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Pravastatin

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Pravastatin does in the body

High cholesterol, and the prevention of heart attacks, strokes and cardiovascular death

Pravastatin blocks the enzyme the liver uses to build cholesterol, so the liver cell puts more LDL receptors on its surface and pulls cholesterol-carrying particles out of the bloodstream instead. What separates it from most statins is that it is water-soluble rather than fat-soluble: it cannot drift through cell membranes and has to be carried into the liver by a specific transporter. That makes it much more confined to the liver than its relatives, and it also means the body clears it by simple chemical rearrangement rather than through the busy CYP3A4 enzyme, so it collides with far fewer other drugs.

What happened in people

Fatal coronary events or non-fatal infarction 10.2% against 13.2% in post-infarction patients with average cholesterol (CARE, p=0.003)

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.

The limit that matters most

That WOSCOPS demonstrated an all-cause mortality benefit in primary prevention — the result was 22% at p=0.051 with a confidence interval touching zero

Where it acts
Hepatocyte cytoplasm — reached almost exclusively through the OATP1B1 transporter, because this statin is water-soluble and cannot cross membranes unaided
Kind of result
A number that stands in for health
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · KXO2KT9N0G · read 2026-08-29

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

A limit recorded against this substance. Not signed off as a reviewed claim.

The four opening statements run to 136 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

Randomisation

Randomisation means chance decides who gets which treatment.

A picture of it, and where the picture fails

It is like a coin toss deciding the groups.

Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.

What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.

Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.

Confidence interval

A confidence interval is the range the true answer is likely to sit in.

A picture of it, and where the picture fails

It is like a weather forecast giving a range rather than one number.

Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.

What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.

An interval estimate that would contain the true parameter in a stated proportion of repeated studies.

Pathway

A pathway is a chain of steps inside a cell, each one setting off the next.

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.

What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.

An ordered series of molecular interactions producing a defined cellular change.

What happened in peopleRead from sources, not yet reviewed

What was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
CholesterolNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved10 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Blood sugarNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved1 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Healthy ageingWaiting for a reviewer1 registered study measure of this kind. No reviewed result yet.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Cholesterol
ldl c; serum ldl c; fasting plasma low density lipoprotein cholesterol; low density lipoprotein cholesterol level after 8 weeks; low density lipoprotein cholesterol; hdl c level n; low density lipoprotein cholesterol from baseline to week 12; change from baseline in non hdl c
Blood sugar
glucose homeostasis; incident type 2 diabetes
Healthy ageing
all cause mortality

Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.

What each mark on this table means
Nothing in the sources checked
No registered study lists a life outcome for this goal.
Only a number moved
10 registered test measure.
Not recorded
Harms were not a registered measure for this goal.
Waiting for a reviewer
Who was studied is listed further down the page.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Combined incidence of definite non-fatal myocardial infarction and death from coronary heart disease in men aged 45 to 64 with hypercholesterolaemia and no prior infarction

The study showed what it set out to show

Who was studied
WOSCOPS — West of Scotland Coronary Prevention Study (N Engl J Med 1995;333:1301-1307)
How many people
6595
Study design
Phase 3, randomised, double-blind, placebo-controlled
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
174 definite coronary events against 248; 31% relative risk reduction (95% CI 17 to 43), p<0.001, over an average 4.9 years
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. All-cause mortality fell 22% but with a 95% CI of 0 to 40 and p=0.051 — not significant, though the trial is routinely cited as though it were. Coronary death counting definite cases alone fell 28% at p=0.13. The population was men only, aged 45 to 64, with mean cholesterol 272 mg/dL, so nothing here transfers directly to women or to lower baseline cholesterol.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet at 10, 20, 40 and 80 mg, taken once daily, usually in the evening

Interval reported. 95% CI 17 to 43), p<0

Written into the record, not signed off as a reviewed claim.

Fatal coronary event or non-fatal myocardial infarction over five years in post-infarction patients with average cholesterol levels

The study showed what it set out to show

Who was studied
CARE — Cholesterol and Recurrent Events (N Engl J Med 1996;335:1001-1009)
How many people
4159
Study design
Phase 3, randomised, double-blind, placebo-controlled
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
10.2% against 13.2%; a 24% relative risk reduction (95% CI 9 to 36), p=0.003, on an absolute difference of three percentage points
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. There were no significant differences in overall mortality or in non-cardiovascular mortality; the trial was not powered for either. The reported greater benefit in women rests on 576 women, and the greater benefit at higher pretreatment LDL is a subgroup analysis — both are hypothesis-generating rather than established.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet at 10, 20, 40 and 80 mg, taken once daily, usually in the evening

Interval reported. 95% CI 9 to 36), p=0

Written into the record, not signed off as a reviewed claim.

Mortality from coronary heart disease over a mean 6.1 years in patients with previous myocardial infarction or unstable angina and a broad range of cholesterol levels

The study showed what it set out to show

Who was studied
LIPID (N Engl J Med 1998;339:1349-1357)
How many people
9014
Study design
Phase 3, randomised, double-blind, placebo-controlled
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
6.4% against 8.3%; a 24% relative reduction (95% CI 12 to 35), p<0.001, with overall mortality 11.0% against 14.1% (22% reduction, 95% CI 13 to 31, p<0.001)
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. The publication reports no clinically significant adverse effects of treatment. Stroke reduction was 19% at p=0.048, which is a real but marginal result and sits against PROSPER, where stroke was entirely unaffected.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet at 10, 20, 40 and 80 mg, taken once daily, usually in the evening

Interval reported. 95% CI 12 to 35), p<0

Written into the record, not signed off as a reviewed claim.

Composite of coronary death, non-fatal myocardial infarction and fatal or non-fatal stroke in men and women aged 70 to 82

The study showed what it set out to show

Who was studied
PROSPER (Lancet 2002;360:1623-1630)
How many people
5804
Study design
Phase 3, randomised, double-blind, placebo-controlled
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
408 events against 473; hazard ratio 0.85 (95% CI 0.74 to 0.97), p=0.014, over an average 3.2 years
Repeated elsewhere
Partially Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. New cancer diagnoses were more frequent on pravastatin: HR 1.25 (95% CI 1.04 to 1.51), p=0.020. A meta-analysis of all pravastatin and all statin trials showed no overall increase. Stroke risk was unaffected (HR 1.03, p=0.8) despite stroke being part of the primary composite. There was no significant effect on cognitive function or disability.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet at 10, 20, 40 and 80 mg, taken once daily, usually in the evening

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

All-cause mortality with follow-up to eight years, pravastatin 40 mg daily against usual care, in hypertensive adults aged 55 or over with moderately elevated LDL cholesterol

The study did not show it

Who was studied
ALLHAT-LLT (JAMA 2002;288:2998-3007)
How many people
10355
Study design
Phase 3, randomised, open-label, usual-care controlled
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Six-year mortality 14.9% against 15.3%; relative risk 0.99 (95% CI 0.89 to 1.11), p=0.88. Coronary events 9.3% against 10.4%, RR 0.91 (95% CI 0.79 to 1.04), p=0.16
Repeated elsewhere
Failed to Replicate

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. During the trial 32% of usual-care participants with known coronary disease and 29% without started lipid-lowering drugs, leaving a differential of only 9.6% in total cholesterol and 16.7% in LDL. The trial is a demonstration of what happens to an unblinded active-control design when the control treatment becomes standard practice mid-trial, and the authors say so in their own conclusion.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet at 10, 20, 40 and 80 mg, taken once daily, usually in the evening

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 5 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.7 registered measures of this kind. No reviewed result.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.14 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

  1. Start

    Pravastatin

    What a person takes: Oral tablet at 10, 20, 40 and 80 mg, taken once daily, usually in the evening.

    The measurement behind this step

    Given in the active acid form, so no metabolic activation is required. Peak plasma concentrations occur at 1 to 1.5 hours; average oral absorption is 34% and absolute bioavailability 17%, with a hepatic extraction ratio of 0.66. Systemic bioavailability after a bedtime dose is 60% lower than after a morning dose, and the evening dose was nonetheless marginally more effective — the drug is aimed at an organ whose cholesterol synthesis peaks overnight, not at the bloodstream. Food reduces systemic bioavailability without changing the lipid-lowering effect. Elimination half-life is about 1.8 hours; 20% of an oral dose appears in urine and 70% in faeces, and after intravenous dosing 47% of total body clearance is renal.

  2. Getting in

    It arrives already switched on

    Unlike simvastatin and lovastatin, this tablet does not need the body to activate it. The molecule that inhibits the enzyme is the molecule you swallow.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    Pravastatin is administered orally in the active open-hydroxyacid form as the sodium salt, not as a lactone prodrug. Average oral absorption is 34% with absolute bioavailability 17%; peak plasma concentrations occur at 1 to 1.5 hours.

  3. Reaching the cell

    Being water-soluble means it needs a door

    Fat-soluble statins slip through cell membranes anywhere in the body. This one cannot: it has to be carried into the liver cell by a specific transporter, and cells without that transporter barely see it.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    The 6β-hydroxyl makes pravastatin hydrophilic, so hepatic entry depends on OATP1B1 rather than on passive diffusion. Hepatic first-pass extraction ratio is 0.66. Plasma protein binding is approximately 50%, against roughly 95% for the lipophilic statins.

  4. What it acts on

    It jams the rate-limiting step of cholesterol synthesis

    Inside the liver cell it blocks the enzyme that performs the slowest step in building cholesterol, and the whole pathway backs up behind it.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Reversible competitive inhibition of HMG-CoA reductase, the enzyme catalysing conversion of HMG-CoA to mevalonate — an early and rate-limiting step in cholesterol biosynthesis. VLDL and triglycerides fall and HDL cholesterol rises.

  5. The change it makes

    The liver starts clearing LDL out of the blood

    Deprived of the cholesterol it used to manufacture, the liver cell puts more receptors on its surface and pulls LDL particles out of the bloodstream. That is what lowers the number on the test.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Depletion of the intracellular sterol pool activates SREBP-2 and upregulates LDL receptor expression, increasing hepatic clearance of circulating LDL. Pravastatin 40 mg lowered LDL cholesterol by 26% in WOSCOPS and 34% in PROSPER.

  6. What that does for a person

    Fewer coronary deaths, in three separate populations

    Men with high cholesterol and no heart disease, people who had had a heart attack with normal cholesterol, and people with established coronary disease — all three groups had measurably fewer coronary events.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    WOSCOPS: definite coronary events 174 against 248, a 31% reduction (p<0.001). CARE: 10.2% against 13.2%, a 24% reduction (p=0.003). LIPID: coronary death 6.4% against 8.3% and overall mortality 11.0% against 14.1%, both p<0.001.

  7. What that does for a person

    And, in one trial, nothing at all

    The largest trial of the lot compared it against ordinary care rather than a dummy tablet, and found no difference in deaths. A third of the comparison group had started taking statins of their own.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    ALLHAT-LLT: all-cause mortality 14.9% against 15.3% at six years, RR 0.99 (95% CI 0.89 to 1.11), p=0.88, in 10,355 participants. Achieved separation was 9.6% in total cholesterol and 16.7% in LDL, against 26 to 35% in the placebo-controlled trials.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

No registered study measured anything of this kind.

Measured

Things only a test, a scale or a device shows.

  • plasma thiobarbituric acid reactive substance levels
  • ldl c
  • serum ldl c
  • fasting plasma low density lipoprotein cholesterol
  • low density lipoprotein cholesterol level after 8 weeks
  • low density lipoprotein cholesterol
  • hdl c level n
  • cmax maximum observed concentration
  • low density lipoprotein cholesterol from baseline to week 12
  • glucose homeostasis

and 4 more.

Meaningful

Things that change how a life goes, not only a number.

  • survival
  • survival at 2 years
  • complete remission rate
  • all cause mortality
  • overall survival
  • composite of death from any cause
  • recurrent stroke

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (19)
  • panss total
  • hiv rna
  • csf abeta levels
  • common carotid artery intima media thickness
  • brachial artery flow mediated vasodilatation
  • pharmacokinetics
  • bioequivalence
  • metabolic syndrome
  • general cardiovascular risk profile framingham heart study
  • bioequivalence based on cmax and auc
  • who stated that they had side effects
  • who took 90 of their doses
  • bioequivalence based on cmax and auc parameters
  • 30 day maces after pci
  • time to radiologic progression
  • auc of simvastatin
  • adverse events as a measure of safety and tolerability
  • incident type 2 diabetes
  • hospitalized for acute kidney injury

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Adults with high cholesterol and no known heart disease, adults with established coronary disease, children from age eight with familial hypercholesterolaemia, and — in practice — people taking drugs that collide with the CYP3A4-metabolised statins.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “The safety and effectiveness of pravastatin sodium have not been established in pediatric patients younger than 10 years of age with HeFH or in pediatric patients with other types of hyperlipidemia (other than HeFH).”

    US prescribing information · 97f826f0-b5c5-410c-b1f0-523873981e8d · read 2026-08-30

  • On older people, the label states: “In clinical studies, 4,797 (36.4%) pravastatin sodium-treated patients were aged 65 and older and 110 (0.8%) were aged 75 and older.”

    US prescribing information · 97f826f0-b5c5-410c-b1f0-523873981e8d · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Discontinue pravastatin sodium when pregnancy is recognized.”

    US prescribing information · 97f826f0-b5c5-410c-b1f0-523873981e8d · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Based on one lactation study in published literature, pravastatin is present in human milk.”

    US prescribing information · 97f826f0-b5c5-410c-b1f0-523873981e8d · read 2026-08-30

  • On people with reduced liver function, the label states: “Pravastatin sodium shows a large inter-subject variability in pharmacokinetics in patients with liver cirrhosis [ Clinical Pharmacology (12.3) ] .”

    US prescribing information · 97f826f0-b5c5-410c-b1f0-523873981e8d · read 2026-08-30

  • On people with reduced kidney function, the label states: “is a risk factor for myopathy and rhabdomyolysis.”

    US prescribing information · 97f826f0-b5c5-410c-b1f0-523873981e8d · read 2026-08-30

Where the result stopped carrying

  • ALLHAT-LLT: no significant reduction in all-cause mortality or coronary events against usual care
  • PROSPER: stroke entirely unaffected, hazard ratio 1.03, p=0.8
  • PROSPER: a statistically significant excess of new cancer diagnoses, which pooled analysis of the whole statin literature did not confirm
  • WOSCOPS: all-cause mortality missed the conventional significance threshold at p=0.051
  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral tablet at 10, 20, 40 and 80 mg, taken once daily, usually in the evening

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S3.

No source is stored against this line.

What is in the pack

Given in the active acid form, so no metabolic activation is required. 66.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold. The rest of the recorded wording: Systemic bioavailability after a bedtime dose is 60% lower than after a morning dose, and the evening dose was nonetheless marginally more effective — the drug is aimed at an organ whose cholesterol synthesis peaks overnight, not at the bloodstream. Food reduces systemic bioavailability without changing the lipid-lowering effect. 8 hours; 20% of an oral dose appears in urine and 70% in faeces, and after intravenous dosing 47% of total body clearance is renal.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeRead from sources, not yet reviewed

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Worth asking a clinician aboutWritten into the record from the studies named on this page

Contraindicated in hypersensitivity, in active liver disease or unexplained persistent transaminase elevation, in pregnancy and during breastfeeding. Myopathy with creatine kinase above ten times the upper limit of normal was rare, under 0.1%, in the trial programme; rare rhabdomyolysis with acute renal failure has been reported. Predisposing factors are age 65 and over, uncontrolled hypothyroidism and renal impairment. Immune-mediated necrotising myopathy is a separate rare entity that persists after the drug is stopped and carries anti-HMG-CoA reductase antibodies. Persistent transaminase elevations occur. Interactions are handled by dose limits rather than contraindications: 20 mg maximum with ciclosporin, 40 mg maximum with clarithromycin, avoid gemfibrozil, caution with other fibrates, colchicine and niacin at 1 g a day or more.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

Reports sent to a regulator

  • These are reports people sent to a regulator. They do not show the medicine caused the reaction.
  • Nobody counted how many people took the medicine and reported nothing.
  • The same event can be reported more than once, and many reports are incomplete.
  • News coverage, lawsuits and new warnings change how often people report.
  • A count is not a rate and not a risk.

Pravastatin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 27533 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • myalgia — 6968 reaction mentions
  • rhabdomyolysis — 6532 reaction mentions
  • drug interaction — 3617 reaction mentions
  • blood creatine phosphokinase increased — 3155 reaction mentions
  • muscular weakness — 2041 reaction mentions
  • myopathy — 1546 reaction mentions
  • renal failure acute — 1476 reaction mentions
  • liver function test abnormal — 990 reaction mentions
  • myositis — 734 reaction mentions
  • immune-mediated myositis — 474 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Oral tablet at 10, 20, 40 and 80 mg, taken once daily, usually in the evening

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

66.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on which forms are sold. The rest of the recorded wording: Systemic bioavailability after a bedtime dose is 60% lower than after a morning dose, and the evening dose was nonetheless marginally more effective — the drug is aimed at an organ whose cholesterol synthesis peaks overnight, not at the bloodstream. Food reduces systemic bioavailability without changing the lipid-lowering effect. 8 hours; 20% of an oral dose appears in urine and 70% in faeces, and after intravenous dosing 47% of total body clearance is renal.

No source is stored against this line.

What is recorded as being sold

  • 200 products list this as an active ingredient in the United States drug directory. 200 of them contain it and nothing else.

    FDA National Drug Code directory · 71610-884 · read 2026-08-29

  • They are sold as powder, tablet and tablet, film coated, taken oral.

    FDA National Drug Code directory · 71610-884 · read 2026-08-29

  • The regulator's established pharmacologic class for it is hmg-coa reductase inhibitor [epc] and hydroxymethylglutaryl-coa reductase inhibitors [moa].

    FDA National Drug Code directory · 71610-884 · read 2026-08-29

  • 127 published labels name it as an active ingredient. 127 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 97f826f0-b5c5-410c-b1f0-523873981e8d · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 97f826f0-b5c5-410c-b1f0-523873981e8d · read 2026-08-29

  • PRAVASTATIN SODIUM is oral at 3 DOSAGE FORMS AND STRENGTHS Pravastatin Sodium Tablets, USP are supplied as: 10 mg of pravastatin sodium: Yellow colored, circular shaped, flat faced tablets with “G5” debossed on one side and “10” debossed on the othe…, recorded as fda label in effect 2026-06-17 in the United States.

    US prescribing information · 97f826f0-b5c5-410c-b1f0-523873981e8d · read 2026-08-30

  • Recorded price in US: 0.05695–0.148 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 86 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Pravastatin studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That WOSCOPS demonstrated an all-cause mortality benefit in primary prevention — the result was 22% at p=0.051 with a confidence interval touching zero

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That the stroke reductions in CARE and LIPID are a property of the drug rather than of the population, when PROSPER found a hazard ratio of 1.03 at p=0.8

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That the greater benefit in women reported in CARE is established, when it rests on a subgroup of 576 women in a trial not powered for it

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That ALLHAT-LLT shows pravastatin does not work, when what it shows is a trial whose control arm adopted the treatment

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Pravastatin are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Every line above can be traced to the study named beside it. Follow the link and read it.

LIPID: overall mortality fell, not just coronary mortality
In plain words
Nine thousand people with previous heart attacks or unstable angina took pravastatin or placebo for six years. Eleven per cent of the drug group died against fourteen per cent on placebo.
What was measured
Coronary and all-cause mortality over a mean 6.1 years in 9,014 patients with established coronary disease
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
LIPID randomised 9,014 patients aged 31 to 75 with previous myocardial infarction or hospitalisation for unstable angina and total cholesterol 155 to 271 mg/dL to pravastatin 40 mg daily or placebo, mean follow-up 6.1 years. Death from coronary heart disease, the primary outcome, occurred in 6.4% against 8.3% — a 24% relative reduction (95% CI 12 to 35, p<0.001). Overall mortality was 11.0% against 14.1%, a 22% relative reduction (95% CI 13 to 31, p<0.001). Myocardial infarction fell 29% (p<0.001), stroke 19% (p=0.048) and coronary revascularisation 20% (p<0.001), with effects similar across all predefined subgroups. This is the trial that carries the label claim of reduced total mortality for this molecule.
Source
LIPID Study Group. N Engl J Med 1998;339:1349-1357 (Long-Term Intervention with Pravastatin in Ischaemic Disease)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
ALLHAT-LLT: nothing, in ten thousand people
In plain words
The largest pravastatin trial compared it not against a placebo but against whatever doctors would normally do. Deaths were identical. Coronary events were not significantly different. The reason is that a third of the comparison group started taking statins too.
What was measured
All-cause mortality at six years, pravastatin 40 mg against usual care, in 10,355 hypertensive adults
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
ALLHAT-LLT randomised 10,355 ambulatory adults aged 55 or over with LDL cholesterol 120 to 189 mg/dL and hypertension plus at least one further coronary risk factor to open-label pravastatin 40 mg daily or usual care, with all-cause mortality as the primary outcome and follow-up to eight years. All-cause mortality was 14.9% against 15.3% at six years — relative risk 0.99 (95% CI 0.89 to 1.11), p=0.88. Coronary events were 9.3% against 10.4%, RR 0.91 (95% CI 0.79 to 1.04), p=0.16. The trial’s own explanation is arithmetic rather than pharmacological: 32% of usual-care participants with known coronary disease and 29% without started lipid-lowering drugs during the trial, so the achieved separation was only 9.6% in total cholesterol and 16.7% in LDL, against roughly 26 to 35% in the placebo-controlled trials. The lesson is not that pravastatin does not work. It is that a trial measures the difference between two arms, not the effect of a drug, and that an unblinded usual-care comparator in an era when the treatment is spreading will erase almost any effect.
Source
ALLHAT Officers and Coordinators. JAMA 2002;288:2998-3007 (ALLHAT-LLT)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
WOSCOPS is cited for a mortality benefit that missed significance
In plain words
The famous primary-prevention trial reduced heart attacks convincingly. Its reduction in deaths from any cause was 22% with a confidence interval that just touched zero, and a p value of 0.051. It is regularly described as though it had proved a survival benefit.
What was measured
That WOSCOPS demonstrated a reduction in all-cause mortality in primary prevention, when the result was 22% at p=0.051 with a confidence interval reaching zero
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
WOSCOPS randomised 6,595 men aged 45 to 64 with mean plasma cholesterol 272 mg/dL and no history of infarction to pravastatin 40 mg each evening or placebo, average follow-up 4.9 years. The primary endpoint — definite non-fatal myocardial infarction or coronary death — occurred 174 times against 248, a 31% relative reduction (95% CI 17 to 43, p<0.001). Death from all cardiovascular causes fell 32% (p=0.033). Death from any cause fell 22%, 95% CI 0 to 40, p=0.051 — on the wrong side of the conventional threshold, with a lower bound of exactly zero. Death from coronary heart disease counting definite cases alone fell 28% at p=0.13, and only reached p=0.042 when suspected cases were added. There was no excess of non-cardiovascular death, which was the specific reassurance the trial was designed to provide. All of that is a strong result. It is not a demonstrated all-cause mortality benefit, and the distinction matters most precisely in primary prevention, where the people being treated are well.
Source
Shepherd J, Cobbe SM, Ford I, et al. N Engl J Med 1995;333:1301-1307 (WOSCOPS)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
PROSPER found more cancers, and the field decided it was noise
In plain words
In the trial of pravastatin in people aged seventy to eighty-two, new cancer diagnoses were 25% more common on the drug, and the difference was statistically significant. Pooling every statin trial afterwards showed no overall increase, and that pooled answer is the one medicine now works from.
What was measured
Incident cancer diagnoses on pravastatin against placebo in 5,804 people aged 70 to 82 (HR 1.25, 95% CI 1.04 to 1.51, p=0.020)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
PROSPER randomised 5,804 men and women aged 70 to 82 with vascular disease or risk factors to pravastatin 40 mg daily or placebo for an average 3.2 years. The primary composite of coronary death, non-fatal myocardial infarction and fatal or non-fatal stroke fell from 473 to 408 events, hazard ratio 0.85 (95% CI 0.74 to 0.97, p=0.014), and coronary death fell 24% (p=0.043). New cancer diagnoses were more frequent on pravastatin: hazard ratio 1.25 (95% CI 1.04 to 1.51), p=0.020. The authors did the correct thing with their own inconvenient finding — they folded it into a meta-analysis of all pravastatin and all statin trials, which showed no overall increase in risk, and reported both. That is the shape of a genuine conclusion shift: a significant signal in one trial, examined against the whole evidence base, and set aside on the strength of it rather than ignored. A reader should note that the setting-aside is itself an inference, drawn from pooled data rather than from a trial designed to test carcinogenicity.
Source
Shepherd J, Blauw GJ, Murphy MB, et al. Lancet 2002;360:1623-1630 (PROSPER)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
PROSPER: no effect on stroke whatsoever
In plain words
The same elderly trial reduced heart attacks and coronary deaths and did absolutely nothing to stroke — a hazard ratio of 1.03 with a p value of 0.8.
What was measured
Fatal and non-fatal stroke on pravastatin against placebo in people aged 70 to 82 (HR 1.03, p=0.8)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Stroke risk in PROSPER was unaffected: hazard ratio 1.03 (95% CI 0.81 to 1.31), p=0.8, over an average 3.2 years in people aged 70 to 82. The hazard ratio for transient ischaemic attack was 0.75 (95% CI 0.55 to 1.00, p=0.051). This sits against LIPID, where stroke fell 19% (p=0.048) in a younger secondary-prevention population, and CARE, where stroke fell 31% (p=0.03). The same molecule at the same dose produced a stroke benefit in two trials and none in a third, and the population that did not benefit is the one at highest absolute stroke risk. Three years may simply be too short for a lipid intervention to move stroke rates in the elderly; the honest statement is that the trial measured no effect and did not explain why.
Source
Shepherd J et al. Lancet 2002;360:1623-1630 (PROSPER)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
The interaction list is short because CYP3A4 is not involved
In plain words
Most statins are broken down by a liver enzyme that dozens of common drugs block. This one is not, and its official interaction list is correspondingly short — dose limits rather than outright bans.
What was measured
Metabolic route and the resulting drug-interaction constraints, from the label pharmacology and interactions sections
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The label describes pravastatin’s major biotransformation pathways as isomerisation to 6-epi pravastatin and the 3α-hydroxyisomer SQ 31,906, and enzymatic ring hydroxylation to SQ 31,945. CYP3A4 is not the route. The consequences are visible in the interactions section: ciclosporin limits pravastatin to 20 mg once daily and clarithromycin to 40 mg once daily, gemfibrozil should be avoided, and fibrates, colchicine and lipid-modifying doses of niacin warrant caution. Every one of these is a dose limit or a caution. Simvastatin, by contrast, is outright contraindicated with strong CYP3A4 inhibitors, ciclosporin, danazol and gemfibrozil. That difference — not potency, in which pravastatin loses to everything modern — is the clinical reason to choose this molecule.
Source
Pravastatin sodium United States prescribing information, sections 7.1 to 7.5 and 12.3
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
CARE: the benefit extended to people whose cholesterol was already normal
In plain words
Four thousand people who had had a heart attack but whose cholesterol was average took pravastatin or placebo. Coronary events fell by a quarter, in people no cholesterol guideline of the time would have treated.
What was measured
Fatal coronary events or non-fatal myocardial infarction over five years in post-infarction patients with average cholesterol
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
CARE randomised 4,159 post-infarction patients — 3,583 men and 576 women — with total cholesterol below 240 mg/dL (mean 209) and LDL 115 to 174 mg/dL (mean 139) to pravastatin 40 mg daily or placebo for five years. The primary endpoint of fatal coronary event or non-fatal myocardial infarction occurred in 10.2% against 13.2%: a 24% relative reduction (95% CI 9 to 36), p=0.003, on an absolute difference of three percentage points. Bypass surgery fell 26% (p=0.005), angioplasty 23% (p=0.01) and stroke 31% (p=0.03). There were no significant differences in overall mortality or in non-cardiovascular mortality — the trial was not powered for them. Two subgroup observations are worth keeping in view precisely because they are subgroup observations: the reduction was larger in women than in men, and larger in patients with higher pretreatment LDL.
Source
Sacks FM, Pfeffer MA, Moye LA, et al. N Engl J Med 1996;335:1001-1009 (CARE)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim

How many documents were read

  • 127 documents were read for this substance.

    RNAWiki source record

  • 127 of them state the same bioavailability, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
KXO2KT9N0G
CAS registry number
81093-37-0
PubChem compound
54687
ChEMBL
CHEMBL1144
ChEBI
63660
WHO international nonproprietary name list entry
6070
RxNorm concept
42463
EMA substance identifier
100000091161
DrugBank
DB00175

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S3.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 20 approved applications cover products containing this substance. The earliest was NDA019898, approved 19911031 to BRISTOL MYERS SQUIBB.

    Drugs@FDA application register · NDA019898 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA019898 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20050101.

    FDA National Drug Code directory · 71610-884 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

4 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

The older medicine-wide conclusion held in this record

Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.

The water-soluble statin with three placebo-controlled mortality trials — LIPID cut overall mortality from 14.1% to 11.0% in 9,014 patients (p<0.001) — and one trial against usual care, ALLHAT-LLT, in which it did nothing at all to all-cause mortality in 10,355 people (RR 0.99, p=0.88) because the control group started taking statins too.

Recorded evidence blocks (11)

What did Pravastatin's largest trial (2133900 people) and its longest (12 years) measure?


2133900 people in Pravastatin's largest registered study, 12 years in its longest registered window, measuring all cause mortality. ClinicalTrials.gov · 2026-09-01

36 phase1, 32 phase4, 28 phase2, 25 phase3, 10 na, 4 na or unstated, 1 early phase1; NCT00840177; 2021-10-21. Last human test completed 2025, NCT04284657.

Interpretation These counts include studies where Pravastatin was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase1
    36
  • phase4
    32
  • phase2
    28
  • phase3
    25
  • na
    10
  • na or unstated
    4
2 more recorded rows
  • early phase1
    1
  • Last recorded human test NCT04284657
    2025-08-04

recorded 2026-09-01 · last checked 2026-09-04

From mouse to human: where has Pravastatin shown lifespan?


mouse: lifespan, rat: lifespan and human: lifespan (133): the rungs where Pravastatin has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation all cause mortality — the recorded outcome words.

Yeast C. elegans Drosophila Mouse lifespanRat lifespanDog Non-human primate Human lifespan
Show the evidence
  • mouse
    lifespan
  • rat
    lifespan
  • human NCT01038154
    lifespan; all cause mortality; 133

recorded 2026-09-01 · last checked 2026-09-04

10 of Pravastatin's trials stopped: accrual/recruitment, other?


accrual/recruitment (3) and other (7): Pravastatin's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Withdrawn due to lack of study participants"; 10 of 133 registered studies

Show the evidence

Trial

  • NCT00305201
    withdrawn; "Withdrawn due to lack of study participants"
  • NCT00467831
    terminated; "insufficient enrollment"
  • NCT00532311
    terminated; "Overall profile of the compound does not offer significant clinical advantage to patients over currently available lipid lowering agents"
  • NCT00738972
    terminated; "Study terminated early due to sample size, not possible to perform further statistical analysis."
  • NCT01173939
    terminated; "With recommendation from IDMC, Steering Committee terminated this trial due to ethical concerns raised by J-ART study."
  • NCT01515813
    withdrawn; "On 05/08/12, team working on revising protocol and re-open study under version 2.0"
4 further recorded trials
  • NCT02484261
    terminated; "Contractual/Funding/Accrual"
  • NCT03944512
    terminated; "participants are no longer being examined or receiving intervention"
  • NCT04190433
    withdrawn; "Administratively closed due to low/no accrual"
  • NCT05251129
    withdrawn; "Study never submitted. Study team instead conducted a retrospective study which did not qualify for registration."

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Pravastatin used 40 mg Pravastatin (Pravachol) — over how long?


studies of Pravastatin used the recorded amount. ClinicalTrials.gov · 2026-09-01

14 recorded entries; human; also "40 mg Pravastatin (Pravachol)", "Combination of Pravastatin 40 mg and Fenofibrate 160 mg", "Pravachol® 80 mg Tablets"

Show the evidence

human

  • NCT00330980
    40 mg Pravastatin (Pravachol)
  • NCT00459745
    Combination of Pravastatin 40 mg and Fenofibrate 160 mg
  • NCT00829309
    Pravachol® 80 mg Tablets
  • NCT00830258
    Pravastatin sodium 80 mg tablets
  • NCT00830258
    Pravachol® 80 mg tablets
  • NCT01146093
    Pravachol 80 mg tablets
8 more recorded rows
  • human NCT01715714
    Pravastatin 40 mg
  • human NCT01856374
    Pravastatin 20mg
  • human NCT01872845
    Pravastatin 40mg
  • human NCT02155530
    pravastatin 20 mg
  • human NCT02155530
    Pravastatin 20 mg (Homogeneous)
  • human NCT04719481
    Pravastatin Sodium 80 MG
  • human NCT05251129
    Pravastatin 40 Mg Oral Tablet
  • human NCT06357104
    Pravastatin Sodium 20 MG

recorded 2026-09-01 · last checked 2026-09-04

Which of 30 day maces after pci, adverse events as a measure of safety and tolerability and all cause mortality did Pravastatin's trials measure?


30 day maces after pci, adverse events as a measure of safety and tolerability and all cause mortality lead 40 outcome terms across Pravastatin's trials. ClinicalTrials.gov · 2026-09-01

ldl c, csf abeta levels, common carotid artery intima media thickness, brachial artery flow mediated vasodilatation, survival and survival at 2 years follow.

Show the evidence
  • plasma thiobarbituric acid reactive substance levels
    1
  • panss total
    1
  • hiv rna
    1
  • ldl c
    1
  • csf abeta levels
    1
  • common carotid artery intima media thickness
    1
14 more recorded rows
  • brachial artery flow mediated vasodilatation
    1
  • survival
    1
  • survival at 2 years
    1
  • serum ldl c
    1
  • fasting plasma low density lipoprotein cholesterol
    1
  • pharmacokinetics
    1
  • low density lipoprotein cholesterol level after 8 weeks
    1
  • bioequivalence
    1
  • low density lipoprotein cholesterol
    1
  • hdl c level n
    1
  • metabolic syndrome
    1
  • general cardiovascular risk profile framingham heart study
    1
  • bioequivalence based on cmax and auc
    1
  • cmax maximum observed concentration
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Pravastatin's 6 ongoing trials reports first?


6 registered trials of Pravastatin are open; earliest completion 2025-09-30. ClinicalTrials.gov · 2026-09-01

Change in Total Kidney Volume; evaluate the benefit on breast-related quality of life of systematic e-PROs; latest 2031-07-31

Show the evidence

Trial

  • NCT03273413
    "Statin Therapy in Patients With Early Stage ADPKD"; n 150; "Change in Total Kidney Volume"; 2025-09-30
  • NCT04356209
    "Improving Theempowerment in Patients With Severe Breast Fibrosis Radio-induced Treated by Pravastatin : Benefit of e-PROs (Electronic " Patient Reported Outcome ") on Breast-related Quality of Life"; n 105; "evaluate the benefit on breast-related quality of life of systematic e-PROs"; 2031-01-31
  • NCT06494111
    "Systemic Therapy of Open-label Prophylactic Pravastatin or Pentoxifylline/Tocopherol Prevention of Lymphedema Advancing to Eventual Fibrosis: an Interventional Registry-embedded Bayesian Randomized Trial for Radiation Sequelae (STOP4-LATE-FIBROSE)"; n 295; "Safety and adverse events (AEs)"; 2031-03-01
  • NCT06912763
    "Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)"; n 250; "Safety and adverse events"; 2031-07-31
  • NCT07098975
    "Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)"; n 154; "Days of prolongation of pregnancy between inclusion and delivery."; 2028-07
  • NCT07217938
    "Novel Treatment of Radiation Associated Dysphagia With Statins"; n 48; "Feasibility of a 12 month trial investigating the use of pravastatin to treat radiation-associated dysphagia"; 2028-10-01

recorded 2026-09-01 · last checked 2026-09-04

Which 69 trials of Pravastatin posted no result?


Posted no result
69 of 69 completed trials
Registrations
NCT00000461, NCT01057654, NCT00000539, NCT00834379, NCT00834847 and NCT00380939, and 63 more
Completion dates
oldest 1992-11; newest 2024-03-20
Show the evidence

Trial

  • NCT00000461
    1992-11
  • NCT01057654
    1998-06
  • NCT00000539
    1999-03
  • NCT00834379
    2000-09
  • NCT00834847
    2000-09
  • NCT00380939
    2000-12
14 further recorded trials
  • NCT00000542
    2002-03
  • NCT00000941
    2002-03
  • NCT01146106
    2002-12
  • NCT01146093
    2003-03
  • NCT00006412
    2003-05
  • NCT00648544
    2003-07
  • NCT00650221
    2003-07
  • NCT03073018
    2003-11
  • NCT00382460
    2003-12
  • NCT00005010
    2004-03
  • NCT00221754
    2004-03
  • NCT00330980
    2004-03
  • NCT00227500
    2004-10
  • NCT00654537
    2004-10

At the median, Pravastatin's trials enrolled 70 people — anything larger?


Median enrolment
70
Largest enrolment
2133900
Registered trials counted
127

What do 27533 spontaneous reports say about Pravastatin — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Pravastatin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 27533 reaction mentions were counted: myalgia 6968; rhabdomyolysis 6532; drug interaction 3617; blood creatine phosphokinase increased 3155. open-targets-adr · CHEMBL1144 · 2026-06-24

Show the evidence
  • myalgia
    6968
  • rhabdomyolysis
    6532
  • drug interaction
    3617
  • blood creatine phosphokinase increased
    3155
  • muscular weakness
    2041
  • myopathy
    1546
4 more recorded rows
  • renal failure acute
    1476
  • liver function test abnormal
    990
  • myositis
    734
  • immune-mediated myositis
    474

recorded 2026-06-24 · last checked 2026-09-04

Was Pravastatin studied with fasting?


fasting is named in Pravastatin's label sentences: "Individuals with elevated fasting low-density lipoprotein cholesterol levels were also randomized to pravastatin versus usual care." openfda-label+europepmc · 2026-08-21

1 recorded statement; fasting

Show the evidence
  • fasting
    Individuals with elevated fasting low-density lipoprotein cholesterol levels were also randomized to pravastatin versus usual care.

recorded 2026-08-21 · last checked 2026-09-04

What is recorded about Pravastatin and NAD+?


"The effect of pravastatin was further investigated using the glucose metabolism assay, which showed that glucose consumption was inhibited both in non-senescent and senescent cells and intracellular nicotinamide adenine dinucleotide (NAD) was decreased in senescent cells." — where Pravastatin and NAD+ appear together. Europe PMC · pathway abstract search · 2023-07-04

NAD+, autophagy, mTOR, AMPK; PMID 35655385, 29686621, 37842233, 19498441

Show the evidence

NAD+

  • PMID 35655385
    "The effect of pravastatin was further investigated using the glucose metabolism assay, which showed that glucose consumption was inhibited both in non-senescent and senescent cells and intracellular nicotinamide adenine dinucleotide (NAD) was decreased in senescent cells."
  • PMID 35655385
    "The results of this study suggest that pravastatin does not induce senolysis, but rather selectively inhibits the proliferation of senescent cells and that cellular senescence is enhanced by decreasing intracellular NAD and promoting IL-1β production."

autophagy

  • PMID 29686621
    "This manuscript determines whether pravastatin protects against dexamethasone-induced avascular necrosis of the femoral head by activating endothelial progenitor cell autophagy."
  • PMID 29686621
    "An autophagy inhibitor, 3-MA, reduced pravastatin protection in endothelial progenitor cells exposed to dexamethasone by attenuating pravastatin-induced autophagy."
  • mTOR PMID 29686621
    "We found that phosphorylation of AMPK was upregulated however phosphorylation of mTOR was downregulated in pravastatin-treated endothelial progenitor cells, which was attenuated by AMPK inhibitor compound C. Furthermore, liver kinase B1 (a phosphorylase of AMPK) knockdown eliminated pravastatin regulated autophagy protein LC3-II in endothelial progenitor cells <i>in vitro</i>."
  • AMPK PMID 29686621
    "We found that phosphorylation of AMPK was upregulated however phosphorylation of mTOR was downregulated in pravastatin-treated endothelial progenitor cells, which was attenuated by AMPK inhibitor compound C. Furthermore, liver kinase B1 (a phosphorylase of AMPK) knockdown eliminated pravastatin regulated autophagy protein LC3-II in endothelial progenitor cells <i>in vitro</i>."
  • autophagy PMID 29686621
    "We found that phosphorylation of AMPK was upregulated however phosphorylation of mTOR was downregulated in pravastatin-treated endothelial progenitor cells, which was attenuated by AMPK inhibitor compound C. Furthermore, liver kinase B1 (a phosphorylase of AMPK) knockdown eliminated pravastatin regulated autophagy protein LC3-II in endothelial progenitor cells <i>in vitro</i>."
  • mTOR PMID 29686621
    "We therefore demonstrated pravastatin rescued endothelial progenitor cells from dexamethasone-induced autophagy dysfunction through the AMPK-mTOR signaling pathway in a liver kinase B1-dependent manner."
  • AMPK PMID 29686621
    "We therefore demonstrated pravastatin rescued endothelial progenitor cells from dexamethasone-induced autophagy dysfunction through the AMPK-mTOR signaling pathway in a liver kinase B1-dependent manner."
  • mTOR PMID 37842233
    "Mechanistic studies involved analysis of Rheb prenylation required for mTOR activation. <b>Results:</b> A strong synergy of CHR2863 with the statins simvastatin, fluvastatin, lovastatin, and pravastatin was demonstrated in U937 cells and two CHR2863-resistant sublines."
2 more recorded rows
  • AMPK PMID 19498441
    "Pravastatin-induced phosphorylation of eNOS, one of the downstreams of AMPK, was inhibited by compound C, an AMPK antagonist."
  • NAD+ PMID 20628008
    "In addition, thrombin increased Rac1/p47(phox)-dependent NAD(P)H oxidase activities of rat aortas within 1 h, resulting in ROS generation, which was prevented by the coadministration of pravastatin."

recorded 2023-07-04 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1144
PubChem CID
54687
CAS number
81093-37-0
RxCUI
42463
InChIKey
TUZYXOIXSAXUGO-PZAWKZKUSA-N
Development code
C10AA03, CS-514, NSC-759253, SQ-31,000, SQ-31000
Also called
Pravastatina, Pravastatine, Pravator, atorvastatin, fluvastatin, rosuvastatin, simvastatin, PRAVASTATIN SODIUM, Dehypotin protect, 1-NAPHTHALENEHEPTANOIC ACID, 1,2,6,7,8,8A-HEXAHYDRO-.BETA.,D,6-TRIHYDROXY-2-METHYL-8-(2-METHYL-1-OXOBUTOXY)-, MONOSODIUM SALT, (1S-(1.ALPHA.(.BETA.S*,DS*),2.ALPHA.,6.ALPHA.,8.BETA.(R*),8A.ALPHA.))-, PRAVASTATIN SODIUM [EP MONOGRAPH], PRAVASTATIN SODIUM [JAN]
Trade name
Elisor, Lipemol, Liplat, Lipostat, Pravachol, Pravafenix
Salt form
Eptastatin sodium, Pravastatin sodium component of pravigard pac
Sources (11)

Sources

  • ClinicalTrials.gov clinicaltrials.gov ·
  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • this record's own fields 2,3,5 ·
  • Europe PMC dose-response search ·
  • Europe PMC pathway abstract search ·
  • Europe PMC search ·
5 more sources

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 11 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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