo de reacciones adversas musculares, incluyendo rabdomiolisis, cuando…»
AEMPS, section 4.5 · Open on CIMA
MajorGemfibrozil
«DRUG INTERACTIONS: Intervention: Avoid concomitant use of gemfibrozil with pravastatin sodium.»
FDA, section 7 · Open on DailyMed
ModerateCiclosporin
«Ciclosporina: La administración concomitante de pravastatina y ciclosporina produce un incremento, aproximadamente, de 4 veces la exposición sistémica a pravastatina. Sin embargo, en algunos…»
AEMPS, section 4.5 · Open on CIMA
ModerateClarithromycin
«Macrólidos: Los macrólidos tienen la capacidad de incrementar la exposición a estatinas cuando se utilizan en combinación con ellas. La pravastatina junto con antibióticos macrólidos (e.j…»
AEMPS, section 4.5 · Open on CIMA
ModerateColchicine
«Colchicina: Precaución de uso: Debido al elevado riesgo de miopatía/rabdomiolisis, se aconseja un control clínico y biológico, especialmente al inicio del tratamiento asociado con pravastatina y…»
AEMPS, section 4.5 · Open on CIMA
ModerateColchicine
«DRUG INTERACTIONS: Intervention: Consider if the benefit of using colchicine concomitantly with pravastatin sodium outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is…»
FDA, section 7 · Open on DailyMed
ModerateErythromycin
«Macrólidos: Los macrólidos tienen la capacidad de incrementar la exposición a estatinas cuando se utilizan en combinación con ellas. La pravastatina junto con antibióticos macrólidos (e.j…»
AEMPS, section 4.5 · Open on CIMA
Moderatefibratesclass named in the label
«DRUG INTERACTIONS: Intervention: Consider if the benefit of using fibrates concomitantly with pravastatin sodium outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is…»
FDA, section 7 · Open on DailyMed
ModerateLenalidomide
«Lenalidomida: Existe un aumento del riesgo de rabdomiolisis cuando se combina la administración de estatinas con lenalidomida. Se debe reforzar el control clínico y biológico especialmente durante…»
AEMPS, section 4.5 · Open on CIMA
Moderatemacrólidosclass named in the label
«Macrólidos: Los macrólidos tienen la capacidad de incrementar la exposición a estatinas cuando se utilizan en combinación con ellas. La pravastatina junto con antibióticos macrólidos (e.j…»
AEMPS, section 4.5 · Open on CIMA
ModerateRifampicin
«Rifampicina: En un estudio de interacción donde se administró pravastatina junto con rifampicina, se observó un incremento cercano de unas 3 veces del AUC y de la C max de pravastatina. Por lo tanto…»
AEMPS, section 4.5 · Open on CIMA
Acetylsalicylic acid
«En estudios de interacción, no se observaron diferencias estadísticamente significativas en la biodisponibilidad cuando se administró pravastatina con ácido acetilsalicílico, antiácidos (cuando se…»
AEMPS, section 4.5 · Open on CIMA
antiácidosclass named in the label
«En estudios de interacción, no se observaron diferencias estadísticamente significativas en la biodisponibilidad cuando se administró pravastatina con ácido acetilsalicílico, antiácidos (cuando se…»
AEMPS, section 4.5 · Open on CIMA
anticoagulantesclass named in the label
«Antagonistas de la vitamina K: Como con otros inhibidores de la HMG-CoA reductasa, el inicio del tratamiento o escalado de dosis de pravastatina en pacientes tratados de manera concomitante con…»
AEMPS, section 4.5 · Open on CIMA
Azithromycin
«DRUG INTERACTIONS: Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of clarithromycin or erythromycin with pravastatin sodium. Other macrolides (e.g…»
FDA, section 7 · Open on DailyMed
Diltiazem
«Productos metabolizados por el citocromo P450: La pravastatina no se metaboliza de manera clínicamente significativa por el sistema citocromo P450. Por esta razón, los productos que se metabolizan…»
AEMPS, section 4.5 · Open on CIMA
Fluconazole
«Productos metabolizados por el citocromo P450: La pravastatina no se metaboliza de manera clínicamente significativa por el sistema citocromo P450. Por esta razón, los productos que se metabolizan…»
AEMPS, section 4.5 · Open on CIMA
inhibidores del CYP2C9class named in the label
«Productos metabolizados por el citocromo P450: La pravastatina no se metaboliza de manera clínicamente significativa por el sistema citocromo P450. Por esta razón, los productos que se metabolizan…»
AEMPS, section 4.5 · Open on CIMA
inhibidores del CYP3A4class named in the label
«Productos metabolizados por el citocromo P450: La pravastatina no se metaboliza de manera clínicamente significativa por el sistema citocromo P450. Por esta razón, los productos que se metabolizan…»
AEMPS, section 4.5 · Open on CIMA
Itraconazole
«Productos metabolizados por el citocromo P450: La pravastatina no se metaboliza de manera clínicamente significativa por el sistema citocromo P450. Por esta razón, los productos que se metabolizan…»
AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

MajorDarunavir
«Established and Other Potentially Significant Drug Interactions: Lipid Modifying Agents: HMG-CoA reductase inhibitors: lovastatin, simvastatin atorvastatin, pravastatin, rosuvastatin Other lipid…»
FDA, section 7 · Open on DailyMed
ModerateClarithromycin
«DRUG INTERACTIONS: Lomitapide Lovastatin Simvastatin Contraindicated Lomitapide, Lovastatin, Simvastatin: Clarithromycin may increase the exposure of these drugs by inhibition of CYP3A metabolism…»
FDA, section 7 · Open on DailyMed
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
ModerateDarunavir
«INHIBIDORES DE LA HMG CO-A REDUCTASA: Cuando se requiera administrar de forma conjunta pravastatina con darunavir potenciado, se recomienda iniciar la administ ración con la dosis de pravastatina más…»
AEMPS, section 4.5 · Open on CIMA
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
ModerateLeflunomide
«Dosis repetidas de A771726 aumentaron la C max media y AUC (2,65- y 2,51-veces, respectivamente) de rosuvastatina. Sin embargo, no hubo impacto aparente de este aumento de la exposición en plasma de…»
AEMPS, section 4.5 · Open on CIMA
ModerateLeflunomide
«DRUG INTERACTIONS: Teriflunomide inhibits the activity of BCRP and OATP1B1/1B3 in vivo . For a patient taking leflunomide, the dose of rosuvastatin should not exceed 10 mg once daily. For other…»
FDA, section 7 · Open on DailyMed
ModerateParoxetine
«Pravastatina: Se ha observado una interacción entre paroxetina y pravastatina en estudios que sugiere que la co- administración de paroxetina y pravastatina puede ocasionar un aumento de los niveles…»
AEMPS, section 4.5 · Open on CIMA
MinorOlmesartan medoxomil
«Los medicamentos investigados en estudios clínicos específicos en voluntarios sanos incluyen warfarina, digoxina, un antiácido (hidróxido de aluminio y magnesio), hidroclorotiazida y pravastatina. No…»
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: Pravastatina»
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
Diltiazem
«Drug Interactions: In a ten-subject randomized, open-label, 4-way crossover study, coadministration of diltiazem (120 mg BID diltiazem SR for 2 weeks) with a single 20 mg dose of lovastatin resulted…»
FDA, section 7 · Open on DailyMed
Efavirenz
«Established and Other Potentially Significant Drug Interactions: HMG-CoA reductase inhibitors: Atorvastatin Pravastatin Simvastatin ↓ atorvastatin * ↓ pravastatin * ↓ simvastatin * Plasma…»
FDA, section 7 · Open on DailyMed
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
Gemfibrozil
«Inhibidores de la HMG CoA reductasa: También se ha comunicado que gemfibrozilo afecta la farmacocinética de simvastatina, lovastatina, pravastatina, rosuvastatina y atorvastatina. Gemfibrozilo…»
AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Pravastatin used for?

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

What are the side effects of Pravastatin?

Common side effects of Pravastatin (≥ 1 in 100): Myalgia (1–5%), Headache, Nausea, Diarrhea or constipation, ALT elevation (modest, reversible). See the Safety section for uncommon and serious reactions.

Is Pravastatin safe during pregnancy?

Is Pravastatin compatible with breastfeeding?

Contraindicated during lactation.

Who should not take Pravastatin?

Pravastatin is contraindicated in: Hypersensitivity to pravastatin or other statins; Active liver disease or transaminase elevation over 3× upper limit; Pregnancy and lactation; Age under 8. Full list in the Safety section.

Official sources

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

AEMPS / CIMALabel dated 12/05/2024
FDA / DailyMedLabel dated 08/17/2026

Other drugs in this group

Rosuvastatin, Rosuvastatin + Ezetimibe, Simvastatin, Simvastatin + Ezetimibe, Atorvastatin + Ezetimibe, Fluvastatin, Lovastatin, Atorvastatin