pravastatin
Brand names: Pravachol
Pravastatin is a drug that lowers cholesterol. It belongs to a class of drugs called statins.
Drug Shortage Alert
pravastatin is currently listed as to be discontinued by the FDA. Affected manufacturer: Teva Pharmaceuticals USA, Inc..
View all drug shortages →Drug Pricing (NADAC)
Generic Price
$0.05/unit
Generic Available
Yes (9 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Pravastatin helps lower bad cholesterol and fats (like triglycerides) in your blood, while raising good cholesterol.
Common side effects
Muscle pain, Nausea, Vomiting
Key warnings
Pravastatin can sometimes cause muscle problems, including muscle pain, tenderness, or weakness.
How It Works
Pravastatin works by blocking a substance your body needs to make cholesterol. This helps to lower the amount of cholesterol in your blood. Lowering cholesterol helps to prevent heart disease and stroke.
How to Take It
Take pravastatin once a day. You can take it at any time of day, with or without food. Try to take it at the same time each day. If you are also taking a bile acid resin (like cholestyramine), take pravastatin 1 hour before or 4 hours after the resin.
Pregnancy & Breastfeeding
You should not take pravastatin if you are pregnant. It can harm your unborn baby. If you become pregnant while taking pravastatin, stop taking it right away and tell your doctor.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
Storage
Store pravastatin at room temperature, away from moisture and light.
Side Effects (from patient reports)
Based on 8,918 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 18,936 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
18,936
Death-Related Reports
1,669
Hospitalization Reports
6,658
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 1,262 |
| 2 | DIARRHOEA | 1,095 |
| 3 | NAUSEA | 954 |
| 4 | DYSPNOEA | 927 |
| 5 | HEADACHE | 842 |
| 6 | FALL | 837 |
| 7 | DRUG INEFFECTIVE | 831 |
| 8 | DIZZINESS | 751 |
| 9 | ASTHENIA | 710 |
| 10 | ARTHRALGIA | 709 |
| 11 | PAIN | 680 |
| 12 | COUGH | 664 |
| 13 | MYALGIA | 638 |
| 14 | PRURITUS | 630 |
| 15 | MALAISE | 618 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Pravastatin can sometimes cause muscle problems, including muscle pain, tenderness, or weakness. In rare cases, this can lead to serious muscle damage called rhabdomyolysis, which can cause kidney failure. Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel sick. This medicine can also cause liver problems. Your doctor should do blood tests to check your liver before you start taking pravastatin and if you have any symptoms of liver problems.
Known Drug Interactions
7 DRUG INTERACTIONS For the concurrent therapy of either cyclosporine, fibrates, niacin (nicotinic acid), or erythromycin, the risk of myopathy increases [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ]. (7) Cyclosporine: combination increases exposure. (2.7, 7.2) 7.1 Cyclosporine The risk of myopathy/rhabdomyolysis is increased with concomitant administration of cyclosporine.
Mechanism: Cyclosporine causes more of the statin to stay in your blood, which can lead to muscle damage.
What to do: Your doctor may need to change your dose or watch you closely for signs of muscle weakness.
7 DRUG INTERACTIONS For the concurrent therapy of either cyclosporine, fibrates, niacin (nicotinic acid), or erythromycin, the risk of myopathy increases [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ]. Other macrolides (e.g., erythromycin and azithromycin) have the potential to increase statin exposures while used in combination. Other macrolides (e.g., erythromycin and azithromycin) have the potential to increase statin exposures while used in combination.
Mechanism: This antibiotic can increase the amount of statin in your system, making muscle side effects more likely.
What to do: Your doctor should monitor you for muscle pain or may need to adjust your medication while you are on the antibiotic.
(2.6, 7.1) Clarithromycin: combination increases exposure. 7.2 Clarithromycin and Other Macrolide Antibiotics The risk of myopathy/rhabdomyolysis is increased with concomitant administration of clarithromycin. Limit pravastatin to 40 mg once daily for concomitant use with clarithromycin [see Dosage and Administration (2.7) , Warnings and Precautions (5.1) , and Clinical Pharmacology (12.3) ].
Mechanism: Clarithromycin increases the amount of pravastatin that stays in your body. This higher level of medicine in your blood increases the risk of serious muscle damage.
What to do: Your doctor should limit your pravastatin dose to no more than 40 mg once daily while you are taking this antibiotic.
7.3 Colchicine The risk of myopathy/rhabdomyolysis is increased with concomitant administration of colchicine [see Warnings and Precautions (5.1) ]. 7.3 Colchicine The risk of myopathy/rhabdomyolysis is increased with concomitant administration of colchicine [see Warnings and Precautions (5.1) ].
Mechanism: Taking these two drugs together increases the risk of developing severe muscle pain or a dangerous type of muscle breakdown.
What to do: Your doctor should monitor you closely for any signs of muscle weakness or pain while you are taking both medications.
7.4 Gemfibrozil Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are coadministered with gemfibrozil, concomitant administration of Pravastatin Sodium with gemfibrozil should be avoided [see Warnings and Precautions (5.1) ]. 7.4 Gemfibrozil Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are coadministered with gemfibrozil, concomitant administration of Pravastatin Sodium with gemfibrozil should be avoided [see Warnings and Precautions (5.1) ].
Mechanism: Using these medications at the same time significantly raises the risk of serious muscle injury and breakdown.
What to do: You should avoid taking these two medications together. Talk to your doctor about alternative treatment options.
Common Questions
Can I drink alcohol while taking pravastatin?
How long will I need to take pravastatin?
Can I stop taking pravastatin if my cholesterol is under control?
Does pravastatin have any effect on my kidneys?
Can pravastatin cause memory loss?
Will pravastatin interact with other medications I am taking?
How often will I need blood tests while taking pravastatin?
Can I take pravastatin if I have diabetes?
Can I take pravastatin while breastfeeding?
What should I do if I experience side effects from pravastatin?
What are the common side effects of pravastatin?
Does pravastatin interact with other medications?
What drug class is pravastatin?
Is pravastatin safe during pregnancy?
Has pravastatin been recalled?
Is pravastatin currently in shortage?
Active Recalls
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
Related Medications in HMG-CoA Reductase Inhibitor (Statin)
Other drugs grouped near pravastatin — same-class peers and common alternatives.
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atorvastatin
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bempedoic acid
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Nexlizet is a combination medicine that helps lower cholesterol.
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bempedoic acid/ezetimibe
Nexlizet
Nexlizet is a combination medicine that helps lower cholesterol.
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cholestyramine
Questran
Cholestyramine is a medicine that helps lower high cholesterol levels in your blood.
Compare with pravastatin →
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What the FDA Data Shows for pravastatin
The FDA label for pravastatin (sold under brand names such as Pravachol) classifies it as a prescription-only medication in the HMG-CoA Reductase Inhibitor (Statin) class. Pravastatin helps lower bad cholesterol and fats (like triglycerides) in your blood, while raising good cholesterol. Official labeling lists 11 commonly reported side effects, including Muscle pain, Nausea, Vomiting.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 8,918 voluntary reports. The database also lists 16 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.05.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 3 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: August 14, 2024
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages