This page shows what was measured, who it was measured in, and what that does not settle.
What Sucralfate does in the body
Nothing about this involves a receptor or a hormone, and nothing about it reduces how much acid the stomach makes.
Sucralfate is a large, heavily charged molecule that the gut hardly absorbs at all, so almost the entire dose stays inside the digestive tract. When it meets stomach acid the molecules link up into a thick, sticky gel. That gel carries a strong negative charge and the raw protein in the floor of an ulcer carries a positive one, so the gel sticks there far more than it sticks to intact lining. The result is a physical patch over the wound that keeps acid and digestive enzymes off it while the tissue underneath repairs.
Why people take it. Duodenal ulcers, and keeping a healed duodenal ulcer from returning
What happened in people
Under 5% of an oral dose absorbed, and serum aluminium higher in dialysed than non-dialysed children on the drug
✎ 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.
3.8% on sucralfate against 1.7% on ranitidine; relative risk 0.44 (95% CI 0.21 to 0.92) favouring ranitidine, P=0.02
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. Ventilator-associated pneumonia, the endpoint sucralfate was expected to win, was 16.2% against 19.1% (RR 1.18, 95% CI 0.92 to 1.51, P=0.19) — the right direction and not significant. ICU mortality and length of stay were identical.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet and oral suspension, both intended to act locally in the stomach and duodenum
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Proportion healed at up to 12 weeks, by drug class
✓ The study showed what it set out to show
Who was studied
Chiba pooled analysis of 43 randomised oesophagitis trials
How many people
7635
Study design
Meta-analysis of single- and double-blind randomised trials
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Sucralfate 39.2% (SD 22.4) against placebo 28.2% (15.6), H2-receptor antagonists 51.9% (17.1) and proton pump inhibitors 83.6% (11.4)
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 standard deviation on the sucralfate estimate is the widest of the four classes. Oesophagitis is also outside this drug’s United States licence, which covers duodenal ulcer only.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet and oral suspension, both intended to act locally in the stomach and duodenum
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Serum aluminium concentration after a median seven days of nasogastric sucralfate
✓ The study showed what it set out to show
Who was studied
Serum aluminium in ventilated children on sucralfate
How many people
19
Study design
Retrospective clinical study, single paediatric intensive care unit
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
No correlation with total dose (P=0.35) or dose per kilogram (P=0.55); higher levels in the nine patients receiving peritoneal dialysis
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. Nineteen patients, retrospective, single centre. It establishes that aluminium accumulates when elimination is impaired, not how often that causes harm.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet and oral suspension, both intended to act locally in the stomach and duodenum
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 3 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Sucralfate
What a person takes: Oral tablet and oral suspension, both intended to act locally in the stomach and duodenum.
The measurement behind this step
The formulation exists to put material in contact with an ulcer, not to get anything into the bloodstream — under 5% of a dose is absorbed. The suspension is used where contact matters more than convenience, including nasogastric administration in hospital and off-label application to the mouth and oesophagus.
Getting in
Swallowed, and almost entirely staying put
The molecule is too large and too heavily charged for the gut to absorb. Under one twentieth of a dose crosses into the body; the rest travels through and out.
╌╌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
Sucralfate is a basic aluminium salt of sucrose octasulfate. Less than 5% of an oral dose is absorbed, chiefly as free sucrose octasulfate and a small quantity of aluminium. Absorbed sucrose octasulfate is excreted unchanged in urine. There is no hepatic metabolism and no systemic pharmacology to speak of.
On contact with acid the molecules cross-link into a thick, sticky paste. This only happens in an acidic environment — in a neutral one the material stays inert.
╌╌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
At gastric pH the aluminium hydroxide moieties are released and the polyanionic sucrose octasulfate polymerises into a viscous, adhesive gel. The transformation is pH-dependent and is the reason the drug is inert until it reaches the stomach.
The paste sticks to the hole, not to the healthy lining
Raw tissue in an ulcer carries a positive charge that intact lining does not. The negatively charged paste is drawn to it, so it concentrates where the damage is.
╌╌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 polyanion binds electrostatically to positively charged proteins exposed in the ulcer base — chiefly albumin and fibrinogen in the crater exudate. Tissue autoradiography in animal models shows several-fold greater adherence to ulcerated than to intact mucosa, which is the empirical basis of the selectivity claim.
The layer keeps acid and the stomach’s protein-digesting enzyme off the exposed tissue. It also soaks up bile salts. None of this changes how much acid the stomach makes.
╌╌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 adherent gel provides a diffusion barrier against hydrogen ions and pepsin, and adsorbs pepsin and bile salts directly. Local stimulation of prostaglandin E2 and bicarbonate secretion and of epidermal growth factor binding at the ulcer site are additional proposed contributions. Gastric acid output is unaffected.
The same stickiness that makes it work catches other tablets. Antibiotics, thyroid tablets, digoxin and several others are absorbed less well if they are in the stomach at the same time.
╌╌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 label records reduced bioavailability for fluoroquinolones, digoxin, phenytoin, levothyroxine, ketoconazole, warfarin, quinidine and theophylline, attributed to binding in the gastrointestinal tract. The mechanism is adsorption, not enzyme inhibition, so it is invisible to interaction screening built around cytochrome P450.
It heals duodenal ulcers, which is what it is licensed for. In the trials that compared it with acid suppression it healed less, and in the trial that compared it in the sickest patients more of them bled.
──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
Pooled erosive oesophagitis healing was 39.2% against 28.2% for placebo, 51.9% for H2 blockers and 83.6% for proton pump inhibitors. In 1,200 ventilated patients, clinically important bleeding was 3.8% on sucralfate against 1.7% on ranitidine (RR 0.44, 95% CI 0.21 to 0.92, P=0.02), with no significant difference in pneumonia, ICU mortality or length of stay.
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.
People with duodenal ulcer, people who cannot take acid suppression, and — off label and very widely — people with radiation proctitis, oral or oesophageal mucosal injury, and bile reflux. Most of those uses are extrapolations from the licensed one.
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 and effectiveness in pediatric patients have not been established.”
US prescribing information · 1a6d96f2-fe1f-4aaf-8520-616973c224aa · read 2026-08-30
On older people, the label states: “Clinical studies of sucralfate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”
US prescribing information · 1a6d96f2-fe1f-4aaf-8520-616973c224aa · read 2026-08-30
On people who are pregnant, the label states: “Teratogenic Effects Pregnancy category B Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to sucralfate.”
US prescribing information · 1a6d96f2-fe1f-4aaf-8520-616973c224aa · read 2026-08-30
On people who are breastfeeding, the label states: “It is not known whether this drug is excreted in human milk.”
US prescribing information · 1a6d96f2-fe1f-4aaf-8520-616973c224aa · read 2026-08-30
Where the result stopped carrying
The intensive-care head-to-head against ranitidine, on the endpoint it was being given for
The pneumonia advantage that was the entire argument for using it in that setting
Erosive oesophagitis healing at 39.2%, the lowest of any active drug in the pooled analysis
Aluminium accumulation in renal impairment, which restricts the drug in exactly the population most likely to be prescribed it in hospital
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
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral tablet and oral suspension, both intended to act locally in the stomach and duodenum
✎ 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
The formulation exists to put material in contact with an ulcer, not to get anything into the bloodstream — under 5% of a dose is absorbed. The suspension is used where contact matters more than convenience, including nasogastric administration in hospital and off-label application to the mouth and 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.
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 commonest adverse effect is constipation, from the aluminium. The label warns against use in chronic renal failure and dialysis, because absorbed aluminium is not excreted and accumulates, and warns about concurrent aluminium-containing antacids adding to that load. Bezoar formation has been reported, chiefly in critically ill patients on enteral feeds and in premature infants. The drug binds several co-administered medicines in the gut and reduces their absorption. There is essentially no systemic pharmacology, which is both the safety argument for the drug and the reason its harms are the unusual kind: a metal, a physical obstruction, and an interaction that is mechanical rather than metabolic.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral tablet and oral suspension, both intended to act locally in the stomach and duodenum
✎ 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 suspension is used where contact matters more than convenience, including nasogastric administration in hospital and off-label application to the mouth and 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.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
93 products list this as an active ingredient in the United States drug directory. 93 of them contain it and nothing else.
FDA National Drug Code directory · 72189-234 · read 2026-08-29
They are sold as paste, powder, suspension and tablet, taken oral.
FDA National Drug Code directory · 72189-234 · read 2026-08-29
The regulator's established pharmacologic class for it is aluminum complex [epc] and organometallic compounds [cs].
FDA National Drug Code directory · 72189-234 · read 2026-08-29
69 published labels name it as an active ingredient. 69 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 98a8fedd-fa06-416a-8a85-b899631978f9 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 98a8fedd-fa06-416a-8a85-b899631978f9 · read 2026-08-29
Sucralfate is oral at HOW SUPPLIED Sucralfate tablets, USP are available as white, capsule-shaped, biconvex, scored tablets, debossed “TEVA” on one side, and “22” and “10” on the scored side, containing 1 gram of sucralfate USP., recorded as fda label in effect 2026-04-07 in the United States.
US prescribing information · 1a6d96f2-fe1f-4aaf-8520-616973c224aa · read 2026-08-30
Recorded price in US: 0.11288–0.1446 USD per one millilitre, across 8 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
Recorded price in US: 0.17247 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 12 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 Sucralfate 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 preserving gastric acidity prevents ventilator-associated pneumonia — tested in the same 1,200-patient trial and not confirmed
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 duodenal barrier mechanism works identically at every other mucosal surface the drug is applied to off label
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 drug which is not absorbed cannot cause systemic harm; the aluminium it carries is absorbed in small quantity and is not excreted in renal failure
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 drug with no systemic pharmacology has no interactions; it binds at least eight named drug classes in the stomach
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Sucralfate 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.
It lost the definitive intensive-care trial: 3.8% bleeding against 1.7% on ranitidine
In plain words
Twelve hundred patients on breathing machines were randomly given sucralfate or ranitidine to prevent stress ulcer bleeding. More than twice as many bled on sucralfate. The theory that sucralfate would cause less pneumonia — because it does not remove the acid that kills swallowed bacteria — was tested in the same trial and did not hold up.
What was measured
Clinically important upper gastrointestinal bleeding, ventilator-associated pneumonia and mortality in 1,200 randomised ventilated patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
A multicentre, randomised, blinded, double-dummy trial in 1,200 patients requiring mechanical ventilation compared nasogastric sucralfate suspension 1 g six-hourly with intravenous ranitidine 50 mg eight-hourly, each with a matching placebo by the other route. Clinically important gastrointestinal bleeding occurred in 10 of 596 (1.7%) on ranitidine against 23 of 604 (3.8%) on sucralfate — relative risk 0.44 (95% CI 0.21 to 0.92, P=0.02). Ventilator-associated pneumonia was 114 of 596 (19.1%) against 98 of 604 (16.2%), relative risk 1.18 (95% CI 0.92 to 1.51, P=0.19), numerically favouring sucralfate but not significantly. Intensive care mortality was 23.5% against 22.9% and median ICU stay was nine days in both groups. The trial settled the question and sucralfate largely left intensive care as a result.
Written into the record, not signed off as a reviewed claim
The weakest healing figure of any active drug in the pooled oesophagitis analysis
In plain words
Across 43 randomised trials in more than 7,600 people, sucralfate healed erosive damage to the gullet in about two in five patients. Placebo healed a bit over one in four. Proton pump inhibitors healed five in six.
What was measured
Proportion healed at up to 12 weeks in erosive oesophagitis, pooled across 43 randomised trials by drug class
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Mean healing proportion within 12 weeks was 39.2% (SD 22.4) for sucralfate, against 28.2% (15.6) for placebo, 51.9% (17.1) for H2-receptor antagonists and 83.6% (11.4) for proton pump inhibitors. The standard deviation on the sucralfate estimate is the largest of the four, which reflects both a smaller pooled sample and genuine heterogeneity between the studies contributing to it. The endpoint is mucosa seen down an endoscope, and the indication sucralfate actually holds a licence for is duodenal ulcer rather than oesophagitis, so this is a measurement of the drug outside its label and should be read as one.
Written into the record, not signed off as a reviewed claim
The mechanism is a laboratory observation applied to every mucosa in the body
In plain words
The claim that sucralfate sticks preferentially to ulcers rests on animal and laboratory work. Its licence covers duodenal ulcers only. It is used very widely for radiation damage to the rectum, mouth ulcers, oesophageal injury and bile reflux — all of them extensions of the same chemistry to places where it was never licensed.
What was measured
That a barrier mechanism demonstrated in the duodenum works at every other mucosal surface it is applied to — a chemically plausible extrapolation, and the basis of most of this drug’s actual use
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The accepted mechanism has three components, each demonstrated in vitro or in animals: acid-driven polymerisation into a viscous adhesive gel; electrostatic binding of the polyanion to positively charged protein exposed in an ulcer crater, with selectivity for ulcerated over intact mucosa shown by tissue autoradiography; and adsorption of pepsin and bile salts. Local prostaglandin and bicarbonate stimulation is also proposed. The United States label indication is short-term treatment of active duodenal ulcer and reduced-dose maintenance after healing — nothing else. Radiation proctitis, oral and oesophageal mucositis, bile reflux gastritis and stoma or wound care are all off-label extrapolations from the chemistry, and while randomised trials exist for several of them, the licence and the mechanism evidence do not extend that far on their own.
Source
CARAFATE (sucralfate) United States prescribing information, Indications and Usage and Clinical Pharmacology (NDA 018333, AbbVie)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
It carries aluminium, and kidneys are what keep that harmless
In plain words
Every gram of sucralfate contains about 207 milligrams of aluminium. Only a tiny fraction is absorbed, which does not matter if the kidneys clear it and does matter if they do not. In critically ill children on the drug for about a week, blood aluminium was higher in those who also needed dialysis.
What was measured
Serum aluminium concentration after a median seven days of nasogastric sucralfate in 19 ventilated children, stratified by dialysis
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
A retrospective study measured serum aluminium in 19 mechanically ventilated children given nasogastric sucralfate suspension for a median of seven days (range 3 to 14). Serum aluminium showed no correlation with total dose (P=0.35) or with dose per kilogram (P=0.55), but was higher in the nine patients who also received peritoneal dialysis. The lack of dose correlation is itself informative: absorption is not the rate-limiting variable, elimination is. The label warns against use in patients with chronic renal failure or on dialysis because absorbed aluminium is not excreted and accumulates, and aluminium accumulation in renal failure is associated with encephalopathy and osteomalacia. Concurrent aluminium-containing antacids add to the load.
Written into the record, not signed off as a reviewed claim
It binds other medicines in the stomach, and that interaction is invisible to interaction checkers
In plain words
The same stickiness that makes it work also makes it grab other tablets sitting in the stomach at the same time. Antibiotics, thyroid hormone, digoxin, phenytoin and warfarin are all absorbed less well when taken with it. Because the mechanism is physical rather than metabolic, most drug-interaction software does not flag it.
What was measured
Reduced bioavailability of co-administered drugs measured in interaction studies recorded in the label
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The label records reduced bioavailability of ciprofloxacin, norfloxacin, ofloxacin and other fluoroquinolones, digoxin, phenytoin, levothyroxine, ketoconazole, warfarin, quinidine and theophylline when co-administered, attributed to binding by sucralfate in the gastrointestinal tract. The label notes the interaction can generally be managed by separating administration in time. The fluoroquinolone effect is the clinically largest and the levothyroxine effect the most easily missed, because thyroid replacement is a long-term background medicine that nobody re-examines when an ulcer drug is added. This is a well-characterised, mechanistically obvious and frequently overlooked interaction class, and it exists precisely because the drug is not absorbed.
Source
CARAFATE (sucralfate) United States prescribing information, Drug Interactions (NDA 018333, AbbVie)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
The pneumonia argument that kept it in intensive care did not survive the trial designed to test it
In plain words
For years the case for sucralfate in intensive care was that it prevents bleeding without removing stomach acid, and stomach acid kills bacteria that would otherwise be aspirated into the lungs. The trial built to test that found no significant difference in pneumonia — and more bleeding on sucralfate.
What was measured
That preserving gastric acidity with a non-absorbed barrier agent prevents ventilator-associated pneumonia — a mechanistically coherent inference that the trial designed to test it did not confirm
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The hypothesis was mechanistically coherent: raising gastric pH permits bacterial overgrowth in the stomach, and retrograde colonisation of the oropharynx and aspiration was proposed as a route to ventilator-associated pneumonia. The 1,200-patient trial measured both endpoints in the same population. Pneumonia was 16.2% on sucralfate against 19.1% on ranitidine, relative risk 1.18 (95% CI 0.92 to 1.51, P=0.19) — numerically in the predicted direction and not significant. Bleeding was 3.8% against 1.7%, relative risk 0.44 (95% CI 0.21 to 0.92, P=0.02) — significantly worse on sucralfate. Twenty years later the same pneumonia question was put to placebo in 4,821 patients in REVISE, and ventilator-associated pneumonia was again no different. The trade-off that justified sucralfate in this setting had one arm that was real and one that was not, and the practice moved accordingly.
Written into the record, not signed off as a reviewed claim
Where else this substance is registered
FDA substance identifier (UNII)
XX73205DH5
RxNorm concept
314234
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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, 2023, for "Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus." (openFDA drug enforcement Class I recall)
What the approval register records
16 approved applications cover products containing this substance. The earliest was NDA018333, approved 19811030 to ABBVIE.
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7 questions this page could not answer
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A sugar molecule wrapped in eight sulfate groups and complexed with aluminium, which is barely absorbed and does nothing systemically: in stomach acid it polymerises into a sticky paste that binds to exposed protein in an ulcer crater and physically covers it — healing 39.2% of erosive oesophagitis against 28.2% for placebo and 83.6% for a proton pump inhibitor across 43 pooled trials, and losing the definitive 1,200-patient intensive-care comparison, where clinically important bleeding was 3.8% on sucralfate against 1.7% on ranitidine.
Recorded evidence blocks (7)
Q1
On the Sucralfate label: indicated for what?
"Sucralfate tablets, USP are indicated in: • Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.": indications and usage on Sucralfate's label. DailyMed label · 444a743a-4843-4b33-bad5-3dfc1fb2d004 · 2026-07-29
Q2
17 registered trials of Sucralfate — at which phases?
"Could not recruit patients - modifying protocol and plan resubmission to our IRB"; 2 of 17 registered studies
Show the evidence
Trial
NCT02039869
withdrawn; "Could not recruit patients - modifying protocol and plan resubmission to our IRB"
NCT02788591
terminated; "lack of accrual"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Which 5 trials of Sucralfate posted no result?
Posted no result
5 of 5 completed trials
Registrations
NCT00702871, NCT01613534, NCT02353078, NCT03635372 and NCT05369234
Completion dates
oldest 2006-04; newest 2024-01-30
Show the evidence
Trial
NCT00702871
2006-04
NCT01613534
2007-06
NCT02353078
2016-12
NCT03635372
2017-11-25
NCT05369234
2024-01-30
Q5
At the median, Sucralfate's trials enrolled 120 people — anything larger?
Median enrolment
120
Largest enrolment
800
Registered trials counted
17
Q6
What do 246 spontaneous reports say about Sucralfate — 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.
Sucralfate appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 246 reaction mentions were counted: drug hypersensitivity 54; constipation 31; pyrexia 28; weight decreased 22. FAERS via Open Targets · CHEMBL6067980 · 2026-06-24
Show the evidence
drug hypersensitivity
54
constipation
31
pyrexia
28
weight decreased
22
aspartate aminotransferase increased
20
drug interaction
20
4 more recorded rows
erythema
19
abdominal pain upper
18
alanine aminotransferase increased
17
hallucination, auditory
17
recorded 2026-06-24 · last checked 2026-09-04
Q7
Which 10 reactions does Sucralfate's label not list?
abdominal pain upper, alanine aminotransferase increased and aspartate aminotransferase increased and 7 more reported for Sucralfate, absent from its label. FAERS via Open Targets · CHEMBL6067980 · 2026-06-24
3 label terms; 10 reported and unlisted; 444a743a-4843-4b33-bad5-3dfc1fb2d004
Show the evidence
abdominal pain upper
count not stated
alanine aminotransferase increased
count not stated
aspartate aminotransferase increased
count not stated
constipation
count not stated
drug hypersensitivity
count not stated
drug interaction
count not stated
4 more recorded rows
erythema
count not stated
hallucination, auditory
count not stated
pyrexia
count not stated
weight decreased
count not stated
recorded 2026-06-24 · last checked 2026-09-04
Where it is registered
Where it’s registered
Withdrawn in United States, 2023, for "Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus." (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
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✓ source coverage passed: 6 source rows
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