This page shows what was measured, who it was measured in, and what that does not settle.
What Celecoxib does in the body
One is always present and keeps the stomach lining protected and the platelets working; the other appears when tissue is inflamed.
There are two versions of the enzyme that makes prostaglandins. Celecoxib was designed to fit a small side pocket that only the inflammation version has, so it blocks that one and leaves the housekeeping one alone. The stomach benefit is real and measured. The problem is that blood vessels also use the inflammation enzyme, to make a substance that keeps platelets calm — so blocking it without touching the platelet enzyme tips the balance toward clotting. That is why the entire class carries a cardiovascular warning, and why two of its members were withdrawn.
Why people take it. Arthritis pain and inflammation, with less stomach damage
What happened in people
24-hour systolic blood pressure change of -0.3 mmHg against ibuprofen’s +3.7 mmHg, with incident hypertension 10.3% against 23.2%
✎ 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.
Hrachovec JB, Mora M. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001;286(19):2398 (11712924) · a recorded source, not a stored snapshot
The only COX-2 selective inhibitor still marketed in the United States from the original class
Where it acts
The COX-2 side pocket in inflamed synovium and in vascular endothelium; platelet COX-1 is left untouched, which is the source of both the gastric advantage and the vascular problem
Kind of result
A number that stands in for health
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · JCX84Q7J1L · read 2026-08-29
Its recorded molecular formula is C17H14F3N3O2S, weighing 381.38.
US prescribing information · 806e5f8a-f986-4f88-ba3e-8265f86afa48 · read 2026-08-30
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The recorded use, written for a reader without medical training. Not signed off.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 144 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in 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 reviewer4 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.
Which registered measures put each goal on this table
Pain
self reported pain; total analgesic use after surgery; rated visual analogue scale pain intensity assessment; global pain intensity as assessed by visual analog scale; visual analogue for pain
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
4 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.
Results from the one trial this record names
In NCT00346216, Primary analysis of the adjudicated Antiplatelet Trialists' Collaboration (APTC) composite endpoint (cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke) was Celecoxib: 188 of 8,072 subjects with events (2.3%) in the intent-to-treat analysis against Ibuprofen: 218 of 8,040 subjects with events (2.7%); naproxen: 201 of 7,969 subjects with events (2.5%) in the comparison group at Intent-to-treat analysis through month 30. The recorded difference is Hazard ratio 0.93 for celecoxib versus naproxen and 0.86 for celecoxib versus ibuprofen (95% CI 0.76 to 1.13 versus naproxen and 0.70 to 1.04 versus ibuprofen).
US prescribing information · 00e67d5e-df6f-4dfd-8c2d-a001c8a99af0 · read 2026-08-27
Incidence of prospectively defined symptomatic upper gastrointestinal ulcers and ulcer complications — bleeding, perforation and obstruction — during the six-month treatment period
✗ The study did not show it
Who was studied
CLASS (JAMA 2000;284:1247-1255)
How many people
8059
Study design
Phase 4, double-blind, randomised controlled trial at 386 North American sites
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Ulcer complications alone 0.76% against 1.45% annualised, P=0.09 — not significant; complications plus symptomatic ulcers 2.08% against 3.54%, P=0.02. Among aspirin users, complications 2.01% against 2.12% (P=0.92) and the combined endpoint 4.70% against 6.00% (P=0.49)
Repeated elsewhere
Failed to Replicate
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. Celecoxib was given at 400 mg twice daily, described in the publication as two and four times the maximum rheumatoid arthritis and osteoarthritis dosages. Only 4,573 patients (57%) received treatment for six months. Correspondence in the same journal the following year was titled "Reporting of 6-month vs 12-month data in a clinical trial of celecoxib", and a subsequent review records discrepancies between the results submitted to the FDA and those published.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsules at 50, 100, 200 and 400 mg, and an oral solution (Elyxyb) for acute migraine; taken once or twice daily
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Hrachovec JB, Mora M. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001;286(19):2398 (11712924) · a recorded source, not a stored snapshot
Malhotra S, Shafiq N, Pandhi P. COX-2 inhibitors: a CLASS act or just VIGORously promoted. MedGenMed 2004;6(1):6 — records that discrepancies were noted betw… · a recorded source, not a stored snapshot
Prevention of colorectal adenomas; cardiovascular events reported as a prespecified blinded safety analysis
✗ The study did not show it
Who was studied
APC — Adenoma Prevention with Celecoxib (N Engl J Med 2005;352:1071-1080)
Composite of cardiovascular death, myocardial infarction, stroke or heart failure: 1.0% on placebo, 2.3% at 200 mg twice daily (hazard ratio 2.3, 95% CI 0.9 to 5.5) and 3.4% at 400 mg twice daily (hazard ratio 3.4, 1.4 to 7.8)
Repeated elsewhere
Partially Replicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. The data and safety monitoring board recommended early discontinuation of study drug on the basis of these observations, so follow-up was truncated at 2.8 to 3.1 years. The dose-response pattern is the finding, not the point estimate at either dose.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsules at 50, 100, 200 and 400 mg, and an oral solution (Elyxyb) for acute migraine; taken once or twice daily
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Hrachovec JB, Mora M. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001;286(19):2398 (11712924) · a recorded source, not a stored snapshot
Malhotra S, Shafiq N, Pandhi P. COX-2 inhibitors: a CLASS act or just VIGORously promoted. MedGenMed 2004;6(1):6 — records that discrepancies were noted betw… · a recorded source, not a stored snapshot
Antiplatelet Trialists Collaboration composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke, adjudicated
Celecoxib 2.3% against naproxen 2.5% and ibuprofen 2.7%; hazard ratio against naproxen 0.93 (0.76 to 1.13) and against ibuprofen 0.85 (0.70 to 1.04), both p<0.001 for non-inferiority. Gastrointestinal events lower than naproxen (p=0.01) and ibuprofen (p=0.002); renal events lower than ibuprofen (p=0.004)
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. Mean achieved celecoxib dose was 209±37 mg daily — approximately a quarter of the 800 mg daily that produced the harm signal in APC — while comparators ran near maximum. 68.8% of patients stopped study drug and 27.4% discontinued follow-up, which biases a non-inferiority comparison toward the null.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsules at 50, 100, 200 and 400 mg, and an oral solution (Elyxyb) for acute migraine; taken once or twice daily
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Hrachovec JB, Mora M. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001;286(19):2398 (11712924) · a recorded source, not a stored snapshot
Malhotra S, Shafiq N, Pandhi P. COX-2 inhibitors: a CLASS act or just VIGORously promoted. MedGenMed 2004;6(1):6 — records that discrepancies were noted betw… · a recorded source, not a stored snapshot
What we know
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.7 registered measures of this kind. No reviewed result.
□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.4 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.4 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in C. elegans (roundworm), Drosophila (fruit fly), Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□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: Demonstrated significant reduction in joint pain compared to placebo in osteoarthritis of the knee and hip
US prescribing information · 00e67d5e-df6f-4dfd-8c2d-a001c8a99af0 · read 2026-08-27
Kidneys: Inhibition of PGE2 synthesis may lead to sodium and water retention through increased reabsorption in the renal medullary thick ascending loop of Henle
US prescribing information · 00e67d5e-df6f-4dfd-8c2d-a001c8a99af0 · read 2026-08-27
Start
Celecoxib
What a person takes: Oral capsules at 50, 100, 200 and 400 mg, and an oral solution (Elyxyb) for acute migraine; taken once or twice daily.
The measurement behind this step
Poorly water-soluble, so absorption depends on particle size and formulation; peak plasma concentration comes at about three hours. Plasma protein binding is about 97%. Metabolism is principally by CYP2C9, so CYP2C9 poor metabolisers and patients on CYP2C9 inhibitors reach substantially higher exposure at the same dose, and the label directs dose reduction accordingly.
What it acts on
One amino acid is the entire drug class
The inflammation enzyme has a small extra pocket that the housekeeping enzyme does not, because one bulky amino acid is swapped for a smaller one. Celecoxib was designed to plug that pocket.
╌╌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
COX-2 carries valine at position 523 where COX-1 has isoleucine, opening a side pocket into which celecoxib’s benzenesulfonamide inserts. That single substitution is the structural basis of COX-2 selectivity and of the whole coxib class.
Hrachovec JB, Mora M. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001;286(19):2398 (11712924) · a recorded source, not a stored snapshot
Because the housekeeping enzyme is untouched, the mucus and bicarbonate that protect the stomach keep being made. That is the measured advantage and it is real.
╌╌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
COX-1-derived prostaglandins maintain gastric mucosal defence and are spared. In PRECISION, gastrointestinal events were significantly lower on celecoxib than on naproxen (p=0.01) or ibuprofen (p=0.002); in the CNT meta-analysis, coxibs had the lowest upper gastrointestinal complication rate ratio of any group at 1.81 (1.17 to 2.81).
Hrachovec JB, Mora M. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001;286(19):2398 (11712924) · a recorded source, not a stored snapshot
Celecoxib does not touch the platelet enzyme, so it neither thins the blood nor gets in the way of aspirin. That is a practical advantage over ibuprofen, which cancels aspirin outright.
╌╌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
Platelet thromboxane A2 generation is COX-1-dependent and is essentially unaffected by celecoxib at therapeutic concentrations. Consequently there is no antiplatelet effect and no competition with aspirin for the COX-1 channel — the interaction that makes ibuprofen problematic in aspirin users.
Hrachovec JB, Mora M. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001;286(19):2398 (11712924) · a recorded source, not a stored snapshot
In the vessel wall, sparing the platelet is the problem
The vessel lining uses the inflammation enzyme to make a substance that keeps platelets calm. Blocking that while leaving the platelet’s own clotting signal intact tips the balance toward clot formation.
╌╌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
Endothelial prostacyclin is largely COX-2-derived and is suppressed; platelet thromboxane A2 is COX-1-derived and is not. The resulting prostacyclin-to-thromboxane imbalance is the mechanism proposed for the class cardiovascular signal, and it predicts a dose-response — which is what the adenoma prevention trial found.
Hrachovec JB, Mora M. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001;286(19):2398 (11712924) · a recorded source, not a stored snapshot
At 800 mg a day in a prevention trial, cardiovascular events roughly tripled and the trial was stopped. At a mean 209 mg a day in 24,081 arthritis patients, it was no worse than ibuprofen or naproxen.
╌╌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
APC: composite cardiovascular endpoint 1.0% on placebo, 2.3% at 400 mg daily (hazard ratio 2.3, 0.9 to 5.5), 3.4% at 800 mg daily (hazard ratio 3.4, 1.4 to 7.8). PRECISION: mean achieved dose 209±37 mg daily, primary composite 2.3%, non-inferior to both comparators. Neither result generalises to the other dose.
Hrachovec JB, Mora M. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001;286(19):2398 (11712924) · a recorded source, not a stored snapshot
Measured and holding: fewer stomach and kidney events, no aspirin interference, non-inferior heart outcomes at low dose. Published and disputed: the six-month gastrointestinal result that built the drug’s reputation, at up to four times its maximum approved dose.
──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
CLASS as published: ulcer complications alone 0.76% against 1.45% (P=0.09, not significant); among aspirin users 2.01% against 2.12% (P=0.92). Celecoxib dose 400 mg twice daily, stated in the paper as two to four times the maximum approved dosages; 57% of patients reached six months of treatment. The accelerated-approval familial adenomatous polyposis indication was withdrawn in 2012 because the required confirmatory study was never completed.
Hrachovec JB, Mora M. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001;286(19):2398 (11712924) · a recorded source, not a stored snapshot
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.
global pain intensity as assessed by visual analog scale
visual analogue for pain
Measured
Things only a test, a scale or a device shows.
serum thromboxane b2
systolic blood pressure at week 6/final visit
urinary pge m levels
urinary lte4 levels
Meaningful
Things that change how a life goes, not only a number.
progression free survival
overall survival
survival at 6 months
overall survival at 6 months
disease free survival
survival
time to disease progression
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 (25)
time to recurrence
response rate
time to prostate specific antigen progression
successes
antitumor activity
toxicity
amplitude of the vasomotor response to stimuli
tumor response rate
time to progression
maximum tolerated dose
safety
pathologic complete response rate
therapy completion rate
overall response
time to treatment failure
time to failure
arterial pressure
total analgesic use after surgery
acr pediatric 30
panss
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. approximately 11 hours hours
Read from the label, which states: “It appears that the low solubility of the drug prolongs the absorption process making terminal half-life (t 1/2 ) determinations more variable. The effective half-life is approximately 11 hours under fasted conditions.”
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 arthritis, particularly those at higher risk of gastrointestinal bleeding or already on aspirin. Contraindicated in people with sulfonamide allergy, in aspirin- or NSAID-triggered asthma or urticaria, and in the setting of coronary artery bypass graft surgery.
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.
Who a named study recorded including and excluding
It included: Subjects with osteoarthritis or rheumatoid Arthritis with or at risk of developing cardiovascular disease and who require and eligible for chronic, daily therapy with an NSAID to control arthritis sign and symptoms.
ClinicalTrials.gov record · NCT00346216 · read 2026-08-27
It excluded: Subjects have had a recent cardiovascular event, unstable cardiovascular conditions, or any major surgery (cardiac or non-cardiac) within 3 months prior to randomization; Subjects with medical or laboratory abnormality that would make the subject inappropriate for entry into this trial; Subjects require treatment with aspirin > 325 mg /day; Subjects with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc..
ClinicalTrials.gov record · NCT00346216 · read 2026-08-27
What the label states about particular groups
On pediatric, the label states: “The use of celecoxib in patients 2 years to 17 years of age with pauciarticular, polyarticular course JRA or in patients with systemic onset JRA was studied in a 12-week, double-blind, active controlled, pharmacokinetic, safety and efficacy study, with a 12-week open-label extension.”
US prescribing information · 806e5f8a-f986-4f88-ba3e-8265f86afa48 · 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 · 806e5f8a-f986-4f88-ba3e-8265f86afa48 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Use of NSAIDs, including celecoxib, 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 · 806e5f8a-f986-4f88-ba3e-8265f86afa48 · read 2026-08-30
On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including celecoxib, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women.”
US prescribing information · 806e5f8a-f986-4f88-ba3e-8265f86afa48 · read 2026-08-30
On people with reduced liver function, the label states: “The daily recommended dose of celecoxib capsules in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by 50%.”
US prescribing information · 806e5f8a-f986-4f88-ba3e-8265f86afa48 · read 2026-08-30
On people with reduced kidney function, the label states: “Celecoxib is not recommended in patients with severe renal insufficiency [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3)] .”
US prescribing information · 806e5f8a-f986-4f88-ba3e-8265f86afa48 · read 2026-08-30
Where the result stopped carrying
The adenoma prevention trial was stopped early by its data monitoring board for cardiovascular harm
The familial adenomatous polyposis indication was withdrawn after twelve years because the confirmatory study was never done
ADAPT found no cognitive benefit and the highest rate of new antihypertensive treatment of its three arms (hazard ratio 1.56 against placebo)
Two other members of the class, rofecoxib and valdecoxib, were withdrawn from the market entirely
The gastrointestinal advantage does not survive concurrent aspirin, which is the situation many candidate patients are in
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
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral capsules at 50, 100, 200 and 400 mg, and an oral solution (Elyxyb) for acute migraine; taken once or twice daily
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1, S3, S4, S6.
No source is stored against this line.
What is in the pack
Poorly water-soluble, so absorption depends on particle size and formulation; peak plasma concentration comes at about three hours. Plasma protein binding is about 97%. Metabolism is principally by CYP2C9, so CYP2C9 poor metabolisers and patients on CYP2C9 inhibitors reach substantially higher exposure at the same dose, and the label directs dose reduction accordingly.
✎ 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 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 known hypersensitivity to celecoxib or sulfonamides; after asthma, urticaria or other allergic-type reactions to aspirin or other NSAIDs, in which severe and sometimes fatal anaphylactic reactions have been reported; and in the setting of coronary artery bypass graft surgery. No antiplatelet effect, so it neither substitutes for nor interferes with cardioprotective aspirin — but adding aspirin removes most of the gastric advantage.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Hrachovec JB, Mora M. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001;286(19):2398 (11712924) · a recorded source, not a stored snapshot
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.
Celecoxib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 9099 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
drug hypersensitivity — 2908 reaction mentions
rheumatoid arthritis — 1098 reaction mentions
pain — 1004 reaction mentions
arthralgia — 913 reaction mentions
condition aggravated — 831 reaction mentions
drug intolerance — 642 reaction mentions
hypersensitivity — 449 reaction mentions
arthropathy — 421 reaction mentions
joint swelling — 421 reaction mentions
musculoskeletal stiffness — 412 reaction mentions
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or 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 at 50, 100, 200 and 400 mg, and an oral solution (Elyxyb) for acute migraine; taken once or twice daily
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Plasma protein binding is about 97%. Metabolism is principally by CYP2C9, so CYP2C9 poor metabolisers and patients on CYP2C9 inhibitors reach substantially higher exposure at the same dose, and the label directs dose reduction accordingly.
✎ 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
264 products list this as an active ingredient in the United States drug directory. 264 of them contain it and nothing else.
FDA National Drug Code directory · 72162-2175 · read 2026-08-29
They are sold as capsule, liquid, powder and suspension, taken oral.
FDA National Drug Code directory · 72162-2175 · 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 · 72162-2175 · read 2026-08-29
138 published labels name it as an active ingredient. 138 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 806e5f8a-f986-4f88-ba3e-8265f86afa48 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 806e5f8a-f986-4f88-ba3e-8265f86afa48 · read 2026-08-29
Celecoxib is capsules at Capsules: 50 mg, 100 mg, 200 mg and 400 mg, recorded as prescription product; fda label in effect 2023-08-24 in the United States.
US prescribing information · 00e67d5e-df6f-4dfd-8c2d-a001c8a99af0 · read 2026-08-27
Recorded price in US: 0.06209–0.22276 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 99 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 Celecoxib 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 celecoxib is cardiovascularly safe as a molecule, when the reassuring result is at roughly a quarter of the dose that produced a randomised harm signal
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 CLASS demonstrated a gastrointestinal advantage, when its complication endpoint was not significant and its advantage disappeared entirely in aspirin users
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 COX-2 selectivity distinguishes celecoxib from "traditional" NSAIDs, when diclofenac’s whole-blood selectivity ratio falls in the same range
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 being gentler on the stomach makes the drug safer overall, when the same selectivity is the proposed mechanism of the vascular harm
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 Celecoxib 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.
CLASS: six months of a longer trial, at up to four times the maximum approved dose
In plain words
The trial that made celecoxib’s reputation reported six months of a study that ran longer, gave celecoxib at two to four times its own maximum licensed dose, and did not reach statistical significance on the endpoint that mattered most — serious ulcer complications.
What was measured
Annualised upper gastrointestinal ulcer complication rates over the reported six-month period, overall and stratified by aspirin use
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
CLASS randomised 8,059 patients with osteoarthritis or rheumatoid arthritis at 386 sites; 7,968 received at least one dose. Celecoxib was given at 400 mg twice daily — described in the publication itself as two and four times the maximum rheumatoid arthritis and osteoarthritis dosages respectively — against ibuprofen 800 mg three times daily and diclofenac 75 mg twice daily. Only 4,573 patients (57%) received treatment for six months. The reported outcome measures were confined to that six-month treatment period. For all patients, annualised upper gastrointestinal ulcer complications alone were 0.76% on celecoxib against 1.45% on NSAIDs, P=0.09 — not significant. Only the softer composite of complications plus symptomatic ulcers reached significance (2.08% against 3.54%, P=0.02). Among patients taking aspirin, there was no advantage at all: complications 2.01% against 2.12% (P=0.92) and the combined endpoint 4.70% against 6.00% (P=0.49). The publication also reported no difference in cardiovascular events between celecoxib and the comparator NSAIDs. Correspondence published in the same journal the following year was titled "Reporting of 6-month vs 12-month data in a clinical trial of celecoxib", and a BMJ editorial in 2002 was subtitled "Adequate analysis of the CLASS trial indicates that this may not be the case". A subsequent review of both CLASS and the rofecoxib VIGOR trial records that several discrepancies were noted between the results submitted to the FDA and those used for publication in scientific journals.
Written into the record, not signed off as a reviewed claim
APC: a dose-related tripling of cardiovascular events, and the trial was stopped
In plain words
A trial testing celecoxib for preventing bowel polyps found cardiovascular events rising with dose — 1.0% on placebo, 2.3% at 200 mg twice daily, 3.4% at 400 mg twice daily. The safety monitoring board stopped the drug early.
What was measured
Composite of cardiovascular death, myocardial infarction, stroke or heart failure by celecoxib dose against placebo over 2.8 to 3.1 years
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The Adenoma Prevention with Celecoxib trial enrolled 2,035 patients with a history of colorectal neoplasia, randomised to celecoxib 200 mg twice daily, 400 mg twice daily, or placebo, with 2.8 to 3.1 years of follow-up available for all patients except those who died. A composite of cardiovascular death, myocardial infarction, stroke or heart failure occurred in 7 of 679 on placebo (1.0%), 16 of 685 on 200 mg twice daily (2.3%; hazard ratio 2.3, 95% CI 0.9 to 5.5) and 23 of 671 on 400 mg twice daily (3.4%; hazard ratio 3.4, 1.4 to 7.8). Similar trends appeared for other composite endpoints. On the basis of these observations the data and safety monitoring board recommended early discontinuation of the study drug. The dose-response is the important part: it is what a mechanism-based effect looks like, and it is why the later reassuring trial at a mean 209 mg daily does not contradict this one.
Written into the record, not signed off as a reviewed claim
PRECISION vindicated it — at a mean of 209 mg a day
In plain words
The largest NSAID safety trial ever run put celecoxib head to head with ibuprofen and naproxen in 24,081 arthritis patients at raised cardiac risk. Celecoxib was not worse on heart events and was better on stomach and kidney ones. It was also given at about a quarter of the dose that had shown harm.
What was measured
Cardiovascular, gastrointestinal and renal event rates against two active comparators in 24,081 randomised patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
PRECISION randomised 24,081 patients to celecoxib (mean daily dose 209±37 mg), naproxen (852±103 mg) or ibuprofen (2,045±246 mg), treated a mean 20.3±16.0 months and followed a mean 34.1±13.4 months. The primary composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke occurred in 2.3% on celecoxib, 2.5% on naproxen and 2.7% on ibuprofen; hazard ratio against naproxen 0.93 (95% CI 0.76 to 1.13) and against ibuprofen 0.85 (0.70 to 1.04), both meeting non-inferiority at p<0.001. Gastrointestinal events were significantly lower with celecoxib than with naproxen (p=0.01) or ibuprofen (p=0.002); renal events were significantly lower than with ibuprofen (p=0.004) but not naproxen (p=0.19). In the ambulatory blood pressure substudy of 444 patients, 24-hour systolic pressure changed by -0.3 mmHg on celecoxib against +3.7 mmHg on ibuprofen (difference -3.9 mmHg, p=0.0009), and incident hypertension among normotensive patients was 10.3% against 23.2%. The result is real and the conditions are narrow: 68.8% of participants stopped study drug and 27.4% discontinued follow-up entirely.
Written into the record, not signed off as a reviewed claim
Celecoxib is safe at 200 mg. That is not the same claim as celecoxib is safe.
In plain words
The trial that showed harm used 800 mg a day. The trial that showed safety used a mean of 209 mg. Both are correct, and the sentence "celecoxib is cardiovascularly safe" quietly drops the dose from the claim.
What was measured
That PRECISION established celecoxib as cardiovascularly safe as a molecule, when it established non-inferiority at a mean dose roughly a quarter of the one that produced a dose-related harm signal in a trial stopped early
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The adenoma prevention trial found a dose-response — hazard ratio 2.3 at 400 mg daily and 3.4 at 800 mg daily against placebo — which is precisely the pattern the prostacyclin-thromboxane imbalance mechanism predicts. PRECISION achieved a mean 209 mg daily because osteoarthritis patients, the large majority of the enrolled population, were capped at 200 mg daily, the low end of the licensed range. So the two trials are not in conflict and neither generalises to the other: the drug has a randomised cardiovascular non-inferiority result at approximately a quarter of the dose at which it has a randomised harm result. Three further constraints on the reassuring reading: the comparators were run near their maximum doses, 68.8% of PRECISION participants stopped study drug, and non-inferiority under that much attrition is biased toward the null. The label reflects none of this asymmetry — the boxed cardiovascular thrombotic warning applies at every dose, as it does for every NSAID.
Written into the record, not signed off as a reviewed claim
The cancer-prevention indication was withdrawn because the confirmatory study was never done
In plain words
Celecoxib held an accelerated approval for reducing polyps in an inherited bowel cancer syndrome from 1999. The study required to confirm that it actually helped patients was never completed, and the indication was withdrawn in 2012.
What was measured
Regulatory status of an accelerated-approval indication and completion status of its required confirmatory postmarketing study
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The Federal Register notice records that the FDA approved the familial adenomatous polyposis indication for CELEBREX on 23 December 1999 under the agency’s accelerated approval regulations, 21 CFR part 314 subpart H. On 2 February 2011 the FDA requested that Pfizer voluntarily withdraw the indication "because the postmarketing study intended to verify clinical benefit and required as a condition of approval under subpart H was never completed". Pfizer requested withdrawal by letter of 3 February 2011, waived its opportunity for a hearing, and noted that the withdrawal was not "due to any new efficacy or safety data". Approval of the indication was withdrawn effective 8 June 2012. The current CELEBREX label lists six indications — osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis in patients 2 years and older, ankylosing spondylitis, acute pain and primary dysmenorrhoea — and familial adenomatous polyposis is not among them. Accelerated approval trades a surrogate endpoint for a promise of confirmation. This is what it looks like when the promise is not kept: twelve and a half years of an indication that was never verified, ended administratively rather than by evidence.
Source
Pfizer, Inc.; Withdrawal of Approval of Familial Adenomatous Polyposis Indication for CELEBREX. Federal Register 2012;77(111):34052 (Docket FDA-2012-N-0494); CELEBREX prescribing information section 1 (NDA 020998)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
retracted
Review state
Written into the record, not signed off as a reviewed claim
ADAPT: no cognitive benefit, and the most blood-pressure treatment of the three arms
In plain words
A prevention trial randomised 2,528 people over seventy to celecoxib, naproxen or placebo to see whether anti-inflammatories prevent Alzheimer’s. They do not. And celecoxib produced the highest rate of new blood pressure treatment of the three groups.
What was measured
Cardiovascular composite hazard ratio, incident antihypertensive treatment and cognitive test trajectories over 1 to 46 months in 2,528 randomised elderly participants
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
ADAPT randomised 2,528 participants aged 70 and over with a family history of Alzheimer’s dementia to celecoxib 200 mg twice daily, naproxen sodium 220 mg twice daily or placebo, and was suspended in December 2004 after the adenoma prevention trial reported cardiovascular harm. The cardiovascular and cerebrovascular composite gave a hazard ratio for celecoxib of 1.10 (95% CI 0.67 to 1.79) — reassuring relative to the adenoma trial, and the ADAPT investigators said so, noting that their data do not show the same level of risk. But antihypertensive treatment was initiated in 47.4% of the celecoxib group against 34.1% on placebo, hazard ratio 1.56 (1.26 to 1.94) — the highest of the three arms, above naproxen’s 1.40. On the question the trial was built for, neither drug improved cognitive function, and lower Modified Mini-Mental State Examination scores over time were seen for both treatment groups against placebo (-0.33 points for celecoxib, P=0.04). Follow-up reassessment in 2010-2011 confirmed no protection against cognitive decline.
This order is fixed in code and does not count clicks or time on the page.
What is not here
3 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A COX-2 selective inhibitor whose gastrointestinal advantage was published from six months of a longer trial at two to four times its maximum approved dose — and where the complication endpoint that mattered did not reach significance (0.76% against 1.45%, P=0.09) and vanished entirely in aspirin users (P=0.92) — which then produced a dose-related tripling of cardiovascular events at 400 mg twice daily in a prevention trial stopped early, and was finally shown non-inferior to ibuprofen and naproxen in 24,081 patients at a mean dose of 209 mg a day.
Recorded evidence blocks (14)
Q2
What did Celecoxib's largest trial (24081 people) and its longest (25 years) measure?
24081 people in Celecoxib's largest registered study, 25 years in its longest registered window, measuring To determine the overall survival time in patients with metastatic pancreatic cancer treated with the combination of gemcitabine, cisplatin and celecoxib. ClinicalTrials.gov · 2026-09-01
191 phase2, 95 phase1, 91 phase4, 86 phase3, 37 na, 13 na or unstated, 10 early phase1; NCT00268476; 2030-12; no ageing endpoint recorded. Last human test completed 2026, NCT04814355.
Interpretation These counts include studies where Celecoxib 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
191
phase1
95
phase4
91
phase3
86
na
37
na or unstated
13
2 more recorded rows
early phase1
10
Last recorded human testNCT04814355
2026-02-28
recorded 2026-09-01 · last checked 2026-09-04
Q3
From C. elegans to human: where has Celecoxib shown lifespan?
Interpretation To determine the overall survival time in patients with metastatic pancreatic cancer treated with the combination of gemcitabine, cisplatin and celecoxib. — the recorded outcome words.
Show the evidence
C. elegans
lifespan
Drosophila
lifespan
mouse
lifespan
rat
mechanism-only
humanNCT00176813
lifespan; To determine the overall survival time in patients with metastatic pancreatic cancer treated with the combination of gemcitabine, cisplatin and celecoxib.; 491
Celecoxib's half-life is approximately 11 hours — which schedules were studied?
approximately 11 hours, the half-life Celecoxib's label states. openfda-label · 59f495e8-3cea-9d98-e063-6394a90a89d4 · 2026-08-27
Show the evidence
half life
approximately 11 hours hours; It appears that the low solubility of the drug prolongs the absorption process making terminal half-life (t 1/2 ) determinations more variable. The effective half-life is approximately 11 hours under fasted conditions.
tmax
Table 4 Summary of Single Dose (200 mg) Disposition Kinetics of Celecoxib in Healthy Subjects 1 Mean (%CV) PK Parameter Values C max, ng/mL T max, hr Effective t 1/2, hr V ss /F, L CL/F, L/hr 705 (38) 2.8 (37) 11.2 (31) 429 (34) 27.7 (28) 1 Subjects under fasting conditions (n = 36, 19-52 yrs.
metabolism
Elimination Metabolism Celecoxib metabolism is primarily mediated via CYP2C9.
recorded 2026-08-27 · last checked 2026-09-04
Q7
Which of acr pediatric 30, adverse events and serious adverse events and amplitude of the vasomotor response to stimuli did Celecoxib's trials measure?
acr pediatric 30, adverse events and serious adverse events and amplitude of the vasomotor response to stimuli lead 40 outcome terms across Celecoxib's trials. ClinicalTrials.gov · 2026-09-01
response rate, survival at 6 months, overall survival at 6 months, disease free survival, time to prostate specific antigen progression and successes follow.
Show the evidence
time to recurrence
1
progression free survival
1
overall survival
1
response rate
1
survival at 6 months
1
overall survival at 6 months
1
14 more recorded rows
disease free survival
1
time to prostate specific antigen progression
1
successes
1
antitumor activity
1
toxicity
1
amplitude of the vasomotor response to stimuli
1
tumor response rate
1
time to progression
1
maximum tolerated dose
1
safety
1
pathologic complete response rate
1
therapy completion rate
1
survival
1
overall response
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Celecoxib's 43 ongoing trials reports first?
Overall survival; Mean celecoxib CSF concentration (ug/L) within 121-180 minutes post ingestion of 7 or 14 mg/kg celecoxib.; latest 2032-12-31
Show the evidence
Trial
NCT00268476
"Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy"; n 11992; "Overall survival"; 2030-12
NCT01344200
"CELECOXIB Plasma and Cerebral Spinal Fluid Pharmacokinetics in Children"; n 65; "Mean celecoxib CSF concentration (ug/L) within 121-180 minutes post ingestion of 7 or 14 mg/kg celecoxib."; 2027-02-01
NCT01356290
"Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors"; n 232; "Efficacy"; 2030-04
NCT02574728
"Sirolimus in Combination With Metronomic Chemotherapy in Children With Recurrent and/or Refractory Solid and CNS Tumors"; n 46; "Radiographic response to treatment for solid tumors"; 2026-06
NCT02993029
"99Tc-MDP Treatment for Knee Osteoarthritis"; n 40; "pain, stiffness and joint function of knee"; 2027-12-30
NCT03026140
"Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer"; n 353; "Incidence of adverse events during the treatment and follow-up (safety)"; 2032-03-01
14 further recorded trials
NCT03498326
"Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer"; n 480; "disease free survival"; 2030-03-31
NCT03590821
"Timed Aspirin Chronobiome Study"; n 60; "Blood pressure [mmHg]"; 2028-11
NCT03825809
"Nonopioid Analgesia After Labral Surgery"; n 100; "Pain Levels"; 2020-05-20
NCT03926338
"Neoadjuvant Toripalimab With or Without Celecoxib in dMMR/MSI-H Colorectal Cancer"; n 270; "Pathological complete response (pCR) rates (PICC-1 and PICC-2 cohorts)"; 2030-04-01
NCT04041050
"A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm"; n 85; "Number of Participants with Dose Limiting Toxicities (DLT) (Part 1 and Part 2)"; 2026-12-31
NCT04147013
"Effect of Celecoxib on Postoperative Analgesia and Disease Severity in AERD Patients with CRS"; n 44; "Post FESS changes in the Lund-Kennedy Endoscopic Score (LKES)"; 2026-07
NCT04469530
"Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors"; n 55; "Two-year progression-free survival in patients with high-risk solid tumors"; 2029-02
NCT04488081
"I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients"; n 1500; "Identify agents that will result in substantial improvements to the clinical condition of participants with COVID-19."; 2030-07-31
NCT05415397
"Treating Immuno-metabolic Depression With Anti-inflammatory Drugs"; n 140; "Depressive symptoms severity"; 2026-07
NCT05434065
"Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage"; n 60; "Hematoma expansion volume percentage"; 2027-12-31
NCT05488847
"Opioid-Free Pain Protocol After Shoulder Arthroplasty"; n 83; "Pain Levels"; 2026-09-01
NCT05637086
"Clinical Study Evaluating Safety of Pentoxifylline and Celecoxib in Patients With Grand-Mal Epilepsy Treated by Phenytoin Monotherapy"; n 90; "The clinical outcome will be assessed through Quality of Life questionnaire (QOLIE-31)"; 2027-11-20
NCT05644301
"INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive Disorder"; n 240; "Change in depressive symptom severity (HDRS-17)"; 2026-09
NCT05731726
"Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer"; n 50; "Pathological complete response rates"; 2026-12-30
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Celecoxib could settle lifespan?
NCT07174570 measures Progression-Free Survival (PFS), reading out 2027-11-13.
4 open trials; n 39; "Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer"
Show the evidence
Trial
NCT07174570
"Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer"; n 39; "Progression-Free Survival (PFS)"; 2027-11-13
NCT04469530
"Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors"; n 55; "Two-year progression-free survival in patients with high-risk solid tumors"; 2029-02
NCT03498326
"Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer"; n 480; "disease free survival"; 2030-03-31
NCT00268476
"Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy"; n 11992; "Overall survival"; 2030-12
Q10
Which 181 trials of Celecoxib posted no result?
Posted no result
181 of 181 completed trials
Registrations
NCT00001693, NCT00620867, NCT00633386, NCT00639483, NCT00001955 and NCT00006299, and 175 more
Completion dates
oldest 2002-01; newest 2023-12-31
Show the evidence
Trial
NCT00001693
2002-01
NCT00620867
2003-03
NCT00633386
2003-08
NCT00639483
2004-01
NCT00001955
2004-02
NCT00006299
2004-02
14 further recorded trials
NCT00006381
2004-02
NCT00032890
2004-02
NCT00630929
2004-02
NCT00036283
2004-04
NCT00640809
2004-04
NCT00633438
2004-06
NCT00638807
2004-07
NCT00640627
2004-09
NCT00640432
2004-10
NCT00073866
2004-12
NCT00471341
2004-12
NCT00525096
2004-12
NCT02090933
2004-12
NCT02099136
2004-12
Q11
At the median, Celecoxib's trials enrolled 67 people — anything larger?
Median enrolment
67
Largest enrolment
24081
Registered trials counted
472
Q12
What do 9099 spontaneous reports say about Celecoxib — 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.
Celecoxib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 9099 reaction mentions were counted: drug hypersensitivity 2908; rheumatoid arthritis 1098; pain 1004; arthralgia 913. open-targets-adr · CHEMBL118 · 2026-06-24
Show the evidence
drug hypersensitivity
2908
rheumatoid arthritis
1098
pain
1004
arthralgia
913
condition aggravated
831
drug intolerance
642
4 more recorded rows
hypersensitivity
449
arthropathy
421
joint swelling
421
musculoskeletal stiffness
412
recorded 2026-06-24 · last checked 2026-09-04
Q13
Celecoxib and CYP2C9: shared by which compounds?
CYP2C9 appear in Celecoxib's recorded interaction sentences, 4 in all. openfda-label+europepmc · 2026-08-30
It is primarily metabolized by CYP2C9 with a half-life of approximately 11 hours.
pharmacokinetics
Elimination Metabolism Celecoxib metabolism is primarily mediated via CYP2C9.
clinical_pharmacology
Limited data from 4 published reports that included a total of 8 subjects with the homozygous CYP2C9*3/*3 genotype showed celecoxib systemic levels that were 3- to 7-fold higher in these subjects compared to subjects with CYP2C9*1/*1 or *I/*3 genotypes.
clinical_pharmacology
The pharmacokinetics of celecoxib have not been evaluated in subjects with other CYP2C9 polymorphisms, such as *2, *5, *6, *9 and *11.
recorded 2026-08-30 · last checked 2026-09-04
Q14
Was Celecoxib studied with exercise?
exercise is named in Celecoxib's label sentences: "We conducted a randomized, counterbalanced, double-masked, crossover trial (NCT05512013) in which 12 healthy adults ingested ibuprofen (IBU, 800 mg), celecoxib (CEL, 200 mg), flurbiprofen (FLU, 100 mg), or placebo (PLA) before a 10 × 10 bout of plyometric exercise." openfda-label+europepmc · 2026-08-30
1 recorded statement; exercise
Show the evidence
exercise
We conducted a randomized, counterbalanced, double-masked, crossover trial (NCT05512013) in which 12 healthy adults ingested ibuprofen (IBU, 800 mg), celecoxib (CEL, 200 mg), flurbiprofen (FLU, 100 mg), or placebo (PLA) before a 10 × 10 bout of plyometric exercise.
recorded 2026-08-30 · last checked 2026-09-04
Q15
What is recorded about Celecoxib and mTOR?
"This review article summarizes and shows the effectiveness and potential of repurposed drugs including metabolic and cardiovascular modulators (metformin, simvastatin), antimicrobial and antiparasitic agents (artesunate, ivermectin, ketoconazole, chloroquine, hydroxychloroquine, niclosamide, doxycycline, pentamidine), mTOR inhibitors…" — where Celecoxib and mTOR appear together. Europe PMC · pathway abstract search · 2026-07-21
"This review article summarizes and shows the effectiveness and potential of repurposed drugs including metabolic and cardiovascular modulators (metformin, simvastatin), antimicrobial and antiparasitic agents (artesunate, ivermectin, ketoconazole, chloroquine, hydroxychloroquine, niclosamide, doxycycline, pentamidine), mTOR inhibitors (temsirolimus, everolimus, rapamycin), anti-inflammatory and…"
autophagyPMID 38821960
"Our chemical screening identified two FDA-approved drugs, celecoxib and memantine, as autophagy activators which effectively restored autophagic flux, NAD levels, and cell viability of NPC1 cells."
NAD+PMID 38821960
"Our chemical screening identified two FDA-approved drugs, celecoxib and memantine, as autophagy activators which effectively restored autophagic flux, NAD levels, and cell viability of NPC1 cells."
mTORPMID 41404692
"The patient received dimethyl fumarate (Nrf2 activator), celecoxib (NF-κB inhibitor), and rapamycin (mTOR pathway modulator) as part of an individualized treatment strategy."
autophagy
PMID 41072307
"The non-selective COX inhibitor indomethacin (IND) can be nephrotoxic, but the impact of selective COX-2 inhibitor celecoxib (CEL) or the non-selective naproxen (NAP) on renal autophagy and EGR1 remain obscure."
PMID 38451396
"Furthermore, celecoxib inhibited muscle proteolysis by reducing the levels of MAFbx, MuRF1, and autophagy related proteins maybe by inhibiting the activation of pro-inflammatory STAT3 pathway in vivo and in vitro."
mTORPMID 37316264
"We found that (1) DMC significantly inhibited the growth of HCC and improved the prognosis of the mice, and this depended on the stronger antitumor activity of natural killer (NK) and T cells; (2) compared with celecoxib and MK-886, DMC significantly enhanced the cytotoxic and stem-like potential, and inhibited exhaustion of NK and T cells; (3) mechanistically, DMC inhibited the expression of…"
AMPKPMID 37316264
"We found that (1) DMC significantly inhibited the growth of HCC and improved the prognosis of the mice, and this depended on the stronger antitumor activity of natural killer (NK) and T cells; (2) compared with celecoxib and MK-886, DMC significantly enhanced the cytotoxic and stem-like potential, and inhibited exhaustion of NK and T cells; (3) mechanistically, DMC inhibited the expression of…"
sirtuinPMID 38313305
"Celecoxib also inhibited the levels of Foxo3a, Fbx32 and MuRF1 in the ubiquitin-proteasome system, as well as the levels of BNIP3, Beclin1, ATG7, and LC3Ⅱ in the autophagic-lysosomal system, and celecoxib protected mitochondria and promoted mitochondrial biogenesis by elevating the levels of SIRT1 and PGC1-α, increased the number of SDH-positive fibers in diabetic skeletal muscles.…"
AMPKPMID 36614295
"By using specific inhibitors celecoxib (coxib), S-methylisothiourea sulfate (SMT), Ferrostatin-1 (Fer-1), and Compound C, we further found that CAN regulated inflammation and ferroptosis through AMP-activated protein (AMPK), and inflammation interacted with ferroptosis."
sirtuinPMID 27528025
"Taken together, these results indicate that celecoxib and sulindac can inhibit TGF-β1-induced EMT and suppress lung cancer cell migration and invasion via downregulation of SIRT1."
IGF-1PMID 36769464
"However, the application of novel therapeutics, celecoxib-coated microspheres, local administration of IGF-1 and activated chondrocytes following surgical debridement of SBCs hinders the expansion of SBCs and prevents the progression of osteoarthritis."
recorded 2026-07-21 · last checked 2026-09-04
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