This page shows what was measured, who it was measured in, and what that does not settle.
What Indometacin does in the body
Severe arthritis, gout attacks and inflamed shoulders
Indomethacin blocks the prostaglandin-making enzymes harder than almost any other drug of its type, and it does so everywhere — the inflamed joint, the stomach lining, the kidney, and the brain, which it enters more freely than most NSAIDs. That is why it puts out an acute gout attack quickly, and why roughly one user in twenty or more gets a headache from it that the label says should end treatment if reducing the dose does not fix it. The same lack of selectivity is why its stomach bleeding and heart attack numbers in observational studies sit near the top of the class.
What happened in people
Death or neurosensory impairment at 18 months in 1,202 extremely-low-birth-weight infants: 47% on indomethacin against 46% on placebo (odds ratio 1.1, P=0.61)
✎ 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.
About fourteen United States cents a capsule at pharmacy acquisition cost across only 25 listed generic products — the most expensive oral NSAID in this file
Where it acts
The cyclooxygenase channel throughout the body, including the central nervous system, which it enters readily — the source of the headache and drowsiness that distinguish it from other NSAIDs
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 · XXE1CET956 · read 2026-08-29
Its recorded molecular formula is C19H16ClNO4, weighing 357.8.
US prescribing information · 73878376-1d24-423b-9f37-3666e83c95da · 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 137 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
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 was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Pain
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
…Waiting for a reviewer3 registered symptom measure.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Healthy ageing
…Waiting for a reviewer1 registered study measure of this kind. No reviewed result yet.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Pain
pain intensity; pain measured by the numeric pain rating scale; pain
Healthy ageing
composite of mortality and/or nec and/or bpd
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
… Waiting for a reviewer
3 registered symptom measure.
— Not recorded
Harms were not a registered measure for this goal.
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.
Composite of death, cerebral palsy, cognitive delay, deafness and blindness at a corrected age of 18 months
✗ The study did not show it
Who was studied
TIPP — Trial of Indomethacin Prophylaxis in Preterms (N Engl J Med 2001;344:1966-1972)
271 of 574 (47%) on indomethacin against 261 of 569 (46%) on placebo; odds ratio 1.1 (95% CI 0.8 to 1.4), P=0.61
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. Both surrogate endpoints moved decisively in the expected direction — patent ductus arteriosus 24% against 50% (odds ratio 0.3, P<0.001) and severe periventricular and intraventricular haemorrhage 9% against 13% (odds ratio 0.6, P=0.02) — and no other outcome was altered. The gap between the surrogates and the outcome is the finding.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsules and extended-release capsules, an oral suspension, rectal suppositories, a low-dose submicron capsule formulation, and an intravenous solution for neonatal use
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Closure of a haemodynamically significant patent ductus arteriosus
✓ The study showed what it set out to show
Who was studied
Network meta-analysis of pharmacotherapy for patent ductus arteriosus (JAMA 2018;319:1221-1238)
How many people
4802
Study design
Bayesian random-effects network meta-analysis of 68 randomised clinical trials
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
High-dose oral ibuprofen against standard-dose intravenous indomethacin: odds ratio 2.35 (95% credible interval 1.08 to 5.31), absolute risk difference 124 more closures per 1,000 infants. Overall closure rate 67.4%
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. There was no significant difference in the odds of mortality, necrotising enterocolitis or intraventricular haemorrhage between placebo or no treatment and any treatment modality. The endpoint that separates the drugs is a surrogate; the endpoints that matter did not separate at all.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsules and extended-release capsules, an oral suspension, rectal suppositories, a low-dose submicron capsule formulation, and an intravenous solution for neonatal use
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Adjusted relative risk of upper gastrointestinal complications, and of acute myocardial infarction, for individual NSAIDs against non-use
✗ The study did not show it
Who was studied
SOS project pooled observational analyses (Drug Saf 2012 and Pharmacoepidemiol Drug Saf 2013)
How many people
28
Study design
Systematic review and meta-analysis of cohort and case-control studies, 28 studies for gastrointestinal and 18 independent populations for myocardial infarction
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Indometacin upper gastrointestinal complications relative risk 4.14 (95% CI 2.91 to 5.90); acute myocardial infarction relative risk 1.40 (1.21 to 1.62)
Repeated elsewhere
Partially Replicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. Observational, with confounding by indication that plausibly runs against indomethacin because it is reserved for more severe disease. The sample-size field records pooled studies, not participants.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsules and extended-release capsules, an oral suspension, rectal suppositories, a low-dose submicron capsule formulation, and an intravenous solution for neonatal use
Interval reported. 95% CI 2
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 3 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.3 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.3 registered measures of this kind.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.6 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.1 registered measure inside human tissue.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it changes in the 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.
Where a source records it acting
Joints: Suppresses inflammation in rheumatoid arthritis; improvement demonstrated by a reduction in joint swelling, average number of joints involved, and morning stiffness
US prescribing information · 009097a5-2c1e-4f5d-8054-896cf896cb3d · read 2026-08-27
Start
Indometacin
What a person takes: Oral capsules and extended-release capsules, an oral suspension, rectal suppositories, a low-dose submicron capsule formulation, and an intravenous solution for neonatal use.
The measurement behind this step
Plasma protein binding is approximately 99%. The molecule is lipophilic enough to enter the central nervous system readily, which is the basis of its distinctive neurological adverse effect profile. Route affects what an endoscope sees more than what a patient reports: the label records significantly fewer gastric mucosal abnormalities with suppositories than capsules in 45 healthy subjects, but comparable upper gastrointestinal adverse effects and more lower gastrointestinal adverse effects with suppositories in a 175-patient clinical comparison.
Getting in
An indole, not a propionic acid
Indomethacin belongs to a different chemical family from ibuprofen and naproxen, and it is more potent at the target than either.
──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
1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl acetic acid. Non-selective and among the most potent cyclooxygenase inhibitors in clinical use. Plasma protein binding approximately 99%. The N-aroyl bond hydrolyses in aqueous and alkaline conditions, which is why formulation and storage matter more here than for most NSAIDs.
Indomethacin crosses into the central nervous system more readily than other anti-inflammatories. That is why headache and drowsiness are among its commonest effects and why its label warns about depression, epilepsy and Parkinson’s disease.
╌╌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
Lipophilicity supports central nervous system penetration. Section 5.15 warns of aggravation of depression and other psychiatric disturbances, epilepsy and parkinsonism, of drowsiness affecting driving, and directs cessation for headache persisting despite dose reduction. Headache and dizziness are listed among adverse reactions occurring at 3% or more.
Prostaglandin production falls sharply, everywhere
The strength that puts out a gout attack in hours is the same strength applied to the stomach lining, the kidney and the platelets. There is no selectivity to soften it.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Non-selective inhibition of PTGS1 and PTGS2. Licensed for moderate to severe rheumatoid arthritis including acute flares, moderate to severe ankylosing spondylitis and osteoarthritis, acute painful shoulder and acute gouty arthritis — indications chosen for intensity of inflammation rather than for duration of treatment.
In a preterm infant, that same block closes a blood vessel
The ductus arteriosus is held open by prostaglandins after birth. Blocking them closes it — and blocks them in the kidney, gut and brain at the same time.
╌╌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
Prostaglandin-mediated ductal patency is the target; drug-induced reductions in renal, intestinal and cerebral blood flow are the same mechanism at other sites. In TIPP, three daily doses of 0.1 mg/kg reduced patent ductus arteriosus from 50% to 24% and severe intraventricular haemorrhage from 13% to 9%.
And it did not change how those children were at eighteen months
Both intermediate measures improved decisively. Death, cerebral palsy, cognitive delay, deafness and blindness at eighteen months came out at 47% against 46%.
╌╌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
TIPP primary composite: 271 of 574 (47%) against 261 of 569 (46%), odds ratio 1.1 (95% CI 0.8 to 1.4, P=0.61). The 2018 network meta-analysis of 68 trials and 4,802 infants found no significant difference in mortality, necrotising enterocolitis or intraventricular haemorrhage between placebo or no treatment and any pharmacotherapy.
Measured: strong, fast suppression of severe inflammation, at the cost of the worst tolerability of the group. Conceded in the label: corneal and retinal changes on prolonged therapy, and that the drug is not indicated for long-term treatment.
╌╌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 observational upper gastrointestinal complications 4.14 (2.91 to 5.90) and acute myocardial infarction 1.40 (1.21 to 1.62). Section 5.16: corneal deposits and retinal disturbances including macular changes on prolonged therapy, often asymptomatic, with periodic ophthalmological examination advised — followed by the statement that indomethacin capsules are not indicated for long-term treatment.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
pain intensity
pain measured by the numeric pain rating scale
pain
Measured
Things only a test, a scale or a device shows.
increase in heart rate standing
24h urine volume
arterial blood pressure
cerebral blood flow
pk profile of lesinurad from plasma and urine
systemic inflammatory response syndrome
c reactive protein levels
Meaningful
Things that change how a life goes, not only a number.
overall survival
event free survival number of an event
composite of mortality and/or nec and/or bpd
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (27)
amplitude of the vasomotor response to stimuli
adverse events and serious adverse events
incidence of oliguria and gastric bleeding
post ercp pancreatitis
bioequivalence according to us fda guidelines
os in low risk
reduction of preterm birth
gestational age at delivery
1st peak rms knee index
resting motor threshold
maximal voluntary contraction
h reflex latency
who developed post ercp pancreatitis
functional index of ankylosing spondylitis of dougados
overall assessment of disease activity by the on vas
maternal who achieve 48 hours of pregnancy prolongation
sedation scores measured by a 4 sedation scale
post operative nausea and vomiting using a 4 scale
post operative pruritis using a 2 scale
efs time to event
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. about 4.5 hours hours
Read from the label, which states: “The mean half-life of indomethacin is estimated to be about 4.5 hours.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
What is missing or 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.
Adults with severe inflammatory arthritis, acute gout or acute shoulder bursitis; and, as an intravenous formulation, preterm infants with a patent ductus arteriosus. Contraindicated in the setting of coronary artery bypass graft surgery and after aspirin- or NSAID-triggered asthma or urticaria.
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 14 years of age and younger has not been established.”
US prescribing information · 73878376-1d24-423b-9f37-3666e83c95da · read 2026-08-30
On older people, the label states: “Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions.”
US prescribing information · 73878376-1d24-423b-9f37-3666e83c95da · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Use of NSAIDs, including INDOCIN, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.”
US prescribing information · 73878376-1d24-423b-9f37-3666e83c95da · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Based on available published clinical data, indomethacin may be present in human milk.”
US prescribing information · 73878376-1d24-423b-9f37-3666e83c95da · read 2026-08-30
Where the result stopped carrying
The primary 18-month outcome in the largest randomised trial of neonatal indomethacin prophylaxis
Its position as the first-choice pharmacotherapy for a preterm patent ductus arteriosus, displaced by high-dose oral ibuprofen
Tolerability: headache severe enough that the label makes it a discontinuation criterion, plus warnings for depression, epilepsy and parkinsonism
Prolonged use: corneal deposits and retinal disturbances including macular changes, often asymptomatic
It has no cardiovascular outcome trial and no head-to-head gastrointestinal outcome trial against a modern comparator
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 for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to 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
Oral capsules and extended-release capsules, an oral suspension, rectal suppositories, a low-dose submicron capsule formulation, and an intravenous solution for neonatal use
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S3, S6.
No source is stored against this line.
What is in the pack
Plasma protein binding is approximately 99%. The molecule is lipophilic enough to enter the central nervous system readily, which is the basis of its distinctive neurological adverse effect profile.
✎ 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: Route affects what an endoscope sees more than what a patient reports: the label records significantly fewer gastric mucosal abnormalities with suppositories than capsules in 45 healthy subjects, but comparable upper gastrointestinal adverse effects and more lower gastrointestinal adverse effects with suppositories in a 175-patient clinical comparison.
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.
The recorded stepping schedule
What follows is the schedule printed on the label, recorded as it is written there. It is a record of what was done, not a recommendation.
US prescribing information · 009097a5-2c1e-4f5d-8054-896cf896cb3d · read 2026-08-27
Initial (moderate to severe rheumatoid arthritis, ankylosing spondylitis, or osteoarthritis): 25 mg twice a day or three times a day — Label-stated initial dosage for these indications
US prescribing information · 009097a5-2c1e-4f5d-8054-896cf896cb3d · read 2026-08-27
At weekly intervals, if well tolerated: Increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, until a total daily dose of 150 to 200 mg is reached — Until a satisfactory response is obtained; the label states the total daily dose should not exceed 200 mg
US prescribing information · 009097a5-2c1e-4f5d-8054-896cf896cb3d · read 2026-08-27
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
Boxed warning for cardiovascular thrombotic events including fatal myocardial infarction and stroke, and for gastrointestinal bleeding, ulceration and perforation. Contraindicated in the setting of coronary artery bypass graft surgery. Additional labelled warnings for hepatotoxicity, hypertension, heart failure and oedema, renal toxicity and hyperkalaemia, anaphylactic reactions, serious skin reactions, haematologic toxicity, central nervous system effects and ocular effects. May aggravate depression, epilepsy and parkinsonism. Persistent headache despite dose reduction requires cessation. Corneal deposits and retinal disturbances have been observed on prolonged therapy, and the label states the capsules are not indicated for long-term treatment.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
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.
Indometacin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 815 reaction mentions were counted. One report can name several reactions.
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or 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
Oral capsules and extended-release capsules, an oral suspension, rectal suppositories, a low-dose submicron capsule formulation, and an intravenous solution for neonatal use
✎ 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 molecule is lipophilic enough to enter the central nervous system readily, which is the basis of its distinctive neurological adverse effect profile.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold. The rest of the recorded wording: Route affects what an endoscope sees more than what a patient reports: the label records significantly fewer gastric mucosal abnormalities with suppositories than capsules in 45 healthy subjects, but comparable upper gastrointestinal adverse effects and more lower gastrointestinal adverse effects with suppositories in a 175-patient clinical comparison.
No source is stored against this line.
What is recorded as being sold
94 products list this as an active ingredient in the United States drug directory. 94 of them contain it and nothing else.
FDA National Drug Code directory · 72162-1302 · read 2026-08-29
They are sold as capsule, capsule, extended release, injection, powder, lyophilized, for solution, powder, suppository and suspension, taken intravenous, oral and rectal.
FDA National Drug Code directory · 72162-1302 · read 2026-08-29
The regulator's established pharmacologic class for it is anti-inflammatory agents, cyclooxygenase inhibitors [moa] and non-steroidal [cs].
FDA National Drug Code directory · 72162-1302 · read 2026-08-29
78 published labels name it as an active ingredient. 78 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · c6ca86fb-df23-42c1-9d29-f15312faf60c · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · c6ca86fb-df23-42c1-9d29-f15312faf60c · read 2026-08-29
5 marketed supplement labels list this ingredient, classed as other combinations and vitamin.
Those labels carry all other and nutrient 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.
Indomethacin is capsules at 25 mg and 50 mg, recorded as prescription product; fda label in effect 2026-05-27 in the United States.
US prescribing information · 009097a5-2c1e-4f5d-8054-896cf896cb3d · read 2026-08-27
Recorded price in US: 0.09173–0.13534 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 14 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 Indometacin 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 closing a patent ductus arteriosus improves what happens to a preterm infant — the surrogate moved and the outcome did not, in a randomised trial and in a network meta-analysis
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 rectal or parenteral administration avoids NSAID gastrointestinal toxicity, which the label’s own clinical comparison contradicts
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 daily cardioprotective aspirin offsets the NSAID cardiovascular warning, which the label states there is no consistent evidence for
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 indomethacin is an appropriate long-term arthritis treatment, when its label states it is not indicated for long-term treatment
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or 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 Indometacin 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.
TIPP: both surrogate endpoints were met and the outcome that mattered did not move
In plain words
Giving indomethacin to extremely small newborns halved the rate of a persistent fetal blood vessel and cut severe brain bleeds. At eighteen months, the proportion who had died or were left with cerebral palsy, cognitive delay, deafness or blindness was identical to placebo.
What was measured
Composite of death, cerebral palsy, cognitive delay, deafness and blindness at 18 months corrected age, against the surrogate endpoints of ductal patency and intraventricular haemorrhage
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The Trial of Indomethacin Prophylaxis in Preterms randomised 1,202 infants with birth weights of 500 to 999 g to intravenous indomethacin 0.1 mg/kg or placebo once daily for three days. The primary outcome — a composite of death, cerebral palsy, cognitive delay, deafness and blindness at a corrected age of 18 months — occurred in 271 of 574 indomethacin infants (47%) against 261 of 569 placebo infants (46%), odds ratio 1.1 (95% CI 0.8 to 1.4, P=0.61). Indomethacin did what it was expected to do on the way there: patent ductus arteriosus fell from 50% to 24% (odds ratio 0.3, P<0.001) and severe periventricular and intraventricular haemorrhage from 13% to 9% (odds ratio 0.6, P=0.02). No other outcome was altered. This is the cleanest surrogate-endpoint failure in neonatal medicine: two intermediate measures moved decisively, in the expected direction, by convincing margins, and survival without neurosensory impairment did not change at all.
Written into the record, not signed off as a reviewed claim
For a preterm ductus, ibuprofen now outranks it — and nothing changes the hard outcomes
In plain words
Indomethacin was the standard drug for closing a persistent vessel in premature babies. The largest comparison of 68 trials and 4,802 infants put high-dose oral ibuprofen ahead of it — and found that treating with anything, versus not treating at all, made no difference to death, gut necrosis or brain haemorrhage.
What was measured
Odds of ductal closure by regimen across 68 randomised trials, and odds of mortality, necrotising enterocolitis and intraventricular haemorrhage against placebo or no treatment
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Bayesian network meta-analysis covered 68 randomised trials of 4,802 preterm infants across 14 different regimens of indomethacin, ibuprofen or acetaminophen. Overall closure was 67.4% (2,867 of 4,256 infants). High-dose oral ibuprofen had significantly higher odds of closure than standard-dose intravenous ibuprofen (odds ratio 3.59, 95% credible interval 1.64 to 8.17; absolute risk difference 199 more per 1,000 infants) and than standard-dose intravenous indomethacin (odds ratio 2.35, 1.08 to 5.31; absolute risk difference 124 more per 1,000). On ranking statistics, high-dose oral ibuprofen ranked best both for closure (mean SUCRA 0.89) and for preventing surgical ligation (0.98). The finding that reframes the whole field is the last one: there was no significant difference in the odds of mortality, necrotising enterocolitis or intraventricular haemorrhage between placebo or no treatment and any of the treatment modalities. So the drug that closes the duct best is not indomethacin, and closing the duct has not been shown to change what happens to the infant.
Written into the record, not signed off as a reviewed claim
Among the worst gastrointestinal and cardiac profiles of any NSAID still in wide use
In plain words
In the pooled observational data, indomethacin ranks near the top for both serious stomach bleeding and heart attacks — 4.14-fold and 1.40-fold against non-use, worse on both counts than ibuprofen, celecoxib and naproxen.
What was measured
Pooled adjusted relative risk of upper gastrointestinal complications and of acute myocardial infarction against non-use, by individual NSAID
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The SOS project meta-analysis of 28 observational studies gave indometacin a pooled relative risk of upper gastrointestinal complications of 4.14 (95% CI 2.91 to 5.90) against non-use, placing it in the 4-to-5 band alongside tenoxicam (4.10), naproxen (4.10) and diflunisal (4.37), above diclofenac (3.34) and meloxicam (3.47), and far above ibuprofen (1.84) and celecoxib (1.45). The companion analysis of acute myocardial infarction across 18 independent study populations gave indometacin 1.40 (1.21 to 1.62), above diclofenac (1.38), rofecoxib (1.34), meloxicam (1.25), ibuprofen (1.14), celecoxib (1.12) and naproxen (1.06). Both estimates carry the confounding-by-indication caveat that applies to all observational NSAID comparisons, and indomethacin is plausibly reserved for more severe disease. What is not in doubt is that nothing in the randomised record offsets these numbers — indomethacin has no cardiovascular outcome trial and no head-to-head gastrointestinal outcome trial against a modern comparator.
Written into the record, not signed off as a reviewed claim
The label warns about the brain and the eye, and says it is not for long-term use
In plain words
Indomethacin’s prescribing information carries warnings no other NSAID here has: it may worsen depression, epilepsy and Parkinson’s disease, it causes headaches that require stopping the drug, and prolonged use has produced corneal deposits and retinal changes. It then states that it is not indicated for long-term treatment.
What was measured
Labelled central nervous system and ocular warnings, common adverse reaction incidence, and the stated duration limitation against the licensed indications
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Section 5.15 states that indomethacin capsules may aggravate depression or other psychiatric disturbances, epilepsy and parkinsonism, and should be used with considerable caution in patients with these conditions; that severe central nervous system adverse reactions require discontinuation; that the drug may cause drowsiness, with a caution against driving; and that headache which persists despite dosage reduction requires cessation of therapy. Section 5.16 records corneal deposits and retinal disturbances including macular changes in some patients on prolonged therapy, notes that these may be asymptomatic, advises periodic ophthalmological examination on prolonged therapy, and closes with the sentence: "Indomethacin capsules are not indicated for long-term treatment." Section 6.1 lists headache and dizziness alongside dyspepsia and nausea as the most common adverse reactions at an incidence of 3% or more. Read together with indications covering three chronic arthritides, this is a label describing a drug whose licensed uses and its own duration advice do not fit each other.
Source
Indomethacin capsules United States prescribing information, sections 5.15, 5.16 and 6.1 (openFDA drug label endpoint, ANDA 091276)
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
Changing the route does not move the risk where it matters
In plain words
Suppositories are often assumed to spare the stomach because the tablet never touches it. In the label’s own comparison, endoscopic damage was lower with suppositories but actual upper gastrointestinal side effects were the same — and lower gut side effects were worse.
What was measured
That a rectal or parenteral route avoids NSAID gastrointestinal toxicity by bypassing the stomach — an inference from a mucosal appearance endpoint that the clinical comparison in the same label contradicts
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The adverse reactions section records two studies side by side. In a gastroscopic study in 45 healthy subjects, the number of gastric mucosal abnormalities was significantly higher with indomethacin capsules than with suppositories or placebo. In a double-blind comparative clinical study of 175 patients with rheumatoid arthritis, the incidence of upper gastrointestinal adverse effects with capsules or suppositories was comparable, and the incidence of lower gastrointestinal adverse effects was greater in the suppository group. The label also states that the adverse reactions reported with capsules may occur with suppositories, and that rectal irritation and tenesmus have additionally been reported. This is a clean demonstration that NSAID gastrointestinal injury is systemic rather than contact-mediated: removing the tablet from the stomach improves what an endoscope sees and does not improve what a patient reports.
Source
Indomethacin capsules United States prescribing information, section 6.1 (openFDA drug label endpoint, ANDA 091276)
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
Cardioprotective aspirin does not offset the class risk, and adding it worsens the stomach
In plain words
A common assumption is that someone already taking a daily aspirin is protected against the NSAID heart warning. The label says there is no consistent evidence of that, and that combining the two raises serious gastrointestinal events.
What was measured
First-year post-infarction mortality per 100 person-years in NSAID-treated against unexposed patients, from the Danish National Registry as cited in the label
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Section 5.1 of the indomethacin label states: "There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as indomethacin, increases the risk of serious gastrointestinal (GI) events." The same section carries the class post-infarction data: observational studies in the Danish National Registry demonstrated that patients treated with NSAIDs in the post-myocardial-infarction period were at increased risk of reinfarction, cardiovascular death and all-cause mortality beginning in the first week of treatment, with death in the first year post-infarction at 20 per 100 person-years in NSAID-treated patients against 12 per 100 person-years in the unexposed, and the elevated relative risk persisting over at least four further years of follow-up. These statements appear in every prescription NSAID label; they belong on this page because indomethacin is the molecule most often reached for when an inflammatory problem is severe, which is also when a cardiac history is most likely to be set aside.
Source
Indomethacin capsules United States prescribing information, section 5.1 (openFDA drug label endpoint, ANDA 091276)
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
How many documents were read
77 documents were read for this substance.
RNAWiki source record
68 of them state the same tMax, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
XXE1CET956
CAS registry number
53-86-1
PubChem compound
3715
RxNorm concept
5781
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S3, S6.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or 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.
What the approval register records
75 approved applications cover products containing this substance. The earliest was NDA016059, approved 19650610 to ZYLA LIFE SCIENCES.
This order is fixed in code and does not count clicks or time on the page.
What is not here
3 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
The most potent and least tolerated of the common NSAIDs — pooled observational relative risk 4.14 for upper gastrointestinal complications and 1.40 for myocardial infarction, with label warnings for aggravation of depression, epilepsy and parkinsonism, corneal deposits and retinal changes, and a statement that it is not indicated for long-term treatment — and whose flagship neonatal use met both its surrogate endpoints in a 1,202-infant randomised trial while leaving death or neurosensory impairment at 18 months unchanged (47% against 46%).
Recorded evidence blocks (11)
Q2
What did Indometacin's largest trial (4874 people) and its longest (33 years) measure?
4874 people in Indometacin's largest registered study, 33 years in its longest registered window, measuring Composite of mortality, and/or NEC, and/or BPD. ClinicalTrials.gov · 2026-09-01
28 phase2, 28 phase3, 23 phase1, 20 phase4, 17 na, 7 early phase1, 5 na or unstated; NCT00262470; 2029-12; no ageing endpoint recorded. Last human test completed 2026, NCT05538247.
Interpretation These counts include studies where Indometacin was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase2
28
phase3
28
phase1
23
phase4
20
na
17
early phase1
7
2 more recorded rows
na or unstated
5
Last recorded human testNCT05538247
2026-03-31
recorded 2026-09-01 · last checked 2026-09-04
Q3
Indometacin was tested only in human — what did it show?
"Administratively complete."; 19 of 113 registered studies
Show the evidence
Trial
NCT00002796
terminated; "Administratively complete."
NCT00116623
terminated; "Funding completed"
NCT00470743
withdrawn; "Funding withdrawn"
NCT00750581
terminated; "Study medication was no longer available for study"
NCT00820612
terminated; "Stopped by DSMB for overwhelming benefit of indomethacin (unethical to withhold indomethacin from patients)"
NCT01070745
withdrawn; "Changes in approach to PDA therapy"
13 further recorded trials
NCT01774604
terminated; "Futility"
NCT01869361
withdrawn; "Due to much lower than expected numbers of eligible patients and lack of PI time, the study was not started."
NCT02438371
terminated; "Study halted due to slow recruitment"
NCT03057769
terminated; "This study was terminated because of an interim analysis suggesting futility of papillary epinephrine spraying in PEP prevention."
NCT03267680
terminated; "Lack of efficacy"
NCT03473665
terminated; "Slow recruitment"
NCT03537144
terminated; "Difficulty enrolling patients"
NCT03648437
terminated; "The PDA patients have vanished. The last recruitment took place in 2022. In the joint discussion of the principal researchers, it was concluded that PDA patients no longer have to be treated in Finland and the study was terminated."
NCT04025177
withdrawn; "Halted due to feasibility issues"
NCT04726085
terminated; "Investigative team moved institutions"
NCT05035407
terminated; "Site plans to become a site for a multicenter study of this therapy"
NCT05947461
terminated; "The data from the interim analysis showed a opposite trend predicting possible of benefit of indomethacin and conditional power analysis revealed a low probability of confirming the benefit of diclofenac if this trial will be continued."
NCT05999708
withdrawn; "Study terminated prior to FSFV for strategic business reasons."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Indometacin used Indocin 75mg SR Capsules — over how long?
10 recorded entries; human; also "Indocin 75mg SR Capsules", "Indomethacin 50 mg", "indomethacin 25 mg"
Show the evidence
human
NCT00858195
Indocin 75mg SR Capsules
NCT01058252
Indomethacin 50 mg
NCT01884272
indomethacin 25 mg
NCT03533803
Indomethacin 100Mg Suppository
NCT03582332
Indomethacin 25 Mg Oral Capsule
NCT04265053
Indomethacin 25 MG/50 MG
4 more recorded rows
humanNCT04425993
Indomethacin 100 MG
humanNCT04726085
Indomethacin 150mg
humanNCT05947461
100mg indomethacin
humanNCT06433453
Indomethacin 50 MG
recorded 2026-09-01 · last checked 2026-09-04
Q6
Indometacin's half-life is about 4.5 hours — which schedules were studied?
about 4.5 hours, the half-life Indometacin's label states. openfda-label · 12821a3a-b5f2-4415-84c9-0a30a4725f1e · 2026-08-27
bioavailability virtually 100% %.
Show the evidence
half life
about 4.5 hours hours; The mean half-life of indomethacin is estimated to be about 4.5 hours.
bioavailability
virtually 100% %; Orally administered indomethacin capsules are virtually 100% bioavailable, with 90% of the dose absorbed within 4 hours.
recorded 2026-08-27 · last checked 2026-09-04
Q7
Which of 1st peak rms knee index, 24h urine volume and adverse events and serious adverse events did Indometacin's trials measure?
1st peak rms knee index, 24h urine volume and adverse events and serious adverse events lead 40 outcome terms across Indometacin's trials. ClinicalTrials.gov · 2026-09-01
incidence of oliguria and gastric bleeding, 24h urine volume, post ercp pancreatitis, bioequivalence according to us fda guidelines, overall survival and os in low risk follow.
Show the evidence
amplitude of the vasomotor response to stimuli
1
adverse events and serious adverse events
1
increase in heart rate standing
1
incidence of oliguria and gastric bleeding
1
24h urine volume
1
post ercp pancreatitis
1
14 more recorded rows
bioequivalence according to us fda guidelines
1
overall survival
1
os in low risk
1
arterial blood pressure
1
cerebral blood flow
1
reduction of preterm birth
1
gestational age at delivery
1
1st peak rms knee index
1
pain intensity
1
resting motor threshold
1
maximal voluntary contraction
1
h reflex latency
1
pk profile of lesinurad from plasma and urine
1
who developed post ercp pancreatitis
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Indometacin's 9 ongoing trials reports first?
Increase in heart rate with standing; Percentage of Patients with Reactivation Free Survival; latest 2031-07
Show the evidence
Trial
NCT00262470
"Treatment of Orthostatic Intolerance"; n 150; "Increase in heart rate with standing"; 2029-12
NCT02205762
"LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis"; n 1400; "Percentage of Patients with Reactivation Free Survival"; 2026-07
NCT03713879
"Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis"; n 1734; "post-ERCP pancreatitis"; 2026-12-31
NCT05252754
"Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis"; n 4874; "The proportion of subjects in each study group with Post ERCP Acute Pancreatitis (PEP)"; 2026-12
NCT06572917
"Single-dose Prophylactic INdomethacin in Extremely Preterm Infants"; n 500; "Survival without severe intraventricular hemorrhage (sIVH)"; 2031-03-31
NCT07071441
"Indomethacin vs Diclofenac for Preventing PEP"; n 4050; "Rate of post-ERCP Pancreatitis"; 2026-12-31
3 further recorded trials
NCT07218653
"Human Cerebrovascular Blood Flow and Sex Differences in Metabolic Syndrome"; n 72; "Cerebral Blood Flow"; 2031-07
NCT07661498
"Indomethacin for Biliary ERCP Patients"; n 860; "Incidence of Post-ERCP Pancreatitis"; 2031-07
NCT07792668
"Pain Control During Hysterosalpingography: A Three-Arm Randomized Trial"; n 180; "Pain Intensity During Contrast-Medium Injection Measured Using the Numeric Rating Scale"; 2027-08-01
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Indometacin could settle lifespan?
NCT02205762 measures Percentage of Patients with Reactivation Free Survival, reading out 2026-07.
2 open trials; n 1400; "LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis"
Show the evidence
Trial
NCT02205762
"LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis"; n 1400; "Percentage of Patients with Reactivation Free Survival"; 2026-07
NCT06572917
"Single-dose Prophylactic INdomethacin in Extremely Preterm Infants"; n 500; "Survival without severe intraventricular hemorrhage (sIVH)"; 2031-03-31
Q10
Which 36 trials of Indometacin posted no result?
Posted no result
36 of 36 completed trials
Registrations
NCT00000494, NCT00009646, NCT01073670, NCT00002535, NCT00432081 and NCT00187447, and 30 more
Completion dates
oldest 1982-03; newest 2024-06-20
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Trial
NCT00000494
1982-03
NCT00009646
2001-03
NCT01073670
2002-04
NCT00002535
2004-07
NCT00432081
2005-08
NCT00187447
2006-07
14 further recorded trials
NCT00858195
2006-07
NCT00462111
2007-09
NCT00152724
2008-11
NCT00226122
2009-12
NCT01280006
2011-12
NCT01884272
2013-10
NCT01577121
2014-09
NCT02110810
2015-03
NCT02577809
2015-09
NCT01428180
2016-03
NCT03582332
2016-06-23
NCT01638962
2016-07
NCT01830335
2016-12
NCT01848665
2016-12
Q11
At the median, Indometacin's trials enrolled 83 people — anything larger?
Median enrolment
83
Largest enrolment
4874
Registered trials counted
110
Q12
What do 815 spontaneous reports say about Indometacin — 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.
Indometacin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 815 reaction mentions were counted: drug hypersensitivity 296; premature baby 94; oligohydramnios 89; renal failure acute 76. open-targets-adr · CHEMBL3989410 · 2026-06-24
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drug hypersensitivity
296
premature baby
94
oligohydramnios
89
renal failure acute
76
gastrointestinal haemorrhage
67
retinopathy of prematurity
62
4 more recorded rows
premature delivery
41
melaena
34
necrotising colitis
29
gastric ulcer
27
recorded 2026-06-24 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 9 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.