Pravastatin: Side Effects, Uses & Monitoring
Therapy with pravastatin sodium tablets should be considered in those individuals at increased risk for atherosclerosis-related clinical events as a function of cholesterol level, the presence or absence of coronary hear
- Data source
- FDA labeling via NIH DailyMed (label a5ca8004…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Arthralgia) | 6% |
| Dyspepsia/heartburn | 3.7% |
| Angina pectoris | 3.4% |
| Fatigue | 3.4% |
| Chest pain | 2.6% |
| Abdominal pain | 2.5% |
| Rash | 2.2% |
| Dizziness | 2.2% |
| Muscle cramp | 2% |
| Headache | 1.9% |
| Nausea/vomiting | 1.6% |
| Dyspnea | 1.6% |
| Vision, diplopia) | 1.6% |
| Myalgia | 1.4% |
| Constipation | 1.3% |
| Upper respiratory infection | 1.3% |
| Flatulence | 1.2% |
| Anxiety/nervousness | 1.2% |
| Sleep disturbance | 1% |
| Depression | 1% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
Therapy with pravastatin sodium tablets should be considered in those individuals at increased risk for atherosclerosis-related clinical events as a function of cholesterol level, the presence or absence of coronary heart disease, and other risk factors. Primary Prevention of Coronary EventsIn hypercholesterolemic patients without clinically evident coronary heart disease, pravastatin sodium tablets are indicated to: - Reduce the risk of myocardial infarction - Reduce the risk of undergoing myocardial revascularization procedures - Reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes HyperlipidemiaPravastatin sodium tablets are indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb).6 Pravastatin sodium tablets are indicated as adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson Type IV). Pravastatin sodium tablets are indicated for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not …
Tests providers may use to monitor Pravastatin therapy
Conditions associated with Pravastatin in labeling
Atherosclerosis
A disease in which plaque builds up inside arteries, narrowing them and reducing blood flow, raising the risk ...
Coronary Artery Disease
Narrowing of the coronary arteries by plaque, reducing blood flow to the heart muscle and causing chest pain, ...
Hyperlipidemia
Elevated levels of cholesterol or triglycerides in the blood, a major risk factor for heart attack and stroke....
Hypothyroidism
A condition in which the thyroid gland does not produce enough thyroid hormone, slowing metabolism and affecti...
Myocardial Infarction
A heart attack, occurring when blood flow to part of the heart muscle is blocked, causing chest pain and heart...
Frequently Asked Questions
What is Pravastatin used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Pravastatin?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Pravastatin. Individual risk varies.
Does Pravastatin require lab monitoring?
Labeling and standard practice associate Pravastatin with periodic laboratory monitoring; the tests above are commonly ordered by clinicians to monitor patients on therapy. Your provider decides what is appropriate.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.