Prescription medication · HMG-CoA Reductase Inhibitor (Statin)
pravastatin
Also sold as Pravachol. Pravastatin helps lower bad cholesterol and fats (like triglycerides) in your blood, while raising good cholesterol.
Data updated 2026-05-15
- 18,936
- FDA reportsModerately reported
- 16
- InteractionsSeveral interactions
- In shortage
- FDA status
What the data shows
pravastatin (Pravachol) is a prescription HMG-CoA Reductase Inhibitor (Statin), reported at a middle-of-the-pack volume (18,936 FDA reports), with 16 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
pravastatin (Pravachol) is a prescription HMG-CoA Reductase Inhibitor (Statin). Pravastatin helps lower bad cholesterol and fats (like triglycerides) in your blood, while raising good cholesterol.
Pravastatin is a drug that lowers cholesterol. It belongs to a class of drugs called statins.
Verify with FDA → · CMS NADAC pricing →
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 →
NADAC price trail: PRAVASTATIN SODIUM 10 MG TAB
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -1.8% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| July 17, 2024 | $0.0529/EA | - | 1 |
| December 18, 2024 | $0.0519/EA | -1.8% | 19 |
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.
The sections below are summarized in plain English from pravastatin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 18,936 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for pravastatin, by number of reports
- Fatigue
Fatigue
1,262 reports
- Diarrhoea
Diarrhoea
1,095 reports
- Nausea
Nausea
954 reports
- Dyspnoea
Dyspnoea
927 reports
- Headache
Headache
842 reports
- Fall
Fall
837 reports
- Dizziness
Dizziness
751 reports
- Asthenia
Asthenia
710 reports
- Arthralgia
Arthralgia
709 reports
- Pain
Pain
680 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for pravastatin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where pravastatin sits
pravastatin has more FDA adverse-event reports than 54% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is pravastatin; the line is the median (50th percentile).
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
Reports Mentioning Death
1,669
8.8% of reports — not proof of cause
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 |
| 8 | DIZZINESS | 751 |
| 9 | ASTHENIA | 710 |
| 10 | ARTHRALGIA | 709 |
| 11 | PAIN | 680 |
| 12 | COUGH | 664 |
| 13 | MYALGIA | 638 |
| 14 | PRURITUS | 630 |
| 15 | MALAISE | 618 |
| 17 | VOMITING | 577 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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.
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.
(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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for pravastatin?
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)
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for pravastatin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 18,936.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 8.81%.
- ertapenem Δ 0.00 pts · 3,848 reports · Carbapenem Antibiotic 8.81%death share
- dexlansoprazole Δ 0.03 pts · 40,790 reports · Proton Pump Inhibitor (PPI) 8.84%death share
- loperamide Δ 0.03 pts · 42,665 reports · Antidiarrheal (Opioid Receptor Agonist) 8.85%death share
- melatonin Δ 0.04 pts · 51,370 reports · Hormone Supplement (Sleep Aid) 8.77%death share
Medication Guides
Understanding Drug Interactions
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Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 18,936 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: August 14, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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