This page shows what was measured, who it was measured in, and what that does not settle.
What Misoprostol does in the body
Reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers
From the FDA-approved label: Diclofenac sodium and misoprostol delayed-release tablets are a combination product containing diclofenac sodium, an NSAID with analgesic, anti-inflammatory and antipyretic properties, and misoprostol, a GI mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac The mechanism of action of diclofenac, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Diclofenac is a potent inhibitor of prostaglandin (PG) synthesis in vitro . Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 0E43V0BB57 · read 2026-08-29
Where each sentence above came from
The recorded explanation is written in label language rather than for a beginner. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 121 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.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
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
Pain
∅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.
…Waiting for a reviewer1 registered symptom measure.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅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
Pain
pain
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.
… Waiting for a reviewer
1 registered symptom measure.
— Not recorded
Harms were not a registered measure for this goal.
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.
The Primary Outcome is a Composite of the Following Three Clinical Outcomes: 1) Severe PPH Defined as Blood Loss ≥1000 ml or; 2) Postpartum Laparotomy for Bleeding or; 3) Postpartum Maternal Death From Bleeding. Please See Below for Further Details.
✗ The study did not show it
Who was studied
NCT04341662
How many people
99659
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
All-cause neonatal mortality
✗ The study did not show it
Who was studied
NCT04798833
How many people
19344
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Facility births
✗ The study did not show it
Who was studied
NCT03024905
How many people
17000
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)
✗ The study did not show it
Who was studied
NCT00373685
How many people
8067
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Number of cases identified as having excessive bleeding
✗ The study did not show it
Who was studied
NCT02853552
How many people
4330
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage
✗ The study did not show it
Who was studied
NCT03254628
How many people
3440
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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 eventNo evidence recorded. Death, a heart attack, a stroke, a hospital stay.0 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
□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.2 registered measures of this kind.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.3 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, Rat. A result in animals says what to test next. It does not say what happens in people.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□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 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.
pain
swiss spinal stenosis questionnaire
Measured
Things only a test, a scale or a device shows.
hemoglobin
changes in hemoglobin levels after delivery
pre and post delivery haemoglobin
Meaningful
Things that change how a life goes, not only a number.
No registered study measured anything of this kind.
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 (35)
placental retention rate
postpartum hemorrhage
caesarean section rate
primary efficacy variable will be bleeding profile
vaginal delivery rates
time to resolution
hematocrit
side effects
complete abortion without recourse to surgical intervention
uterine tachysystole
vaginal delivery
cesarean section
complete miscarriage
cesarean birth rate
rate of induction to delivery
operative blood loss
blood loss
amount of blood loss
complete abortion rate
intraoperative bleeding
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.
Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer.
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 of Cytotec in pediatric patients have not been established.”
US prescribing information · 4ab12da7-5731-4e06-bf1c-bc3f2e711f12 · read 2026-08-30
On people who are pregnant, the label states: “Teratogenic effects See boxed WARNINGS .”
US prescribing information · 4ab12da7-5731-4e06-bf1c-bc3f2e711f12 · read 2026-08-30
On people who are breastfeeding, the label states: “Misoprostol is rapidly metabolized in the mother to misoprostol acid, which is biologically active and is excreted in breast milk.”
US prescribing information · 4ab12da7-5731-4e06-bf1c-bc3f2e711f12 · read 2026-08-30
Where the result stopped carrying
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.
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 (10)
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
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S3.
No source is stored against this line.
What is in the pack
Sold as tablet, delayed release, tablet, tablet, film coated, liquid, given by the oral, topical route.
✎ 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∅Nothing found in the sources checked
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.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
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.
Misoprostol appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4534 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
haemorrhage — 1073 reaction mentions
abortion incomplete — 1034 reaction mentions
pregnancy — 414 reaction mentions
anaemia — 397 reaction mentions
pain — 345 reaction mentions
muscle spasms — 298 reaction mentions
drug hypersensitivity — 293 reaction mentions
dizziness — 233 reaction mentions
menorrhagia — 225 reaction mentions
pyrexia — 222 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
✎ 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
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
63 products list this as an active ingredient in the United States drug directory. 37 of them contain it and nothing else.
FDA National Drug Code directory · 71335-9631 · read 2026-08-29
They are sold as liquid, powder, tablet, tablet, delayed release and tablet, film coated, taken oral and topical.
FDA National Drug Code directory · 71335-9631 · read 2026-08-29
The regulator's established pharmacologic class for it is prostaglandin e1 analog [epc], prostaglandins e and synthetic [cs].
FDA National Drug Code directory · 71335-9631 · read 2026-08-29
37 published labels name it as an active ingredient. 20 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 9462d969-d3e5-4e7f-b556-bd647ab28c42 · read 2026-08-29
Those labels are classed as human otc drug and human prescription drug.
US prescribing information · 9462d969-d3e5-4e7f-b556-bd647ab28c42 · read 2026-08-29
Cytotec is oral at HOW SUPPLIED Cytotec 100-mcg tablets are white, round, with SEARLE debossed on one side and 1451 on the other side; supplied as: NDC Number Size 0025-1451-60 unit-of-use bottle of 60 Cytotec 200-mcg tablets are white, h…, recorded as fda label in effect 2026-06-04 in the United States.
US prescribing information · 4ab12da7-5731-4e06-bf1c-bc3f2e711f12 · read 2026-08-30
Recorded price in US: 0.48163–0.73379 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 17 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.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Misoprostol 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
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 Misoprostol 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.
How many documents were read
19 documents were read for this substance.
RNAWiki source record
19 of them state the same proteinBinding, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
0E43V0BB57
RxNorm concept
311727
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S3.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
13 approved applications cover products containing this substance. The earliest was NDA019268, approved 19881227 to PFIZER.
This order is fixed in code and does not count clicks or time on the page.
What is not here
6 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.
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Recorded evidence blocks (10)
Q2
What did Misoprostol's largest trial (4330 people) and its longest (9.4 years) measure?
4330 people in Misoprostol's largest registered study, 9.4 years in its longest registered window, measuring AUC480 (the area under the curve of serum concentration of misoprostol acid against time up to 480 minutes). ClinicalTrials.gov · 2026-09-01
117 na, 88 phase4, 68 phase3, 59 phase2, 13 phase1, 12 na or unstated, 10 early phase1; NCT01033903; 2018-03-01; no ageing endpoint recorded. Last human test completed 2026, NCT06259097.
Interpretation These counts include studies where Misoprostol 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
na
117
phase4
88
phase3
68
phase2
59
phase1
13
na or unstated
12
2 more recorded rows
early phase1
10
Last recorded human testNCT06259097
2026-08-10
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Misoprostol shown biomarker?
20 recorded entries; human; tablet, orally, vaginal, buccal; also "Cytotec, one quarter of a 0.100mg tablet", "600 mcg misoprostol", "two misoprostol tablets taken orally (400µg"
Show the evidence
human
NCT00602095
tablet; Cytotec, one quarter of a 0.100mg tablet
NCT00674232
600 mcg misoprostol
NCT01113229
orally; two misoprostol tablets taken orally (400µg
NCT01406392
Misoprostol 25mcg
NCT01615224
Cytotec 200mcg Pfizer
NCT01805115
two tablets of Cytotec (200 μg)
14 more recorded rows
humanNCT02633761
Misoprostol 200mcg
humanNCT03064568
Misoprostol 200Mcg Tab
humanNCT03523754
Misoprostol 25Mcg
humanNCT03744364
Misoprostol 25 mcg
humanNCT03829696
Misoprostol 800 mcg
humanNCT04595812
vaginal; Misoprostol 200mcg Tab vaginal
humanNCT05088720
misoprostol 800 µg
humanNCT05088720
misoprostol 400 µg
humanNCT05103098
misoprostol 400 mcg
humanNCT05103098
misoprostol 800 mcg
humanNCT05857059
Misoprostol 50 mcg
humanNCT06078501
buccal; Misoprostol 400mcg buccal
humanNCT06114758
Cytotec 200Mcg Tablet
humanNCT06970483
Misoprostol 200mcg Tab
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which of amount of bleeding, amount of blood loss and amplitude of contraction did Misoprostol's trials measure?
amount of bleeding, amount of blood loss and amplitude of contraction lead 40 outcome terms across Misoprostol's trials. ClinicalTrials.gov · 2026-09-01
Interpretation primary efficacy variable will be bleeding profile, vaginal delivery rates, time to resolution, hematocrit, side effects and complete abortion without recourse to surgical intervention follow.
Show the evidence
placental retention rate
1
postpartum hemorrhage
1
caesarean section rate
1
primary efficacy variable will be bleeding profile
1
vaginal delivery rates
1
time to resolution
1
14 more recorded rows
hematocrit
1
side effects
1
complete abortion without recourse to surgical intervention
1
uterine tachysystole
1
vaginal delivery
1
cesarean section
1
complete miscarriage
1
cesarean birth rate
1
rate of induction to delivery
1
operative blood loss
1
blood loss
1
amount of blood loss
1
complete abortion rate
1
intraoperative bleeding
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Misoprostol's 17 ongoing trials reports first?
"Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer"; n 154; "Recurrent ulcer bleeding"; 2027-03-31
NCT05674487
"Prostaglandins Versus Trans-cervical Balloon for Induction of Labor in Fetal Growth Restriction (PROBIN)"; n 774; "cesarean section"; 2026-12-01
NCT06199154
"Induction of Labor in Morbidly Obese Patients"; n 162; "Achievement of complete cervical dilation"; 2027-05
NCT06270056
"Evaluation of Telemedicine Medical Abortion Service in Ecuador"; n 100; "Adverse events (safety)"; 2025-09
NCT06502158
"Mifepristone vs Misoprostol"; n 94; "Percentage of participants achieving Intended dilation"; 2027-06
NCT06669533
"Use Misoprostol to Optimize Prevention of Cervical Cancer"; n 420; "Conversion rate from Type 3 transformation zone (TZ) to Types 1 or 2"; 2028-11-11
11 further recorded trials
NCT06765473
"Comparison Between Preoperative Vaginal and Postoperative Sublingual Misoprostol for Prevention of Postpartum Hemorrhage During Cesarean Section"; n 400; "the amount of blood loss"; 2026-03-01
NCT06850974
"Foley Balloon for Cervical Preparation Before Dilation and Evacuation"; n 102; "Total Procedure Time (TPT)"; 2027-03
NCT06874049
"Comparison Between Vaginal Misoprostol Gel and Oral Misoprostol Solution in Induction of Labor"; n 80; "The primary outcome measure is induction to cervical ripening (Bishop score ≥6) time interval."; 2025-09
NCT06946914
"Misoprostol Before Caesarean Section"; n 160; "the incidence of Transient tachypnea of the newborn which defined by increase respiratory rate more than 60 cycle per minute in pregnant women with gestational age less than 38 weeks before elective cesarean section"; 2025-08-01
NCT07109258
"Effect of Dexamethasone on Labour Induction in Term Pregnancies"; n 150; "The interval between initiation of induction and beginning of the active phase of labour."; 2025-09-15
NCT07160855
"Letrozole Plus Misoprostol Versus Misoprostol Alone for Treating Women With Missed Miscarriage"; n 92; "Complete abortion"; 2025-11-12
NCT07353281
"Carbetocin vs Misoprostol for Postpartum Hemorrhage Prevention"; n 146; "Postpartum hemorrhage (PPH)"; 2028-01-01
NCT07526064
"Comparison of Efficacy and Safety of Oral Versus Vaginal Misoprostol in Missed Abortion in First Trimester of Pregnancy"; n 100; "Induction to Expulsion Interval"; 2026-07-31
NCT07559812
"Comparison of Vaginal PGE2 (Dinoprostone) and Vaginal Misoprostol for Induction of Labour in Primigravid Term Pregnancy"; n 240; "Successful Vaginal Delivery"; 2026-04-29
NCT07685756
"Cervical Ripening Balloon Compared With Vaginal Misoprostol for Cervical Ripening in Obese Woman at Term"; n 108; "Less rate of instrumental delivery and c section"; 2027-06-01
NCT07690007
"Combined Misoprostol and Cervical Balloon vs Misoprostol Alone for Induction on the First Day in Primiparas"; n 220; "Time from initiation of labor induction to delivery"; 2026-12-31
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which 172 trials of Misoprostol posted no result?
Posted no result
172 of 172 completed trials
Registrations
NCT03489928, NCT00148473, NCT00107874, NCT00299754, NCT00945997 and NCT01700478, and 166 more
Completion dates
oldest 2000-12-01; newest 2024-06-15
Show the evidence
Trial
NCT03489928
2000-12-01
NCT00148473
2001-10
NCT00107874
2002-02
NCT00299754
2004-12
NCT00945997
2005-03
NCT01700478
2005-04
14 further recorded trials
NCT00129506
2005-10
NCT00097123
2005-12
NCT00310921
2006-05
NCT00140114
2006-09
NCT00426491
2006-10
NCT00529295
2007-03
NCT00602095
2007-03
NCT00116480
2007-04
NCT00324519
2007-04
NCT00325026
2007-04
NCT00393731
2007-08
NCT00200226
2007-09
NCT00124540
2007-10
NCT00674232
2007-10
Q9
At the median, Misoprostol's trials enrolled 149.5 people — anything larger?
Median enrolment
149.5
Largest enrolment
4330
Registered trials counted
342
Q10
What do 4534 spontaneous reports say about Misoprostol — 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.
Misoprostol appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4534 reaction mentions were counted: haemorrhage 1073; abortion incomplete 1034; pregnancy 414; anaemia 397. open-targets-adr · CHEMBL606 · 2026-06-24
Show the evidence
haemorrhage
1073
abortion incomplete
1034
pregnancy
414
anaemia
397
pain
345
muscle spasms
298
4 more recorded rows
drug hypersensitivity
293
dizziness
233
menorrhagia
225
pyrexia
222
recorded 2026-06-24 · last checked 2026-09-04
Q11
Was Misoprostol studied with fasting?
fasting is named in Misoprostol's label sentences: "Eighteen participants were randomly assigned to treatment sequences of 800 μg oral, sublingual and buccal misoprostol administered under fasting conditions, with a 7-day washout period." openfda-label+europepmc · 2016-04-22
1 recorded statement; fasting
Show the evidence
fasting
Eighteen participants were randomly assigned to treatment sequences of 800 μg oral, sublingual and buccal misoprostol administered under fasting conditions, with a 7-day washout period.
recorded 2016-04-22 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · 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
✗ required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 10 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
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