This page shows what was measured, who it was measured in, and what that does not settle.
What Tranexamic acid does in the body
Heavy bleeding — from injury, after childbirth, during surgery, during periods, or after a dental extraction in haemophilia
A clot is a mesh, and the enzyme that dissolves it has to hold on to the mesh before it can cut. It holds on at spots shaped to fit the amino acid lysine. Tranexamic acid is a stiff, ring-shaped copy of lysine that fits those spots tightly and does not let go easily. The dissolving enzyme is still there and still working, but it cannot get a grip, so clots that form stay formed.
What happened in people
All-cause death 14.5% against 16.0% in 20,211 randomised trauma patients (RR 0.91, 95% CI 0.85-0.97, p=0.0035), with death due to bleeding 4.9% against 5.7%
✎ 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.
That WOMAN showed a reduction in maternal death overall or in hysterectomy — the registered primary composite was not reduced (RR 0.97, p=0.65) and hysterectomy was unchanged (RR 1.02, p=0.84)
Where it acts
Blood plasma and the fibrin clot surface; it also crosses into cerebrospinal fluid, which is where the seizures come from
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 · 6T84R30KC1 · read 2026-08-29
Its recorded molecular formula is C8H15N0, weighing 157.2.
US prescribing information · 031bf7c2-3b07-469d-bc5a-31fc6238e25f · read 2026-08-30
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 128 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.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
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.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
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.
What happened in people◇Read 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.
Death in hospital within four weeks of injury
✓ The study showed what it set out to show
Who was studied
CRASH-2 (NCT00375258, ISRCTN86750102)
How many people
20211
Study design
Phase 3 randomised placebo-controlled trial, 274 hospitals in 40 countries
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
All-cause mortality 14.5% vs 16.0%, RR 0.91 (95% CI 0.85-0.97), p = 0.0035
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. 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. Intravenous infusion, oral tablet, and topical or mouthwash preparations
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
5.3% vs 5.5%, RR 0.97 (95% CI 0.87-1.09), p = 0.65
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. The primary endpoint was missed and hysterectomy alone was unchanged (RR 1.02, p=0.84). The widely quoted result — death due to bleeding, RR 0.81, p=0.045 — became the trial's focus after the sample size was raised from 15,000 to 20,000 mid-study, a change the investigators report and explain in the paper.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous infusion, oral tablet, and topical or mouthwash preparations
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Head injury-related death in hospital within 28 days, in patients treated within three hours
✗ The study did not show it
Who was studied
CRASH-3 (NCT01402882, ISRCTN15088122)
How many people
12737
Study design
Randomised placebo-controlled trial, 175 hospitals in 29 countries
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
18.5% vs 19.8%, RR 0.94 (95% CI 0.86-1.02) — interval includes 1
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. The reported benefit rests on the prespecified mild-to-moderate subgroup (RR 0.78, 95% CI 0.64-0.95) against no effect in severe injury (RR 0.99), p for heterogeneity 0.030.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous infusion, oral tablet, and topical or mouthwash preparations
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Death due to bleeding within five days of randomisation
✗ The study did not show it
Who was studied
HALT-IT (NCT01658124, ISRCTN11225767)
How many people
12009
Study design
Randomised placebo-controlled trial, 164 hospitals in 15 countries
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
4% vs 4%, RR 0.99 (95% CI 0.82-1.18)
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. Venous thromboembolic events were higher on tranexamic acid, 0.8% vs 0.4%, RR 1.85 (95% CI 1.15-2.98). The investigators recommended against use in gastrointestinal bleeding outside a trial.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous infusion, oral tablet, and topical or mouthwash preparations
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Composite of death and thrombotic complications within 30 days after coronary artery surgery
✗ The study did not show it
Who was studied
ATACAS (ACTRN12605000557639)
How many people
4631
Study design
Randomised placebo-controlled trial with a two-by-two factorial aspirin comparison
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
16.7% vs 18.1%, relative risk 0.92 (95% CI 0.81-1.05), p = 0.22
Repeated elsewhere
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. Seizures occurred in 0.7% on tranexamic acid against 0.1% on placebo (p=0.002). Blood product use fell from 7,994 to 4,331 units (p<0.001) and reoperation for major haemorrhage from 2.8% to 1.4% (p=0.001), which is what the trial is remembered for.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous infusion, oral tablet, and topical or mouthwash preparations
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Composite bleeding outcome at 30 days, with a coprimary non-inferiority safety test on a composite cardiovascular outcome
✗ The study did not show it
Who was studied
POISE-3 tranexamic acid comparison (NCT03505723)
How many people
9535
Study design
Randomised placebo-controlled trial in noncardiac surgery, partial factorial design
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Bleeding 9.1% vs 11.7%, HR 0.76 (95% CI 0.67-0.87), p<0.001 for superiority; cardiovascular HR 1.02, upper bound of the one-sided 97.5% CI 1.14 against a prespecified margin of 1.125, one-sided p = 0.04 against a required 0.025
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. Non-inferiority on the cardiovascular safety composite was prespecified and was not established. This is a failure to exclude harm, not a demonstration of harm, and it is seldom quoted next to the bleeding result.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous infusion, oral tablet, and topical or mouthwash preparations
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 6 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 it changes in the body◇Read 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.
Start
Tranexamic acid
What a person takes: Intravenous infusion, oral tablet, and topical or mouthwash preparations.
The measurement behind this step
Stable at room temperature and given as a slow intravenous injection or infusion in bleeding emergencies, as oral tablets for cyclic heavy menstrual bleeding, and as a mouthwash for mucosal bleeding in people on anticoagulants or with bleeding disorders. The tablet formulation reached the United States in 2009, twenty-three years after the injection.
Getting in
A drip, a tablet, or a paramedic at the roadside
It is a small, stable, water-soluble molecule that needs no refrigeration. That is why it can be given in an ambulance in a country with no blood bank, and it is the reason the trials could be run at the scale they were.
╌╌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
Given intravenously in trauma, obstetric and surgical bleeding, and orally as tablets for cyclic heavy menstrual bleeding. Elimination is renal and largely of unchanged drug, so exposure rises in renal impairment. The molecule is a zwitterionic amino acid analogue with no chiral centre in the pharmacological sense but a critical ring geometry.
It reaches the clot, and it also reaches the brain
Most of it circulates in the blood where the clots are. A fraction crosses into the fluid around the brain and spinal cord, and that fraction arrives late — the peak comes after the drip has been switched off.
──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
In patients undergoing major cardiovascular surgery, peak cerebrospinal fluid concentration occurred after termination of the infusion, and in one patient coincided with the onset of seizures. The central compartment lags the plasma compartment, which is why post-operative seizures happen hours after the drug is stopped.
The ring locks into the pocket plasmin uses as a handhold
The molecule is a stiff ring with a lysine-shaped arm. That stiffness is the whole trick: it holds the shape the target pocket wants instead of having to be bent into it, so it binds tightly.
╌╌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
Trans-4-(aminomethyl)cyclohexanecarboxylic acid occupies the lysine-binding sites in the kringle domains of plasminogen and plasmin. The cyclohexane ring fixes the amine and the carboxylate at the separation the site requires, giving far higher affinity than the freely rotating chain of aminocaproic acid. The FDA label describes native plasminogen as carrying four to five low-affinity sites with a dissociation constant near 750 micromol/L and one high-affinity site near 1.1 micromol/L.
Clot dissolution is not something plasmin does from a distance. It has to line up on the clot alongside the enzyme that activates it. Blocking the handhold prevents the line-up, so the reaction never gets going.
╌╌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
Fibrinolysis is a surface-templated reaction: plasminogen and tissue plasminogen activator both bind lysine residues exposed on partially degraded fibrin, and that colocalisation accelerates plasmin generation by orders of magnitude. Occupying the lysine-binding sites blocks assembly rather than catalysis, which is why the effect is described as preserving and stabilising the fibrin matrix rather than as inhibiting an enzyme.
Clots that would have come apart hold. In injured patients treated within a few hours that translated into fewer deaths. In people bleeding from the gut it translated into nothing, and into more clots in the legs and lungs.
──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
All-cause mortality 14.5% against 16.0% in 20,211 trauma patients (RR 0.91, 95% CI 0.85-0.97). Death due to bleeding 4% against 4% in 12,009 patients with gastrointestinal bleeding (RR 0.99, 95% CI 0.82-1.18), with venous thromboembolism 0.8% against 0.4% (RR 1.85, 95% CI 1.15-2.98). The mechanism is the same in both trials. The outcome is not.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 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 is missing or unclear◇Read 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.
Trauma patients within three hours of injury, women with post-partum haemorrhage, surgical patients at risk of significant bleeding, people with haemophilia undergoing dental work, and women with heavy periods. It is on the WHO Model List of Essential Medicines.
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 tranexamic acid USP tablets have been established in females of reproductive potential.”
US prescribing information · 031bf7c2-3b07-469d-bc5a-31fc6238e25f · read 2026-08-30
On older people, the label states: “Tranexamic acid USP tablets are indicated for females of reproductive potential and is not intended for use by postmenopausal women.”
US prescribing information · 031bf7c2-3b07-469d-bc5a-31fc6238e25f · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Tranexamic acid USP tablets are not indicated for use in pregnant women.”
US prescribing information · 031bf7c2-3b07-469d-bc5a-31fc6238e25f · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Tranexamic acid is present in the mother’s milk at a concentration of about one hundredth of the corresponding serum concentration (see Data ).”
US prescribing information · 031bf7c2-3b07-469d-bc5a-31fc6238e25f · read 2026-08-30
On people with reduced liver function, the label states: “The effect of hepatic impairment on the pharmacokinetics of tranexamic acid USP tablets has not been studied.”
US prescribing information · 031bf7c2-3b07-469d-bc5a-31fc6238e25f · read 2026-08-30
On people with reduced kidney function, the label states: “The effect of renal impairment on the pharmacokinetics of tranexamic acid USP tablets has not been studied.”
US prescribing information · 031bf7c2-3b07-469d-bc5a-31fc6238e25f · read 2026-08-30
Where the result stopped carrying
HALT-IT found no reduction in death due to gastrointestinal bleeding and a near-doubling of venous thromboembolism, and its investigators recommended against the use they had set out to support
ATACAS missed its primary composite of death and thrombotic complications (p=0.22) while succeeding decisively on the bleeding endpoints it is remembered for
POISE-3 failed its prespecified cardiovascular non-inferiority test
The first oral formulation in the United States arrived in 2009, twenty-three years after the injection, as a Type 3 new dosage form rather than as a new molecule
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 take◇Read 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 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 (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
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 take◇Read 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
Given by a clinician
❝ 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
Intravenous infusion, oral tablet, and topical or mouthwash preparations
✎ 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: S6.
No source is stored against this line.
What is in the pack
Stable at room temperature and given as a slow intravenous injection or infusion in bleeding emergencies, as oral tablets for cyclic heavy menstrual bleeding, and as a mouthwash for mucosal bleeding in people on anticoagulants or with bleeding disorders.
✎ 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: The tablet formulation reached the United States in 2009, twenty-three years after the injection.
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 take◇Read 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
Rapid intravenous injection causes hypotension. Post-operative seizures are the characteristic serious adverse effect and are concentration-dependent, mediated by competitive antagonism at glycine receptors; in coronary surgery the rate was 0.7% against 0.1% on placebo. Venous thromboembolism was increased in gastrointestinal bleeding (0.8% against 0.4%). It is cleared renally, so exposure rises with impaired kidney function. It is contraindicated in active intravascular clotting, and its use in upper urinary tract bleeding risks a clot that cannot be dissolved obstructing the ureter. Colour vision disturbance is described with prolonged use.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
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 unclear◇Read 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
Intravenous infusion, oral tablet, and topical or mouthwash preparations
✎ 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
The tablet formulation reached the United States in 2009, twenty-three years after the injection.
✎ 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
65 products list this as an active ingredient in the United States drug directory. 65 of them contain it and nothing else.
FDA National Drug Code directory · 72888-178 · read 2026-08-29
They are sold as injection, injection, solution, powder, tablet and tablet, film coated, taken intravenous and oral.
FDA National Drug Code directory · 72888-178 · read 2026-08-29
The regulator's established pharmacologic class for it is antifibrinolytic agent [epc] and decreased fibrinolysis [pe].
FDA National Drug Code directory · 72888-178 · read 2026-08-29
47 published labels name it as an active ingredient. 47 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 031bf7c2-3b07-469d-bc5a-31fc6238e25f · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 031bf7c2-3b07-469d-bc5a-31fc6238e25f · read 2026-08-29
Tranexamic Acid is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: 650 mg white oval-shaped debossed with the marking “FP650” Tablets: 650 mg ( 3 ), recorded as fda label in effect 2025-09-29 in the United States.
US prescribing information · 031bf7c2-3b07-469d-bc5a-31fc6238e25f · read 2026-08-30
Recorded price in US: 0.38684 USD per one millilitre, across 17 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
Recorded price in US: 0.85674 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 10 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 take◇Read 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 Tranexamic acid 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 unclear◇Read 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 WOMAN showed a reduction in maternal death overall or in hysterectomy — the registered primary composite was not reduced (RR 0.97, p=0.65) and hysterectomy was unchanged (RR 1.02, p=0.84)
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 CRASH-3 showed a mortality benefit in traumatic brain injury — the primary comparison did not exclude no effect (RR 0.94, 95% CI 0.86-1.02) and the quoted number is a subgroup
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 a benefit in trauma generalises to bleeding as a category — the same investigators found nothing in 12,009 patients bleeding from the gut
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 drug is thrombotically neutral — the prespecified non-inferiority test in 9,535 surgical patients was not passed, and venous thromboembolism nearly doubled in HALT-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.
What is missing or unclear◇Read 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 Tranexamic acid 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 people◇Read 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.
CRASH-2: all-cause death fell from 16.0% to 14.5% in 20,211 randomised patients
In plain words
In the largest trial ever run in trauma, giving tranexamic acid within eight hours of injury reduced deaths from any cause. It is the clearest survival result of any drug on these twelve pages.
What was measured
All-cause death in hospital within four weeks of injury
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
CRASH-2 randomised 20,211 adult trauma patients with, or at risk of, significant bleeding across 274 hospitals in 40 countries within eight hours of injury, to tranexamic acid or matching placebo, both participants and staff masked. 10,060 and 10,067 patients respectively were analysed. All-cause mortality within four weeks was 1,463 (14.5%) against 1,613 (16.0%), relative risk 0.91 (95% CI 0.85 to 0.97, p=0.0035). Death due to bleeding was 489 (4.9%) against 574 (5.7%), RR 0.85 (95% CI 0.76 to 0.96, p=0.0077). Vascular occlusive events were not increased. All analyses were by intention to treat.
Written into the record, not signed off as a reviewed claim
WOMAN missed its registered primary endpoint, and is cited as though it had not
In plain words
The trial of tranexamic acid for bleeding after childbirth is quoted everywhere as a success. Its actual primary endpoint — death from any cause or hysterectomy — was not reduced. Hysterectomy was not reduced at all.
What was measured
Composite of death from all causes or hysterectomy within 42 days of giving birth
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
WOMAN randomised 20,060 women with clinically diagnosed post-partum haemorrhage across 193 hospitals in 21 countries. The composite primary endpoint of death from all causes or hysterectomy within 42 days occurred in 534 (5.3%) on tranexamic acid against 546 (5.5%) on placebo, RR 0.97 (95% CI 0.87 to 1.09, p=0.65). Hysterectomy alone was 358 (3.6%) against 351 (3.5%), RR 1.02 (95% CI 0.88 to 1.07, p=0.84). Death due to bleeding, which is the number everyone quotes, was 155 (1.5%) against 191 (1.9%), RR 0.81 (95% CI 0.65 to 1.00, p=0.045), and 1.2% against 1.7% in women treated within three hours, RR 0.69 (95% CI 0.52 to 0.91, p=0.008). The investigators state in the paper why: during the trial it became apparent that the decision to perform a hysterectomy was often taken at the same moment as randomisation, so the drug could not influence it, and the sample size was raised from 15,000 to 20,000 to power the death-due-to-bleeding estimate instead. That is a defensible change, transparently reported. It is still a primary endpoint that was not met, and almost nothing citing this trial says so.
Written into the record, not signed off as a reviewed claim
HALT-IT: no benefit in gastrointestinal bleeding, and more venous thrombosis
In plain words
Twelve thousand patients bleeding from the gut were randomised. Deaths from bleeding were identical. Clots in the legs and lungs were nearly twice as common on the drug.
What was measured
Death due to bleeding within five days of randomisation, and venous thromboembolic events
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
HALT-IT randomised 12,009 patients with significant upper or lower gastrointestinal bleeding across 164 hospitals in 15 countries. Death due to bleeding within five days occurred in 222 of 5,956 (4%) on tranexamic acid and 226 of 5,981 (4%) on placebo, RR 0.99 (95% CI 0.82 to 1.18). Arterial thromboembolic events were similar (0.7% versus 0.8%, RR 0.92, 95% CI 0.60 to 1.39). Venous thromboembolic events were higher on tranexamic acid: 48 of 5,952 (0.8%) against 26 of 5,977 (0.4%), RR 1.85 (95% CI 1.15 to 2.98). The investigators concluded that tranexamic acid should not be used for gastrointestinal bleeding outside a randomised trial. This is the same investigator group, the same design and the same drug as CRASH-2, and it is why the trauma result cannot be generalised to bleeding as a category.
Written into the record, not signed off as a reviewed claim
CRASH-3 did not reach significance on the endpoint it was designed around
In plain words
The head injury trial is widely described as positive. Its primary result — deaths from the head injury — had a confidence interval that crossed no effect. The positive number people quote comes from a subgroup.
What was measured
Head injury-related death in hospital within 28 days, in patients treated within three hours
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
CRASH-3 randomised 12,737 patients with traumatic brain injury across 175 hospitals in 29 countries; 9,202 (72.2%) were treated within three hours, the prespecified primary population. Head injury-related death in hospital within 28 days was 18.5% on tranexamic acid against 19.8% on placebo, risk ratio 0.94 (95% CI 0.86 to 1.02) — the interval includes 1. A prespecified sensitivity analysis excluding patients with a Glasgow Coma Scale of 3 or bilateral unreactive pupils gave 12.5% against 14.0%, RR 0.89 (95% CI 0.80 to 1.00). The result that is quoted comes from a subgroup split: RR 0.78 (95% CI 0.64 to 0.95) in mild-to-moderate head injury against 0.99 (95% CI 0.91 to 1.07) in severe injury, p for heterogeneity 0.030. Vascular occlusive events and seizures were not increased. The subgroup was prespecified and the heterogeneity test supports it, which is the strongest version of this argument; it is still a subgroup, and the trial as designed did not clear its own threshold.
Written into the record, not signed off as a reviewed claim
ATACAS: half the blood products, twice the reoperations avoided, and seven times the seizures
In plain words
In 4,631 coronary bypass patients the drug halved transfusion and halved reoperation for bleeding. It also raised post-operative seizures from one in a thousand to seven in a thousand, and did not change death or thrombosis.
What was measured
Units of blood product transfused, reoperation for major haemorrhage, and incidence of post-operative seizure
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ATACAS randomly assigned patients scheduled for coronary artery surgery at risk of complications, in a two-by-two factorial design with aspirin; 4,631 underwent surgery with available outcome data, 2,311 on tranexamic acid and 2,320 on placebo. The primary composite of death and thrombotic complications within 30 days occurred in 386 (16.7%) against 420 (18.1%), relative risk 0.92 (95% CI 0.81 to 1.05, p=0.22) — no difference. Total units of blood products transfused were 4,331 against 7,994 (p<0.001). Major haemorrhage or cardiac tamponade leading to reoperation occurred in 1.4% against 2.8% (p=0.001). Seizures occurred in 0.7% against 0.1% (p=0.002 by Fisher exact test). The mechanism is understood: tranexamic acid is a competitive antagonist at glycine receptors, its cerebrospinal fluid concentration peaks after the infusion has stopped, and in one patient in the pharmacokinetic study that peak coincided with the seizure.
Written into the record, not signed off as a reviewed claim
POISE-3: cardiovascular non-inferiority was not established in 9,535 patients
In plain words
In the largest surgical trial of the drug, bleeding fell clearly. The safety test — proving it does not cause more heart attacks, strokes and clots — was set up in advance and the drug did not pass it.
What was measured
Composite of myocardial injury after noncardiac surgery, nonhaemorrhagic stroke, peripheral arterial thrombosis or symptomatic proximal venous thromboembolism at 30 days
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
POISE-3 randomised 9,535 patients undergoing noncardiac surgery to a tranexamic acid bolus at the start and end of surgery or placebo. The composite bleeding outcome at 30 days occurred in 433 of 4,757 (9.1%) against 561 of 4,778 (11.7%), hazard ratio 0.76 (95% CI 0.67 to 0.87), absolute difference -2.6 percentage points, two-sided p<0.001 for superiority. The composite cardiovascular outcome occurred in 649 of 4,581 (14.2%) against 639 of 4,601 (13.9%), hazard ratio 1.02 (95% CI 0.92 to 1.14). Non-inferiority required the upper boundary of the one-sided 97.5% confidence interval to fall below 1.125 and the one-sided p value to be below 0.025; the observed upper boundary was 1.14 and the one-sided p was 0.04. The authors state directly that non-inferiority was not established. The point estimate is close to 1 and the absolute difference is 0.3 percentage points, so this is a failure to exclude harm rather than a demonstration of it — but it is a prespecified test that the drug did not pass, and it is rarely mentioned alongside the bleeding result.
Written into the record, not signed off as a reviewed claim
How many documents were read
47 documents were read for this substance.
RNAWiki source record
46 of them state the same halfLife, and they agree.
RNAWiki source record
15 of them state the same bioavailability, and they agree.
RNAWiki source record
15 of them state the same tMax, and they agree.
RNAWiki source record
31 of them state the same proteinBinding, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
6T84R30KC1
RxNorm concept
883826
Checks this page had to pass
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The opening statement carries the origin: Written into the record, not signed off.
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Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
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Safety mode resolved
Suppression classes recorded: S6.
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Canonical metadata present
slug and display name present
What is missing or unclear◇Read 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.
Withdrawn in United States, 2020, for "Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to…" (openFDA drug enforcement Class I recall)
What the approval register records
35 approved applications cover products containing this substance. The earliest was NDA019280, approved 19861230 to PHARMACIA AND UPJOHN.
This order is fixed in code and does not count clicks or time on the page.
What is not here
7 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 was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
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.
A rigid lysine mimic that blocks plasmin from docking on a clot, and the only drug in this group with a randomised all-cause mortality reduction — 14.5% versus 16.0% in 20,211 trauma patients in CRASH-2 — while the obstetric trial it is most often credited with missed its registered primary endpoint, the gastrointestinal bleeding trial found no benefit and more venous thrombosis, and the head injury trial did not reach significance on the outcome it was designed around.
Recorded evidence blocks (10)
Q2
On the Tranexamic acid label: indicated for what?
"Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term…": indications and usage on Tranexamic acid's label. DailyMed label · a93d6ef3-e160-db0d-142f-9b91af8d8428 · 2026-08-14
Q3
542 registered trials of Tranexamic acid — at which phases?
Registered studies posting no result
447 of 542
542 registered studies of Tranexamic acid: 168 phase4, 139 phase3, 121 na, 91 phase2, 23 phase1, 17 early phase1, 17 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01
Treatment (tranexamic acid and 1% lidocaine with 1:100,000 epinephrine)
recorded 2026-09-01 · last checked 2026-09-04
Q6
Tranexamic acid's half-life is 2 hours — which schedules were studied?
2 hours, the half-life Tranexamic acid's label states: "Elimination After an intravenous dose of 1 g, the plasma concentration time curve shows a triexponential decay with a half-life of about 2 hours for the terminal elimination phase." DailyMed label · a93d6ef3-e160-db0d-142f-9b91af8d8428 · 2026-08-14
Show the evidence
half lifepharmacokinetics
2 hours; Elimination After an intravenous dose of 1 g, the plasma concentration time curve shows a triexponential decay with a half-life of about 2 hours for the terminal elimination phase.
recorded 2026-08-14 · last checked 2026-09-04
Q7
Which running trial of Tranexamic acid could settle inflammatory markers?
NCT07332910 measures Anti-inflammatory response: Variation of IL-6 over 24 hours, reading out 2026-06-01.
5 open trials; n 60; "Study the Anti-inflammatory Effect of Tranexamic Acid When Used in Anterior Cruciate Ligament Reconstruction."
Show the evidence
Trial
NCT07332910
"Study the Anti-inflammatory Effect of Tranexamic Acid When Used in Anterior Cruciate Ligament Reconstruction."; n 60; "Anti-inflammatory response: Variation of IL-6 over 24 hours"; 2026-06-01
NCT04910464
"Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis"; n 80; "ICU mortality"; 2027-01-30
NCT05053867
"A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients"; n 60; "28 day all-cause mortality rate"; 2027-07-31
NCT06070350
"Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children"; n 1000; "24 hours all cause mortality"; 2028-10-01
NCT06736860
"Tranexamic Acid in Patients With Traumatic Bleeding Based on Dynamic Monitoring of Thromboelastography"; n 580; "30-day all-cause mortality rate"; 2028-12-31
Q8
Which 185 trials of Tranexamic acid posted no result?
Posted no result
185 of 185 completed trials
Registrations
NCT00111215, NCT00147862, NCT00327106, NCT00444470, NCT00994994 and NCT01027546, and 179 more
Completion dates
oldest 2006-09; newest 2024-09-01
Show the evidence
Trial
NCT00111215
2006-09
NCT00147862
2007-01
NCT00327106
2007-02
NCT00444470
2007-05
NCT00994994
2008-04
NCT01027546
2008-05
14 further recorded trials
NCT00697385
2008-06
NCT00588133
2008-08
NCT01449552
2008-11
NCT00375466
2008-12
NCT00755209
2009-10
NCT00985920
2009-11
NCT00375258
2010-03
NCT00355108
2010-05
NCT00670345
2010-06
NCT01067638
2010-09
NCT01228136
2010-12
NCT00809393
2011-01
NCT01060163
2011-10
NCT01191554
2011-10
Q9
At the median, Tranexamic acid's trials enrolled 100 people — anything larger?
Median enrolment
100
Largest enrolment
30000
Registered trials counted
540
Q10
What do 557 spontaneous reports say about Tranexamic acid — 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.
Tranexamic acid appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 557 reaction mentions were counted: seizure 87; pulmonary embolism 71; anaphylactic reaction 63; hypotension 59. FAERS via Open Targets · CHEMBL877 · 2026-06-24
Show the evidence
seizure
87
pulmonary embolism
71
anaphylactic reaction
63
hypotension
59
deep vein thrombosis
56
haemorrhage
54
4 more recorded rows
myoclonus
46
grand mal convulsion
45
rash maculo-papular
38
haemoglobin decreased
38
recorded 2026-06-24 · last checked 2026-09-04
Q11
Which 10 reactions does Tranexamic acid's label not list?
2 label terms; 10 reported and unlisted; a93d6ef3-e160-db0d-142f-9b91af8d8428
Show the evidence
anaphylactic reaction
count not stated
deep vein thrombosis
count not stated
grand mal convulsion
count not stated
haemoglobin decreased
count not stated
haemorrhage
count not stated
hypotension
count not stated
4 more recorded rows
myoclonus
count not stated
pulmonary embolism
count not stated
rash maculo-papular
count not stated
seizure
count not stated
recorded 2026-06-24 · last checked 2026-09-04
Where it is registered
Where it’s registered
Withdrawn in United States, 2020, for "Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to…" (openFDA drug enforcement Class I recall)
ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work · openFDA enforcement — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 7 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
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.