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pravastatin

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Brand names: Pravachol

HMG-CoA Reductase Inhibitor (Statin) Rx

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..

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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.

Tiredness
1,261
Diarrhea
1,095
Feeling sick to your stomach
954
Shortness of breath
928
Headache
842
Fall
837
Medicine not working
831
Dizziness
751
Weakness
710
Joint pain
709

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

Female 10,005 (57%)
Male 7,653 (43%)

Age Distribution

0–17 81
18–44 479
45–64 3,847
65–74 3,866
75+ 4,093

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

DEATH 504
DYSPNOEA 209
FALL 209
SEPSIS 205
CARDIO-RESPIRATORY ARREST 202
DIARRHOEA 198
HAEMORRHAGIC STROKE 186
ALTERED STATE OF CONSCIOUSNESS 171
COMA 167
FATIGUE 164

Reactions in Hospitalization Reports

PNEUMONIA 423
FALL 406
DYSPNOEA 390
DIARRHOEA 364
ACUTE KIDNEY INJURY 301
NAUSEA 273
ASTHENIA 268
FATIGUE 267
PYREXIA 254
VOMITING 241

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.

moderate colchicine

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.

moderate gemfibrozil

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.

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Common Questions

Can I drink alcohol while taking pravastatin?
Talk to your doctor about drinking alcohol while taking pravastatin. Alcohol can increase your risk of liver problems.
How long will I need to take pravastatin?
You may need to take pravastatin for the rest of your life to manage your cholesterol.
Can I stop taking pravastatin if my cholesterol is under control?
Do not stop taking pravastatin without talking to your doctor first. Your cholesterol levels may increase if you stop taking it.
Does pravastatin have any effect on my kidneys?
In rare cases, pravastatin can cause kidney problems, especially if you develop rhabdomyolysis. Tell your doctor if you have kidney disease.
Can pravastatin cause memory loss?
Memory loss has been reported with statins, including pravastatin. If you experience memory problems, talk to your doctor.
Will pravastatin interact with other medications I am taking?
Pravastatin can interact with other medications, including cyclosporine, clarithromycin, and other antibiotics. Tell your doctor about all the medications you are taking.
How often will I need blood tests while taking pravastatin?
Your doctor will likely order blood tests to check your cholesterol levels and liver function regularly.
Can I take pravastatin if I have diabetes?
Yes, you can take pravastatin if you have diabetes. It may even help to reduce your risk of heart disease.
Can I take pravastatin while breastfeeding?
No, you should not take pravastatin while breastfeeding. It can pass into breast milk and harm your baby.
What should I do if I experience side effects from pravastatin?
Tell your doctor if you experience any side effects from pravastatin. They may be able to adjust your dose or recommend a different medication.
What are the common side effects of pravastatin?
The most commonly reported side effects of pravastatin include Muscle pain, Nausea, Vomiting, Diarrhea, Headache. Based on 8,918 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does pravastatin interact with other medications?
Yes, pravastatin has 16 known drug interactions. Notable interactions include cyclosporine, erythromycin, clarithromycin. Always inform your doctor about all medications you are taking.
What drug class is pravastatin?
pravastatin belongs to the HMG-CoA Reductase Inhibitor (Statin) drug class. It requires a prescription (Rx). Pravastatin helps lower bad cholesterol and fats (like triglycerides) in your blood, while raising good cholesterol.
Is pravastatin safe during pregnancy?
You should not take pravastatin if you are pregnant. It can harm your unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has pravastatin been recalled?
There are 3 recalls associated with pravastatin products. CGMP Deviations. Check the recalls section below for full details and affected products.
Is pravastatin currently in shortage?
Yes, pravastatin is currently listed as to be discontinued by the FDA. Affected manufacturer: Teva Pharmaceuticals USA, Inc.. Visit the FDA Drug Shortages database for the latest updates.

Active Recalls

Class II March 13, 2025

CGMP Deviations

Glenmark Pharmaceuticals Inc., USA

Class II March 13, 2025

CGMP Deviations

Glenmark Pharmaceuticals Inc., USA

Class II March 13, 2025

CGMP Deviations

Glenmark Pharmaceuticals Inc., USA

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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

All federal data sources used on this page