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pravastatin

Pronunciation

Generic Name: pravastatin (PRAV a STAT in)
Brand Name: Pravachol

What is pravastatin?

Pravastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Pravastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).

Pravastatin is used to lower cholesterol and triglycerides (types of fat) in the blood.

Pravastatin is also used to lower the risk of stroke, heart attack, and other heart complications in people with or without coronary heart disease or other risk factors.

Pravastatin is used in adults and children who are at least 8 years old.

Pravastatin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about pravastatin?

You should not take pravastatin if you are pregnant or breast-feeding, or if you have liver disease.

Stop taking this medication and tell your doctor right away if you become pregnant.

Serious drug interactions can occur when certain medicines are used together with pravastatin. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

In rare cases, pravastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

What should I discuss with my healthcare provider before taking pravastatin?

You should not use pravastatin if you are allergic to it, or if you have:

  • liver disease; or

  • if you are pregnant or breast-feeding.

To make sure pravastatin is safe for you, tell your doctor if you have:

  • kidney disease;

  • abnormal liver function tests;

  • a thyroid disorder; or

  • if you drink more than 2 alcoholic beverages daily.

Pravastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

This medicine can harm an unborn baby or cause birth defects. Do not use if you are pregnant. Stop taking pravastatin and tell your doctor right away if you become pregnant. Use effective birth control to prevent pregnancy while you are taking this medicine.

Pravastatin can pass into breast milk and may harm a nursing baby. Do not breast-feed while using this medicine.

Pravastatin is not approved for use by anyone younger than 8 years old.

How should I take pravastatin?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Pravastatin is usually taken once a day, with or without food. Take the medicine at the same time each day.

Pravastatin doses are based on age, and are lower in children and teenagers. People taking this medicine during childhood or adolescence may need a different dose as adults.

You may need to stop using pravastatin for a short time if you have:

  • uncontrolled seizures;

  • an electrolyte imbalance (such as high or low potassium levels in your blood);

  • severely low blood pressure;

  • a severe infection or illness; or

  • surgery or a medical emergency.

While using pravastatin, you may need frequent blood tests.

Pravastatin is only part of a complete treatment program that may also include diet, exercise, and weight control. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking pravastatin?

If you also take cholestyramine or colestipol, avoid taking them within 1 hour after or 4 hours before you take pravastatin.

Avoid eating foods that are high in fat or cholesterol. Pravastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Grapefruit and grapefruit juice may interact with pravastatin and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Pravastatin side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, pravastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure.

Stop using pravastatin and call your doctor at once if you have:

  • unexplained muscle pain, tenderness, or weakness;

  • fever, unusual tiredness;

  • dark colored urine;

  • chest pain;

  • upper stomach pain, loss of appetite; or

  • jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • muscle or joint pain;

  • nausea, vomiting, diarrhea;

  • headache; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Pravastatin dosing information

Usual Adult Dose for Hyperlipidemia:

Initial dose: 40 mg orally once a day
Maintenance dose: 40 mg to 80 mg orally once a day

Comments:
-Since maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted accordingly.

Uses: As an adjunct to diet in the following conditions: to reduced total cholesterol (total-C), low density lipoprotein (LDL-C), apolipoprotein B (Apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb); for the treatment of elevated TG levels (Fredrickson Type IV); and for the treatment of primary dysbetalipoproteinemia (Fredrickson Type III) in patients who do not respond adequately to diet

Usual Adult Dose for Hyperlipoproteinemia Type IIa (Elevated LDL):

Initial dose: 40 mg orally once a day
Maintenance dose: 40 mg to 80 mg orally once a day

Comments:
-Since maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted accordingly.

Uses: As an adjunct to diet in the following conditions: to reduced total cholesterol (total-C), low density lipoprotein (LDL-C), apolipoprotein B (Apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb); for the treatment of elevated TG levels (Fredrickson Type IV); and for the treatment of primary dysbetalipoproteinemia (Fredrickson Type III) in patients who do not respond adequately to diet

Usual Adult Dose for Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL):

Initial dose: 40 mg orally once a day
Maintenance dose: 40 mg to 80 mg orally once a day

Comments:
-Since maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted accordingly.

Uses: As an adjunct to diet in the following conditions: to reduced total cholesterol (total-C), low density lipoprotein (LDL-C), apolipoprotein B (Apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb); for the treatment of elevated TG levels (Fredrickson Type IV); and for the treatment of primary dysbetalipoproteinemia (Fredrickson Type III) in patients who do not respond adequately to diet

Usual Adult Dose for Hyperlipoproteinemia Type III (Elevated beta-VLDL + IDL):

Initial dose: 40 mg orally once a day
Maintenance dose: 40 mg to 80 mg orally once a day

Comments:
-Since maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted accordingly.

Uses: As an adjunct to diet in the following conditions: to reduced total cholesterol (total-C), low density lipoprotein (LDL-C), apolipoprotein B (Apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb); for the treatment of elevated TG levels (Fredrickson Type IV); and for the treatment of primary dysbetalipoproteinemia (Fredrickson Type III) in patients who do not respond adequately to diet

Usual Adult Dose for Hyperlipoproteinemia Type IV (Elevated VLDL):

Initial dose: 40 mg orally once a day
Maintenance dose: 40 mg to 80 mg orally once a day

Comments:
-Since maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted accordingly.

Uses: As an adjunct to diet in the following conditions: to reduced total cholesterol (total-C), low density lipoprotein (LDL-C), apolipoprotein B (Apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb); for the treatment of elevated TG levels (Fredrickson Type IV); and for the treatment of primary dysbetalipoproteinemia (Fredrickson Type III) in patients who do not respond adequately to diet

Usual Adult Dose for Hypertriglyceridemia:

Initial dose: 40 mg orally once a day
Maintenance dose: 40 mg to 80 mg orally once a day

Comments:
-Since maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted accordingly.

Uses: As an adjunct to diet in the following conditions: to reduced total cholesterol (total-C), low density lipoprotein (LDL-C), apolipoprotein B (Apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb); for the treatment of elevated TG levels (Fredrickson Type IV); and for the treatment of primary dysbetalipoproteinemia (Fredrickson Type III) in patients who do not respond adequately to diet

Usual Adult Dose for Prevention of Cardiovascular Disease:

Initial dose: 40 mg orally once a day
Maintenance dose: 40 mg to 80 mg orally once a day

Comments:
-Since maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted accordingly.

Uses:
-In hypercholesterolemic patients without clinically evident coronary heart disease (CHD) to reduce the risk of myocardial infarction (MI); to reduce the risk of undergoing myocardial revascularization procedures; and to reduce the risk of cardiovascular (CV) mortality with no increase in death from non-CV causes

-In patients with clinically evident CHD to reduce the risk of total mortality by reducing coronary death; to reduce the risk of MI; to reduce the risk of undergoing myocardial revascularization procedures; to reduce the risk of stroke and stroke/transient ischemic attack; and to slow the progression of coronary atherosclerosis

Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia:

8 to 13 years: 20 mg orally once a day; doses greater than 20 mg have not been studied in this patient population.

14 to 18 years: 40 mg orally once a day; doses greater than 40 mg have not been studied in this patient population.

Use: As an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolemia if, after an adequate trial of diet, the following findings are present: LDL-C remains 190 mg/dL or greater, or LDL-C remains 160 mg/dL or greater and there is a positive family history of premature cardiovascular disease (CVD) or 2 or more other CVD risk factors are present in the pediatric patient

What other drugs will affect pravastatin?

Using certain other drugs together with pravastatin can increase your risk of serious muscle problems. It is very important to tell your doctor about all medicines you use, and those you start or stop using during your treatment with pravastatin, especially:

  • colchicine;

  • cyclosporine;

  • an antibiotic such as azithromycin, clarithromycin, or erythromycin;

  • gemfibrozil, fenofibric acid, fenofibrate; or

  • medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others).

This list is not complete. Other drugs may interact with pravastatin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about pravastatin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 13.01. Revision Date: 2016-08-17, 2:56:24 PM.

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