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Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  • Difficulty with moving
  • Muscle or bone pain
  • Muscle stiffness
  • Pain in the joints
  • Pain, localized

Less common

  • Arm, back, or jaw pain
  • Body aches or pain
  • Chest pain or discomfort
  • Chest tightness or heaviness
  • Chills
  • Cough
  • Dark-colored urine
  • Diarrhea
  • Difficult or labored breathing
  • Ear congestion
  • Fast or irregular heartbeat
  • Fever
  • General feeling of discomfort or illness
  • Headache
  • Loss of appetite
  • Loss of voice
  • Muscle cramps or spasms
  • Muscular tenderness, wasting, or weakness
  • Nasal congestion
  • Nausea
  • Runny nose
  • Shivering
  • Shortness of breath
  • Sneezing
  • Sore throat
  • Sweating
  • Swollen joints
  • Tightness in the chest
  • Trouble with sleeping
  • Unusual tiredness or weakness
  • Vomiting
  • Wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Stomach pain

Less common

  • Acid or sour stomach
  • Belching
  • Bloated full feeling
  • Blurred vision or other changes in vision
  • Burning while urinating
  • Difficult or painful urination
  • Difficulty having a bowel movement (stool)
  • Discouragement
  • Dizziness
  • Double vision
  • Excess air or gas in the stomach or intestines
  • Fear or nervousness
  • Feeling of indigestion
  • Feeling sad or empty
  • Increased urge to urinate during the night
  • Irritability
  • Loss of interest or pleasure
  • Pain in the chest below the breastbone
  • Passing gas
  • Passing urine more often
  • Rash
  • Seeing double
  • Stomach discomfort or upset
  • Stuffy nose
  • Tiredness
  • Trouble concentrating
  • Waking to urinate at night

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride levels and to decide if you should continue to take it. Blood tests will be needed to check for unwanted effects.

Your doctor will need to check your liver before you start using this medicine.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Do not drink large amounts of alcohol while taking pravastatin. This could cause side effects on the liver.

Check with your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if it is accompanied by unusual tiredness or fever. These may be symptoms of a muscle condition called rhabdomyolysis, which can lead to serious kidney problems.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Proper Use

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor ordered. Also, this medicine works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same time each day.

Remember that this medicine will not cure your condition, but it does help control it. You must continue to take it as directed if you expect to keep your cholesterol levels down.

Before prescribing medicine for your cholesterol problem, your doctor will probably try to control it by changing your diet. Such a diet may be low in fats, sugars, or cholesterol. Many people are able to control their cholesterol levels by carefully following a special diet and by adding exercise to their daily routine. Medicine is prescribed only when additional help is needed, and is effective only when used together with a modified diet and exercise. .

This medicine may be taken with or without food.

If you are also taking other medicines to lower your cholesterol (e.g., cholestyramine, colestipol, Colestid®, or Questran®), take these medicines at least 4 hours before or 1 hour after taking pravastatin.


The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For high cholesterol:
      • Adults—At first, 40 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
      • Teenagers 14 to 18 years of age—40 mg once a day.
      • Children 8 to 13 years of age—20 mg once a day.
      • Children younger than 8 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pravastatin in children 8 to 18 years of age. However, safety and efficacy have not been established in children younger than 8 years of age.

Teenagers (girls) taking pravastatin should be counseled on appropriate birth control methods.


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pravastatin in the elderly. However, elderly patients are more likely to have age-related heart or muscle problems, which may require caution in patients receiving pravastatin.


Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Bezafibrate
  • Ciprofibrate
  • Clofibrate
  • Colchicine
  • Dalfopristin
  • Daptomycin
  • Fenofibrate
  • Gemfibrozil
  • Quinupristin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amprenavir
  • Clarithromycin
  • Cyclosporine
  • Darunavir
  • Efavirenz
  • Eltrombopag
  • Nefazodone
  • Nelfinavir
  • Oat Bran
  • Pectin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse, or history of or
  • Liver disease, recent history—Use with caution. May cause side effects to become worse.
  • Age (over 65 years) or
  • Convulsions (seizures), uncontrolled or
  • Electrolyte disorder, severe or
  • Endocrine disorder, severe or
  • Hypotension (low blood pressure) or
  • Hypothyroidism, uncontrolled or
  • Infection in the blood or
  • Kidney impairment or
  • Major surgery, recent or
  • Major trauma, recent or
  • Metabolic disorder, severe or
  • Muscle pain or weakness, history of—Patients with these conditions may be at risk of developing muscle problems (causing the release of muscle pigment into the urine) that may lead to kidney failure.
  • Liver disease, active or
  • Liver enzymes, persistently high levels—Should not be used in these conditions.


Pravastatin is used together with a proper diet to lower cholesterol and triglycerides (fats) in the blood. This medicine may help prevent or slow down medical problems, like atherosclerosis (hardening of the arteries), that are caused by fats clogging the blood vessels. It may also be used to prevent certain types of heart and blood vessel problems in patients with risk factors for heart problems.

Pravastatin belongs to the group of medicines called HMG-CoA reductase inhibitors or ” statins”. It works by blocking an enzyme that is needed by the body to make cholesterol, so this reduces the amount of cholesterol in the blood.

This medicine is available only with your doctor’s prescription.