This page shows what was measured, who it was measured in, and what that does not settle.
What Tegaserod does in the body
A tablet for irritable bowel syndrome with constipation, in women under 65 without heart disease
Serotonin is a signalling molecule the gut uses to coordinate the wave of muscle contraction that moves food along. Tegaserod switches on one particular serotonin receptor in the gut wall, which makes that wave stronger and more frequent, so stool moves faster and the gut becomes less sensitive to stretch. The same receptor family exists in blood vessels and platelets, which is where the cardiovascular question came from.
What happened in people
Internal adjudication: 13 cardiovascular ischaemic events in 11,614 tegaserod patients (0.11%) against 1 in 7,031 on placebo (0.014%)
✎ 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.
FDA notice of the joint meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on tegaserod, 11 … · a recorded source, not a stored snapshot
The limit that matters most
That a non-significant odds ratio of 4.24 with an upper bound of 34.74 demonstrates the absence of cardiovascular risk
Where it acts
Enteric nervous system of the gastrointestinal tract; 5-HT4 receptors on interneurons and motor neurons of the myenteric plexus
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 · 458VC51857 · read 2026-08-29
Its recorded molecular formula is C16H23N5O, weighing 301.39.
PubChem record · 135409453 · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 107 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Adjudicated cardiovascular ischaemic events in 11,614 tegaserod and 7,031 placebo patients
✗ The study did not show it
Who was studied
Pooled placebo-controlled tegaserod safety database (internal adjudication, 2007)
How many people
18645
Study design
Pooled analysis of the placebo-controlled programme
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
13 events (0.11%) on tegaserod against 1 (0.014%) on placebo; all 14 patients had at least one cardiovascular risk factor and 11 had two or more
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. Fourteen events across 18,645 patients is close to the resolution limit of the dataset; a single reclassification moves the ratio substantially, which is what the later adjudications demonstrated.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, 6 mg twice daily before meals
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
FDA notice of the joint meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on tegaserod, 11 … · a recorded source, not a stored snapshot
21 CFR 216.24 — Drug products withdrawn or removed from the market for reasons of safety or effectiveness (entry: tegaserod maleate) (https://www.ecfr.gov/cu… · a recorded source, not a stored snapshot
Probable new or worsening cardiovascular events, and coronary or cerebrovascular ischaemic events specifically
✓ The study showed what it set out to show
Who was studied
External re-adjudication for the 2018 advisory committee
How many people
18645
Study design
Independent external adjudication of the same pooled dataset
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Coronary or cerebrovascular ischaemic events 7 (0.06%) versus 1 (0.01%); odds ratio 4.24, 95% CI 0.52 to 34.74, P = 0.273
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. The interval extends to 34.74. A non-significant result on eight events is uninformative rather than reassuring, and the restricted label reflects that.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, 6 mg twice daily before meals
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
FDA notice of the joint meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on tegaserod, 11 … · a recorded source, not a stored snapshot
21 CFR 216.24 — Drug products withdrawn or removed from the market for reasons of safety or effectiveness (entry: tegaserod maleate) (https://www.ecfr.gov/cu… · a recorded source, not a stored snapshot
Subjective global assessment of IBS-C symptom relief over the final four weeks, in women under 65 without a history of cardiovascular ischaemic events
✓ The study showed what it set out to show
Who was studied
Pooled efficacy analysis in the indicated population (Shah et al.)
How many people
2752
Study design
Pooled analysis of four 12-week randomised placebo-controlled trials
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
44.1% versus 36.5%; pooled odds ratio 1.38 (95% CI 1.18 to 1.61), P < 0.001
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Diarrhoea was the most frequent adverse event. The trials were not powered for cardiovascular outcomes and were never intended to settle that question.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, 6 mg twice daily before meals
Interval reported. 95% CI 1
Written into the record, not signed off as a reviewed claim.
FDA notice of the joint meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on tegaserod, 11 … · a recorded source, not a stored snapshot
21 CFR 216.24 — Drug products withdrawn or removed from the market for reasons of safety or effectiveness (entry: tegaserod maleate) (https://www.ecfr.gov/cu… · 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 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
Tegaserod
What a person takes: Oral tablet, 6 mg twice daily before meals.
The measurement behind this step
Tegaserod maleate tablets taken twice daily shortly before eating. Low absolute bioavailability, reduced further by food, with rapid absorption and a short elimination half-life.
Getting in
An oral tablet taken before meals
Swallowed twice a day, shortly before eating.
╌╌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 tegaserod maleate 6 mg twice daily before meals. Absolute bioavailability is low and food reduces absorption further, which is why the timing is specified.
FDA notice of the joint meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on tegaserod, 11 … · a recorded source, not a stored snapshot
Reaching the cell
Reaches the nerve network in the gut wall
It reaches the layer of nerve cells embedded between the muscle coats of the intestine.
╌╌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 to the myenteric plexus, the enteric neuronal network lying between the circular and longitudinal muscle layers, where 5-HT4 receptors sit on interneurons and motor neurons.
FDA notice of the joint meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on tegaserod, 11 … · a recorded source, not a stored snapshot
What it acts on
Partial agonist at the 5-HT4 receptor
It switches on a serotonin receptor on those nerve cells — partly, not fully, which limits how far the effect can be pushed.
╌╌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
Selective partial agonism at 5-HT4, a Gs-coupled receptor. Receptor occupancy raises intracellular cyclic AMP in enteric neurons and enhances release of acetylcholine and calcitonin gene-related peptide.
FDA notice of the joint meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on tegaserod, 11 … · a recorded source, not a stored snapshot
The change it makes
The peristaltic reflex is amplified
The coordinated squeeze that moves contents along the gut becomes stronger and more frequent, and the gut becomes less sensitive to stretch.
╌╌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
Enhanced neurotransmitter release amplifies the peristaltic reflex: contraction above the bolus and relaxation below it. Intestinal secretion increases and visceral afferent sensitivity to distension falls.
FDA notice of the joint meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on tegaserod, 11 … · a recorded source, not a stored snapshot
What that does for a person
Faster transit, fewer symptoms — and the ischaemic question
Stool frequency rises and pain and bloating fall. The unresolved question is whether the same receptor family acting outside the gut raises cardiovascular risk.
╌╌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: subjective global assessment response 44.1% against 36.5% on placebo, odds ratio 1.38 (95% CI 1.18 to 1.61), in the indicated population. Unresolved: adjudicated coronary and cerebrovascular ischaemic events 7 versus 1, odds ratio 4.24 (95% CI 0.52 to 34.74).
FDA notice of the joint meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on tegaserod, 11 … · 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 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Women under 65 with irritable bowel syndrome with constipation, no history of myocardial infarction, stroke, transient ischaemic attack or angina, and at most one cardiovascular risk factor.
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
Voluntarily withdrawn from the United States market in March 2007 on the internal adjudication
The original application, NDA 021200, is recorded in Drugs@FDA with all Zelnorm products Discontinued
The entry "Tegaserod maleate: All drug products containing tegaserod maleate" remains in 21 CFR 216.24 today
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
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, 6 mg twice daily before meals
✎ 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
Tegaserod maleate tablets taken twice daily shortly before eating. Low absolute bioavailability, reduced further by food, with rapid absorption and a short elimination half-life.
✎ 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
Diarrhoea is the most common adverse effect and the dose-limiting one; ischaemic colitis has been reported. The cardiovascular ischaemic signal that caused the 2007 withdrawal was not eliminated by re-adjudication — the point estimate remained an odds ratio of 4.24 with a confidence interval from 0.52 to 34.74 — and the current label manages it by excluding women 65 and over, anyone with a history of myocardial infarction, stroke, transient ischaemic attack or angina, and anyone with more than one cardiovascular risk factor. Contraindicated in severe renal impairment and moderate or severe hepatic impairment.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
FDA notice of the joint meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on tegaserod, 11 … · 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 tablet, 6 mg twice daily before meals
✎ 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
Low absolute bioavailability, reduced further by food, with rapid absorption and a short elimination half-life.
✎ 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
1 product lists this as an active ingredient in the United States drug directory. 1 of them contain it and nothing else.
FDA National Drug Code directory · 73435-022 · read 2026-08-29
They are sold as powder.
FDA National Drug Code directory · 73435-022 · read 2026-08-29
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 Tegaserod 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 non-significant odds ratio of 4.24 with an upper bound of 34.74 demonstrates the absence of cardiovascular risk
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the 2007 withdrawal was refuted by new evidence — no new patients were studied; the same records were re-adjudicated
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 "5-HT4 agonists are cardiotoxic" summarises both this drug and cisapride, whose failure was hERG-mediated arrhythmia rather than ischaemia
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.
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 Tegaserod 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.
Thirteen ischaemic events in 11,614 patients against one in 7,031 on placebo
In plain words
Pooling every placebo-controlled trial, thirteen people on tegaserod had a cardiovascular ischaemic event and one person on placebo did. That is 0.11% against 0.014%.
What was measured
Adjudicated cardiovascular ischaemic events in pooled placebo-controlled trials, tegaserod versus placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The 2007 withdrawal rested on an internal adjudication of pooled placebo-controlled tegaserod data covering 18,645 patients — 11,614 on tegaserod and 7,031 on placebo. Twenty-four possible cardiovascular ischaemic events were identified internally, twenty on tegaserod and four on placebo. The first adjudication classified 14 of these (0.075% of the pooled population) as events: 13 on tegaserod (0.11%) and 1 on placebo (0.014%). Every one of the 14 patients had at least one cardiovascular risk factor and 11 had two or more. The absolute numbers are what make this a hard case: thirteen events is a small enough count that a single reclassification moves the ratio substantially.
Written into the record, not signed off as a reviewed claim
Two external adjudications of the same data reached a different answer
In plain words
Independent committees re-reviewed the same patient records. Restricted to coronary and cerebrovascular events, the difference was 7 against 1, and the confidence interval ran from 0.52 to 34.74 — it crosses 1.
What was measured
Odds ratio 4.24 (95% CI 0.52 to 34.74, P = 0.273) for coronary or cerebrovascular ischaemic events on external re-adjudication
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
For the 2018 advisory committee an independent committee re-adjudicated the 24 possible events, and a second independent external adjudication followed. The second adjudication reviewed 390 events, of which 24 (0.13%) were classified as probable new or worsening cardiovascular events: 18 on tegaserod (0.16%) and 6 on placebo (0.09%). Restricting to coronary or cerebrovascular ischaemic events gave 7 on tegaserod (0.06%) against 1 on placebo (0.01%), an odds ratio of 4.24 with a 95% confidence interval of 0.52 to 34.74 and P = 0.273. Among women under 65 with no history of cardiovascular ischaemic events and at most one risk factor, there were no major adverse cardiovascular events at all. The dataset did not change between 2007 and 2018. The classification of the events, and the definition of the population, did.
Written into the record, not signed off as a reviewed claim
A non-significant odds ratio of 4.24 is not evidence of no effect
In plain words
The re-adjudicated result did not reach statistical significance, but its central estimate is still a fourfold difference. Failing to reach significance on eight events is not the same as showing there is no risk.
What was measured
That the external re-adjudication showed tegaserod carries no cardiovascular ischaemic risk
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The confidence interval on the re-adjudicated coronary and cerebrovascular comparison runs from 0.52 to 34.74. It includes 1, which is why P = 0.273, and it also includes 30, which is why the result cannot be read as reassurance. Eight events in 18,645 patients is close to the limit of what a pooled trial programme can resolve. The 2019 approval is better described as a decision that the residual uncertainty is acceptable in a low-risk population than as a finding that the 2007 signal was spurious. The label carries the restriction precisely because the uncertainty was not eliminated.
Written into the record, not signed off as a reviewed claim
Efficacy in the reapproval population: 44.1% responded against 36.5% on placebo
In plain words
In the four trials pooled for the 2019 label, 44.1% of women rated themselves relieved on tegaserod against 36.5% on placebo. The odds ratio is 1.38.
What was measured
Pooled 12-week subjective global assessment responder rate, tegaserod 6 mg twice daily versus placebo, in women under 65 without cardiovascular ischaemic history
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
A pooled analysis of four 12-week randomised placebo-controlled trials of tegaserod 6 mg twice daily. The indicated population — women under 65 with IBS-C and no history of cardiovascular ischaemic events — comprised 2,752 participants, 1,386 on tegaserod and 1,366 on placebo. The primary endpoint was subjective global assessment of symptom relief, with a responder rating themselves considerably or completely relieved at least half the time, or at least somewhat relieved all of the time, over the final four weeks. Clinical response during the last four weeks was 44.1% on tegaserod against 36.5% on placebo, pooled odds ratio 1.38 (95% CI 1.18 to 1.61, P < 0.001). In the overall female population the figures were 43.3% against 35.9%, odds ratio 1.37 (1.18 to 1.59). The effect size here is the other half of the benefit-risk arithmetic the adjudication argument was about.
Written into the record, not signed off as a reviewed claim
It is on the market and still on the federal withdrawn-for-safety list
In plain words
Tegaserod has been approved again since 2019, but the federal regulation listing drugs withdrawn for safety reasons still names it. Both statements are currently true.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
21 CFR 216.24, the codified list of drug products withdrawn or removed from the market for reasons of safety or effectiveness, still carries the entry "Tegaserod maleate: All drug products containing tegaserod maleate", added after the 2007 withdrawal. That list governs which substances may be used in pharmacy compounding; it is not a statement about the current marketing status of the approved product, which is a separate determination. The result is that a reader checking the regulation and a reader checking the label get opposite impressions, and both are reading a current federal document. Recording only one of them would misrepresent the record.
Source
21 CFR 216.24, current as of August 2026
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
It is not cisapride: the mechanism of failure is different
In plain words
The previous gut prokinetic to be withdrawn, cisapride, caused fatal heart rhythm disturbances by blocking a specific cardiac potassium channel. Tegaserod does not do that.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Cisapride is a substituted benzamide that blocks the hERG potassium channel, prolonging cardiac repolarisation and producing torsades de pointes; it was withdrawn in 2000 for that reason. Tegaserod is an aminoguanidine indole with no comparable hERG activity and no QT signal in its trial programme. The 2007 tegaserod question was ischaemic — myocardial infarction, unstable angina, stroke — not arrhythmic. Two 5-HT4 agonists for the same indication were removed from the United States market seven years apart for two unrelated cardiac mechanisms, which is why "5-HT4 agonists are cardiotoxic" is not a usable summary of either case.
Written into the record, not signed off as a reviewed claim
The original NDA was withdrawn outright in 2022
In plain words
The 2019 return did not revive the old application. Novartis's original approval was formally withdrawn in December 2022, after the drug was already back on sale under new ownership.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Zelnorm returned to the market in 2019 under a new sponsor arrangement, and the original application, NDA 021200, appears in Drugs@FDA with all listed Zelnorm products in Discontinued marketing status. The Federal Register notice of 8 December 2022 records the withdrawal of approval of 35 new drug applications by Teva Branded Pharmaceutical Products R and D and others. The administrative history and the commercial history of this drug diverge, which is why an approval-status field alone cannot describe it.
Source
Drugs@FDA NDA 021200 (ZELNORM, Alfasigma) — all products Discontinued; Federal Register 87 FR (8 December 2022) withdrawal notice
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Where else this substance is registered
FDA substance identifier (UNII)
458VC51857
CAS registry number
145158-71-0
PubChem compound
135409453
ChEMBL
CHEMBL76370
ChEBI
51043
WHO international nonproprietary name list entry
7606
RxNorm concept
139778
EMA substance identifier
100000084790
DrugBank
DB01079
Checks this page had to pass
✓ Passed
Identity resolved
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✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
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No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S8.
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Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
Withdrawn in United States; Australia; Canada, 2007, for "neurotoxicity" (ChEMBL; Open Targets)
Withdrawn in United States; Australia; Canada, 2007, for "cardiotoxicity" (ChEMBL; Open Targets)
What the approval register records
1 approved application covers products containing this substance. The earliest was NDA021200, approved 20020724 to ALFASIGMA.
This order is fixed in code and does not count clicks or time on the page.
What is not here
7 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A 5-HT4 agonist withdrawn in 2007 on an internal adjudication that found cardiovascular ischaemic events in 13 of 11,614 tegaserod patients against 1 of 7,031 on placebo, and reapproved in 2019 after two independent external adjudications of the same dataset put the coronary and cerebrovascular signal at an odds ratio of 4.24 with a confidence interval from 0.52 to 34.74.
Recorded evidence blocks (7)
Q2
23 registered trials of Tegaserod — at which phases?
"This study was terminated early in April 2005 due to low patient enrollment"; 7 of 23 registered studies
Show the evidence
Trial
NCT00142974
terminated; "This study was terminated early in April 2005 due to low patient enrollment"
NCT00171431
terminated; "This study was terminated early in May 2006 due to low patient enrollment"
NCT00348634
terminated; "Terminated early due to regulatory action suspending tegaserod use in 2007"
NCT00365820
terminated; "This study was terminated early as a result of regulatory action suspending tegaserod use in 2007"
NCT00390975
terminated; "This study was terminated early as a result of regulatory action suspending tegaserod use in 2007"
NCT00399659
terminated; "This study was terminated early as a result of regulatory action suspending tegaserod use in 2007"
1 further recorded trialNCT00414024
terminated; "This study was terminated early as a result of regulatory action suspending tegaserod use in 2007"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Which 13 trials of Tegaserod posted no result?
Posted no result
13 of 13 completed trials
Registrations
NCT00141089, NCT00171418, NCT00171483, NCT00142987, NCT00149851 and NCT00139568, and 7 more
Completion dates
oldest 2005-02; newest 2006-09
Show the evidence
Trial
NCT00141089
2005-02
NCT00171418
2005-02
NCT00171483
2005-04
NCT00142987
2005-06
NCT00149851
2005-06
NCT00139568
2005-10
7 further recorded trials
NCT00149877
2006-02
NCT00232024
2006-05
NCT00232089
2006-06
NCT00171470
2006-08
NCT00232037
2006-08
NCT00232102
2006-08
NCT00171457
2006-09
Q6
At the median, Tegaserod's trials enrolled 250 people — anything larger?
Median enrolment
250
Largest enrolment
1296
Registered trials counted
22
Q7
What do 951 spontaneous reports say about Tegaserod — 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.
Tegaserod appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 951 reaction mentions were counted: abdominal pain 172; diarrhoea 159; nausea 97; chest pain 87. FAERS via Open Targets · CHEMBL1516474 · 2026-06-24
Show the evidence
abdominal pain
172
diarrhoea
159
nausea
97
chest pain
87
constipation
87
dyspnoea
75
4 more recorded rows
vomiting
74
dizziness
72
colitis ischaemic
70
abdominal distension
58
recorded 2026-06-24 · last checked 2026-09-04
Q9
Where do the label and the trials disagree about Tegaserod?
"neurotoxicity" against "approved": withdrawal status vs register status for Tegaserod.
OPEN_TARGETS_DRUG_WARNING, Drugs@FDA; 1 recorded pair
Show the evidence
OPEN_TARGETS_DRUG_WARNINGCHEMBL1516474
neurotoxicity; 2026-06-24
Drugs@FDANDA021200
approved; 2026-08-28
Where it is registered
Where it’s registered
Withdrawn in United States; Australia; Canada, 2007, for "neurotoxicity" (ChEMBL; Open Targets)
Withdrawn in United States; Australia; Canada, 2007, for "cardiotoxicity" (ChEMBL; Open Targets)
ChEMBL 37 — CC BY-SA 3.0 Unported · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 5 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.