This page shows what was measured, who it was measured in, and what that does not settle.
What Pantoprazole does in the body
Reflux that has damaged the lining of the gullet, and rare conditions that make the stomach produce far too much acid
Pantoprazole is inactive when you swallow it and stays inactive everywhere in the body except the acid-secreting pocket inside stomach cells. There the acid converts it into a reactive form that bonds permanently to the pump making the acid, so that pump is finished and the cell has to build a replacement. Pantoprazole attaches at a second anchor point buried inside the membrane that the other drugs in its class do not reliably reach, which is why its grip is the hardest of the four to undo. It is also the least dependent of the four on the liver enzyme that varies most between people, so its behaviour is the most predictable.
What happened in people
Ninety-day death 29.1% against 30.9% in REVISE and 31.1% against 30.4% in SUP-ICU — two null results totalling more than 8,000 patients
✎ 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.
The molecule that supplied the class its only large placebo-controlled long-term safety dataset
Where it acts
Gastric parietal cell — the secretory canaliculus, and specifically the membrane-embedded face of the pump that a reducing agent cannot reach
Kind of result
Living longer, or avoiding a major event
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
Its recorded molecular formula is C16H14F2N3NaO4S, weighing 432.4.
US prescribing information · 8748a588-a1e5-9dfc-e053-2a95a90a846c · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 161 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.
Fourteen prespecified safety outcomes collected every six months over a median 3.01 years, including pneumonia, C. difficile, enteric infection, fracture, gastric atrophy, chronic kidney disease, dementia, cancer and all-cause mortality
Phase 3, randomised, double-blind, placebo-controlled, 3 x 2 partial factorial
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
No significant difference on any outcome except enteric infections, 1.4% against 1.0% (odds ratio 1.33, 95% CI 1.01 to 1.75)
Repeated elsewhere
Unreplicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. C. difficile infection was roughly twice as common on pantoprazole, on 13 events in total. The trial cannot exclude a real effect on so few events, and the authors say so.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral delayed-release tablet, oral delayed-release granules for suspension, and intravenous powder for injection (sodium salt)
Interval reported. 95% CI 1
Written into the record, not signed off as a reviewed claim.
Time to first upper gastrointestinal event: composite of overt bleeding, bleeding from a gastroduodenal lesion or of unknown origin, occult bleeding, symptomatic ulcer or five or more erosions, obstruction, or perforation
102 of 8,791 against 116 of 8,807; hazard ratio 0.88 (95% CI 0.67 to 1.15). Prespecified bleeding from gastroduodenal lesions HR 0.52 (95% CI 0.28 to 0.94), P=0.03, number needed to treat 982.
Repeated elsewhere
Unreplicated
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 headline that circulated was the significant component, not the missed primary. A number needed to treat of 982 belongs next to it.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral delayed-release tablet, oral delayed-release granules for suspension, and intravenous powder for injection (sodium salt)
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Clinically important upper gastrointestinal bleeding in the ICU at 90 days (efficacy) and death from any cause at 90 days (safety)
✓ The study showed what it set out to show
Who was studied
REVISE (NCT03374800)
How many people
4821
Study design
Phase 3, randomised, double-blind, placebo-controlled, international
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
Bleeding 1.0% against 3.5%, hazard ratio 0.30 (95% CI 0.19 to 0.47), P<0.001. Death 29.1% against 30.9%, hazard ratio 0.94 (95% CI 0.85 to 1.04), P=0.25.
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. The efficacy endpoint was met and the mortality endpoint was null. Reporting only the first would misrepresent the trial.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral delayed-release tablet, oral delayed-release granules for suspension, and intravenous powder for injection (sodium salt)
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Phase 4, randomised, blinded, placebo-controlled, multicentre European
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
31.1% against 30.4%; relative risk 1.02 (95% CI 0.91 to 1.13), P=0.76
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. Clinically important gastrointestinal bleeding was 2.5% against 4.2%, but that was a secondary outcome and the trial was not designed to test it.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral delayed-release tablet, oral delayed-release granules for suspension, and intravenous powder for injection (sodium salt)
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 4 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.
Where a source records it acting
Stomach: Suppresses the final step in gastric acid production by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell
US prescribing information · 014f9762-6948-46b7-8659-5c89f35ad8bf · read 2026-08-27
Start
Pantoprazole
What a person takes: Oral delayed-release tablet, oral delayed-release granules for suspension, and intravenous powder for injection (sodium salt).
The measurement behind this step
Oral forms are enteric-protected because the free base is destroyed by gastric acid. The intravenous form removes both the coating problem and the absorption question, which is why almost all inpatient use runs through it. Bioavailability of the oral tablet is about 77% and does not change with repeated dosing.
Getting in
Swallowed in armour, or given straight into a vein
The tablet has a coating that survives stomach acid, because the drug itself does not. In hospital it is often given as a drip instead, which skips the problem entirely.
──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
Pantoprazole free base degrades rapidly in acid. Oral products are enteric-coated for release above pH 5.5; bioavailability is about 77% and, unlike omeprazole, does not change with repeated dosing. The intravenous sodium salt bypasses the gut. Plasma half-life is roughly one hour, far shorter than the duration of effect.
In blood and in every organ other than the stomach lining, the drug is chemically dead. It has no target it recognises and no receptor it binds.
╌╌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
Circulating pantoprazole is a neutral weak base, about 98% protein bound, with no meaningful reversible affinity for any protein. Its selectivity comes entirely from where the chemistry can happen, not from molecular recognition of the pump.
Needs a stronger acid than its rivals to switch on
It only becomes active below a certain acidity, and its threshold is a little lower than the other drugs in the class. That narrows the range of places in the body where it can do anything at all.
╌╌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 pyridine pKa is around 3.9, below omeprazole’s. Protonation traps the molecule in the secretory canaliculus, and the lower pKa means accumulation and activation are more sharply confined to compartments below about pH 3 — in practice, the parietal cell canaliculus and nowhere else.
Once trapped, the acid converts it into a form that grabs the first sulfur atom it meets. That form lives for a fraction of a second, which is exactly why it cannot leak out and react elsewhere.
╌╌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
Second protonation triggers rearrangement to a cyclic sulfenamide, a short-lived electrophile with high affinity for accessible cysteine thiols. The half-life of the activated species in solution is measured in seconds at canalicular pH, which is the structural reason a highly reactive molecule produces no off-target chemistry.
It bonds to the pump at the usual place and also at a second site buried inside the membrane, where the cell’s own repair chemistry cannot easily reach. That is why its block is the most stubborn of the four.
╌╌Measured in animals. A result in animals says what to test next. It does not say what happens in people.
The measurement behind this step
Beyond the cysteine 813 disulfide common to the class, pantoprazole also derivatises cysteine 822, which sits within the membrane domain and is inaccessible to cytoplasmic reducing agents such as glutathione. In vitro, reducing agents reverse omeprazole inhibition more completely than pantoprazole inhibition, and the residual is attributed to that second anchor.
Acid falls, erosions heal, and stress ulcers in intensive care bleed far less often. What two trials in more than 7,000 critically ill patients could not show is that anyone lives longer for 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
Recovery of secretion requires pump resynthesis, with a half-life near 50 hours. Suppression raises gastrin and total pump mass, the basis of rebound hypersecretion on withdrawal. On the outcome side, REVISE gives a hazard ratio of 0.30 for clinically important bleeding against 0.94 for 90-day death, and SUP-ICU gives a relative risk of 1.02 for 90-day death. The surrogate and the outcome part company, and this page keeps them apart.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Adults and children aged 5 and over with erosive reflux disease, and — through the intravenous form — a very large number of hospital inpatients, many of whom were started on it for stress ulcer prophylaxis and never taken off.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “Safety of pantoprazole sodium in the treatment of EE associated with GERD in pediatric patients 1 through 16 years of age was evaluated in three multicenter, randomized, double-blind, parallel - treatment studies, involving 249 pediatric patients, including 8 with EE (4 patients ages 1 year to 5 years and 4 patients 5 years to 11 years).”
US prescribing information · 8748a588-a1e5-9dfc-e053-2a95a90a846c · read 2026-08-30
On older people, the label states: “In short-term US clinical trials, erosive esophagitis healing rates in the 107 elderly patients (≥ 65 years old) treated with pantoprazole sodium were similar to those found in patients under the age of 65.”
US prescribing information · 8748a588-a1e5-9dfc-e053-2a95a90a846c · read 2026-08-30
On people who are pregnant, the label states: “The studies have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole.”
US prescribing information · 8748a588-a1e5-9dfc-e053-2a95a90a846c · read 2026-08-30
On people who are breastfeeding, the label states: “Pantoprazole and its metabolites are excreted in the milk of rats.”
US prescribing information · 8748a588-a1e5-9dfc-e053-2a95a90a846c · read 2026-08-30
Where the result stopped carrying
SUP-ICU chose mortality as its primary endpoint and returned a relative risk of 1.02
The COMPASS gastroduodenal primary endpoint was not met, and the component that was significant carried a number needed to treat of 982
Pre-endoscopy dosing improves what the endoscopist sees and nothing the patient experiences
C. difficile was numerically doubled in COMPASS on 13 events, too few to interpret and too few to dismiss
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
Given by a clinician
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral delayed-release tablet, oral delayed-release granules for suspension, and intravenous powder for injection (sodium salt)
✎ 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
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Oral forms are enteric-protected because the free base is destroyed by gastric acid. The intravenous form removes both the coating problem and the absorption question, which is why almost all inpatient use runs through it. Bioavailability of the oral tablet is about 77% and does not change with repeated dosing.
✎ 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
The label carries warnings for acute tubulointerstitial nephritis, Clostridioides difficile-associated diarrhoea, bone fracture with long-term high-dose use, cutaneous and systemic lupus erythematosus, cyanocobalamin deficiency, hypomagnesaemia, and fundic gland polyps with use beyond one year. Commonest trial adverse events are headache, diarrhoea, nausea, abdominal pain and flatulence. In the largest randomised safety dataset in the class, three years of exposure produced no significant excess of pneumonia, fracture, kidney disease, dementia, cancer or death, and a small excess of enteric infection.
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 delayed-release tablet, oral delayed-release granules for suspension, and intravenous powder for injection (sodium salt)
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
The intravenous form removes both the coating problem and the absorption question, which is why almost all inpatient use runs through it. Bioavailability of the oral tablet is about 77% and does not change with repeated dosing.
✎ 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
200 products list this as an active ingredient in the United States drug directory. 200 of them contain it and nothing else.
FDA National Drug Code directory · 72603-177 · read 2026-08-29
They are sold as for suspension, granule, delayed release, injection, powder, for solution, injection, powder, lyophilized, for solution, injection, solution and powder, taken intravenous and oral.
FDA National Drug Code directory · 72603-177 · read 2026-08-29
The regulator's established pharmacologic class for it is proton pump inhibitor [epc] and proton pump inhibitors [moa].
FDA National Drug Code directory · 72603-177 · read 2026-08-29
136 published labels name it as an active ingredient. 136 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 58d32be2-166e-1a64-e063-6394a90a26ea · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 58d32be2-166e-1a64-e063-6394a90a26ea · read 2026-08-29
Pantoprazole Sodium is for injection (freeze-dried powder in a single-dose vial) at For Injection: 40 mg of pantoprazole in a single-dose vial for reconstitution or dilution, recorded as prescription product; fda label in effect 2025-06-27 in the United States.
US prescribing information · 014f9762-6948-46b7-8659-5c89f35ad8bf · read 2026-08-27
Recorded price in US: 2.374 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 11 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Pantoprazole 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 preventing stress ulcer bleeding improves survival, the reasoning behind three decades of routine intensive-care prophylaxis
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 reducing stigmata of recent haemorrhage before endoscopy improves mortality, rebleeding or need for surgery, none of which moved across six randomised trials
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 pantoprazole’s lower CYP2C19 affinity produces fewer cardiovascular events on clopidogrel — a mechanistic preference never tested against an outcome
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 three years of placebo-controlled safety data settles the question of twenty years of use; it does not, and no trial of that length exists
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Pantoprazole 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.
COMPASS: 17,598 people, three years, placebo-controlled, and none of the feared harms appeared
In plain words
This is the trial the whole class was waiting for. Nearly eighteen thousand people were randomly given a proton pump inhibitor or a dummy tablet and followed for three years, with dementia, kidney disease, pneumonia, fractures, cancer and death all counted every six months. Nothing differed except gut infections, which were slightly more common on the drug.
What was measured
Fourteen prespecified safety outcomes collected six-monthly over a median 3.01 years, against matching placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
A 3 x 2 partial factorial double-blind trial randomised 17,598 participants with stable cardiovascular and peripheral artery disease to pantoprazole 40 mg daily (n=8,791) or placebo (n=8,807), on top of a separate randomisation to rivaroxaban with aspirin, rivaroxaban alone or aspirin alone. Median follow-up was 3.01 years, 53,152 patient-years. Pneumonia, Clostridioides difficile infection, other enteric infections, fracture, gastric atrophy, chronic kidney disease, diabetes, chronic obstructive lung disease, dementia, cardiovascular disease, cancer, hospitalisation and all-cause mortality were collected every six months. No outcome differed significantly except enteric infections, 1.4% against 1.0% (odds ratio 1.33, 95% CI 1.01 to 1.75). C. difficile was roughly twice as common on pantoprazole but there were only 13 events in total, so the difference was not significant. Three years is not a lifetime, and the trial does not speak to longer exposure.
Written into the record, not signed off as a reviewed claim
The same trial missed its gastroduodenal endpoint: hazard ratio 0.88, confidence interval crossing one
In plain words
The other half of the same trial asked whether routinely adding this drug to aspirin or a blood thinner prevents upper gut problems. It did not — the primary result was a statistical draw. It did reduce one specific kind of bleeding, but 982 people had to be treated to prevent one event.
What was measured
Time to first upper gastrointestinal event, composite, against matching placebo in 17,598 randomised patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The primary outcome was time to first upper gastrointestinal event: a composite of overt bleeding, upper gastrointestinal bleeding from a gastroduodenal lesion or of unknown origin, occult bleeding, symptomatic gastroduodenal ulcer or five or more erosions, obstruction, or perforation. Events occurred in 102 of 8,791 on pantoprazole against 116 of 8,807 on placebo, hazard ratio 0.88 (95% CI 0.67 to 1.15). The prespecified component of bleeding from a gastroduodenal lesion was reduced, hazard ratio 0.52 (95% CI 0.28 to 0.94, P=0.03), and a post-hoc definition gave 0.45 (95% CI 0.27 to 0.74) — but with a number needed to treat of 982 (95% CI 609 to 2,528). The authors concluded that routine use in this population does not reduce upper gastrointestinal events.
Written into the record, not signed off as a reviewed claim
REVISE: bleeding cut from 3.5% to 1.0% in 4,821 ventilated patients
In plain words
In the largest trial of stress ulcer prevention ever run, patients on a breathing machine got pantoprazole or a dummy drip. Serious bleeding from the stomach fell by about two thirds. The number of people who died was the same in both groups.
What was measured
Clinically important upper gastrointestinal bleeding in the ICU at 90 days, and all-cause death at 90 days, against matching placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
REVISE randomised 4,821 critically ill adults undergoing invasive ventilation across 68 intensive care units to intravenous pantoprazole 40 mg daily or matching placebo. Clinically important upper gastrointestinal bleeding occurred in 25 of 2,385 (1.0%) on pantoprazole against 84 of 2,377 (3.5%) on placebo, hazard ratio 0.30 (95% CI 0.19 to 0.47, P<0.001). The primary safety outcome, death from any cause at 90 days, was 696 of 2,390 (29.1%) against 734 of 2,379 (30.9%), hazard ratio 0.94 (95% CI 0.85 to 1.04, P=0.25). Patient-important bleeding was also reduced; every other multiplicity-adjusted secondary outcome, ventilator-associated pneumonia included, was similar.
Written into the record, not signed off as a reviewed claim
SUP-ICU: the primary endpoint was death, and it did not move
In plain words
A European trial of 3,298 intensive care patients set out to test whether preventing stress ulcers saves lives. It did not: 31.1% of patients on the drug died within 90 days against 30.4% on placebo.
What was measured
Death from any cause at 90 days, against matching placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
SUP-ICU randomised 3,298 adults with an acute unplanned intensive care admission and at least one risk factor for gastrointestinal bleeding to intravenous pantoprazole 40 mg daily or placebo for the ICU stay. Data on the primary outcome were available for 99.5% of patients. At 90 days, 510 of 1,645 (31.1%) in the pantoprazole group and 499 of 1,653 (30.4%) in the placebo group had died, relative risk 1.02 (95% CI 0.91 to 1.13, P=0.76). The composite of clinically important gastrointestinal bleeding, pneumonia, C. difficile infection or myocardial ischaemia occurred in 21.9% against 22.6% (RR 0.96, 95% CI 0.83 to 1.11). Clinically important gastrointestinal bleeding was 2.5% against 4.2%, a difference the trial was not powered to test as a primary outcome.
Written into the record, not signed off as a reviewed claim
Stress ulcer prophylaxis moved from "prevents bleeds, therefore saves lives" to "prevents bleeds, full stop"
In plain words
For thirty years intensive care units gave acid suppression to almost every ventilated patient, on the reasoning that stress ulcers bleed and bleeding kills. Two enormous randomised trials since 2018 have confirmed the first half and refuted the inference in the second. Bleeding falls a great deal. Survival does not change.
What was measured
That preventing stress ulcer bleeding in ventilated patients improves survival — an inference held for three decades that two trials totalling more than 8,000 patients did not support
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
SUP-ICU in 2018 chose 90-day mortality as its primary outcome and found 31.1% against 30.4% (RR 1.02, 95% CI 0.91 to 1.13). REVISE in 2024 chose bleeding as the primary efficacy outcome and mortality as the primary safety outcome, and found a hazard ratio of 0.30 for bleeding against 0.94 (95% CI 0.85 to 1.04) for death. Read together, 7,000 randomised patients establish a large, replicated effect on the surrogate and a null on the outcome, with confidence intervals now tight enough that a large mortality benefit can be excluded. Neither trial found the harms — pneumonia, C. difficile — that had been the main argument against the practice. The remaining case for prophylaxis is bleeding avoidance on its own terms, which is a defensible goal and a different claim from the one made for three decades.
Written into the record, not signed off as a reviewed claim
Giving it before the endoscope changes what the endoscopist sees, not what happens to the patient
In plain words
Starting acid suppression before someone with a gastrointestinal bleed is scoped makes the ulcer look less angry and reduces the need to treat it during the procedure. It does not change how many people die, rebleed or need surgery.
What was measured
That reducing visible stigmata of recent haemorrhage before endoscopy improves survival or rebleeding — a procedural surrogate that six randomised trials did not connect to any clinical outcome
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Cochrane review of six randomised trials in 2,223 participants found no significant difference in mortality (6.1% against 5.5%, OR 1.12, 95% CI 0.72 to 1.73), rebleeding (13.9% against 16.6%, OR 0.81, 95% CI 0.61 to 1.09) or surgery (9.9% against 10.2%, OR 0.96, 95% CI 0.68 to 1.35). Proton pump inhibitor treatment did reduce the proportion with stigmata of recent haemorrhage at index endoscopy (37.2% against 46.5%, OR 0.67, 95% CI 0.54 to 0.84), though that finding was not robust to sensitivity analysis, and reduced the need for endoscopic therapy at index endoscopy (8.6% against 11.7%, OR 0.68, 95% CI 0.50 to 0.93). The practice is near-universal and the endpoints it improves are procedural.
Written into the record, not signed off as a reviewed claim
The interaction advantage is a pharmacokinetic fact with no outcome behind it
In plain words
Pantoprazole is routinely chosen over the others for patients on clopidogrel, because it interferes least with the liver enzyme both drugs use. That reasoning is sound chemistry. No trial has ever shown that choosing it produces fewer heart attacks.
What was measured
That the lower CYP2C19 affinity of pantoprazole translates into fewer cardiovascular events in patients on clopidogrel — never tested against an outcome in any randomised comparison
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Pantoprazole is metabolised by CYP2C19 to a demethylated intermediate that is then conjugated by sulphotransferase, giving it a lower affinity for CYP2C19 than omeprazole, esomeprazole or lansoprazole and correspondingly less inhibition of clopidogrel bioactivation in platelet-function studies. The one randomised trial that measured cardiovascular outcomes when a proton pump inhibitor was added to clopidogrel used omeprazole and found no excess (hazard ratio 0.99, 95% CI 0.68 to 1.44). No trial has randomised pantoprazole against another proton pump inhibitor with a cardiovascular endpoint. The preference is a mechanistic inference from a surrogate, and a reasonable one, but it has never been tested.
Written into the record, not signed off as a reviewed claim
How many documents were read
133 documents were read for this substance.
RNAWiki source record
107 of them state the same bioavailability, and they agree.
RNAWiki source record
107 of them state the same tMax, and they agree.
RNAWiki source record
133 of them state the same proteinBinding, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
6871619Q5X
CAS registry number
102625-70-7
PubChem compound
4679
RxNorm concept
40790
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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, 2017, for "Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass" (openFDA drug enforcement Class I recall)
What the approval register records
48 approved applications cover products containing this substance. The earliest was NDA020987, approved 20000202 to WYETH PHARMS.
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What is not here
7 questions this page could not answer
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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 proton pump inhibitor that is activated by stomach acid into a form that welds itself to the acid pump, and the only one in its class with a three-year placebo-controlled safety trial behind it — 17,598 people, in which none of the harms observational studies had pinned on the class appeared except gut infections at 1.4% against 1.0% — while the two largest trials ever run on it in intensive care cut clinically important bleeding from 3.5% to 1.0% and left 90-day mortality unmoved at 29.1% against 30.9%.
Recorded evidence blocks (10)
Q1
On the Pantoprazole label: indicated for what?
"Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium delayed-release tablet is a proton pump inhibitor (PPI) indicated for the following: • Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1) • Maintenance of Healing of Erosive…": indications and usage on Pantoprazole's label. DailyMed label · 59f50bcb-85e5-e3f6-e063-6294a90a11ae · 2026-08-26
Q2
149 registered trials of Pantoprazole — at which phases?
Registered studies posting no result
115 of 149
149 registered studies of Pantoprazole: 40 phase4, 35 phase1, 28 na, 28 phase3, 16 phase2, 6 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01
545 with a PubMed record
Show the evidence
phase4
40
phase1
35
na
28
phase3
28
phase2
16
na or unstated
6
7 more recorded rows
completed
108
unknown
17
withdrawn
8
terminated
7
recruiting
6
not yet recruiting
2
enrolling by invitation
1
recorded 2026-09-01 · last checked 2026-09-04
Q3
15 of Pantoprazole's trials stopped: futility/efficacy, accrual/recruitment, funding/business, other?
futility/efficacy (1), accrual/recruitment (4), funding/business (2) and other (8): Pantoprazole's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"Inclusion-rate does not seem feasible anymore to obtain te required number of patients before the end of the trial."; 15 of 149 registered studies
Show the evidence
Trial
NCT00449813
terminated; "Inclusion-rate does not seem feasible anymore to obtain te required number of patients before the end of the trial."
NCT00699361
withdrawn; "Study withdrawn for financial issues"
NCT00713947
withdrawn; "no inclusion"
NCT00857597
terminated; "Study was terminated after unplanned interim analysis of single centre data and results were reported"
NCT00881413
withdrawn; "problems in funding"
NCT01016717
withdrawn; "Since the published data resolved the study goals we decided not to start it"
9 further recorded trials
NCT02123498
withdrawn; "IRB not approved"
NCT02167633
terminated; "Due to low accrual rate"
NCT02213887
withdrawn; "Unable to recruit participants"
NCT02235311
terminated; "Difficulty recruiting and consenting participants"
NCT02788123
terminated; "Internal reassessment of the medicinal product development strategy by Sponsor"
NCT02987920
terminated; "The surgeon changed pain control protocol for all patients. Continued enrollment impossible under approved protocol."
NCT03038009
withdrawn; "A new registration has been submitted due to a redesign of the study protocol."
NCT03095547
withdrawn; "study no longer required in current format"
NCT05251233
terminated; "Investigator and study team chose to end study early."
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Pantoprazole used pantoprazole 20 mg (drug) — over how long?
Human studies of Pantoprazole used "pantoprazole 20 mg (drug)". ClinicalTrials.gov · 2026-09-01
10 recorded entries; human; capsule, tablet; also "Pantoprazole 40mg", "Pantoprazole Sodium 40 mg delayed-release tablets", "PROTONIX® 40 mg delayed-release tablets."
Show the evidence
human
NCT00161096
pantoprazole 20 mg (drug)
NCT00410592
Pantoprazole 40mg
NCT00835393
Pantoprazole Sodium 40 mg delayed-release tablets
NCT00835393
PROTONIX® 40 mg delayed-release tablets.
NCT01283919
Protonix DR Tablets 40 mg
NCT01847404
capsule; Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one
4 more recorded rows
humanNCT01847404
capsule; Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two
Pantoprazole's half-life is 7 to 9 hours — which schedules were studied?
7 to 9 hours, the half-life Pantoprazole's label states: "Although serum half-life values increased to 7 to 9 hours and AUC values increased by 5- to 7-fold in hepatic-impaired patients, these increases were no greater than those observed in CYP2C19 poor metabolizers, where no dosage adjustment is warranted." DailyMed label · 59f50bcb-85e5-e3f6-e063-6294a90a11ae · 2026-08-26
tmax 2.5 h; bioavailability 77 %.
Show the evidence
half lifepharmacokinetics
7 to 9 hours; Although serum half-life values increased to 7 to 9 hours and AUC values increased by 5- to 7-fold in hepatic-impaired patients, these increases were no greater than those observed in CYP2C19 poor metabolizers, where no dosage adjustment is warranted.
tmaxpharmacokinetics
2.5 h; In extensive metabolizers with normal liver function receiving an oral dose of the enteric-coated 40 mg pantoprazole tablet, the peak concentration (C max ) is 2.5 mcg/mL; the time to reach the peak concentration (t max ) is 2.5 h, and the mean total area under the plasma concentration versus time curve (AUC) is 4.8 mcg•h/mL (range 1.4 to 13.3 mcg•h/mL).
bioavailabilitypharmacokinetics
77 %; Pantoprazole undergoes little first-pass metabolism, resulting in an absolute bioavailability of approximately 77%.
metabolismpharmacokinetics
In extensive metabolizers with normal liver function receiving an oral dose of the enteric-coated 40 mg pantoprazole tablet, the peak concentration (C max ) is 2.5 mcg/mL; the time to reach the peak concentration (t max ) is 2.5 h, and the mean total area under the plasma concentration versus time curve (AUC) is 4.8 mcg•h/mL (range 1.4 to 13.3 mcg•h/mL).
recorded 2026-08-26 · last checked 2026-09-04
Q6
Which 58 trials of Pantoprazole posted no result?
Posted no result
58 of 58 completed trials
Registrations
NCT00037570, NCT00040495, NCT00835393, NCT00625274, NCT00206050 and NCT01283919, and 52 more
Completion dates
oldest 2002-02; newest 2024-01-31
Show the evidence
Trial
NCT00037570
2002-02
NCT00040495
2003-01
NCT00835393
2003-12
NCT00625274
2004-11
NCT00206050
2004-12
NCT01283919
2004-12
14 further recorded trials
NCT01283932
2004-12
NCT00307944
2006-08
NCT00383916
2006-10
NCT00915239
2006-10
NCT00246909
2006-11
NCT00600041
2006-11
NCT00247715
2007-01
NCT00133770
2007-03
NCT00374101
2007-03
NCT00336219
2007-04
NCT00410592
2007-05
NCT00312806
2007-07
NCT00367614
2007-08
NCT00304421
2007-09
Q7
At the median, Pantoprazole's trials enrolled 76 people — anything larger?
Median enrolment
76
Largest enrolment
4238504
Registered trials counted
145
Q8
What do 15492 spontaneous reports say about Pantoprazole — 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.
Pantoprazole appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 15492 reaction mentions were counted: acute kidney injury 2608; chronic kidney disease 2599; hyponatraemia 1991; hypomagnesaemia 1834. FAERS via Open Targets · CHEMBL1502 · 2026-06-24
Show the evidence
acute kidney injury
2608
chronic kidney disease
2599
hyponatraemia
1991
hypomagnesaemia
1834
drug interaction
1649
hypocalcaemia
1133
4 more recorded rows
tubulointerstitial nephritis
1098
renal failure
938
hypokalaemia
932
gastrooesophageal reflux disease
710
recorded 2026-06-24 · last checked 2026-09-04
Q9
Which 10 reactions does Pantoprazole's label not list?
Elimination Metabolism Pantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP) system.
pharmacokinetics
The main metabolic pathway is demethylation, by CYP2C19, with subsequent sulfation; other metabolic pathways include oxidation by CYP3A4.
pharmacokinetics
In in vivo drug-drug interaction studies with CYP2C19 substrates (diazepam [also a CYP3A4 substrate] and phenytoin [also a CYP3A4 inducer] and clopidogrel), nifedipine, midazolam, and clarithromycin (CYP3A4 substrates), metoprolol (a CYP2D6 substrate), diclofenac, naproxen and piroxicam (CYP2C9 substrates), and theophylline (a CYP1A2 substrate) in healthy subjects, the pharmacokinetics of…
clinical_pharmacology
Elimination Metabolism Pantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP) system.
clinical_pharmacology
The main metabolic pathway is demethylation, by CYP2C19, with subsequent sulfation; other metabolic pathways include oxidation by CYP3A4.
clinical_pharmacology
In in vivo drug-drug interaction studies with CYP2C19 substrates (diazepam [also a CYP3A4 substrate] and phenytoin [also a CYP3A4 inducer] and clopidogrel), nifedipine, midazolam, and clarithromycin (CYP3A4 substrates), metoprolol (a CYP2D6 substrate), diclofenac, naproxen and piroxicam (CYP2C9 substrates), and theophylline (a CYP1A2 substrate) in healthy subjects, the pharmacokinetics of…
Withdrawn in United States, 2017, for "Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass" (openFDA drug enforcement Class I recall)
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 · openFDA / DailyMed — US Government work · openFDA enforcement — US Government work
✗ 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: 7 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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