Pravastatin

Pronunciation: prah-vah-STAT-in.

Generic name
pravastatin sodium
Drug class
HMG-CoA reductase inhibitor (statin)
Form
Tablet
Route
Oral
Legal status
Prescription-only medicine in all markets reviewed

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Pravachol (6), Multiple generics (Pravastatin AN, Pravastatin-WGR, APX-Pravastatin, Pravastatin Sandoz, Pharmacy Clinice Pravastatin) (6) · Full directory

What pravastatin sodium is and how it works

Pravastatin is a statin medicine that lowers LDL ('bad') cholesterol by blocking an enzyme the body needs to make cholesterol. It is used both to reduce high cholesterol and to lower the risk of heart attack, stroke, and other cardiovascular problems in people at risk of, or who already have, heart disease. (1) (2)

Pravastatin does not carry a boxed warning, but like all statins it carries a real, non-boxed risk of muscle problems (myopathy) and, rarely, a serious muscle-breakdown condition called rhabdomyolysis -- the risk is higher with certain other medicines, kidney problems, an underactive thyroid, or older age. Its pregnancy guidance has genuinely evolved: current US labelling no longer lists pregnancy as an absolute contraindication (following a 2021 regulatory change across the whole statin class), while UK labelling still does -- either way, most people are advised to stop a statin as soon as pregnancy is confirmed, and this should always be discussed with, and directed by, your prescriber.

Mechanism of action: how pravastatin sodium works

Pravastatin is a competitive inhibitor of HMG-CoA reductase, the enzyme catalysing the rate-limiting step in hepatic cholesterol biosynthesis, resulting in reduced LDL cholesterol production and upregulated LDL-receptor activity. Approximately 47% of total drug clearance occurs via renal excretion of intact pravastatin, and approximately 53% via non-renal routes (biliary excretion and biotransformation), per the Canadian source reviewed. (1) (5)

What pravastatin sodium is used for

Lowering high cholesterol

Used as an adjunct to diet to reduce elevated LDL cholesterol in adults with primary hyperlipidaemia, and in children and adolescents 8 years and older with heterozygous familial hypercholesterolaemia. Also used to treat certain other lipid disorders (primary dysbetalipoproteinaemia and hypertriglyceridaemia) as a dietary adjunct. (1)

Reducing cardiovascular risk

Used to reduce the risk of heart attack, the need for artery-opening procedures, and cardiovascular death in adults with high cholesterol, whether or not they already have heart disease -- including in people with a history of heart attack or unstable angina (secondary prevention), and in high-risk people without known heart disease (primary prevention). Also used to reduce the risk of stroke or mini-stroke (TIA) and to slow progression of narrowed arteries in those with existing coronary heart disease. (1) (3)

Managing cholesterol after organ transplantation

Used to manage high cholesterol that can occur after an organ transplant, per the UK source reviewed. (3)

Before taking pravastatin sodium

Do not take / not appropriate for

  • Do not take pravastatin if you have active liver disease, including unexplained persistently elevated liver enzyme (transaminase) levels, or a known allergy to pravastatin or any of its ingredients. (all countries) (1) (3)
  • Pravastatin is contraindicated during pregnancy and while breastfeeding, per the UK source reviewed. (United Kingdom) (3)

Tell your clinician about

  • Whether you are pregnant, planning to become pregnant, or breastfeeding.
  • Any history of liver or kidney problems.
  • Any history of muscle problems, or an underactive thyroid (hypothyroidism).
  • All other medicines you take, especially other cholesterol medicines (fibrates, niacin), ciclosporin, certain antibiotics (macrolides such as clarithromycin or erythromycin, or fusidic acid), and colchicine.
  • If you drink large amounts of alcohol.
(1) (3)

How to take pravastatin sodium

  • Take pravastatin exactly as your prescriber directs, usually once daily, and continue taking it even if you feel well, since it works to reduce long-term risk rather than treat symptoms.
  • It can be taken with or without food, preferably in the evening.
  • Continue any diet, exercise, and weight-management advice from your prescriber alongside pravastatin, since it works best combined with these lifestyle measures.
  • Report any unexplained muscle pain, tenderness, or weakness promptly to your prescriber, especially if it comes with unusual tiredness or fever.
(1) (3)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)

Missed dose

If you miss a dose, take it as soon as you remember unless it is almost time for your next dose -- in that case, skip the missed dose and continue your normal schedule. do not take an extra dose to make up for a missed one.

Overdose

Seek medical advice if too much pravastatin has been taken. There is limited experience with overdose; no specific antidote exists, and treatment is symptomatic and supportive. (3)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Headache.

What to notice: Headache.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Nausea, upset stomach, or diarrhoea.

What to notice: Nausea, upset stomach, or diarrhoea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Muscle or joint pain.

What to notice: Muscle or joint pain.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (3)

Common cold-like symptoms.

What to notice: Common cold-like symptoms.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Myopathy and rhabdomyolysis (muscle breakdown) — high caution

Symptoms: Unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever, unusual tiredness, or dark-coloured urine.

Action: Contact your prescriber promptly if these symptoms occur -- your prescriber may check a blood test (creatine kinase) and decide whether to pause or stop pravastatin. Risk is higher with age 65 or older, an underactive thyroid, kidney problems, higher doses, and certain other medicines. (1) (3)

Liver problems — moderate caution

Symptoms: Yellowing of the skin or eyes, unusual fatigue, loss of appetite, or dark urine.

Action: Contact your prescriber promptly -- your prescriber may check liver function tests before and during treatment. (1) (3)

Changes in blood sugar control — moderate caution

Symptoms: Not always noticeable directly -- usually detected through blood tests (HbA1c or fasting glucose).

Action: Your prescriber may monitor your blood sugar, especially if you have or are at risk of diabetes, since statins including pravastatin have been associated with modest increases in blood glucose and HbA1c. (1)

Interactions

  • Gemfibrozil: significantly increases the risk of myopathy and rhabdomyolysis -- this combination should generally be avoided. (1)
  • Ciclosporin: can increase pravastatin levels in the blood up to fourfold and increase myopathy/rhabdomyolysis risk -- your prescriber will use a lower pravastatin dose if these are combined. (1) (3)
  • Clarithromycin or erythromycin (macrolide antibiotics): increase myopathy/rhabdomyolysis risk -- your prescriber may limit your pravastatin dose while you take these. (1) (3)
  • Fusidic acid (an antibiotic): increases rhabdomyolysis risk -- the UK source reviewed advises pravastatin should be paused during fusidic acid treatment, under your prescriber's direction. (3)
  • Niacin, other fibrates, and colchicine: each carries a real, reported risk of myopathy or rhabdomyolysis when combined with pravastatin -- your prescriber will weigh the benefits and risks. (1) (3)
  • Colestyramine or colestipol (bile-acid-binding cholesterol medicines): can reduce pravastatin absorption -- the UK source reviewed advises spacing doses 1-4 hours apart. (3)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

This is a genuinely evolving area, not a single universal answer. The UK SmPC reviewed lists pregnancy as an outright contraindication. In the United States, the FDA formally removed the absolute pregnancy contraindication from the entire statin class's labelling in July 2021, replacing it with individualised risk/benefit language, while still recommending that most patients stop taking a statin as soon as they learn they are pregnant. Any decision about statin use in pregnancy should always be made with your prescriber. (1) (2) (3) (4) (5) (6) (7)

Breastfeeding

Not recommended while breastfeeding (contraindicated per the UK source reviewed), since a small amount of pravastatin passes into breast milk. (1) (2) (3) (4) (5) (6) (7)

Children

May be used, as an adjunct to diet, in children and adolescents 8 years and older with heterozygous familial hypercholesterolaemia, under specialist supervision. (1) (2) (3) (4) (5) (6) (7)

Elderly

Age 65 and older is itself a recognised risk factor for myopathy and rhabdomyolysis -- your prescriber may monitor more closely. (1) (2) (3) (4) (5) (6) (7)

Hepatic_impairment

Contraindicated in active liver disease or unexplained persistent transaminase elevation; liver function is typically checked before starting and during treatment. (1) (2) (3) (4) (5) (6) (7)

Renal_impairment

A recognised risk factor for myopathy and rhabdomyolysis -- your prescriber may adjust monitoring or dosing if you have kidney problems. (1) (2) (3) (4) (5) (6) (7)

Source_ids

UK-EMC-PRAVASTATIN-40MG-2026,US-DAILYMED-PRAVASTATIN-2026,US-FDA-STATIN-PREGNANCY-LABEL-CHANGE-2021 (1) (2) (3) (4) (5) (6) (7)

Monitoring

Before starting

  • Liver function tests
  • Assessment of risk factors for myopathy (age, thyroid function, kidney function, other medicines)
  • Pregnancy status in anyone who could become pregnant

During treatment

  • Watch for unexplained muscle pain, tenderness, or weakness, and report it promptly.
  • Liver function may be rechecked if clinically indicated.
  • Blood sugar (HbA1c/fasting glucose) may be monitored, especially in those at risk of diabetes.
(1) (3)

Storage

Store at room temperature, away from moisture, out of reach of children.

Study the drug class: Statins

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information, the 2021 FDA statin-pregnancy drug safety communication, and the UK emc SmPC reviewed for this dossier; verify against the current full label before prescribing.

United States

Indication: Primary/secondary cardiovascular risk reduction; hyperlipidaemia; paediatric heterozygous familial hypercholesterolaemia (8+ years)

Dose summary: 10-80 mg once daily, individualised; dose capped when combined with ciclosporin (max 20 mg/day) or clarithromycin/erythromycin (max 40 mg/day).

Renal context: Not specifically detailed by renal band in the sources reviewed; renal impairment is a recognised myopathy/rhabdomyolysis risk factor. (1)

United Kingdom / European Union

Indication: Primary/mixed hypercholesterolaemia; primary/secondary cardiovascular prevention; post-transplantation hyperlipidaemia

Dose summary: 10-40 mg once daily, usually in the evening, individualised.

Renal context: Not specifically detailed in the sources reviewed. (3) (4)

Mechanism of action

Hepatic guidance

Increases in serum transaminases have been reported, with rare fatal and non-fatal hepatic failure reported post-marketing; baseline and as-needed liver function testing is recommended.

Overdose note

Limited overdose experience; no specific antidote; manage supportively. (1) (5)

Frequently asked questions

Is pravastatin available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes, pravastatin is authorised and marketed in all six regions reviewed, mostly as generic pravastatin sodium tablets, alongside the originator brand Pravachol in the United States, Canada, and Australia. (1) (3) (4) (5) (6) (7)

Does pravastatin have a boxed warning?

No. This was directly checked against the current US FDA label, and pravastatin does not carry a boxed warning. It still has a real, well-known statin-class risk of muscle problems (myopathy) and, rarely, a more serious muscle-breakdown condition (rhabdomyolysis), which your prescriber will discuss with you. (1)

Is pravastatin safe in pregnancy?

This has genuinely changed over time and differs by country's current labelling. The UK's current product information lists pregnancy as an outright contraindication. In the United States, the FDA removed the absolute pregnancy contraindication from the entire statin class in July 2021, after determining that a blanket contraindication for all pregnant patients was not appropriate, since a small group of very high-risk patients may benefit from continuing a statin. Even so, most patients are still advised to stop a statin as soon as pregnancy is confirmed. This decision should always be made with your prescriber, not on your own. (3) (2)

What medicines increase the risk of muscle problems with pravastatin?

Several medicines increase this risk, including gemfibrozil and other fibrates, ciclosporin, the antibiotics clarithromycin, erythromycin, and fusidic acid, niacin, and colchicine. Always tell your prescriber about all the medicines you take so they can adjust your pravastatin dose or monitoring if needed. (1) (3)

What is the mechanism of action of pravastatin sodium?

Pravastatin is a competitive inhibitor of HMG-CoA reductase, the enzyme catalysing the rate-limiting step in hepatic cholesterol biosynthesis, resulting in reduced LDL cholesterol production and upregulated LDL-receptor activity. Approximately 47% of total drug clearance occurs via renal excretion of intact pravastatin, and approximately 53% via non-renal routes (biliary excretion and biotransformation), per the Canadian source reviewed. (1) (5)

What is the generic name of Pravastatin?

The generic name is pravastatin sodium. (1)

What class of drug is pravastatin sodium?

Pravastatin is classed as: HMG-CoA reductase inhibitor (statin). (1)

References

  1. PRAVASTATIN SODIUM tablets -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information · United States · dated 2026-01-01 · accessed 2026-07-30 · source 1
  2. FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancyU.S. Food and Drug Administration -- Drug Safety Communication · United States · dated 2021-07-20 · accessed 2026-07-30 · source 2
  3. Pravastatin sodium 40 mg tablets -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Summary of Product Characteristics (SmPC) · United Kingdom · dated 2025-01-01 · accessed 2026-07-30 · source 3
  4. Pravastatin -- list of nationally authorised medicinal products (PSUSA/00002500/202303)European Medicines Agency (EMA) -- nationally-authorised-medicinal-products list · European Union · dated 2023-12-14 · accessed 2026-07-30 · source 4
  5. PRAVACHOL (pravastatin sodium) and generic pravastatin products -- Product MonographsHealth Canada -- Product Monograph · Canada · dated 2017-10-18 · accessed 2026-07-30 · source 5
  6. PRAVACHOL pravastatin sodium tablets and multiple generic pravastatin products -- ARTG entriesTherapeutic Goods Administration (TGA), Australia -- Australian Register of Therapeutic Goods (ARTG) · Australia · dated 2020-06-23 · accessed 2026-07-30 · source 6
  7. PRAVASTATIN TABLETS (generic pravastatin) -- New Zealand Data SheetMedsafe (New Zealand Medicines and Medical Devices Safety Authority) -- New Zealand Data Sheet · New Zealand · dated 2026-01-01 · accessed 2026-07-30 · source 7

Brand names by country

Single-ingredient pravastatin sodium names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Pravastatin sodium (generic; originator brand Pravachol) (1)FDA approved currently labeled · 10 mg, 20 mg, 40 mg, 80 mg · Multiple generic manufacturers

United Kingdom

  • Pravastatin sodium (generic) (3)emc current smpc confirmed · 10 mg, 20 mg, 40 mg · Multiple generic manufacturers

Canada

  • PRAVACHOL -

Australia

  • Pravachol (6)tga artg registered confirmed · 20 mg, 40 mg, 80 mg · Arrotex Pharmaceuticals Pty Ltd
  • Multiple generics (Pravastatin AN, Pravastatin-WGR, APX-Pravastatin, Pravastatin Sandoz, Pharmacy Clinice Pravastatin) (6)tga artg registered confirmed · 10 mg, 20 mg, 40 mg, 80 mg · Multiple generic manufacturers

New Zealand

  • Pravastatin (generic) (7)medsafe data sheet confirmed · 10 mg, 20 mg, 40 mg · Confirmed via Medsafe data sheet
View brands in additional countries.

European Union

Maxudin (and numerous other nationally authorised generic brands, varying by member state) (4)

This page provides general reference information about pravastatin and is not a substitute for advice from the prescriber managing your treatment. All dosing and treatment decisions, including starting, changing, or stopping this medicine, should be made with your prescriber.

Related medicines

Related conditions