This page shows what was measured, who it was measured in, and what that does not settle.
What Cisapride does in the body
A tablet for night-time heartburn that made the stomach empty faster
Cisapride told the nerve network in the gut wall to release more acetylcholine, so the stomach emptied faster and less acid washed back up. Separately, and by a completely different route, it plugged the potassium channel that heart muscle uses to reset itself after each beat. Because it was broken down by a liver enzyme that many common drugs — including some antibiotics and antifungals — block, ordinary co-prescribing could raise its blood level into the range where the heart effect became lethal.
What happened in people
hERG channel block with a half-maximal inhibitory concentration of 6.5 nM in stably transfected HEK293 cells
✎ 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.
That 341 reports and 80 deaths represent the incidence of harm — spontaneous reports have no denominator and under-capture events by an unknown factor
Where it acts
Enteric nervous system of the gut wall; the toxicity site is the ventricular myocyte
Kind of result
A step measured inside a person
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 · UVL329170W · read 2026-08-29
Its recorded molecular formula is C23H29ClFN3O4, weighing 465.9.
PubChem record · 6917698 · 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 111 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.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
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.
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.
Reports of QT prolongation, torsades de pointes and ventricular arrhythmia in association with cisapride, with assessment of probable aetiology and risk factors
✓ The study showed what it set out to show
Who was studied
FDA postmarketing surveillance analysis (Wysowski et al.)
How many people
341
Study design
Spontaneous adverse event report analysis, 1993 to 1999
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Not a hypothesis test; 341 individual patients reported, 80 (23%) died, with positive dechallenge and rechallenge in some cases
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. Spontaneous reporting has no denominator and captures an unknown fraction of true events, so the count cannot be converted into a per-patient risk. In most affected individuals other drugs or medical conditions were present.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet and suspension, taken before meals and at bedtime
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
FDA final rule: Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effecti… · a recorded source, not a stored snapshot
Concentration-dependent block of hERG tail current in stably transfected HEK293 cells
✓ The study showed what it set out to show
Who was studied
hERG patch-clamp characterisation (Mohammad et al.)
How many people
25
Study design
In vitro electrophysiology
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
IC50 6.5 nM at 22 degrees Celsius across 25 cells; 100 nM reduced tail-current amplitude by 66% at -20 mV and 90% at +20 mV
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. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet and suspension, taken before meals and at bedtime
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
FDA final rule: Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effecti… · 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 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
Cisapride
What a person takes: Oral tablet and suspension, taken before meals and at bedtime.
The measurement behind this step
Oral prokinetic taken 15 minutes before meals and at bedtime. Cleared principally by CYP3A4, which is the disposition feature that made it dangerous: azole antifungals, macrolide antibiotics, protease inhibitors and grapefruit juice all raise its plasma concentration towards the range where hERG block becomes clinically significant.
Getting in
An oral tablet before meals and at bedtime
Taken shortly before eating and at night, to work on the meal that follows.
╌╌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 tablets and suspension. Absorbed rapidly and cleared principally by CYP3A4, the enzyme responsible for metabolising a very large share of prescription drugs and the point at which the fatal interactions occurred.
It switches on a serotonin receptor in the gut. Quite separately, it plugs a potassium channel in heart muscle.
╌╌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
Agonism at HTR4 on enteric cholinergic neurons enhances acetylcholine release. Independently, open- and inactivated-state block of the hERG (KCNH2) channel with an IC50 of 6.5 nM, voltage dependent and rapidly reversible on washout.
The gut speeds up; the heart takes longer to reset
Stomach emptying accelerates and reflux falls. In the heart, each beat takes longer to recover, which shows on an ECG as a longer QT interval.
╌╌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
Increased acetylcholine release enhances antral and oesophageal motility and lower oesophageal sphincter tone. In ventricular myocytes, reduced IKr prolongs repolarisation and the action potential duration, widening the QT interval and creating the substrate for early afterdepolarisations and torsades de pointes.
Heartburn improves; some patients go into torsades
The symptom it was licensed for got better. In hundreds of reported patients the heart rhythm broke down, and about a quarter of those reported died.
──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
Measured endpoints: symptomatic improvement in nocturnal heartburn, against 341 reported patients with QT prolongation or ventricular arrhythmia between 1993 and 1999, of whom 80 (23%) died.
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.
Nobody by prescription in the United States. It remains available in veterinary medicine and, in some countries, through limited-access programmes.
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
Four rounds of FDA regulatory action while the drug was marketed did not stop arrhythmia reports arising from contraindicated co-prescribing
Withdrawn from the United States market in 2000 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 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 and suspension, taken before meals and at bedtime
✎ 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
Oral prokinetic taken 15 minutes before meals and at bedtime.
✎ 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: Cleared principally by CYP3A4, which is the disposition feature that made it dangerous: azole antifungals, macrolide antibiotics, protease inhibitors and grapefruit juice all raise its plasma concentration towards the range where hERG block becomes clinically significant.
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 from the United States market in 2000 for QT prolongation and torsades de pointes. The measured harms are hERG block at 6.5 nM and 341 reported patients with QT prolongation or ventricular arrhythmia between 1993 and 1999, of whom 80 died. Risk was concentrated in patients taking CYP3A4 inhibitors or with electrolyte abnormalities, structural heart disease or existing QT prolongation.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
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 and suspension, taken before meals and at bedtime
✎ 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: Cleared principally by CYP3A4, which is the disposition feature that made it dangerous: azole antifungals, macrolide antibiotics, protease inhibitors and grapefruit juice all raise its plasma concentration towards the range where hERG block becomes clinically significant.
No source is stored against this line.
What is recorded as being sold
4 products list this as an active ingredient in the United States drug directory. 4 of them contain it and nothing else.
FDA National Drug Code directory · 66577-023 · read 2026-08-29
They are sold as powder.
FDA National Drug Code directory · 66577-023 · 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 Cisapride 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 341 reports and 80 deaths represent the incidence of harm — spontaneous reports have no denominator and under-capture events by an unknown factor
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 labelling contraindications would control an interaction-driven risk, when most reported events occurred in exactly the contraindicated circumstances
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 Cisapride 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.
FDA received reports on 341 patients; 80 of them died
In plain words
Over six years on the market, the FDA collected reports of 341 patients who developed dangerous heart rhythm disturbances on cisapride. Eighty of them died.
What was measured
Postmarketing reports of QT prolongation and ventricular arrhythmia, and associated deaths
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Between 1993 and 1999 the FDA received reports of 117 patients with QT prolongation, 107 with torsades de pointes, 16 with polymorphic ventricular tachycardia, 18 with ventricular fibrillation, 27 with ventricular tachycardia, 25 with cardiac arrest, 16 with unspecified serious arrhythmia and 15 with sudden death — 341 individual patients in total. Eighty (23%) died, with deaths directly or indirectly associated with an arrhythmic event. The evidence supporting attribution included temporal relationship, absence of other identified risk factors in some patients, and cases of positive dechallenge and rechallenge. In most patients the arrhythmia occurred in the presence of risk factors, meaning other drugs or medical conditions.
Written into the record, not signed off as a reviewed claim
hERG block at 6.5 nanomolar — the mechanism, measured directly
In plain words
Patch-clamp recording showed cisapride plugs the heart's repolarising potassium channel at billionths-of-a-mole concentrations. That is extraordinarily potent for a heartburn drug.
What was measured
Half-maximal inhibitory concentration for hERG channel block
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Whole-cell patch clamp of hERG channels stably expressed in HEK293 cells gave dose-dependent block with a half-maximal inhibitory concentration of 6.5 nM at 22 degrees Celsius across 25 cells. Currents recovered rapidly on washout. Onset of block required channel activation, indicating open- or inactivated-state block, and the block was voltage dependent: at -20 mV, 10 nM cisapride reduced tail-current amplitude by 5%, while at +20 mV the same concentration reduced it by 45%; 100 nM reduced tail current by 66% and 90% at those two voltages. The authors concluded that hERG block may account for the clinical QT prolongation and ventricular arrhythmias.
Written into the record, not signed off as a reviewed claim
The benefit-risk judgement turned on the indication, not the effect size
In plain words
The drug worked. It was withdrawn because it was being taken for night-time heartburn, and a risk of fatal arrhythmia cannot be justified for that.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The FDA's stated conclusion was that the risk of fatal arrhythmia with cisapride was believed to outweigh the benefit for the approved indication — treatment of nocturnal heartburn due to gastro-oesophageal reflux disease — leading to discontinuation in the United States. That framing is precise and unusual: the finding was not that the drug failed, but that the harm was disproportionate to what the benefit was for. Cisapride now appears in the FDA's codified list of drug products withdrawn or removed from the market for reasons of safety or effectiveness, published at 81 FR 69668 on 7 October 2016, as "all drug products containing cisapride".
Written into the record, not signed off as a reviewed claim
Four rounds of labelling changes did not stop the co-prescribing
In plain words
Regulators tried repeatedly to fix the problem with warnings and contraindications rather than withdrawal. The reports kept coming, and most of them involved exactly the interactions the label warned about.
What was measured
Proportion of arrhythmia reports occurring in the presence of contraindicated risk factors
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Wysowski and colleagues set out the FDA regulatory actions taken while cisapride was marketed, alongside the accumulating reports. The pattern is the important part: in most affected individuals the arrhythmia occurred in the presence of risk factors — concomitant drugs or medical conditions — which are precisely the circumstances successive label revisions had contraindicated. A contraindication is only a control if it changes prescribing, and here the same interaction categories kept appearing in reports after each revision. The eventual conclusion was that labelling could not manage the risk for this indication and the product had to come off the market.
Written into the record, not signed off as a reviewed claim
Spontaneous reports count events, and they cannot give you a rate
In plain words
The 341 figure is the number of reports the FDA received, not the number of people harmed. Under-reporting means the true count is higher, and without knowing how many people took the drug it is not a risk per patient.
What was measured
That 341 reported patients and 80 deaths is a measure of how often cisapride caused fatal arrhythmia, rather than a count of reports with no denominator
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The FDA case series is a spontaneous reporting analysis, and its own field has documented the limits. Pharmacoepidemiological studies of cisapride and QT prolongation have been criticised specifically for the difficulty of establishing incidence from these data. Spontaneous reports have no denominator, capture an unknown and variable fraction of true events, and are subject to stimulated reporting after publicity. What they establish well is that the events occur, that they are temporally associated, and — through positive dechallenge and rechallenge — that individual cases are drug-related. What they cannot supply is the per-patient risk, which is the number a prescriber would actually want.
Written into the record, not signed off as a reviewed claim
Cisapride is now a standard positive control in the assay that would have caught it
In plain words
Screening drugs for this heart channel effect was not routine when cisapride was approved. It is now mandatory, and cisapride itself is one of the reference compounds used to check the test works.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The identification of hERG as the molecular target of QT-prolonging drugs, published for terfenadine in 1996 and for cisapride in 1997, arrived after both were already marketed. Systematic preclinical assessment of hERG block and of clinical QT effect subsequently became a standard regulatory expectation for new drugs. Cisapride, with an IC50 of 6.5 nM, is now widely used as a reference blocker in hERG assay validation. The successor 5-HT4 agonist prucalopride was designed against exactly this liability. The scientific yield of the withdrawal was therefore a screening method, and the method arrived because the drugs failed first.
Written into the record, not signed off as a reviewed claim
Where else this substance is registered
FDA substance identifier (UNII)
UVL329170W
CAS registry number
81098-60-4
PubChem compound
6917698
ChEMBL
CHEMBL1729
ChEBI
3720
WHO international nonproprietary name list entry
5338
RxNorm concept
35255
EMA substance identifier
100000081525
European Chemicals Agency number
279-689-7
DrugBank
DB00604
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S8.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
Withdrawn in Armenia; Brunei; Mauritius; Bhutan; United Kingdom; Philippines; United States; Oman; Canada; Singapore; Germany; Bahrain; Turkey; Cuba; Japan, 2000, for "cardiotoxicity" (ChEMBL; Open Targets)
Withdrawn in Armenia; Brunei; Mauritius; Bhutan; United Kingdom; Philippines; United States; Oman; Canada; Singapore; Germany; Bahrain; Turkey; Cuba; Japan, 2000, for "Association with cardiac arrhythmias and a number of deaths" (ChEMBL; Open Targets)
Withdrawn in Armenia; Brunei; Mauritius; Bhutan; United Kingdom; Philippines; United States; Oman; Canada; Singapore; Germany; Bahrain; Turkey; Cuba; Japan, 2000, for "Documented reports on adverse events including deaths associated with its use; Rare but serious heart complications including arrhythmias and sudden death" (ChEMBL; Open Targets)
Withdrawn in Armenia; Brunei; Mauritius; Bhutan; United Kingdom; Philippines; United States; Oman; Canada; Singapore; Germany; Bahrain; Turkey; Cuba; Japan, 2000, for "Risk/benefit ratio is further reviewed" (ChEMBL; Open Targets)
What the approval register records
3 approved applications cover products containing this substance. The earliest was NDA020210, approved 19930729 to JANSSEN PHARMS.
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 heartburn drug that blocked the hERG cardiac potassium channel with a half-maximal inhibitory concentration of 6.5 nanomolar, and that the FDA linked to 341 reported patients with QT prolongation or ventricular arrhythmia, 80 of whom died.
Recorded evidence blocks (6)
Q2
4 registered trials of Cisapride — at which phases?
Approved in 1993, withdrawn in 2000: what happened to Cisapride in Armenia; Brunei; Mauritius; Bhutan; United Kingdom; Philippines; United States; Oman; Canada; Singapore; Germany; Bahrain; Turkey; Cuba; Japan?
Approved 1993, withdrawn 2000 in Armenia; Brunei; Mauritius; Bhutan; United Kingdom; Philippines; United States; Oman; Canada; Singapore; Germany; Bahrain; Turkey; Cuba; Japan; the register's words: "cardiotoxicity". Open Targets drug warning · CHEMBL1200788 · 2026-06-24
8 recorded reasons; Armenia; Brunei; Mauritius; Bhutan; United Kingdom; Philippines; United States; Oman; Canada; Singapore; Germany; Bahrain; Turkey; Cuba; Japan
Show the evidence
Reason
"cardiotoxicity"
"Association with cardiac arrhythmias and a number of deaths"
"Documented reports on adverse events including deaths associated with its use; Rare but serious heart complications including arrhythmias and sudden death"
"Risk/benefit ratio is further reviewed"
"cardiotoxicity"
"Documented reports on adverse events including deaths associated with its use; Rare but serious heart complications including arrhythmias and sudden death"
2 more recorded rows
Reason
"Association with cardiac arrhythmias and a number of deaths"
At the median, Cisapride's trials enrolled 7 people — anything larger?
Median enrolment
7
Largest enrolment
20
Registered trials counted
4
Q6
What do 268 spontaneous reports say about Cisapride — 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.
Cisapride appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 268 reaction mentions were counted: electrocardiogram qt prolonged 219; atrial fibrillation 12; torsade de pointes 7; ventricular tachycardia 7. FAERS via Open Targets · CHEMBL1729 · 2026-06-24
Show the evidence
electrocardiogram qt prolonged
219
atrial fibrillation
12
torsade de pointes
7
ventricular tachycardia
7
electrocardiogram qt corrected interval prolonged
6
ventricular extrasystoles
6
4 more recorded rows
abdominal hernia
4
electrocardiogram t wave abnormal
3
feeding intolerance
2
fundoplication
2
recorded 2026-06-24 · last checked 2026-09-04
Q8
Where do the label and the trials disagree about Cisapride?
"cardiotoxicity" against "approved": withdrawal status vs register status for Cisapride.
OPEN_TARGETS_DRUG_WARNING, Drugs@FDA; 1 recorded pair
Show the evidence
OPEN_TARGETS_DRUG_WARNINGCHEMBL1200788
cardiotoxicity; 2026-06-24
Drugs@FDANDA020767
approved; 2026-08-28
Where it is registered
Where it’s registered
Withdrawn in Armenia; Brunei; Mauritius; Bhutan; United Kingdom; Philippines; United States; Oman; Canada; Singapore; Germany; Bahrain; Turkey; Cuba; Japan, 2000, for "cardiotoxicity" (ChEMBL; Open Targets)
Withdrawn in Armenia; Brunei; Mauritius; Bhutan; United Kingdom; Philippines; United States; Oman; Canada; Singapore; Germany; Bahrain; Turkey; Cuba; Japan, 2000, for "Association with cardiac arrhythmias and a number of deaths" (ChEMBL; Open Targets)
Withdrawn in Armenia; Brunei; Mauritius; Bhutan; United Kingdom; Philippines; United States; Oman; Canada; Singapore; Germany; Bahrain; Turkey; Cuba; Japan, 2000, for "Documented reports on adverse events including deaths associated with its use; Rare but serious heart complications including arrhythmias and sudden death" (ChEMBL; Open Targets)
Withdrawn in Armenia; Brunei; Mauritius; Bhutan; United Kingdom; Philippines; United States; Oman; Canada; Singapore; Germany; Bahrain; Turkey; Cuba; Japan, 2000, for "Risk/benefit ratio is further reviewed" (ChEMBL; Open Targets)
ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md
✗ 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
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