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Raloxifene

  • Hormone
  • 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 Raloxifene does in the body

In bone the receptor, holding this drug, recruits the helpers that switch bone-preserving genes on, so bone loss slows.

The drug latches onto the same receptor inside cells that estrogen uses. What happens next depends on the tissue. In breast tissue the same drug-receptor pair recruits blockers instead, so estrogen-driven growth is suppressed rather than stimulated. One molecule, opposite effects, decided by which partner proteins are available where.

Why people take it. Thinning bones after menopause, and lowering the chance of developing one type of breast cancer

What happened in people

Fatal stroke hazard ratio 1.49 (95% CI 1.00 to 2.24) and venous thromboembolism 1.44 (1.06 to 1.95) in RUTH

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

The label carries a boxed warning for venous thromboembolism and for death from stroke, and states the drug should not be used for cardiovascular prevention

Where it acts
The nucleus of bone, breast and uterine cells — the same receptor, reading out differently in each tissue
Kind of result
Living longer, or avoiding a major event
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 · 4F86W47BR6 · read 2026-08-29

  • Its recorded molecular formula is C28H27NO4S•HCl, weighing 510.05.

    US prescribing information · f5c25553-1546-451d-8069-c0f484c47741 · read 2026-08-30

Where each sentence above came from

A person wrote this explanation into the record, with the studies named in the path below.

The recorded use, written for a reader without medical training. Not signed off.

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

The four opening statements run to 108 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 32 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
MoodNothing 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.Waiting for a reviewer1 registered symptom measure.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.
Body weightNothing 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.
FocusNothing 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.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
Mood
center for epidemiologic studies depression scale
Body weight
total body fat mass
Focus
alzheimer s disease assessment scale cognitive subscale

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.
Waiting for a reviewer
1 registered symptom measure.
Not recorded
Harms were not a registered measure for this goal.
Only a number moved
1 registered test measure.

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.

Incident vertebral fracture by radiograph at 24 and 36 months

The study showed what it set out to show

Who was studied
MORE — Multiple Outcomes of Raloxifene Evaluation (Ettinger 1999)
How many people
7705
Study design
Phase 3, randomised, blinded, placebo-controlled
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
6.6% at 60 mg against 10.1% on placebo, relative risk 0.7 (95% CI 0.5 to 0.8)
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. Non-vertebral fracture relative risk was 0.9 (95% CI 0.8 to 1.1) — no effect — and venous thromboembolism relative risk was 3.1 (1.5 to 6.2). Both appear in the same abstract as the headline result.

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

Form and route. Oral tablet, 60 mg once daily

Interval reported. 95% CI 0

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

Two co-primary outcomes: coronary events, and invasive breast cancer, over a median 5.6 years

The study did not show it

Who was studied
RUTH — Raloxifene Use for The Heart (NCT00190593)
How many people
10101
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
Coronary events hazard ratio 0.95 (95% CI 0.84 to 1.07) — not met; invasive breast cancer hazard ratio 0.56 (0.38 to 0.83) — met
Repeated elsewhere
Unreplicated

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. Fatal stroke 59 against 39 events, hazard ratio 1.49 (1.00 to 2.24), and venous thromboembolism 103 against 71, hazard ratio 1.44 (1.06 to 1.95). Both are now in the boxed warning.

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

Form and route. Oral tablet, 60 mg once daily

Interval reported. 95% CI 0

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

Incidence of invasive breast cancer

The study showed what it set out to show

Who was studied
STAR P-2 (NCT00003906), initial analysis 2006
How many people
19747
Study design
Phase 3, randomised, double-blind, active-controlled against tamoxifen
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
168 against 163 cases; risk ratio 1.02 (95% CI 0.82 to 1.28) — reported as equivalence
Repeated elsewhere
Failed to Replicate

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. No limitation is recorded for this study.

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

Form and route. Oral tablet, 60 mg once daily

Interval reported. 95% CI 0

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

Incidence of invasive breast cancer at a median 81 months

The study did not show it

Who was studied
STAR P-2, 81-month update (Vogel 2010)
How many people
19747
Study design
Extended follow-up of the same randomised cohort
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Risk ratio raloxifene against tamoxifen 1.24 (95% CI 1.05 to 1.47) — raloxifene significantly worse, retaining 76% of the effect
Repeated elsewhere
Partially Replicated

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. The 2006 conclusion of equivalence supported an approval. The reversal at longer follow-up is in the same trial and is far less widely quoted.

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

Form and route. Oral tablet, 60 mg once daily

Interval reported. 95% CI 1

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

What we know
RNAWiki holds 4 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.3 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 Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.2 registered measures of this kind.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.8 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

    Raloxifene

    What a person takes: Oral tablet, 60 mg once daily.

    The measurement behind this step

    Taken with or without food, which is a real practical advantage over the oral bisphosphonates. A high-fat meal raises peak concentration by 28% without a clinically meaningful change in overall exposure.

  2. Getting in

    Swallowed, well absorbed, and then almost entirely inactivated

    Most of the tablet crosses the gut wall, and then the body tags nearly all of it for disposal before it reaches the circulation. Only about one fiftieth arrives as the working molecule.

    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

    Roughly 60% of an oral dose is absorbed; extensive presystemic glucuronidation in gut wall and liver leaves an absolute bioavailability of 2%. The glucuronides are not simply waste: systemic interconversion and enterohepatic cycling between parent and conjugate govern exposure, and are the reason variability is about 30%.

  3. Reaching the cell

    It enters cells and binds the estrogen receptor

    The molecule slips into cells everywhere and binds the same receptor estrogen uses. That much is identical in bone, breast and womb.

    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

    The benzothiophene core’s two phenolic hydroxyls hydrogen-bond to the glutamate-arginine pair and to a histidine at opposite ends of the ligand-binding pocket, the same contacts the A-ring and D-ring hydroxyls of estradiol make. Apparent volume of distribution is 2348 L/kg and protein binding of parent and monoglucuronides is about 95%.

  4. What it acts on

    A side chain forces the receptor into a different shape

    Unlike estrogen, this molecule has an arm that sticks out of the binding pocket and pushes a lid on the receptor out of place. That displaced lid is why the same receptor behaves differently in different tissues.

    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

    The 4-(2-piperidinylethoxy)benzoyl side chain protrudes from the pocket and displaces helix 12, which in the estradiol-bound receptor caps the pocket and completes the coactivator groove. With helix 12 displaced, the surface that partner proteins read is a different one.

  5. The change it makes

    Which partner proteins are available decides the answer

    In bone the altered receptor still recruits switches-on. In breast and womb it recruits switches-off. Same drug, same receptor, opposite result, decided by what else is in the cell.

    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

    The label attributes agonism or antagonism to the extent of coactivator and corepressor recruitment at estrogen receptor target gene promoters. Cell-type differences in the abundance of SRC-family coactivators and NCoR-family corepressors, and in the ratio of receptor alpha to beta, are what convert one conformation into two opposite transcriptional outcomes.

  6. What that does for a person

    In bone, resorption slows and spinal fractures fall

    Bone turnover markers drop within three months and stay down. Spinal fractures fell by about a third. Fractures elsewhere did not fall at all.

    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

    Suppression of bone resorption and formation markers is evident by 3 months and persists through 36 months. Density gains are modest — 2.1% at the femoral neck and 2.6% at the spine at 60 mg — and the fracture effect is confined to the vertebrae: non-vertebral relative risk was 0.9 (95% CI 0.8 to 1.1).

  7. What that does for a person

    In breast tissue it blocks growth; in veins it raises clot risk

    Invasive breast cancers were roughly halved in the cardiovascular trial. In the same trial, clots and fatal strokes were more frequent, and both are in the boxed warning.

    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

    RUTH: invasive breast cancer hazard ratio 0.56 (95% CI 0.38 to 0.83), driven by estrogen-receptor-positive tumours; venous thromboembolism hazard ratio 1.44 (1.06 to 1.95); fatal stroke 1.49 (1.00 to 2.24). The thromboembolic effect is a residual estrogenic action on hepatic coagulation factor synthesis — a case where the tissue selectivity does not hold.

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.

  • center for epidemiologic studies depression scale
  • positive and negative syndrome scale

Measured

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

  • total body fat mass
  • bone mineral density at the lumbar spine
  • urine n telopeptide of type 1 collagen
  • serum markers of skeletal turnover
  • area under the plasma concentration versus time curve
  • peak plasma concentration
  • serum c telopeptide
  • bone mineral density

Meaningful

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

  • progression free survival rate
  • survival time
  • hip fracture

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)
  • calcium values after beginning teriparatide
  • total abdominal fat area
  • visceral abdominal fat area
  • lumbar spine bmd after 24 months
  • panss at trial completion
  • alzheimer s disease assessment scale cognitive subscale
  • lumbar spine bmd
  • ovulation detected by ultrasound
  • freedom from progression of cancer at 4 months
  • breast density
  • measurable or evaluable disease as assessed by recist
  • cumulative incidence of venous thromboembolism
  • pregnancy
  • brain derived neurotrophic factor
  • collection and interrogation of prostate cancer samples
  • response in negative symptoms
  • incidence of diarrhea
  • clinical response to at 12 months after study enrollment
  • hippocampal volume changes

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

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

How long anything takes

Nine different lengths of time that get confused with each other. None of them is worked out from another.

  1. Before anything is noticed. RNAWiki does not store this separately, and never works it out from another figure on this page.

  2. Before a test result moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  3. Before performance moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  4. How long the result was watched. No finished study window is recorded for a study that tested this substance.

  5. How long people took it. How long people actually took it is not stored. The study window is not the same thing.

  6. How long people were followed. Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.

  7. How fast the body clears it. 27.7 hours hours

    Read from the label, which states: “Raloxifene and its glucuronide conjugates are interconverted by reversible systemic metabolism and enterohepatic cycling, thereby prolonging its plasma elimination half-life to 27.7 hours after oral dosing.”

  8. How long effects linger. RNAWiki does not store this separately, and never works it out from another figure on this page.

  9. Beyond the studies. Nothing is recorded about the long term.

    The longest finished study sets the edge of what anyone measured.

A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.

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.

  • Postmenopausal women with or at risk of osteoporosis, and postmenopausal women at high risk of invasive breast cancer.

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: “Safety and effectiveness in pediatric patients have not been established.”

    US prescribing information · f5c25553-1546-451d-8069-c0f484c47741 · read 2026-08-30

  • On older people, the label states: “Of the total number of patients in placebo-controlled clinical studies of raloxifene hydrochloride tablets, 61% were 65 and over, while 15.5% were 75 and over.”

    US prescribing information · f5c25553-1546-451d-8069-c0f484c47741 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Raloxifene Hydrochloride is contraindicated for use in pregnant women, and is not indicated for use in females of reproductive potential.”

    US prescribing information · f5c25553-1546-451d-8069-c0f484c47741 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Raloxifene hydrochloride tablets are not indicated for use in females of reproductive potential.”

    US prescribing information · f5c25553-1546-451d-8069-c0f484c47741 · read 2026-08-30

  • On people with reduced liver function, the label states: “Raloxifene hydrochloride tablets should be used with caution in patients with hepatic impairment [see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3) ].”

    US prescribing information · f5c25553-1546-451d-8069-c0f484c47741 · read 2026-08-30

  • On people with reduced kidney function, the label states: “Raloxifene hydrochloride tablets should be used with caution in patients with moderate or severe renal impairment [see Warnings and Precautions (5.8) and Clinical Pharmacology (12.3) ].”

    US prescribing information · f5c25553-1546-451d-8069-c0f484c47741 · read 2026-08-30

Where the result stopped carrying

  • The coronary co-primary endpoint of RUTH was not met: hazard ratio 0.95 (95% CI 0.84 to 1.07) in 10,101 women
  • Non-vertebral fracture was not reduced in MORE, in RUTH, or against tamoxifen in STAR
  • Venous thromboembolism relative risk was 3.1 (95% CI 1.5 to 6.2) in MORE and the class of harm reached the boxed warning
  • The equivalence conclusion of STAR did not survive four more years of follow-up of the same women
  • 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, 60 mg once daily

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, S6.

No source is stored against this line.

What is in the pack

Taken with or without food, which is a real practical advantage over the oral bisphosphonates. A high-fat meal raises peak concentration by 28% without a clinically meaningful change in overall exposure.

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 and what that means for what is in the pack.

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

Boxed warning for increased risk of venous thromboembolism and for death from stroke. Deep vein thrombosis, pulmonary embolism and retinal vein thrombosis are labelled risks, greatest in the first four months, with the label directing discontinuation at least 72 hours before and during prolonged immobilisation. The drug is not to be used for primary or secondary prevention of cardiovascular disease, is not recommended in premenopausal women, and is not recommended with systemic estrogens. Hot flushes and leg cramps are the commonest reasons for stopping and follow directly from the mechanism.

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.

Raloxifene appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 947 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • breast cancer — 155 reaction mentions
  • pulmonary embolism — 141 reaction mentions
  • deep vein thrombosis — 139 reaction mentions
  • fall — 120 reaction mentions
  • endometrial cancer — 75 reaction mentions
  • cerebrovascular accident — 72 reaction mentions
  • fracture — 67 reaction mentions
  • hip fracture — 65 reaction mentions
  • bone density decreased — 59 reaction mentions
  • cerebral infarction — 54 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, 60 mg once daily

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

A high-fat meal raises peak concentration by 28% without a clinically meaningful change in overall exposure.

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 and how they compare.

No source is stored against this line.

What is recorded as being sold

  • 39 products list this as an active ingredient in the United States drug directory. 39 of them contain it and nothing else.

    FDA National Drug Code directory · 72162-2418 · read 2026-08-29

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

    FDA National Drug Code directory · 72162-2418 · read 2026-08-29

  • The regulator's established pharmacologic class for it is estrogen agonist/antagonist [epc] and selective estrogen receptor modulators [moa].

    FDA National Drug Code directory · 72162-2418 · read 2026-08-29

  • 23 published labels name it as an active ingredient. 23 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · f5c25553-1546-451d-8069-c0f484c47741 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · f5c25553-1546-451d-8069-c0f484c47741 · read 2026-08-29

  • Raloxifene Hydrochloride is oral at 3 DOSAGE FORMS AND STRENGTHS 60 mg, White film coated round biconvex tablets (not scored) de-bossed with IG on one side and 256 on the other., recorded as fda label in effect 2024-05-13 in the United States.

    US prescribing information · f5c25553-1546-451d-8069-c0f484c47741 · read 2026-08-30

  • Recorded price in US: 0.23589 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 25 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 Raloxifene 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 an osteoporosis drug which reduces spinal fractures also reduces hip fractures — this one does not, in any trial

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 it protects the heart, which is what RUTH was built to test and did not find

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 it matches tamoxifen for breast cancer prevention, the 2006 conclusion that 81-month follow-up reversed

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 tissue selectivity is complete — the clotting and stroke effects are estrogenic actions the selectivity did not exclude

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 Raloxifene 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.

Spinal fractures fell by about a third in 7705 women
In plain words
In the main osteoporosis trial, ten in a hundred women on placebo had a new spinal fracture over three years, against about seven in a hundred on the drug.
What was measured
New vertebral fracture at 36 months, 6.6% at 60 mg against 10.1% on placebo, RR 0.7 (95% CI 0.5 to 0.8)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
MORE randomised 7705 postmenopausal women aged 31 to 80 in 25 countries who met World Health Organization criteria for osteoporosis to raloxifene 60 mg/d, 120 mg/d or placebo, with calcium and cholecalciferol given to all. Among 6828 women with evaluable radiographs at 36 months, at least one new vertebral fracture occurred in 10.1% on placebo, 6.6% at 60 mg and 5.4% at 120 mg; relative risk 0.7 (95% CI 0.5 to 0.8) at 60 mg. Femoral-neck bone mineral density rose 2.1% and spine 2.6% at 60 mg against placebo, all P<0.001.
Source
Ettinger B et al., JAMA 1999;282:637-645 (Multiple Outcomes of Raloxifene Evaluation)
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
It has never reduced a non-vertebral or hip fracture in any trial
In plain words
The same trial counted fractures outside the spine and found no difference at all. That includes hip fractures, which are the ones that end independence.
What was measured
Non-vertebral fracture relative risk 0.9 (95% CI 0.8 to 1.1) in MORE — confidence interval spans 1
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
In MORE, non-vertebral fracture risk for raloxifene against placebo was a relative risk of 0.9 (95% CI 0.8 to 1.1) with both dose groups combined, in 7705 women over three years. In RUTH, over a median 5.6 years in 10,101 women, clinical vertebral fractures fell (64 against 97 events, hazard ratio 0.65, 95% CI 0.47 to 0.89) with an absolute risk reduction of 1.3 per 1000. In STAR, comparing raloxifene with tamoxifen in 19,747 women, the number of osteoporotic fractures in the two groups was similar. No randomised trial has demonstrated a hip fracture reduction with this drug, and none of the three largest trials found one.
Source
Ettinger B et al., JAMA 1999;282:637-645; Barrett-Connor E et al., N Engl J Med 2006;355:125-137
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 cardiovascular trial missed its coronary endpoint and found fatal strokes
In plain words
Ten thousand women with heart disease or heart risk took the drug or placebo for over five years. It did nothing to coronary events, which was one of the two things the trial was set up to measure. Fatal strokes were higher: 59 against 39.
What was measured
Coronary events hazard ratio 0.95 (95% CI 0.84 to 1.07); fatal stroke 59 against 39 events, hazard ratio 1.49 (1.00 to 2.24)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
RUTH randomised 10,101 postmenopausal women of mean age 67.5 with coronary heart disease or multiple risk factors for it, median follow-up 5.6 years, with two primary outcomes. Coronary events showed no significant effect: 533 against 553 events, hazard ratio 0.95 (95% CI 0.84 to 1.07). Invasive breast cancer fell: 40 against 70 events, hazard ratio 0.56 (0.38 to 0.83). Total stroke and all-cause death did not differ, but fatal stroke was increased — 59 against 39 events, hazard ratio 1.49 (95% CI 1.00 to 2.24), absolute increase 0.7 per 1000 woman-years — as was venous thromboembolism, 103 against 71 events, hazard ratio 1.44 (1.06 to 1.95). Both findings are in the boxed warning, and the label states the drug should not be used for primary or secondary prevention of cardiovascular disease.
Source
Barrett-Connor E et al., N Engl J Med 2006;355:125-137 (RUTH, NCT00190593)
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
STAR said it matched tamoxifen; longer follow-up said it did not
In plain words
The head-to-head trial reported in 2006 that the two drugs prevented invasive breast cancer equally well, and the drug was approved for that use. Four years of extra follow-up showed the newer drug was significantly worse, keeping about three-quarters of the older drug’s effect.
What was measured
That raloxifene is as effective as tamoxifen at preventing invasive breast cancer — the initial conclusion, reversed by the same trial at longer follow-up
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
STAR randomised 19,747 postmenopausal women of mean age 58.5 with a mean five-year breast cancer risk of 4.03% to tamoxifen 20 mg/d or raloxifene 60 mg/d for five years. The 2006 analysis reported 163 invasive breast cancers on tamoxifen against 168 on raloxifene, risk ratio 1.02 (95% CI 0.82 to 1.28), and concluded raloxifene was as effective. At a median follow-up of 81 months the risk ratio had widened to 1.24 (95% CI 1.05 to 1.47) — a significant disadvantage — with raloxifene retaining 76% of tamoxifen’s effectiveness against invasive disease. The toxicity advantages strengthened over the same period: endometrial cancer risk ratio 0.55 (0.36 to 0.83, P=0.003, not significant in the initial analysis), uterine hyperplasia 0.19 (0.12 to 0.29) and thromboembolic events 0.75 (0.60 to 0.93). There were no significant mortality differences at either analysis.
Source
Vogel VG et al., JAMA 2006;295:2727-2741 (STAR P-2, NCT00003906); Vogel VG et al., Cancer Prev Res 2010;3:696-706 (81-month update)
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
The label separates the cancers it prevents from the ones it does not
In plain words
It is approved to lower the risk of one kind of breast cancer. The label states in the indications section that it is not for treating breast cancer, not for preventing recurrence, and not for preventing the non-invasive kind.
What was measured
Noninvasive breast cancer, raloxifene against tamoxifen: 80 against 57 cases, risk ratio 1.40 (95% CI 0.98 to 2.00)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Important Limitations paragraph of the label states that raloxifene is not indicated for the treatment of invasive breast cancer, for reduction of the risk of recurrence, or for reduction of the risk of noninvasive breast cancer. That last exclusion tracks the STAR data directly: noninvasive breast cancer occurred in 57 cases on tamoxifen against 80 on raloxifene in the 2006 analysis, risk ratio 1.40 (95% CI 0.98 to 2.00), narrowing to 1.22 (0.95 to 1.59) at 81 months. A limitation written into the indications rather than into the warnings is unusual, and it is there because the distinction is easy for a reader to miss.
Source
Raloxifene hydrochloride United States prescribing information, Indications and Usage 1.3 (openFDA label endpoint); Vogel VG et al., JAMA 2006;295:2727-2741
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
Two percent of the tablet reaches the bloodstream intact
In plain words
About sixty percent of the dose is absorbed from the gut, and almost all of it is chemically tagged and inactivated on the way through the gut wall and liver. Two percent survives as the active drug.
What was measured
Absolute bioavailability 2% despite approximately 60% absorption; within-subject pharmacokinetic variability about 30%
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Approximately 60% of an oral dose is absorbed, but presystemic glucuronide conjugation is extensive and absolute bioavailability is 2%. Time to maximum concentration and bioavailability are both functions of systemic interconversion and enterohepatic cycling between raloxifene and its glucuronides, which is why within-subject variability of most pharmacokinetic parameters is around 30%. A high-fat meal raises Cmax by 28% and AUC by 16% without a clinically meaningful change in exposure, so unlike a bisphosphonate this drug can be taken with food. The disposition data come from more than 3000 women in the osteoporosis programme analysed by a population approach.
Source
Raloxifene hydrochloride United States prescribing information, Clinical Pharmacology 12.3 (openFDA label endpoint)
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

  • 23 documents were read for this substance.

    RNAWiki source record

  • 23 of them state the same halfLife, and they agree.

    RNAWiki source record

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

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
4F86W47BR6
RxNorm concept
1490065

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, S6.

  • 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

  • 10 approved applications cover products containing this substance. The earliest was NDA020815, approved 19971209 to LILLY.

    Drugs@FDA application register · NDA020815 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA020815 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19971209.

    FDA National Drug Code directory · 72162-2418 · 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

3 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.

  • 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.

A tissue-selective estrogen receptor modulator that cut new spinal fractures from 10.1% to 6.6% over three years in 7705 women but left non-vertebral fractures untouched at a relative risk of 0.9 (95% CI 0.8 to 1.1), and that carries a boxed warning for venous thromboembolism and for death from stroke after a 10,101-woman cardiovascular trial found 59 fatal strokes against 39 on placebo.

Recorded evidence blocks (12)

What did Raloxifene's largest trial (684815 people) and its longest (13 years) measure?


684815 people in Raloxifene's largest registered study, 13 years in its longest registered window, measuring Survival time. ClinicalTrials.gov · 2026-09-01

20 phase4, 15 phase3, 13 phase2, 7 na, 6 na or unstated, 4 phase1, 1 early phase1; NCT00030147; 2015-06. Last human test completed 2024, NCT04926545.

Interpretation These counts include studies where Raloxifene 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
  • phase4
    20
  • phase3
    15
  • phase2
    13
  • na
    7
  • na or unstated
    6
  • phase1
    4
2 more recorded rows
  • early phase1
    1
  • Last recorded human test NCT04926545
    2024-07-20

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

From mouse to human: where has Raloxifene shown lifespan?


mouse: lifespan, rat: mechanism-only and human: lifespan (64): the rungs where Raloxifene has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Survival time — the recorded outcome words.

Yeast C. elegans Drosophila Mouse lifespanRat mechanism-onlyDog Non-human primate Human lifespan
Show the evidence
  • mouse
    lifespan
  • rat
    mechanism-only
  • human NCT01050842
    lifespan; Survival time; 64

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

3 of Raloxifene's trials stopped: accrual/recruitment, other?


accrual/recruitment (2) and other (1): Raloxifene's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"See termination reason in detailed description."; 3 of 64 registered studies

Show the evidence

Trial

  • NCT00847821
    terminated; "See termination reason in detailed description."
  • NCT01607320
    terminated; "Over budget, slow recruitment, and personnel change"
  • NCT03147196
    withdrawn; "lack of accrual"

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

Human studies of Raloxifene used Raloxifene 60 Mg Oral Tablet — over how long?


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

9 recorded entries; human; oral; also "Raloxifene 60 Mg Oral Tablet", "Evista 60 Mg Oral Tablet", "Raloxifene 30 Mg Oral Tablet"

Show the evidence

human

  • NCT00723398
    Raloxifene 60 Mg Oral Tablet
  • NCT00723398
    Evista 60 Mg Oral Tablet
  • NCT00723398
    Raloxifene 30 Mg Oral Tablet
  • NCT00723398
    Evista 30 Mg Oral Tablet
  • NCT00723398
    Lovaza 4gm & Raloxifene 30mg
  • NCT00723398
    oral; Pitavastatin 4 gm and Evista 30 mg oral tablet
3 more recorded rows
  • human NCT00774267
    Raloxifene 60 mg
  • human NCT01573637
    Raloxifene hydrochloride 60 mg, Laboratory Esteve.
  • human NCT03764462
    Raloxifene 60mg

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

Raloxifene's half-life is 27.7 hours — which schedules were studied?


27.7 hours, the half-life Raloxifene's label states. openfda-label · 3798c70b-a4b0-4811-9788-e4c9cff47ebe · 2026-08-30

bioavailability 2% %.

Show the evidence
  • half life
    27.7 hours hours; Raloxifene and its glucuronide conjugates are interconverted by reversible systemic metabolism and enterohepatic cycling, thereby prolonging its plasma elimination half-life to 27.7 hours after oral dosing.
  • bioavailability
    2% %; Absolute bioavailability of raloxifene is 2%.
  • metabolism
    Metabolism — Biotransformation and disposition of raloxifene in humans have been determined following oral administration of 14 C-labeled raloxifene.

recorded 2026-08-30 · last checked 2026-09-04

Which of alzheimer s disease assessment scale cognitive subscale, area under the plasma concentration versus time curve and bone mineral density did Raloxifene's trials measure?


alzheimer s disease assessment scale cognitive subscale, area under the plasma concentration versus time curve and bone mineral density lead 32 outcome terms across Raloxifene's trials. ClinicalTrials.gov · 2026-09-01

total abdominal fat area, visceral abdominal fat area, lumbar spine bmd after 24 months, panss at trial completion, bone mineral density at the lumbar spine and alzheimer s disease assessment scale cognitive subscale follow.

Show the evidence
  • center for epidemiologic studies depression scale
    1
  • calcium values after beginning teriparatide
    1
  • total body fat mass
    1
  • total abdominal fat area
    1
  • visceral abdominal fat area
    1
  • lumbar spine bmd after 24 months
    1
14 more recorded rows
  • panss at trial completion
    1
  • bone mineral density at the lumbar spine
    1
  • alzheimer s disease assessment scale cognitive subscale
    1
  • lumbar spine bmd
    1
  • ovulation detected by ultrasound
    1
  • urine n telopeptide of type 1 collagen
    1
  • freedom from progression of cancer at 4 months
    1
  • breast density
    1
  • progression free survival rate
    1
  • survival time
    1
  • measurable or evaluable disease as assessed by recist
    1
  • serum markers of skeletal turnover
    1
  • cumulative incidence of venous thromboembolism
    1
  • pregnancy
    1

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

Which of Raloxifene's 4 ongoing trials reports first?


4 registered trials of Raloxifene are open; earliest completion 2023-08-01. ClinicalTrials.gov · 2026-09-01

Serum c-telopeptide (CTX); Incidence of diarrhea (grade ≥2); latest 2031-03

Show the evidence

Trial

  • NCT03623633
    "Comparative Antiresorptive Efficacy Discontinuation of Denosumab"; n 51; "Serum c-telopeptide (CTX)"; 2023-08-01
  • NCT06055179
    "XCHT for Irinotecan-Induced Gut Toxicities (Randomized Controlled Trial)"; n 98; "Incidence of diarrhea (grade ≥2)"; 2026-12-01
  • NCT06944145
    "New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia"; n 242; "Clinical response to at 12 months after study enrollment"; 2030-08-31
  • NCT07470606
    "Memantine +/- Raloxifene for Cognitive Preservation After Radiation Therapy to the Brain"; n 108; "Hippocampal volume changes"; 2031-03

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

Which 40 trials of Raloxifene posted no result?


Posted no result
40 of 40 completed trials
Registrations
NCT00670319, NCT00004915, NCT00031811, NCT00532246, NCT00532428 and NCT00332553, and 34 more
Completion dates
oldest 1999-09; newest 2024-07-20
Show the evidence

Trial

  • NCT00670319
    1999-09
  • NCT00004915
    2000-02
  • NCT00031811
    2003-04
  • NCT00532246
    2003-08
  • NCT00532428
    2003-09
  • NCT00332553
    2004-05
14 further recorded trials
  • NCT00065767
    2005-03
  • NCT00019500
    2005-06
  • NCT00035256
    2005-07
  • NCT00163137
    2005-10
  • NCT00190593
    2005-11
  • NCT00191425
    2005-11
  • NCT00001848
    2006-01
  • NCT00675688
    2006-01
  • NCT00149604
    2006-02
  • NCT00108238
    2006-12
  • NCT00206557
    2007-04
  • NCT00031850
    2007-05
  • NCT00079924
    2007-05
  • NCT00310531
    2007-06

At the median, Raloxifene's trials enrolled 108 people — anything larger?


Median enrolment
108
Largest enrolment
684815
Registered trials counted
60

What do 947 spontaneous reports say about Raloxifene — 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.

Raloxifene appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 947 reaction mentions were counted: breast cancer 155; pulmonary embolism 141; deep vein thrombosis 139; fall 120. open-targets-adr · CHEMBL1116 · 2026-06-24

Show the evidence
  • breast cancer
    155
  • pulmonary embolism
    141
  • deep vein thrombosis
    139
  • fall
    120
  • endometrial cancer
    75
  • cerebrovascular accident
    72
4 more recorded rows
  • fracture
    67
  • hip fracture
    65
  • bone density decreased
    59
  • cerebral infarction
    54

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

Was Raloxifene studied with exercise?


exercise is named in Raloxifene's label sentences: "They related to the five interventions (alendronate, etidronate, risedronate, raloxifene and teriparatide) and to five comparators (calcium, calcium plus vitamin D, calcitriol, hormone replacement therapy and exercise), as well as placebo or no treatment." openfda-label+europepmc · 2005-01-01

1 recorded statement; exercise

Show the evidence
  • exercise
    They related to the five interventions (alendronate, etidronate, risedronate, raloxifene and teriparatide) and to five comparators (calcium, calcium plus vitamin D, calcitriol, hormone replacement therapy and exercise), as well as placebo or no treatment.

recorded 2005-01-01 · last checked 2026-09-04

What is recorded about Raloxifene and autophagy?


"Recent studies report that raloxifene, a selective oestrogen receptor modulator, can induce cellular autophagy." — where Raloxifene and autophagy appear together. Europe PMC · pathway abstract search · 2024-07-09

autophagy, AMPK, mTOR, sirtuin, NAD+; PMID 35260900, 33203845, 25537862, 38978136

Show the evidence

autophagy

  • PMID 35260900
    "Recent studies report that raloxifene, a selective oestrogen receptor modulator, can induce cellular autophagy."
  • PMID 35260900
    "Our results demonstrate raloxifene's potential as a broad-spectrum antibacterial agent through autophagic induction in host cells and prevention of intracellular invasion and proliferation of pathogenic bacteria."
  • PMID 33203845
    "Raloxifene and hypoxia also demonstrated a block in late autophagy similar to the known autophagy inhibitor chloroquine (CQ)."

AMPK

  • PMID 25537862
    "Interestingly, raloxifene decreased the level of intracellular adenosine triphosphate (ATP) and activated the AMPK/ULK1 pathway."
  • PMID 25537862
    "Our current study demonstrates that raloxifene induces autophagy via the activation of AMPK by sensing decreases in ATP, and that the overactivation of autophagy promotes cell death and thereby mediates the anti-cancer effects of raloxifene in breast cancer cells."
  • mTOR PMID 38978136
    "Use of numerous medications such as tyrosine kinase inhibitors (sunitinib), monoclonal antibodies (bevacizumab), fusion proteins (aflibercept), mTOR inhibitors (everolimus), radiopharmaceuticals (radium 223), selective estrogen receptor modulators (raloxifene), and immunosuppressants (methotrexate and corticosteroids) has been reported to be a risk factor for development of medication-related…"
  • sirtuin PMID 29990529
    "Neither activators of estrogen receptors (diethylstilbestrol [18 μM] and raloxifene [8 μM]) nor activator of SIRT1 (SRT1720 [2.4-3.2 μM]) caused morphological and molecular alterations that are comparable to trans-resveratrol (10 μM)."

NAD+

  • PMID 11980689
    "Administration of raloxifene had no effect on the expression of the essential NAD(P)H oxidase subunits p22phox and nox1 in the vasculature but reduced the activity and expression of vascular membrane-bound rac1, a GTPase required for the activation of the NAD(P)H oxidase."
  • PMID 16899047
    "Raloxifene, which inhibits O(2*-) production by NAD(P)H oxidase, reduced the effects of AC on H(2)O(2) and O(2*-) production."

recorded 2024-07-09 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1116
PubChem CID
54900
CAS number
82640-04-8
RxCUI
166551
InChIKey
GZUITABIAKMVPG-UHFFFAOYSA-N
Also called
RALOXIFENE HYDROCHLORIDE, Raloxifene teva, Eviden, Keoxifene, Raloxifeno, Raloxiphene, Raxeto, raloxifene 60 mg, selective estrogen receptor modulator, selective estrogen receptor modulators, serm, 6-HYDROXY-2-(P-HYDROXYPHENYL)BENZO(.BETA.)THIEN-3-YL-P-(2-PIPERIDINOETHOXY)PHENYL KETONE, HYDROCHLORIDE
Trade name
Evirex, Evista, Optruma, Ostiral, Razylan
Salt form
Keoxifene hydrochloride, Raloxifene hcl
Development code
LY-156758, LY156758, NSC-706725, J22.982B, LY-139481, NSC-747974
Sources (10)

Sources

4 more sources
  • open-targets-adr CHEMBL1116 ·
  • openfda-label 3798c70b-a4b0-4811-9788-e4c9cff47ebe ·
  • openfda-label+europepmc K1:YX9162EO3I ·
  • national registers US, EU, CA ·

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: 10 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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