This page shows what was measured, who it was measured in, and what that does not settle.
What Valdecoxib does in the body
Valdecoxib blocks the enzyme that makes the prostaglandins of inflammation and pain, and leaves the enzyme that protects the stomach lining alone.
That is the coxib idea and it works. Two problems came with it. The first is shared with the class: blocking the vessel-wall enzyme without touching the platelet one tilts blood towards clotting. The second is specific to this molecule: it contains a sulfonamide group, the chemical feature associated with the severe skin reactions that sulfa drugs cause.
Why people take it. Formerly used for arthritis and period pain.
What happened in people
Severe skin reactions were reported about 25 times as often as the background rate.
✓ Reviewed first-read answer
Where this came from
A person wrote this and a reviewer approved it against this exact record. It carries no effect size.
A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.
No source is stored against this line.
The limit that matters most
The main heart-risk study involved people just after heart surgery, so its exact risk does not transfer to everyone.
Where it acts
Inflamed synovium and vascular endothelium; the skin is the second injury site
Kind of result
The kind of result is not recorded
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 · 2919279Q3W · read 2026-08-29
Its recorded molecular formula is C16H14N2O3S, weighing 314.4.
PubChem record · 119607 · read 2026-08-29
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
A reviewer approved this sentence against this exact record and its sources.
The limit a reviewer approved as the one that matters most here.
The four opening statements run to 101 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.
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.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
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 8 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 reviewer6 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
s assessment of arthritis pain; summed pain intensity through 24 hours; assessment of pain visual analogue scale; s assessment of arthritis pain using a visual analogue scale; visual analogue scale pain intensity; s assessment of ankle pain vas
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
6 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.
Frequency of predefined adverse events — cardiovascular, renal, gastroduodenal ulceration and wound healing — over 10 days of treatment and 30 days of follow-up after coronary-artery bypass grafting
✗ The study did not show it
Who was studied
Parecoxib/valdecoxib after CABG (Nussmeier et al.)
At least one confirmed adverse event 7.4% versus 4.0%, RR 1.9 (95% CI 1.1 to 3.2), P = 0.02; cardiovascular events 2.0% versus 0.5%, RR 3.7 (95% CI 1.0 to 13.5), P = 0.03
Repeated elsewhere
Replicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. The cardiovascular confidence interval runs from 1.0 to 13.5, so the point estimate is imprecise. The population is at exceptional thrombotic risk and does not represent the outpatient arthritis population the drug was licensed for.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet (10 and 20 mg); intravenous parecoxib as a prodrug in some countries
Interval reported. 95% CI 1
Written into the record, not signed off as a reviewed claim.
FDA final rule 81 FR 69668, 7 October 2016 — "Valdecoxib: All drug products containing valdecoxib" (https://www.federalregister.gov/documents/2016/10/07/2016… · a recorded source, not a stored snapshot
Reporting rates of Stevens-Johnson syndrome and toxic epidermal necrolysis for celecoxib, rofecoxib, valdecoxib and meloxicam over the first two years of marketing
✓ The study showed what it set out to show
Who was studied
FDA AERS serious cutaneous reaction comparison (La Grenade et al.)
How many people
123
Study design
Spontaneous adverse event report analysis with drug-use denominators
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Valdecoxib 49, celecoxib 6, rofecoxib 3 cases per million person-years, meloxicam none; background 1.9 cases per million population per year
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Reporting rates are not incidence rates: spontaneous reporting under-captures events by an unknown factor and is affected by publicity. The four-drug internal comparison is what carries the conclusion.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet (10 and 20 mg); intravenous parecoxib as a prodrug in some countries
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
FDA final rule 81 FR 69668, 7 October 2016 — "Valdecoxib: All drug products containing valdecoxib" (https://www.federalregister.gov/documents/2016/10/07/2016… · a recorded source, not a stored snapshot
What we know
RNAWiki holds 2 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 eventNo evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
□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.6 registered measures of this kind.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■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 Drosophila (fruit fly). A result in animals says what to test next. It does not say what happens in people.
□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.
Start
Valdecoxib
What a person takes: Oral tablet (10 and 20 mg); intravenous parecoxib as a prodrug in some countries.
The measurement behind this step
Once- or twice-daily oral tablet. Parecoxib sodium is a water-soluble injectable prodrug hydrolysed to valdecoxib in the liver, developed for perioperative use — which is how a coxib came to be tested in patients recovering from cardiac surgery in the first place.
Getting in
An oral tablet, or an injection of its prodrug
Taken as a tablet, or given as an injection of a related compound that the body converts into 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
Oral valdecoxib 10 and 20 mg. Parecoxib sodium is a water-soluble injectable prodrug, an N-propionyl amide of the sulfonamide, hydrolysed enzymatically in the liver to valdecoxib.
Reaches inflamed joint tissue and vascular endothelium
It spreads into the inflamed joint where it relieves pain, and also into the lining of blood vessels.
╌╌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
Distributes into synovial tissue and vascular endothelium. COX-2 is inducible in inflamed synovium and constitutively expressed in endothelial cells, which is the anatomical basis of the split between benefit and harm.
A sulfur-containing group fits into a small cavity that COX-2 has and COX-1 does not, which is what makes the drug selective — and is also the chemical group that sulfa allergies react to.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The benzenesulfonamide binds the hydrophilic side pocket created by the Val523-for-Ile523 substitution in COX-2. The same free arylsulfonamide is the moiety associated with severe cutaneous adverse reactions in the sulfonamide drug class.
Prostacyclin falls; separately, an immune reaction can start in the skin
Vessel walls stop making the substance that keeps platelets apart, tilting blood towards clotting. Independently, the sulfonamide can trigger an immune attack on the skin.
╌╌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
Suppressed endothelial COX-2-derived prostacyclin with platelet COX-1 thromboxane intact leaves unopposed prothrombotic tone. Severe cutaneous adverse reactions to arylsulfonamides are immune-mediated, HLA-restricted, and mechanistically unrelated to prostaglandin synthesis.
Pain relieved; cardiovascular events and skin failure raised
The analgesic effect was real. After heart surgery, cardiovascular events quadrupled. Severe skin reactions ran at about twenty-five times background.
╌╌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
Measured endpoints: at least one confirmed adverse event in 7.4% versus 4.0% after CABG (RR 1.9, 95% CI 1.1 to 3.2); cardiovascular events 2.0% versus 0.5% (RR 3.7, 95% CI 1.0 to 13.5); Stevens-Johnson syndrome and toxic epidermal necrolysis reported at 49 per million person-years against a background of 1.9 per million population per year.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What 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.
s assessment of arthritis pain
summed pain intensity through 24 hours
assessment of pain visual analogue scale
s assessment of arthritis pain using a visual analogue scale
visual analogue scale pain intensity
s assessment of ankle pain vas
Measured
Things only a test, a scale or a device shows.
No registered study measured anything of this kind.
Meaningful
Things that change how a life goes, not only a number.
No registered study measured anything of this kind.
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 (2)
s global evaluation of study medication
acr 20 criteria responder
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
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.
Nobody. Its intravenous prodrug parecoxib remains available in some countries outside the United States.
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.
Where the result stopped carrying
The dedicated post-CABG safety trial found more cardiovascular events on active treatment than on placebo
Withdrawn from the United States market in April 2005 and codified in the FDA withdrawn-for-safety list at 81 FR 69668
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
Withdrawn
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral tablet (10 and 20 mg); intravenous parecoxib as a prodrug in some countries
✎ 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: S8.
No source is stored against this line.
What is in the pack
Once- or twice-daily oral tablet.
✎ 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: Parecoxib sodium is a water-soluble injectable prodrug hydrolysed to valdecoxib in the liver, developed for perioperative use — which is how a coxib came to be tested in patients recovering from cardiac surgery in the first place.
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
Withdrawn in April 2005 on two grounds. Cardiovascular: at least one confirmed adverse event in 7.4% versus 4.0% and cardiovascular events in 2.0% versus 0.5% in the 30 days after coronary bypass grafting. Cutaneous: Stevens-Johnson syndrome and toxic epidermal necrolysis reported at 49 cases per million person-years, approximately 25 times the background rate and 8 to 9 times the celecoxib rate. The cutaneous risk is attributed to the sulfonamide group and is not a property of COX-2 inhibition.
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.
Valdecoxib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 605 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∅Nothing found in the sources checked
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral tablet (10 and 20 mg); intravenous parecoxib as a prodrug in some countries
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
A recorded note compares this form with the others that are sold. It is kept below, word for word.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
The recorded note, unchanged: Parecoxib sodium is a water-soluble injectable prodrug hydrolysed to valdecoxib in the liver, developed for perioperative use — which is how a coxib came to be tested in patients recovering from cardiac surgery in the first place.
No source is stored against this line.
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, withdrawn medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Valdecoxib 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 a 3.7-fold cardiovascular risk ratio measured after cardiac surgery is the risk facing an outpatient taking the drug for arthritis
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 49 reported cases per million person-years is the true incidence of Stevens-Johnson syndrome rather than a floor set by reporting behaviour
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.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
How fast does the body clear it?
The sources RNAWiki checked hold nothing for this field.
Why it matters. Without this, nothing on this page can say how long anything lasts.
What would answer it
A stored source that records it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Valdecoxib 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.
After coronary bypass surgery, cardiovascular events were 2.0% against 0.5%
In plain words
In 1,671 patients recovering from heart bypass surgery, serious cardiovascular events were nearly four times more common on the drug than on placebo.
What was measured
Frequency of predefined adverse events and of cardiovascular events after CABG
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Randomised, double-blind trial with 10 days of treatment and 30 days of follow-up in 1,671 patients after coronary-artery bypass grafting, assigned to intravenous parecoxib for at least three days followed by oral valdecoxib through day 10, intravenous placebo followed by oral valdecoxib, or placebo for 10 days, all with access to standard opioids. The primary endpoint was the frequency of predefined adverse events including cardiovascular events, renal failure or dysfunction, gastroduodenal ulceration and wound-healing complications. Both active groups had a higher proportion of patients with at least one confirmed adverse event — 7.4% in each against 4.0% on placebo, risk ratio 1.9 (95% CI 1.1 to 3.2, p=0.02 for each comparison). Cardiovascular events specifically, comprising myocardial infarction, cardiac arrest, stroke and pulmonary embolism, occurred in 2.0% of the parecoxib-plus-valdecoxib group against 0.5% on placebo, risk ratio 3.7 (95% CI 1.0 to 13.5, p=0.03).
Written into the record, not signed off as a reviewed claim
Stevens-Johnson syndrome reported at 49 cases per million person-years
In plain words
The FDA compared four anti-inflammatory drugs. Valdecoxib produced severe skin reactions at about twenty-five times the background rate, eight to nine times celecoxib's rate, and meloxicam produced none.
What was measured
Reported cases of Stevens-Johnson syndrome and toxic epidermal necrolysis per million person-years of use
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The FDA reviewed all United States Adverse Event Reporting System cases of Stevens-Johnson syndrome and toxic epidermal necrolysis for celecoxib, rofecoxib, valdecoxib and meloxicam since first marketing. Up to the end of March 2004 there were 63 cases with valdecoxib, 43 with celecoxib, 17 with rofecoxib — the non-sulfonamide coxib — and none with meloxicam. Reporting rates over the first two years of marketing were 49 cases per million person-years for valdecoxib, 6 for celecoxib and 3 for rofecoxib, against a background incidence of 1.9 cases per million population per year taken from the literature. The valdecoxib rate is 8 to 9 times that of celecoxib and approximately 25 times background. The authors' conclusion names the chemistry: a strong association between these reactions and the sulfonamide COX-2 inhibitors, particularly valdecoxib.
Written into the record, not signed off as a reviewed claim
Two independent grounds, either of which would have been enough
In plain words
Most withdrawn drugs have one problem. Valdecoxib had two unrelated ones: a class cardiovascular effect and a chemistry-specific skin reaction.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The cardiovascular signal arises from COX-2 selectivity itself — suppressed endothelial prostacyclin with platelet thromboxane intact — and is shared with rofecoxib. The severe cutaneous reactions arise from the benzenesulfonamide group and are not shared with rofecoxib, which uses a methylsulfonyl group and had a reporting rate of 3 per million person-years against valdecoxib's 49. Two mechanistically independent liabilities in one molecule is unusual, and it is why the withdrawal in April 2005 was less contested than rofecoxib's. Valdecoxib appears in the FDA's codified withdrawn-for-safety list at 81 FR 69668 as "all drug products containing valdecoxib".
Written into the record, not signed off as a reviewed claim
A CABG population is the wrong denominator for the ordinary arthritis patient
In plain words
The cardiovascular trial studied people who had just had heart surgery. That is a group at exceptional risk, and the numbers do not transfer directly to someone taking the drug for arthritis.
What was measured
That a 3.7-fold cardiovascular risk ratio measured in the 30 days after coronary bypass grafting is the risk faced by an outpatient taking valdecoxib for arthritis
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Nussmeier trial enrolled patients in the 10 days after coronary-artery bypass grafting — a period of maximal thrombotic risk, in patients with established coronary disease, on a background of surgical inflammation. The 3.7 risk ratio has a 95% confidence interval running from 1.0 to 13.5, which is wide, and the absolute difference is 2.0% versus 0.5% over 30 days. Applying that directly to a 60-year-old taking valdecoxib for osteoarthritis overstates the risk to that person. What it does establish, unambiguously, is a contraindication after cardiac surgery, and — read alongside the rofecoxib data — that the class effect is real rather than idiosyncratic to one molecule.
Written into the record, not signed off as a reviewed claim
Spontaneous reporting rates are not incidence, and the comparison is what carries the weight
In plain words
The 49-per-million figure counts reports, not cases, and reporting is influenced by publicity. What makes it convincing is that all four drugs were counted the same way at the same time.
What was measured
That 49 reported cases per million person-years is the incidence of Stevens-Johnson syndrome on valdecoxib
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The FDA analysis uses spontaneous reports with drug-use data as a denominator, which yields a reporting rate rather than an incidence rate. Spontaneous reporting under-captures events by an unknown factor and is subject to stimulated reporting after publicity, so 49 cases per million person-years is a floor of unknown depth rather than a measurement of true incidence. The design compensates by comparing four drugs from the same database, over the same first-two-years-of-marketing window, with meloxicam deliberately chosen because it reached the market at a similar time. The internal comparison — 49 versus 6 versus 3 versus zero — is far more robust than any single number in it.
Written into the record, not signed off as a reviewed claim
The non-sulfonamide coxib had the lowest skin-reaction rate of the three
In plain words
Rofecoxib, which was withdrawn for heart risk, had the fewest severe skin reactions of the three coxibs — because it is the one without a sulfonamide group.
What was measured
Serious cutaneous adverse reaction reporting rate by coxib, stratified by sulfonamide status
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In the same FDA dataset, rofecoxib — explicitly identified as the non-sulfonamide coxib — accounted for 17 Stevens-Johnson syndrome or toxic epidermal necrolysis cases and a first-two-years reporting rate of 3 per million person-years, against celecoxib's 6 and valdecoxib's 49. This is a clean structure-activity observation running across three drugs with the same therapeutic target: the cardiovascular liability tracks the pharmacology and is shared, while the cutaneous liability tracks the sulfonamide substituent and is not. Two drugs in the same class can fail for entirely different chemical reasons, and this dataset shows both at once.
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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 inhibitor withdrawn in 2005 on two independent grounds — a 3.7-fold cardiovascular risk ratio after coronary bypass surgery, and Stevens-Johnson syndrome and toxic epidermal necrolysis reported at about 25 times the background rate.
Recorded evidence blocks (7)
Q2
What did Valdecoxib's largest trial (490 people) and its longest (3.2 years) measure?
490 people in Valdecoxib's largest registered study, 3.2 years in its longest registered window, measuring Cerebrospinal fluid (CSF) valdecoxib concentration. ClinicalTrials.gov · 2026-09-01
8 phase3, 8 phase4, 3 phase2, 1 na; NCT00122096; 2006-01; no ageing endpoint recorded. Last human test completed 2006, NCT00115752.
Interpretation These counts include studies where Valdecoxib 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
phase3
8
phase4
8
phase2
3
na
1
Last recorded human testNCT00115752
2006-10-04
recorded 2026-09-01 · last checked 2026-09-04
Q3
From Drosophila to human: where has Valdecoxib shown lifespan?
"Because one of the drugs Valdecoxib was withdrawn due to safety concerns."; 2 of 19 registered studies
Show the evidence
Trial
NCT00419549
terminated; "Because one of the drugs Valdecoxib was withdrawn due to safety concerns."
NCT00657449
terminated; "See termination reason in detailed description."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Which of acr 20 criteria responder, assessment of pain visual analogue scale and s assessment of ankle pain vas did Valdecoxib's trials measure?
acr 20 criteria responder, assessment of pain visual analogue scale and s assessment of ankle pain vas lead 8 outcome terms across Valdecoxib's trials. ClinicalTrials.gov · 2026-09-01
acr 20 criteria responder, assessment of pain visual analogue scale, s assessment of arthritis pain using a visual analogue scale, visual analogue scale pain intensity and s assessment of ankle pain vas follow.
Show the evidence
s assessment of arthritis pain
1
summed pain intensity through 24 hours
1
s global evaluation of study medication
1
acr 20 criteria responder
1
assessment of pain visual analogue scale
1
s assessment of arthritis pain using a visual analogue scale
1
2 more recorded rows
visual analogue scale pain intensity
1
s assessment of ankle pain vas
1
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which 17 trials of Valdecoxib posted no result?
Posted no result
17 of 17 completed trials
Registrations
NCT00683137, NCT00653354, NCT00649610, NCT00649415, NCT00661635 and NCT00671320, and 11 more
Completion dates
oldest 2003-02; newest 2006-10-04
Show the evidence
Trial
NCT00683137
2003-02
NCT00653354
2003-03
NCT00649610
2003-05
NCT00649415
2003-07
NCT00661635
2003-07
NCT00671320
2003-10
11 further recorded trials
NCT00647829
2003-12
NCT00650624
2004-01
NCT00021996
2004-02
NCT00648258
2004-04
NCT00650598
2004-08
NCT00652808
2004-09
NCT00650455
2005-01
NCT00650039
2005-02
NCT00122096
2006-01
NCT00260325
2006-04
NCT00115752
2006-10-04
Q7
At the median, Valdecoxib's trials enrolled 296.5 people — anything larger?
Median enrolment
296.5
Largest enrolment
490
Registered trials counted
18
Q8
What do 605 spontaneous reports say about Valdecoxib — 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.
Valdecoxib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 605 reaction mentions were counted: drug hypersensitivity 111; stevens-johnson syndrome 106; myocardial infarction 74; cerebrovascular accident 70. open-targets-adr · CHEMBL865 · 2026-06-24
Show the evidence
drug hypersensitivity
111
stevens-johnson syndrome
106
myocardial infarction
74
cerebrovascular accident
70
chest pain
65
gastrointestinal haemorrhage
57
4 more recorded rows
oedema peripheral
43
erythema multiforme
31
blood cholesterol increased
24
rash erythematous
24
recorded 2026-06-24 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · 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
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