This page shows what was measured, who it was measured in, and what that does not settle.
What Esomeprazole does in the body
The liver enzyme that clears them is itself handed, and it clears one of the two faster.
Omeprazole comes as a 50:50 mixture of two forms that are mirror images of each other, like a left and a right hand. Esomeprazole is just the slower-cleared half on its own, so for the same milligram it stays in the blood a little longer and reaches the stomach pump in slightly greater quantity. Once there it does exactly what omeprazole does: the stomach’s own acid converts it into a reactive form that bonds permanently to the acid pump, and the cell has to build a new pump before it can make acid again.
Why people take it. Reflux and heartburn, including reflux that has visibly damaged the gullet, and prevention of stomach ulcers caused by anti-inflammatory painkillers
What happened in people
Time ratio 1.27 (95% CI 1.01 to 1.58) for death, oesophageal adenocarcinoma or high-grade dysplasia on high-dose against low-dose esomeprazole over a median 8.9 years in 2,557 patients with Barrett’s oesophagus
✎ 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 the S-enantiomer is intrinsically superior to its racemic parent, when the trial that established superiority gave twice the dose
Where it acts
Gastric parietal cell — the secretory canaliculus, reached through the bloodstream rather than from the stomach lumen
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 C17H18N3O3SNa, weighing 367.4 g/mol.
US prescribing information · 9354958c-e997-41c8-8605-23f0a58993c0 · read 2026-08-30
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The recorded use, written for a reader without medical training. Not signed off.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 168 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
Formulation
A formulation is the exact made-up form a substance comes in.
A picture of it, and where the picture fails
It is like the difference between a whole bean and instant coffee.
Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.
What people get wrong. Two products with the same name are assumed to behave the same. They often do not.
The specific composition and physical form of a product, including salt, excipients and release profile.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Blood sugar
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
△Only a number moved1 registered test measure.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Blood sugar
insulin secretion
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
△ Only a number moved
1 registered test measure.
— Not recorded
Harms were not a registered measure for this goal.
… Waiting for a reviewer
Who was studied is listed further down the page.
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.
Proportion of patients with healed erosive oesophagitis at week 8
✓ The study showed what it set out to show
Who was studied
Esomeprazole 40 mg against omeprazole 20 mg in erosive oesophagitis
How many people
2425
Study design
Phase 3, randomised, double-blind, active-controlled, 163 United States centres
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
93.7% against 84.2% at 8 weeks, P<0.001 (life-table estimates, intention-to-treat); 81.7% against 68.7% at 4 weeks
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. The comparison is 40 mg against 20 mg. No published trial compares equal milligram doses of the two molecules, so the result cannot distinguish a molecular advantage from a dose difference.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral delayed-release capsule, delayed-release granules for oral suspension, and intravenous powder for injection (sodium salt)
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Time to all-cause mortality, oesophageal adenocarcinoma or high-grade dysplasia over a median 8.9 years
✓ The study showed what it set out to show
Who was studied
AspECT (EudraCT 2004-003836-77)
How many people
2557
Study design
Randomised, 2 x 2 factorial, unblinded with masked reporting pathologists
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
High-dose against low-dose PPI: time ratio 1.27 (95% CI 1.01 to 1.58), P=0.038, number needed to treat 34. Combination with aspirin against low-dose PPI alone: TR 1.59 (95% CI 1.14 to 2.23), P=0.0068.
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. Unblinded treatment allocation, and a composite endpoint dominated by all-cause mortality rather than by cancer. Aspirin alone missed significance at P=0.068 and only reached it after censoring NSAID users.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral delayed-release capsule, delayed-release granules for oral suspension, and intravenous powder for injection (sodium salt)
Interval reported. 95% CI 1
Written into the record, not signed off as a reviewed claim.
Clinically significant recurrent bleeding within 72 hours
✓ The study showed what it set out to show
Who was studied
Intravenous esomeprazole after endoscopic haemostasis
How many people
764
Study design
Phase 3, randomised, blinded, placebo-controlled, 91 centres in 16 countries
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
5.9% against 10.3%; difference 4.4 percentage points (95% CI 0.6 to 8.3), P=0.026, sustained at 7 and 30 days (P=0.010)
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. Surgery (2.7% against 5.4%) and all-cause mortality (0.8% against 2.1%) both favoured esomeprazole and neither reached significance. Endoscopic technique was not standardised. Funded by AstraZeneca.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral delayed-release capsule, delayed-release granules for oral suspension, and intravenous powder for injection (sodium salt)
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
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 prespecified rescue hypothesis also failed: pH monitoring found reflux in 40% of participants and that subgroup showed no benefit either.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral delayed-release capsule, delayed-release granules for oral suspension, and intravenous powder for injection (sodium salt)
Interval reported. Not recorded in this summary
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 happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.1 registered measure of this kind. No reviewed result.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.1 registered measure of this kind.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.4 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Esomeprazole
What a person takes: Oral delayed-release capsule, delayed-release granules for oral suspension, and intravenous powder for injection (sodium salt).
The measurement behind this step
All oral forms are enteric-protected, because the free base is destroyed by gastric acid within minutes. The intravenous sodium salt exists specifically for the acute ulcer-bleeding indication, which is where the randomised evidence for this molecule rather than its parent is strongest.
Getting in
One hand of a two-handed molecule
Omeprazole exists as two mirror-image forms in equal amounts. Esomeprazole is one of those two, separated out and sold on its own. Nothing about the target or the chemistry changes.
╌╌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 stereocentre is the sulfoxide sulfur. Esomeprazole is the S-enantiomer, manufactured by asymmetric oxidation with a titanium-tartrate catalyst rather than by resolving the racemate, and dispensed as the magnesium trihydrate.
The liver enzyme that breaks these drugs down is itself asymmetric, so it handles the two mirror images at different speeds. This one is the slower of the two, which means more of it reaches the stomach for a given tablet.
──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
CYP2C19 is a poorer catalyst for the S-enantiomer than for the R-enantiomer, so a larger fraction of the S-form is cleared by CYP3A4 to the sulfone instead. Area under the plasma concentration curve per milligram is correspondingly higher, and the difference widens with repeated dosing. This is the entire pharmacological distinction between the two drugs.
Trapped in the acid pocket, exactly as omeprazole is
From the blood it drifts into the acid-secreting channel of the stomach cell, picks up a charge, and can no longer get out. The trapping is identical for both mirror images.
──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
Pyridine pKa near 4; protonation in a compartment at pH 1 gives roughly thousandfold accumulation relative to plasma. Accumulation is a property of the weak base, not of its handedness, and the two enantiomers behave identically here.
The acid rearranges it, and the handedness disappears
The reactive form the acid produces is the same for both mirror images. Whatever advantage the isolated form had, it ends here — from this point on the two are the same molecule.
╌╌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 drives rearrangement to the cyclic sulfenamide. The reacting centre in that species is not a stereocentre, so the activated intermediates from the R- and S-enantiomers are identical. Any difference in effect must therefore be a difference in how much drug arrived, not in what it does.
The reactive form welds itself to the pump. That pump is finished, and the cell must build a replacement before it can make acid again.
──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
The sulfenamide forms a disulfide with cysteine 813 on the luminal loop of the H+/K+-ATPase alpha subunit. Inhibition is reversed in vitro by dithiothreitol. Recovery in vivo depends on pump resynthesis with a half-life near 50 hours, which is why a one-to-one-and-a-half-hour plasma half-life produces a multi-day effect.
In Barrett’s oesophagus, high-dose treatment over nearly nine years delayed cancer, severe dysplasia or death, with 34 people treated per event prevented. In poorly controlled asthma it did nothing at all, including in the people proven by pH testing to have silent reflux.
──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
AspECT gives a time ratio of 1.27 (95% CI 1.01 to 1.58) for high dose against low dose on a composite dominated by all-cause mortality. SARA gives 2.5 against 2.3 episodes of poor asthma control per person-year (P=0.66), with no effect in the 40% of participants with pH-documented reflux. Acid suppression is not a general anti-inflammatory, and the two results together mark where its reach ends.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
total nasal symptom scores
Measured
Things only a test, a scale or a device shows.
insulin secretion
observed maximum concentration
time of maximum concentration
auc of dabigatran in plasma
Meaningful
Things that change how a life goes, not only a number.
hospitalization for community acquired pneumonia
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (34)
treatment failure
monitored for long term safety of pn 400
pk variables
intestinal calcium absorption
histological response to treatment
symptomatic response to treatment
gerd symptoms
time to progression
apparent terminal rate constant apparent terminal half life
apparent systemic clearance after extravascular dosing
efficacy
tear film thickness as measured oct
recurrent bleeding
eradication rate of helicobacter pylori
helicobacter pylori eradication rate
iars
proportion and type of serious iars
proportion by type
helicobacter pylori eradication
rate of h pylori eradication
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Adults and children with reflux disease, and — through the over-the-counter version approved in 2014 — a very large number of people self-treating heartburn without a diagnosis.
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: “The safety and effectiveness of esomeprazole sodium have not been established in patients less than 1 month of age for the treatment of GERD with EE or for risk reduction of rebleeding of gastric or duodenal ulcer following therapeutic endoscopy.”
US prescribing information · 9354958c-e997-41c8-8605-23f0a58993c0 · read 2026-08-30
On older people, the label states: “In a clinical trial of patients with bleeding gastric or duodenal ulcers, 52% of 375 patients randomized to esomeprazole were 65 years of age and over.”
US prescribing information · 9354958c-e997-41c8-8605-23f0a58993c0 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary There are no adequate and well-controlled studies with esomeprazole in pregnant women.”
US prescribing information · 9354958c-e997-41c8-8605-23f0a58993c0 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Esomeprazole is the S-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk.”
US prescribing information · 9354958c-e997-41c8-8605-23f0a58993c0 · read 2026-08-30
On people with reduced liver function, the label states: “GERD with EE Exposure to esomeprazole was increased substantially in patients with severe hepatic impairment (Child-Pugh Class C) but not in patients with mild to moderate hepatic impairment (Child-Pugh Classes A and B) compared to patients with normal liver function [see Clinical Pharmacology (12.3) ].”
US prescribing information · 9354958c-e997-41c8-8605-23f0a58993c0 · read 2026-08-30
Where the result stopped carrying
SARA: no effect on any asthma outcome, and no subgroup identified by pH monitoring that benefited
The AspECT aspirin arm missed its endpoint at P=0.068 and only reached significance after censoring NSAID users post hoc
Surgery and mortality both favoured intravenous esomeprazole after endoscopy and neither reached significance
No dose-equivalence trial against omeprazole has ever been published, twenty-five years after launch
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
A different form was studied
The studied form is not the form on the shelf.
On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.
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 (9)
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 capsule, delayed-release granules for oral 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
All oral forms are enteric-protected, because the free base is destroyed by gastric acid within minutes. The intravenous sodium salt exists specifically for the acute ulcer-bleeding indication, which is where the randomised evidence for this molecule rather than its parent is strongest.
✎ 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 adverse events are headache, diarrhoea, nausea, flatulence and abdominal pain. Because it is the more CYP2C19-avid of the two omeprazole enantiomers at the inhibitory step, the clopidogrel interaction statement applies. In AspECT, at a median 8.9 years of exposure, study-treatment-related serious adverse events were reported by 1% of participants.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Esomeprazole appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 211 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
pruritus — 34 reaction mentions
nausea — 29 reaction mentions
asthenia — 22 reaction mentions
headache — 21 reaction mentions
arthritis — 19 reaction mentions
neuropathy peripheral — 18 reaction mentions
palpitations — 18 reaction mentions
rheumatoid arthritis — 18 reaction mentions
condition aggravated — 16 reaction mentions
drug abuse — 16 reaction mentions
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral delayed-release capsule, delayed-release granules for oral 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 sodium salt exists specifically for the acute ulcer-bleeding indication, which is where the randomised evidence for this molecule rather than its parent is strongest.
✎ 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
50 products list this as an active ingredient in the United States drug directory. 50 of them contain it and nothing else.
FDA National Drug Code directory · 65977-0057 · read 2026-08-29
They are sold as capsule, delayed release, injection, injection, powder, lyophilized, for solution and powder, taken intravenous and oral.
FDA National Drug Code directory · 65977-0057 · read 2026-08-29
The regulator's established pharmacologic class for it is cytochrome p450 2c19 inhibitors [moa], proton pump inhibitor [epc] and proton pump inhibitors [moa].
FDA National Drug Code directory · 65977-0057 · read 2026-08-29
42 published labels name it as an active ingredient. 42 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · c9472b82-d345-4531-bf07-bd55c94876ab · read 2026-08-29
Those labels are classed as human otc drug and human prescription drug.
US prescribing information · c9472b82-d345-4531-bf07-bd55c94876ab · 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.
Evidence on this page does not automatically apply to this one.
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 Esomeprazole 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 the S-enantiomer is intrinsically superior to its racemic parent, when the trial that established superiority gave twice the dose
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the placebo-controlled long-term safety record of pantoprazole applies to this molecule, which has no equivalent trial of its own
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 treating silent reflux improves asthma control — refuted, including in the pH-documented subgroup
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 a composite endpoint dominated by all-cause mortality is a measurement of cancer prevention
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 Esomeprazole 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.
The superiority result was measured at 40 mg against 20 mg, and no equal-dose comparison exists
In plain words
The trial that established esomeprazole as better than omeprazole gave twice as much of the new drug as of the old one. It healed more people. What it did not test is whether the same amount of each performs differently, which is the question a reader assumes was asked.
What was measured
That the S-enantiomer is intrinsically more effective than its racemic parent — an inference from a trial that gave the S-enantiomer twice the milligram dose
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Richter, Kahrilas and colleagues randomised 2,425 patients with endoscopically confirmed erosive oesophagitis, Helicobacter pylori negative by serology, to esomeprazole 40 mg or omeprazole 20 mg once daily for eight weeks across 163 United States centres. Healing at week 8 was 93.7% against 84.2% (P<0.001, life-table estimates, intention-to-treat), and at week 4 was 81.7% against 68.7%. Esomeprazole was superior on every secondary measure, with a comparable safety profile. The comparison is between different milligram quantities of two molecules that act on the same target by the same chemistry, one of which is a component of the other. A dose-equivalence trial would answer the question the headline implies; none has been published.
Written into the record, not signed off as a reviewed claim
AspECT: nearly nine years of follow-up, and high-dose PPI delayed cancer, dysplasia or death
In plain words
This is the only trial on any page in this file that ran long enough to count cancers. Two and a half thousand people with a pre-cancerous change in the gullet took high-dose or low-dose esomeprazole, with or without aspirin, for at least eight years. High dose delayed the composite of death, oesophageal cancer and severe dysplasia, and 34 people had to be treated to prevent one event.
What was measured
Time to all-cause mortality, oesophageal adenocarcinoma or high-grade dysplasia over a median 8.9 years, high-dose against low-dose esomeprazole
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
AspECT was a 2 x 2 factorial trial at 84 centres in the United Kingdom and one in Canada. Between March 2005 and March 2009 it recruited 2,557 patients with Barrett’s oesophagus of at least 1 cm, randomising to high-dose (40 mg twice daily) or low-dose (20 mg once daily) esomeprazole, with or without aspirin, for at least eight years. Median follow-up and treatment duration was 8.9 years (IQR 8.2 to 9.8), with 20,095 follow-up years and 99.9% of planned data collected. The primary composite endpoint was time to all-cause mortality, oesophageal adenocarcinoma or high-grade dysplasia; 313 primary events occurred. High-dose gave 139 events in 1,270 patients against 174 in 1,265 on low dose, time ratio 1.27 (95% CI 1.01 to 1.58, P=0.038), number needed to treat 34. Aspirin alone did not reach significance (TR 1.24, 95% CI 0.98 to 1.57, P=0.068) unless NSAID users were censored. The combination against low-dose PPI alone gave TR 1.59 (95% CI 1.14 to 2.23, P=0.0068). The trial was unblinded, though reporting pathologists were masked, and the composite is dominated by all-cause mortality rather than by cancer.
Written into the record, not signed off as a reviewed claim
Intravenous esomeprazole after endoscopic haemostasis: rebleeding 5.9% against 10.3%
In plain words
After a bleeding ulcer has been treated through an endoscope, a 72-hour drip of high-dose esomeprazole nearly halved the chance of bleeding again in the next three days. Deaths and operations were fewer too, but not by enough to be certain.
What was measured
Clinically significant recurrent bleeding within 72 hours after endoscopic haemostasis, against matching placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
A randomised, blinded trial across 91 emergency departments in 16 countries assigned patients with peptic ulcer bleeding from a single gastric or duodenal ulcer showing high-risk stigmata, after successful endoscopic haemostasis, to an 80 mg intravenous esomeprazole bolus followed by an 8 mg/h infusion over 72 hours, or matching placebo; both groups then received oral esomeprazole for 27 days. Of 767 randomised, 764 were analysed. Clinically significant recurrent bleeding within 72 hours occurred in 22 of 375 (5.9%) against 40 of 389 (10.3%), a difference of 4.4 percentage points (95% CI 0.6 to 8.3, P=0.026), sustained at 7 and 30 days (P=0.010). Endoscopic re-treatment fell from 11.6% to 6.4% (difference 5.2 points, 95% CI 1.1 to 9.2, P=0.012). Surgery was 2.7% against 5.4% and all-cause mortality 0.8% against 2.1%, neither significant. The trial was funded by AstraZeneca and endoscopic therapy was not fully standardised.
Written into the record, not signed off as a reviewed claim
It did nothing for poorly controlled asthma, and silent reflux did not identify anyone it helped
In plain words
Reflux is common in asthma, often without symptoms, and treating it was widely expected to improve asthma control. A trial of 412 adults on high-dose esomeprazole found no difference at all — and testing people to find the ones who really did have reflux did not find a group that benefited either.
What was measured
Rate of episodes of poor asthma control over 24 weeks, against matching placebo, with a prespecified pH-monitored subgroup
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
A parallel-group, double-blind trial randomised 412 participants with inadequately controlled asthma despite inhaled corticosteroids and with minimal or no reflux symptoms to esomeprazole 40 mg twice daily or matching placebo, following them for 24 weeks with daily asthma diaries, four-weekly spirometry and symptom questionnaires. Episodes of poor asthma control occurred at 2.3 against 2.5 events per person-year (P=0.66). There was no effect on any component of the primary outcome or on any secondary outcome: pulmonary function, airway reactivity, asthma control, symptom scores, nocturnal awakening or quality of life. Ambulatory pH monitoring documented reflux in 40% of participants with minimal or no symptoms, and that subgroup did not benefit either. Serious adverse events were fewer on esomeprazole (11 against 17).
Written into the record, not signed off as a reviewed claim
The chiral switch: launched the year its parent went generic
In plain words
Esomeprazole reached the United States market in February 2001, the year the omeprazole patent expired. It is one half of omeprazole with its own patent. The strategy has a name in the health-policy literature and this drug is its standard example.
What was measured
That a separately patented single enantiomer represented a therapeutic advance proportional to its price — a commercial claim whose clinical support is a set of unequal-dose comparisons
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Omeprazole was approved under NDA 019810 in 1989 and its composition-of-matter protection expired in 2001. Esomeprazole magnesium was approved under NDA 021153 on 20 February 2001 as a separately patented product, and became one of the highest-grossing pharmaceuticals in history. The pharmacological difference is genuine but narrow — the S-enantiomer is a poorer CYP2C19 substrate, so exposure per milligram is higher — and the clinical demonstration rests on comparisons at unequal doses. The field’s reading of this drug has shifted accordingly: the pharmacology textbooks describe a modest and real pharmacokinetic advantage, while the health-policy literature uses it as the worked example of enantiomer evergreening. Both descriptions are of the same molecule and neither is wrong.
Source
Drugs@FDA records for NDA 019810 (PRILOSEC, approved 14 September 1989) and NDA 021153 (NEXIUM, approved 20 February 2001)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
The long-term safety evidence for this molecule is borrowed, not its own
In plain words
The reassuring three-year randomised safety data that this class now has came from a trial of pantoprazole. Esomeprazole has no equivalent. What it does have is AspECT, which followed people for nearly nine years and found study-treatment-related serious adverse events in 1% of participants.
What was measured
That the placebo-controlled safety record established for pantoprazole applies to esomeprazole — a mechanistic inference, not a measurement of this molecule
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
COMPASS randomised 17,598 people to pantoprazole or placebo for a median 3.01 years and found no significant excess of pneumonia, C. difficile, fracture, gastric atrophy, chronic kidney disease, dementia, cancer or death, with enteric infections at 1.4% against 1.0% (OR 1.33, 95% CI 1.01 to 1.75). No comparable placebo-controlled trial of esomeprazole exists. AspECT provides the longest exposure data for this molecule specifically — a median 8.9 years in 2,557 patients — and reports study-treatment-related serious adverse events in 28 participants (1%), but it randomised dose rather than drug against placebo, so it cannot separate drug effects from background rates. Reading the pantoprazole safety result across to esomeprazole is a class inference from shared mechanism.
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What is not here
4 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.
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.
The single slower-cleared mirror image of omeprazole, isolated and patented as a new product the year its parent went generic: it healed erosive oesophagitis in 93.7% of patients against 84.2% for omeprazole in 2,425 people — at 40 mg against 20 mg, twice the dose — and in the one trial that ran nearly nine years, high-dose esomeprazole delayed death, oesophageal cancer or high-grade dysplasia in Barrett’s oesophagus with a time ratio of 1.27 and a number needed to treat of 34.
Recorded evidence blocks (12)
Q1
What did Esomeprazole's largest trial (4238504 people) and its longest (12 years) measure?
4238504 people in Esomeprazole's largest registered study, 12 years in its longest registered window, measuring Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval. ClinicalTrials.gov · 2026-09-01
132 phase4, 77 phase1, 77 phase3, 41 na, 36 phase2, 6 na or unstated, 1 early phase1; NCT00357682; 2017-05-31; no ageing endpoint recorded. Last human test completed 2026, NCT06717269.
Interpretation These counts include studies where Esomeprazole was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase4
132
phase1
77
phase3
77
na
41
phase2
36
na or unstated
6
2 more recorded rows
early phase1
1
Last recorded human testNCT06717269
2026-05-01
recorded 2026-09-01 · last checked 2026-09-04
Q2
From mouse to human: where has Esomeprazole shown biomarker?
futility/efficacy (1), accrual/recruitment (6), funding/business (2), sponsor decision unspecified (1) and other (10): Esomeprazole's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"No suitable patients and many patients refused the study"; 20 of 360 registered studies
Show the evidence
Trial
NCT00164788
terminated; "No suitable patients and many patients refused the study"
NCT00206440
terminated; "Accrual was not optimized"
NCT00222079
terminated; "Project canceled due to the implementation of IMRT, fewer patients reporting xerostomia."
NCT00361985
withdrawn; "Insufficient enrollment"
NCT00443963
withdrawn; "The study was not approved by the Human Studies Subcommittee."
NCT00444236
terminated; "The sponsor decided to terminate the study due to slow enrollment."
14 further recorded trials
NCT00567658
withdrawn; "The decision of terminate the study was reached due to difficulties surrounding recruitment and enrollment of subjects since the inception of the study."
NCT00604942
terminated; "prototype catheter never delivered"
NCT00730665
terminated; "This study has been placed on clinical hold by the sponsor due to operational reasons."
NCT00857597
terminated; "Study was terminated after unplanned interim analysis of single centre data and results were reported"
NCT00881413
withdrawn; "problems in funding"
NCT01123031
withdrawn; "The study was terminated and the PI has left the institution."
NCT01142128
terminated; "Viokase was taken off market during study and remained off over a year."
NCT01471925
withdrawn; "Change company strategy"
NCT02624544
withdrawn; "Sponsor decision"
NCT02840929
terminated; "Slow recruitment"
NCT03021590
withdrawn; "No Participants Enrolled"
NCT03488147
withdrawn; "Change in Investigational Drug Service policies resulting in the need to change the operational design of the overall protocol."
NCT05250050
withdrawn; "Unable to complete in vitro culture of Helicobacter pylori in our hospital"
NCT06359015
terminated; "Lost funding"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Esomeprazole used Esomeprazole 40mg — over how long?
Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2); Timepoint of first unplanned re-hospitalization or death (whichever occurs first); latest 2032-07-31
Show the evidence
Trial
NCT03866668
"A Study of Esomeprazole in Children With Autism"; n 25; "Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2)"; 2028-12
NCT04448028
"Stop of Proton-pump Inhibitor Treatment in Patients With Liver Cirrhosis - a Double-blind, Placebo-controlled Trial"; n 476; "Timepoint of first unplanned re-hospitalization or death (whichever occurs first)"; 2028-02
NCT04527055
"The Efficacy of 10-day and 14-day Bismuth-based Quadruple Therapy in First-line H. Pylori Eradication"; n 312; "The successful eradication rate"; 2028-07-31
NCT05267613
"Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis."; n 53; "Presence / absence of Erosive Esophagitis"; 2026-08-19
NCT05582174
"PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers"; n 594; "The number of recurrent bleeding"; 2028-07-03
NCT05874570
"Doxycycline for Helicobacter Pylori Rescue Treatment"; n 368; "Helicobacter pylori eradication rate"; 2025-10-31
14 further recorded trials
NCT06065267
"Levofloxacin Concomitant Versus Levofloxacin Sequential"; n 150; "Eradication rate of Helicobacter pylori infection"; 2027-06-30
NCT06120803
"Esomeprazole and Radiation Induced Esophagitis"; n 48; "Grade 2 or higher radiation induced esophagitis"; 2028-06-30
NCT06509139
"Optimal Duration of Bismuth Quadruple Therapy for Helicobacter Pylori Eradication in Females As Compared with Males"; n 661; "The successful eradication rate"; 2032-07-31
NCT06523764
"Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment"; n 208; "Helicobacter pylori eradication rate"; 2025-10-01
NCT06526455
"Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection"; n 196; "Rate of ulcer reduction"; 2029-06-30
NCT06720610
"Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis"; n 216; "Number of Participants with Symptoms Resolution of Erosive Esophagitis"; 2025-06-27
NCT06733675
"Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination"; n 96; "Part 1 Plasma PK AUC0-∞ (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)"; 2026-12-30
NCT06810492
"The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment"; n 40; "Objective response rate (ORR)"; 2027-12-01
NCT06903585
"Non Steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy"; n 385; "Occurrence of a pain flare within the first 10 days after palliative radiation therapy"; 2029-04
NCT06953986
"A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks"; n 414; "• Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis)."; 2027-12-12
NCT06955520
"Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM"; n 300; "• Endoscopic healing of reflux esophagitis at 8 weeks (absence of LA grade B or higher esophagitis)."; 2028-12-25
NCT07139366
"Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment"; n 1248; "Helicobacter pylori eradication"; 2026-09
NCT07268820
"Heartburn, Gastroesophageal Reflux Disease"; n 160; "Proportion of participants without sleep disturbance related to nighttime heartburn during the last 7 days"; 2026-09-30
NCT07312370
"Esomeprazole Plus Sucralfate for Post-ESD Ulcer Healing"; n 120; "Ulcer Reduction Rate at 4 Weeks Post-ESD"; 2026-12-30
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which 179 trials of Esomeprazole posted no result?
Posted no result
179 of 179 completed trials
Registrations
NCT00241540, NCT00241527, NCT00626262, NCT00629564, NCT00635414 and NCT00625495, and 173 more
Completion dates
oldest 2002-08; newest 2024-08-30
Show the evidence
Trial
NCT00241540
2002-08
NCT00241527
2002-09
NCT00626262
2002-10
NCT00629564
2002-10
NCT00635414
2002-10
NCT00625495
2002-11
14 further recorded trials
NCT02670642
2002-11
NCT00629512
2002-12
NCT00241514
2003-02
NCT00241553
2003-02
NCT00637845
2003-02
NCT00628667
2003-03
NCT00629928
2003-03
NCT00633412
2003-03
NCT00637559
2003-04
NCT00637988
2003-06
NCT00628342
2003-08
NCT00641602
2003-08
NCT00633672
2003-10
NCT00644735
2004-01
Q8
At the median, Esomeprazole's trials enrolled 122 people — anything larger?
Median enrolment
122
Largest enrolment
4238504
Registered trials counted
357
Q9
What do 211 spontaneous reports say about Esomeprazole — 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.
Esomeprazole appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 211 reaction mentions were counted: pruritus 34; nausea 29; asthenia 22; headache 21. open-targets-adr · CHEMBL1200470 · 2026-06-24
Show the evidence
pruritus
34
nausea
29
asthenia
22
headache
21
arthritis
19
neuropathy peripheral
18
4 more recorded rows
palpitations
18
rheumatoid arthritis
18
condition aggravated
16
drug abuse
16
recorded 2026-06-24 · last checked 2026-09-04
Q10
Esomeprazole and CYP2C19 and CYP3A4: shared by which compounds?
CYP2C19 and CYP3A4 appear in Esomeprazole's recorded interaction sentences, 12 in all. openfda-label+europepmc · 2026-08-30
The major part of esomeprazole’s metabolism is dependent upon the CYP2C19 isoenzyme, which forms the hydroxy and desmethyl metabolites.
clinical_pharmacology
The CYP2C19*1 allele is fully functional while the CYP2C19*2 and *3 alleles are nonfunctional.
clinical_pharmacology
Approximately 3% of Caucasians and 15 to 20% of Asians are CYP2C19 poor metabolizers.
clinical_pharmacology
Systemic esomeprazole exposures were modestly higher (approximately 17%) in CYP2C19 intermediate metabolizers (IM; n=6) compared to extensive metabolizers (EM; n=17) of CYP2C19.
pharmacokinetics
Esomeprazole is a time-dependent inhibitor of CYP2C19, resulting in autoinhibition and nonlinear pharmacokinetics.
pharmacokinetics
Cilostazol Omeprazole acts as an inhibitor of CYP2C19.
3 more recorded rows
CYP2C19pharmacokinetics
Voriconazole Concomitant administration of omeprazole and voriconazole (a combined inhibitor of CYP2C19 and CYP3A4) resulted in more than doubling of the omeprazole exposure.
CYP2C19clinical_pharmacology
Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and, in hospitalized patients, possibly also Clostridium difficile . 12.5 Pharmacogenomics CYP2C19, a polymorphic enzyme, is involved in the metabolism of esomeprazole.
CYP2C19pharmacokinetics
Diazepam Co-administration of esomeprazole 30 mg and diazepam, a CYP2C19 substrate, resulted in a 45% decrease in clearance of diazepam.
CYP3A4
pharmacokinetics
The remaining amount is dependent on CYP3A4 which forms the sulphone metabolite.
pharmacokinetics
Voriconazole Concomitant administration of omeprazole and voriconazole (a combined inhibitor of CYP2C19 and CYP3A4) resulted in more than doubling of the omeprazole exposure.
CYP2C19clinical_pharmacology
CYP2C19 isoenzyme exhibits polymorphism in the metabolism of esomeprazole, since some 3% of Caucasians and 15 to 20% of Asians lack CYP2C19 and are termed Poor Metabolizers.
recorded 2026-08-30 · last checked 2026-09-04
Q11
Was Esomeprazole studied with fasting?
fasting is named in Esomeprazole's label sentences: "In this randomized, double-blind controlled study, 245 patients diagnosed with FD who completed Ramadan fasting were randomly assigned (1:1 ratio) to receive either esomeprazole (n = 122) or placebo (n = 123) for 30 days." openfda-label+europepmc · 2026-08-30
1 recorded statement; fasting
Show the evidence
fasting
In this randomized, double-blind controlled study, 245 patients diagnosed with FD who completed Ramadan fasting were randomly assigned (1:1 ratio) to receive either esomeprazole (n = 122) or placebo (n = 123) for 30 days.
recorded 2026-08-30 · last checked 2026-09-04
Q12
What is recorded about Esomeprazole and autophagy?
"In this study, we investigated the role of excessive placental autophagy during PE pathogenesis and explored whether esomeprazole ameliorates PE by inhibiting the autophagy in the placenta." — where Esomeprazole and autophagy appear together. Europe PMC · pathway abstract search · 2025-03-07
autophagy, mTOR, AMPK; PMID 35091806, 40055205
Show the evidence
autophagyPMID 35091806
"In this study, we investigated the role of excessive placental autophagy during PE pathogenesis and explored whether esomeprazole ameliorates PE by inhibiting the autophagy in the placenta."
mTORPMID 35091806
"Esomeprazole inhibits L-NAME-induced autophagy in mice by inhibiting AMPKα and activating mTOR."
autophagyPMID 35091806
"Esomeprazole inhibits L-NAME-induced autophagy in mice by inhibiting AMPKα and activating mTOR."
mTORPMID 35091806
"However, esomeprazole treatment inhibits AMPKα but activates mTOR, resulting in the inhibition of autophagy in the placenta and, therefore, mitigates PE symptoms."
autophagyPMID 35091806
"However, esomeprazole treatment inhibits AMPKα but activates mTOR, resulting in the inhibition of autophagy in the placenta and, therefore, mitigates PE symptoms."
AMPKPMID 40055205
"This research investigated the hepatoprotective effects of esomeprazole (ESOM) and canagliflozin (CANA) against methotrexate-induced liver toxicity, focusing on AMPK modulation and its regulation of MAPK/JNK/ERK, JAK1/STAT3, and PI3K/Akt pathways."
1 more recorded row
mTOR
"Esomeprazole could enhance the inhibitory effects of rapamycin on p-mTOR at a concentration of 20 μg/ml , and could enhance the inhibitory effects of rapamycin on HIF-1α at 10 μg/ml ( P <0.05)."
recorded 2025-03-07 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
Nexium iv, Emozul, Esomeprazole magnesium component of pn400, Esomeprazole magnesium component of vimovo, Nexium, Nexium 24hr, Nexium control, Nexium i.v., Ventra, Good Sense Esomeprazole Magnesium, Dg Health Esomeprazole Magnesium, Basic Care Esomeprazole Magnesium
Development code
A02BC05, FM-0F67, FM0F67, HIP-1601
Sources (11)
Sources
ClinicalTrials.govclinicaltrials.gov ·
ClinicalTrials.govClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 11 source rows
✓ no critical contamination: no quarantine open
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