Prescription medicine
Pravastatin First approved as Pravachol
Pravastatin (Pravachol) is a prescription medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 37 generic labelers, and pharmacies paid $0.058 per pravastatin sodium 20 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the pravastatin FDA label on DailyMed (effective July 31, 2026, Apotex Corp.); the NDA 19898 record on Drugs@FDA; every pravastatin label on DailyMed.
Highlights of the record
FDA label of July 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePravastatin sodium tablets are indicated: To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD).
Forms and strengths
- 10 mg
- 20 mg
- 40 mg
- 80 mg
Tablet; film-coated tablet.
On the market
- Earliest approval on file
- October 31, 1991 Pravachol, Bristol Myers Squibb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first April 24, 2006; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 37 of which 37 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.058 per tablet Pravastatin sodium 20 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 17 since 2013 1 Class I among all firms' recalls; latest March 13, 2025
- FAERS reports
- 19,683 through July 30, 2026
What is pravastatin used for?
From the label: indications and usagePravastatin sodium tablets are indicated: To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. […]
Conditions named in the indications of pravastatin's FDA labels, with every medicine labeled for each:
From other pravastatin labelsHigh triglycerides: Hypertriglyceridemia.
FDA pharmacologic class: HMG-CoA Reductase Inhibitor.
Source: FDA drug label (PRAVASTATIN SODIUM), Apotex Corp., effective July 31, 2026 (SPL set dcf45e4f-b46e-6fbb-b67a-2ff619ab1780), via openFDA; the full label on DailyMed
Is there a generic for pravastatin (Pravachol)?
The FDA approved the first generic pravastatin on April 24, 2006. 16 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists pravastatin from 37 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1991 earliest approval on file
- 2006 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for pravastatin (Pravachol)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.058 per Pravastatin sodium 20 mg tablet, down 18% from $0.0703 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Pravastatin sodium 20 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Pravastatin sodium 10 mg tablet | Generic | $0.0555 per tablet | $1.66 | -15% |
| Pravastatin sodium 20 mg tablet | Generic | $0.058 per tablet | $1.74 | -18% |
| Pravastatin sodium 40 mg tablet | Generic | $0.0828 per tablet | $2.48 | -8% |
| Pravastatin sodium 80 mg tablet | Generic | $0.143 per tablet | $4.30 | -10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has pravastatin been recalled?
The FDA's Enforcement Report lists 17 recalls naming pravastatin since 2013: 1 Class I (the most serious), 14 Class II, 2 Class III; 6 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 13, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
| June 28, 2024 | Class II | Glenmark Pharmaceuticals Inc., USA | Failed Dissolution Specifications: results below specifications |
| March 23, 2023 | Class II | Preferred Pharmaceuticals, Inc. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. |
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| March 25, 2019 | Class II | Glenmark Pharmaceuticals Inc., USA | Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg. |
| January 12, 2018 | Class II | International Laboratories, Inc. | Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle. |
| November 17, 2017 | Class II | Lupin Limited | Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was … |
| August 7, 2017 | Class I | International Laboratories, Inc. | Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the pravastatin label say about other medicines?
The pravastatin label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 33 other medicines name pravastatin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Azithromycin | drug interactions | Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of clarithromycin or erythromycin with pravastatin. Other macrolides (e.g., azithromycin) have the potential to increase pravastatin exposures and increase the risk of … Intervention: For patients taking erythromycin or clarithromycin, do not exceed 40 mg pravastatin once daily [see Dosage and Administration ( 2.5 )]. |
| Cholestyramine | drug interactions | Bile Acid Sequestrants Clinical Impact: Concomitant cholestyramine or colestipol administration decreased the mean exposure of pravastatin approximately 51% and 47%, respectively. Intervention: In patients taking a bile acid sequestrant, administer pravastatin at least 1 hour before or at least 4 hours after the bile acid sequestrant [see Dosage and Administration ()]. |
| Clarithromycin | drug interactions | Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of clarithromycin or erythromycin with pravastatin. Other macrolides (e.g., azithromycin) have the potential to increase pravastatin exposures and increase the risk of … Intervention: For patients taking erythromycin or clarithromycin, do not exceed 40 mg pravastatin once daily [see Dosage and Administration ( 2.5 )]. |
| Colchicine | drug interactions | Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with pravastatin. Intervention: Consider if the benefit of using colchicine concomitantly with pravastatin outweighs the increased risk of myopathy and rhabdomyolysis. … |
| Colestipol | drug interactions | Bile Acid Sequestrants Clinical Impact: Concomitant cholestyramine or colestipol administration decreased the mean exposure of pravastatin approximately 51% and 47%, respectively. Intervention: In patients taking a bile acid sequestrant, administer pravastatin at least 1 hour before or at least 4 hours after the bile acid sequestrant [see Dosage and Administration ()]. |
| Cyclosporine | drug interactions | Clinical Impact: The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine with pravastatin. Intervention: Initiate with a dosage of pravastatin sodium 10 mg once daily. Do not exceed pravastatin 20 mg once daily [see Dosage and Administration ( 2.5 )]. |
| Erythromycin | drug interactions | Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of clarithromycin or erythromycin with pravastatin. Other macrolides (e.g., azithromycin) have the potential to increase pravastatin exposures and increase the risk of … Intervention: For patients taking erythromycin or clarithromycin, do not exceed 40 mg pravastatin once daily [see Dosage and Administration ( 2.5 )]. |
| Gemfibrozil | drug interactions | Gemfibrozil Clinical Impact: There is an increased risk of myopathy/rhabdomyolysis when pravastatin is administered with gemfibrozil Intervention: Avoid concomitant use of gemfibrozil with pravastatin. |
| Niacin | drug interactions | Clinical Impact: Cases of myopathy and rhabdomyolysis have been observed with concomitant use of niacin with pravastatin. Intervention: Consider if the benefit of using niacin concomitantly with pravastatin outweighs the increased risk of myopathy and rhabdomyolysis. … |
Other labels that name pravastatin
Source: FDA drug label (PRAVASTATIN SODIUM), Apotex Corp., effective July 31, 2026 (SPL set dcf45e4f-b46e-6fbb-b67a-2ff619ab1780), via openFDA; the full label on DailyMed
What do FAERS reports show for pravastatin?
The FDA Adverse Event Reporting System holds 19,683 reports that list pravastatin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,710 are coded as a death and 6,897 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as pravastatin?
13 other medicines are given the same way (oral) and in the same FDA class as pravastatin or labeled mainly for the same use (heart attack and coronary artery disease), the same class first. Heart attack and coronary artery disease lists all 38 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Atorvastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 61 labelers | $0.0228 per tablet 10 mg tablet | No current entry |
| Rosuvastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 46 labelers | $0.0692 per tablet 40 mg tablet | No current entry |
| Simvastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 27 labelers | $0.0321 per tablet 20 mg tablet | No current entry |
| Amlodipine and atorvastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 6 labelers | $1.34 per unit 10-40 mg | No current entry |
| Lovastatin | Heart attack and coronary artery disease, High cholesterol | 19 labelers | $0.0436 per tablet 20 mg tablet | No current entry |
| Pitavastatin | High cholesterol | 12 labelers | $0.954 per tablet 2 mg tablet | No current entry |
| Ezetimibe and simvastatin | Heart attack and coronary artery disease, High cholesterol | 7 labelers | $0.285 per unit 10-80 mg | No current entry |
| Fluvastatin | High cholesterol | 4 labelers | $2.88 per tablet 80 mg tablet | A presentation being discontinued |
Every medicine labeled for the same conditions as pravastatin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does pravastatin compare with medicines for the same use?
7 side-by-side pages set pravastatin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to pravastatin
- 13 medicines for the same use
- Other statins
- the pharmacologic class, with prices and generics
- Pravastatin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other