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Aminocaproic acid

  • Prescription medicine
  • Given by a clinician
  • 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 Aminocaproic acid does in the body

Bleeding that will not stop because the body is dissolving its own clots too fast

Your body dissolves its own clots using an enzyme called plasmin, which has to grab hold of the clot before it can cut it up. It grabs on at spots shaped to fit an amino acid called lysine. Aminocaproic acid is very nearly the same shape as lysine, so it sits in those spots and occupies them. Plasmin can still exist, but it can no longer get a grip on the clot, so the clot lasts.

What happened in people

Comparable blood loss and transfusion against tranexamic acid in a 64-patient randomised aortic surgery trial and in a 1,544-patient retrospective cardiac surgery cohort

Source-linked record

Where this came from

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

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

The limit that matters most

That preventing a rebleed into the eye preserves vision — pooled visual acuity at up to three years was unchanged (RR 1.05, 95% CI 0.93 to 1.18)

Where it acts
Blood plasma and the surface of the forming fibrin clot
Kind of result
A number that stands in for health
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · U6F3787206 · read 2026-08-29

Where each sentence above came from

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

Shown as the opening line on this page.

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

The four opening statements run to 117 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 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.

Rate of recurrent anterior chamber haemorrhage

The study showed what it set out to show

Who was studied
Cochrane pooled analysis of six randomised trials of systemic aminocaproic acid in traumatic hyphema (CD005431.pub5)
How many people
330
Study design
Systematic review and meta-analysis of randomised and quasi-randomised trials
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
RR 0.28, 95% CI 0.13 to 0.60; sensitivity analysis excluding two non-intention-to-treat studies gives RR 0.43, 95% CI 0.17 to 1.08
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. Certainty of evidence graded low. The result is fragile to the exclusion of two studies that did not analyse by intention to treat.

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 oral solution

Interval reported. 95% CI 0

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

Long-term and final visual acuity up to three years after the injury

The study did not show it

Who was studied
Cochrane pooled analysis of visual acuity after aminocaproic acid for traumatic hyphema (CD005431.pub5)
How many people
2969
Study design
Meta-analysis of two randomised trials within the same review
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Long-term visual acuity RR 1.03, 95% CI 0.82 to 1.29; final visual acuity RR 1.05, 95% CI 0.93 to 1.18
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. The 2,969 figure is the whole review population across all interventions; the visual acuity meta-analysis for aminocaproic acid rests on two trials within it. The reviewers found no evidence of an effect on visual acuity for any intervention studied.

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 oral solution

Interval reported. 95% CI 0

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

Cumulative blood loss and blood product requirement to 24 hours, with renal and neurological safety

The study showed what it set out to show

Who was studied
Makhija thoracic aortic surgery head-to-head against tranexamic acid
How many people
64
Study design
Prospective randomised trial, single tertiary centre
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Blood loss and transfusion comparable; significant renal injury 40% versus 16%, p = 0.04
Repeated elsewhere
Unreplicated

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. Renal failure occurred in 10% of the aminocaproic acid arm and 0% of the tranexamic acid arm (p=0.11, RR 2.15). At 64 patients the trial cannot exclude or establish this.

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 oral solution

Interval reported. Not recorded in this summary

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

Total blood loss over the hospital stay, number of transfusions, and the fall from pre-operative to lowest post-operative haemoglobin

The study showed what it set out to show

Who was studied
NCT02030821 — tranexamic acid versus Amicar in total knee and hip arthroplasty
How many people
246
Study design
Phase 4 randomised trial, Duke University, results posted
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Registry posting reports p < 0.05 for the primary outcome comparisons without identifying which pairwise contrast each belongs to
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. All three registered primary outcomes are surrogates. No clinical outcome — function, revision, thrombosis or death — was registered as a primary endpoint.

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 oral solution

Interval reported. Not recorded in this summary

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 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

    Aminocaproic acid

    What a person takes: Intravenous infusion, oral tablet and oral solution.

    The measurement behind this step

    Given intravenously in the operating theatre and the intensive care unit, and by mouth for longer courses such as mucosal bleeding in haemophilia or bleeding into the eye. Oral absorption is complete, so the route is chosen by how quickly the effect is wanted, not by how much reaches the blood.

  2. Getting in

    It goes in by drip or by mouth, and it is absorbed completely

    Given intravenously it is in the bloodstream immediately. Swallowed, all of it is absorbed, and blood levels peak a little over an hour later.

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

    The measurement behind this step

    The FDA label reports oral absorption as a zero-order process at 5.2 g/hr with a mean lag of 10 minutes and complete bioavailability (F=1). Peak plasma concentration after a single oral dose was 164 ± 28 mcg/mL at 1.2 ± 0.45 hours. Apparent volume of distribution was 23.1 ± 6.6 L.

  3. Reaching the cell

    It spreads out of the blood and into cells

    It does not stay in the bloodstream. The volume it occupies in the body is several times the volume of blood, because it moves into red cells and into tissue.

    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

    An apparent volume of distribution near 23 L against a plasma volume of roughly 3 L indicates extensive extravascular distribution, including into erythrocytes. The molecule is a small zwitterionic amino acid analogue, and it is eliminated largely unchanged by the kidney, which is why renal impairment raises exposure.

  4. What it acts on

    It occupies the handhold that plasmin uses to grab a clot

    Plasmin, the enzyme that dissolves clots, has to hold on to the clot before it can cut. It holds on at pockets shaped for the amino acid lysine. This drug is shaped almost exactly like lysine and sits in those pockets.

    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

    Aminocaproic acid is 6-aminohexanoic acid: a six-carbon chain with a free amine at one end and a carboxylate at the other, the same distance apart as in the side chain and backbone of a lysine residue. It occupies the lysine-binding sites in the kringle domains of plasminogen and plasmin. Its affinity for those sites is substantially lower than that of the conformationally constrained cyclohexane analogue tranexamic acid.

  5. The change it makes

    Plasminogen can no longer dock on the fibrin surface

    Blocking the handhold means the enzyme and its inactive precursor float free in the blood instead of assembling on the clot. The cutting still could happen; it just has nothing to hold on to.

    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-assembly reaction: plasminogen and tissue plasminogen activator both bind lysine residues exposed on partially degraded fibrin, and that colocalisation is what accelerates plasmin generation by orders of magnitude. Occupying the lysine-binding sites prevents the assembly rather than inhibiting the catalytic site, which is why the label describes the effect as principally inhibition of plasminogen activators with a lesser antiplasmin component.

  6. What that does for a person

    The clot survives, and less blood is lost

    Clots that would have been taken apart stay in place. Measured blood loss falls and fewer units of blood are transfused. Whether the patient does better is a different measurement, and it has largely not been made.

    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

    Pooled across randomised surgical trials the relative risk of requiring an allogeneic red cell transfusion is 0.81 (95% CI 0.67 to 0.99). In traumatic hyphema, recurrent haemorrhage falls (RR 0.28, 95% CI 0.13 to 0.60) while pooled visual acuity at up to three years does not move (RR 1.05, 95% CI 0.93 to 1.18). The gap between those two sentences is the whole audit.

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 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.

  • Given in hospital, usually intravenously, by surgeons, haematologists and intensivists. In the United States it is also used off-label in orthopaedic and cardiac surgery, and topically or systemically for bleeding into the front chamber of the eye after blunt trauma.

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 · c5dc0c33-a0f9-43c4-9f10-3668f4361b87 · read 2026-08-30

  • On people who are pregnant, the label states: “Animal reproduction studies have not been conducted with aminocaproic acid.”

    US prescribing information · c5dc0c33-a0f9-43c4-9f10-3668f4361b87 · read 2026-08-30

  • On people who are breastfeeding, the label states: “It is not known whether this drug is excreted in human milk.”

    US prescribing information · c5dc0c33-a0f9-43c4-9f10-3668f4361b87 · read 2026-08-30

Where the result stopped carrying

  • A randomised head-to-head in thoracic aortic surgery found significant renal injury in 40% of the aminocaproic acid arm against 16% on tranexamic acid (p=0.04), with all cases of renal failure in the aminocaproic acid arm
  • The Cochrane reviewers graded the hyphema evidence low to very low certainty and found the rebleeding benefit fragile to the exclusion of two non-intention-to-treat studies
  • Cochrane funnel plots indicate the lysine-analogue surgical trials may be subject to publication bias, and data on uncommon harms across those small trials were sparse
  • 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 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 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

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 oral solution

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

RNAWiki has not recorded a supervision or regulatory status for this substance.

Quoted from a source

Where this came from

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

No register row and no identity class settled the question.

No source is stored against this line.

What is in the pack

Given intravenously in the operating theatre and the intensive care unit, and by mouth for longer courses such as mucosal bleeding in haemophilia or bleeding into the eye. Oral absorption is complete, so the route is chosen by how quickly the effect is wanted, not by how much reaches the blood.

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

Eliminated largely unchanged by the kidney, so renal impairment raises exposure. Rapid intravenous administration is associated with hypotension, bradycardia and arrhythmia. Prolonged use has been associated with myopathy and rhabdomyolysis with raised creatine kinase, and the label directs that creatine kinase be monitored during long courses. It should not be given where there is active intravascular clotting. Its use in upper urinary tract bleeding risks obstructing the ureter with a clot that cannot dissolve.

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

Where this came from

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

Intravenous infusion, oral tablet and oral solution

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

Oral absorption is complete, so the route is chosen by how quickly the effect is wanted, not by how much reaches the blood.

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

  • 43 products list this as an active ingredient in the United States drug directory. 43 of them contain it and nothing else.

    FDA National Drug Code directory · 80005-129 · read 2026-08-29

  • They are sold as injection, solution, powder, solution, syrup and tablet, taken intravenous and oral.

    FDA National Drug Code directory · 80005-129 · 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 · 80005-129 · read 2026-08-29

  • 28 published labels name it as an active ingredient. 28 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · c5dc0c33-a0f9-43c4-9f10-3668f4361b87 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · c5dc0c33-a0f9-43c4-9f10-3668f4361b87 · read 2026-08-29

  • 22310 marketed supplement labels list this ingredient, classed as botanical with nutrients, non-nutrient/non-botanical and other combinations.

    NIH Dietary Supplement Label Database · 213895 · read 2026-08-29

  • Those labels carry all other, nutrient and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.

    NIH Dietary Supplement Label Database · 213895 · read 2026-08-29

  • Aminocaproic acid is oral at HOW SUPPLIED: Aminocaproic acid Tablets USP, 500 mg Each white to off white colored, round shaped, uncoated tablets with break line debossed with “MA” and “17“ on one side and plain on other side, contains 500 mg of ami…, recorded as fda label in effect 2023-09-06 in the United States.

    US prescribing information · c5dc0c33-a0f9-43c4-9f10-3668f4361b87 · read 2026-08-30

  • Recorded price in US: 0.57878 USD per one millilitre, across 9 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: 2.67647 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 9 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.

RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.

Questions worth asking

  • Which of the trials of Aminocaproic 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 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 preventing a rebleed into the eye preserves vision — pooled visual acuity at up to three years was unchanged (RR 1.05, 95% CI 0.93 to 1.18)

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 reducing measured blood loss reduces death — no trial of this drug has ever been powered for mortality in sixty-two years on the market

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 mortality evidence belonging to tranexamic acid transfers to aminocaproic acid because the mechanism is shared

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 aminocaproic acid is the safer antifibrinolytic — the comparison that established this rests mainly on observational data, and the randomised layer was inconclusive

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.

How much did people take in the studies?

The sources RNAWiki checked hold nothing for this field.

Why it matters. A result belongs to an amount. Without the amount the result floats free.

What would answer it

A stored source that records 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 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 Aminocaproic 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 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.

It reduces the chance of needing a red cell transfusion by about a fifth
In plain words
Pooling every randomised surgical trial Cochrane could find, patients given aminocaproic acid were about 19% less likely to need a blood transfusion than untreated controls. That is the effect the drug actually owns.
What was measured
Relative risk of requiring an allogeneic red blood cell transfusion, pooled across randomised surgical trials
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Henry et al. summarised 252 randomised controlled trials recruiting more than 25,000 participants scheduled for non-urgent surgery. Against control, epsilon-aminocaproic acid reduced the probability of requiring red blood cell transfusion with a relative risk of 0.81 (95% CI 0.67 to 0.99). Re-operation for bleeding showed the same direction (RR 0.32, 95% CI 0.11 to 0.99), though on far fewer events. The reviewers note the transfusion data were heterogeneous and that funnel plots indicated the lysine-analogue trials may be subject to publication bias, and that data on uncommon harms were sparse across the small trials contributing to the pool.
Source
Henry DA et al., Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev 2011;(3):CD001886
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 stops the eye rebleeding and does not change what the patient can see three years later
In plain words
For bleeding into the front of the eye after a blow, aminocaproic acid cuts the chance of a second bleed by roughly two-thirds. Pooled across the trials that measured it, the vision people ended up with was no different at all.
What was measured
Rate of recurrent anterior chamber haemorrhage, and visual acuity at up to three years
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The 2023 Cochrane review of medical interventions for traumatic hyphema included 23 randomised and seven quasi-randomised studies totalling 2,969 participants. Systemic aminocaproic acid reduced the rate of recurrent haemorrhage with a relative risk of 0.28 (95% CI 0.13 to 0.60) across six trials and 330 participants; a sensitivity analysis omitting two studies that did not use intention-to-treat weakened this to RR 0.43 (95% CI 0.17 to 1.08). Topical aminocaproic acid gave RR 0.48 (95% CI 0.20 to 1.10). On the endpoint that matters, a meta-analysis of two trials found no effect on long-term visual acuity (RR 1.03, 95% CI 0.82 to 1.29) or on final visual acuity measured up to three years after the injury (RR 1.05, 95% CI 0.93 to 1.18). The reviewers graded the certainty of the evidence as low to very low and state that no intervention studied showed an effect on visual acuity, whether short-term or longer.
Source
Woreta FA, Lindsley KB, Gharaibeh A, Ng SM, Scherer RW, Goldberg MF. Medical interventions for traumatic hyphema. Cochrane Database Syst Rev 2023;3(3):CD005431
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
Sixty-two years on the market and no trial has ever been powered for death
In plain words
Aminocaproic acid was approved in 1964. Its sibling drug tranexamic acid has been tested in two trials of more than twenty thousand patients each with survival as the endpoint. Aminocaproic acid has never had one.
What was measured
That reducing measured blood loss with this specific agent translates into fewer deaths — an extrapolation from a sibling molecule that has been tested, to one that has not
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The FDA approved Amicar under NDA 015197 on 3 June 1964 as a Type 1 new molecular entity under priority review, on the basis of reduced fibrinolytic bleeding. The registered randomised evidence since has been surgical and small: the largest completed randomised comparison on ClinicalTrials.gov with posted results is a 246-participant Duke trial in hip and knee arthroplasty (NCT02030821) whose three registered primary outcomes are total blood loss, number of transfusions and the fall in haemoglobin. By contrast the same drug class in the form of tranexamic acid has CRASH-2 (20,211 randomised trauma patients, all-cause mortality) and WOMAN (20,060 randomised women, death due to bleeding). The absence is not evidence of no effect; it is an absence, and it is the central fact about this drug.
Source
openFDA Drugs@FDA record for NDA 015197 (AMICAR), original approval 3 June 1964; ClinicalTrials.gov NCT02030821
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
It inherited cardiac surgery when aprotinin was withdrawn, not by winning a trial
In plain words
Until 2007 the standard antifibrinolytic in heart surgery was aprotinin. It was pulled after a trial found more deaths. The lysine analogues took over the space by default, and the evidence that they are safer comes mostly from observational data, not from randomised comparisons.
What was measured
That aminocaproic acid is the safe choice in cardiac surgery — a position established by a competitor being removed and supported mainly by non-randomised comparisons
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Hutton et al. ran a network meta-analysis of 106 randomised controlled trials and 11 propensity-matched or adjusted observational studies, 43,270 patients in total, explicitly to estimate comparative harm after aprotinin was suspended in 2008 and then reintroduced in Europe and Canada. In the randomised data alone the comparisons were largely inconclusive, with tranexamic acid showing a lower risk of death than aprotinin (OR 0.64, 95% credible interval 0.41 to 0.99). Once observational data were incorporated, aprotinin carried an increased mortality risk relative to tranexamic acid (OR 0.71, 95% CrI 0.50 to 0.98) and to epsilon-aminocaproic acid (OR 0.60, 95% CrI 0.43 to 0.87), and an increased risk of renal failure or dysfunction against every comparator including no treatment. The authors' own summary is that the randomised meta-analyses were "largely inconclusive" and that the concern rests on the observational layer.
Source
Hutton B, Joseph L, Fergusson D, Mazer CD, Shapiro S, Tinmouth A. Risks of harms using antifibrinolytics in cardiac surgery: systematic review and network meta-analysis. BMJ 2012;345:e5798
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
A randomised head-to-head found more kidney injury on aminocaproic acid
In plain words
In a small randomised trial in aortic surgery, the two drugs stopped bleeding equally well. Significant kidney injury was more than twice as common in the aminocaproic acid group, and every case of kidney failure was in that group.
What was measured
Incidence of significant post-operative renal injury and renal failure, and cumulative blood loss at 24 hours
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Makhija et al. randomised 64 consecutive adults undergoing thoracic aortic surgery on cardiopulmonary bypass to epsilon-aminocaproic acid or tranexamic acid. Cumulative mean blood loss, packed red cell use and total blood product requirement to 24 hours were comparable between groups. Significant renal injury occurred in 40% of the aminocaproic acid group against 16% of the tranexamic acid group (p=0.04), and renal failure in 10% against 0% (p=0.11, relative risk 2.15). Seizure ran the other way, 3.3% on aminocaproic acid against 10% on tranexamic acid, not statistically significant. D-dimer rose significantly from pre- to post-operative values in the aminocaproic acid group (p<0.01). This is 64 patients at a single centre, and the authors close by calling for adequately sized placebo-controlled trials, which have not been done.
Source
Makhija N, Sarupria A, Kumar Choudhary S, Das S, Lakshmy R, Kiran U. Comparison of epsilon aminocaproic acid and tranexamic acid in thoracic aortic surgery. J Cardiothorac Vasc Anesth 2013;27(6):1201-1207
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
In 1,544 real cardiac surgery patients it was indistinguishable from tranexamic acid
In plain words
When a drug shortage forced one hospital to switch between the two agents, the records of more than fifteen hundred heart surgery patients showed no difference in how much they bled.
What was measured
Chest tube output at 12 hours, 24 hours and 7 days, and incidence of blood product transfusion
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Dannemiller et al. conducted a single-centre retrospective chart review at a 793-bed academic hospital comparing fixed-dose tranexamic acid with epsilon-aminocaproic acid in cardiac surgery, 1,544 patients in total, a natural experiment created by a drug shortage. Chest tube output at 12 hours, 24 hours and 7 days was similar between groups. The tranexamic acid group required more intraoperative blood product transfusions (22.7% versus 18.2%, p=0.03), with no difference in the median quantity of total blood products at 24 hours or 7 days. Reported safety events were similar. This is a retrospective cohort, not a randomised comparison, and the transfusion difference is the kind of finding that appears and disappears between such cohorts.
Source
Dannemiller RE et al. Comparison of trauma-dosed tranexamic acid versus aminocaproic acid in cardiac surgery in the setting of drug shortage. J Card Surg 2022;37(10):3243-3249
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

  • 28 documents were read for this substance.

    RNAWiki source record

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

    RNAWiki source record

  • 28 of them state the same tMax, and they agree.

    RNAWiki source record

  • 28 of them state the same volumeOfDistribution, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
U6F3787206
RxNorm concept
197351

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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

  • 31 approved applications cover products containing this substance. The earliest was NDA015197, approved 19640603 to HIKMA.

    Drugs@FDA application register · NDA015197 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA015197 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19811231.

    FDA National Drug Code directory · 80005-129 · read 2026-08-29

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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 lysine look-alike that plugs the docking site plasmin uses to attach to a clot, licensed in 1964 on the strength of reduced bleeding: it demonstrably lowers transfusion requirement and cuts rebleeding into the eye by roughly two-thirds, and in sixty-two years on the market no trial has ever been powered to find out whether it saves a life.

Recorded evidence blocks (8)

On the Aminocaproic acid label: indicated for what?


"Aminocaproic acid tablets are useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required.": indications and usage on Aminocaproic acid's label. DailyMed label · 2612ee97-1723-40f2-99e6-3a736f63200f · 2026-08-04

21 registered trials of Aminocaproic acid — at which phases?


Registered studies posting no result
13 of 21

21 registered studies of Aminocaproic acid: 8 phase4, 4 na or unstated, 4 phase2, 2 na, 2 phase1, 1 early phase1, 1 phase3. CLINICALTRIALS_SNAPSHOT · 2026-09-01

156 with a PubMed record

Show the evidence
  • phase4
    8
  • na or unstated
    4
  • phase2
    4
  • na
    2
  • phase1
    2
  • early phase1
    1
8 more recorded rows
  • phase3
    1
  • completed
    13
  • terminated
    3
  • active not recruiting
    1
  • not yet recruiting
    1
  • recruiting
    1
  • unknown
    1
  • withdrawn
    1

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

4 of Aminocaproic acid's trials stopped: accrual/recruitment, other?


accrual/recruitment (2) and other (2): Aminocaproic acid's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"the study was suspended due to shortage of the study drug (amicar)."; 4 of 21 registered studies

Show the evidence

Trial

  • NCT01965730
    terminated; "the study was suspended due to shortage of the study drug (amicar)."
  • NCT02074436
    terminated; "Slow accrual"
  • NCT02639819
    withdrawn; "Study was withdrawn from IRB review on 03/08/16"
  • NCT04814433
    terminated; "Both lack of enrollment as well as study staff turnover"

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

Aminocaproic acid's half-life is 2 hours — which schedules were studied?


2 hours, the half-life Aminocaproic acid's label states: "The terminal elimination half-life for aminocaproic acid is approximately 2 hours." DailyMed label · 2612ee97-1723-40f2-99e6-3a736f63200f · 2026-08-04

tmax 1.2 ± 0.45 hours.

Show the evidence
  • half life clinical_pharmacology
    2 hours; The terminal elimination half-life for aminocaproic acid is approximately 2 hours.
  • tmax clinical_pharmacology
    1.2 ± 0.45 hours; Mean ± SD peak plasma concentrations (164 ± 28 mcg/mL) were reached within 1.2 ± 0.45 hours.

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

Which 7 trials of Aminocaproic acid posted no result?


Posted no result
7 of 7 completed trials
Registrations
NCT00617955, NCT00912119, NCT01391182, NCT01873768, NCT03365999 and NCT01431326, and 1 more
Completion dates
oldest 2009-06; newest 2019-12-30
Show the evidence

Trial

  • NCT00617955
    2009-06
  • NCT00912119
    2011-10
  • NCT01391182
    2015-01
  • NCT01873768
    2015-12
  • NCT03365999
    2019-07-01
  • NCT01431326
    2019-11
  • 1 further recorded trial NCT04424563
    2019-12-30

At the median, Aminocaproic acid's trials enrolled 60 people — anything larger?


Median enrolment
60
Largest enrolment
5000
Registered trials counted
21

What do 38 spontaneous reports say about Aminocaproic 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.

Aminocaproic acid appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 38 reaction mentions were counted: deep vein thrombosis 9; wrong drug administered 7; angina unstable 4; troponin increased 4. FAERS via Open Targets · CHEMBL1046 · 2026-06-24

Show the evidence
  • deep vein thrombosis
    9
  • wrong drug administered
    7
  • angina unstable
    4
  • troponin increased
    4
  • electrocardiogram t wave inversion
    3
  • periorbital oedema
    3
4 more recorded rows
  • choroidal detachment
    2
  • conjunctival oedema
    2
  • intercepted drug dispensing error
    2
  • intracardiac thrombus
    2

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

Which 10 reactions does Aminocaproic acid's label not list?


angina unstable, choroidal detachment and conjunctival oedema and 7 more reported for Aminocaproic acid, absent from its label. FAERS via Open Targets · CHEMBL1046 · 2026-06-24

3 label terms; 10 reported and unlisted; 2612ee97-1723-40f2-99e6-3a736f63200f

Show the evidence
  • angina unstable
    count not stated
  • choroidal detachment
    count not stated
  • conjunctival oedema
    count not stated
  • deep vein thrombosis
    count not stated
  • electrocardiogram t wave inversion
    count not stated
  • intercepted drug dispensing error
    count not stated
4 more recorded rows
  • intracardiac thrombus
    count not stated
  • periorbital oedema
    count not stated
  • troponin increased
    count not stated
  • wrong drug administered
    count not stated

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1046
PubChem CID
564
CAS number
60-32-2
RxCUI
99
InChIKey
SLXKOJJOQWFEFD-UHFFFAOYSA-N
Development code
177 J.D, 177 JD, CL 10304, CY-116, EACA, NSC-26154, NSC-400230
Also called
6-aminocaproic acid, Acide aminocaproique, Acido aminocaproico, Epsilcapramin, Hexanoic acid, 6-amino-, .EPSILON.-AMINOCAPROIC ACID [JAN], .EPSILON.-AMINOCAPROIC ACID [MI], AMINOCAPROIC ACID [EP IMPURITY], AMINOCAPROIC ACID [EP MONOGRAPH], AMINOCAPROIC ACID [HSDB], AMINOCAPROIC ACID [MART.], AMINOCAPROIC ACID [ORANGE BOOK]
Trade name
Amicar, Aminocaproic, Epsikapron, Aminocaproic Acid in Plastic Container
Japanese name
.epsilon.-aminocaproic acid
Sources (5)

Sources

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

How these records are assembled · Which registers were checked

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