This page shows what was measured, who it was measured in, and what that does not settle.
What Amisulpride does in the body
Amisulpride blocks two closely related dopamine receptors and, unusually for this class, almost nothing else.
In the brainstem there is a small region that triggers vomiting when it detects dopamine, which is why blocking those receptors stops sickness — and that is the use America approved. Deeper in the brain the same blockade reduces hallucinations and delusions, which is why the rest of the world uses it as an antipsychotic. The two uses are the same molecule acting on the same receptors in different places, at very different amounts.
Why people take it. In America, sickness after an operation. Everywhere else, schizophrenia.
What happened in people
A standardised mean difference of 0.66 against placebo for overall symptom change, second of fifteen ranked antipsychotics
✎ 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.
NCT02337062 — phase 3 combination prophylaxis trial of intravenous amisulpride against postoperative nausea and vomiting, posted results (NCT02337062) · a recorded source, not a stored snapshot
The limit that matters most
No United States pharmacy acquisition price is listed, because the only approved product is a hospital-administered injection rather than a dispensed prescription
Where it acts
The chemoreceptor trigger zone and area postrema in the brainstem for the antiemetic effect, and mesolimbic dopamine synapses for the antipsychotic effect it is not licensed for in the United States
Kind of result
Symptoms and quality of life
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 8110R61I4U · read 2026-08-29
Its recorded molecular formula is C17H27N3O4S, weighing 369.48.
US prescribing information · ab23bc6e-b6a8-165f-e053-2a95a90ab144 · 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 115 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.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
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.
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.
Complete response — no vomiting and no rescue antiemetic — with 5 mg intravenous amisulpride added to a standard antiemetic, against placebo added to the same standard antiemetic
Complete response 330 of 572 (57.7%) against 268 of 575 (46.6%), p<0.001
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. The comparison is drug-plus-standard-care against standard care alone, so the eleven-percentage-point difference is an increment on top of existing therapy rather than a standalone effect.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. In the United States, an intravenous injection of 5 or 10 mg given as a single dose over one to two minutes. Elsewhere, an oral tablet taken daily.
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
NCT02337062 — phase 3 combination prophylaxis trial of intravenous amisulpride against postoperative nausea and vomiting, posted results (NCT02337062) · a recorded source, not a stored snapshot
NCT02646566 — treatment of established postoperative nausea and vomiting after failed prophylaxis, posted results showing p=0.109 for the 5 mg arm (NCT02646566) · a recorded source, not a stored snapshot
Complete response in patients with established postoperative nausea and vomiting who had already received antiemetic prophylaxis
10 mg 96 of 230 (41.7%), p=0.003; 5 mg 80 of 237 (33.8%), p=0.109; placebo 67 of 235 (28.5%)
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 5 mg arm did not separate from placebo in this trial, and both amounts appear on the label without an efficacy distinction between them.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. In the United States, an intravenous injection of 5 or 10 mg given as a single dose over one to two minutes. Elsewhere, an oral tablet taken daily.
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
NCT02337062 — phase 3 combination prophylaxis trial of intravenous amisulpride against postoperative nausea and vomiting, posted results (NCT02337062) · a recorded source, not a stored snapshot
NCT02646566 — treatment of established postoperative nausea and vomiting after failed prophylaxis, posted results showing p=0.109 for the 5 mg arm (NCT02646566) · a recorded source, not a stored snapshot
Complete response in patients with established postoperative nausea and vomiting who had not received prophylaxis
5 mg 60 of 191 (31.4%) and 10 mg 59 of 188 (31.4%), both p=0.016, against placebo 39 of 181 (21.5%)
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 two active amounts produced numerically identical response rates, so this trial provides no dose-response signal either.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. In the United States, an intravenous injection of 5 or 10 mg given as a single dose over one to two minutes. Elsewhere, an oral tablet taken daily.
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
NCT02337062 — phase 3 combination prophylaxis trial of intravenous amisulpride against postoperative nausea and vomiting, posted results (NCT02337062) · a recorded source, not a stored snapshot
NCT02646566 — treatment of established postoperative nausea and vomiting after failed prophylaxis, posted results showing p=0.109 for the 5 mg arm (NCT02646566) · a recorded source, not a stored snapshot
Mean overall change in symptoms against placebo in acute schizophrenia, with all-cause discontinuation, weight gain, extrapyramidal effects, prolactin, QTc and sedation as secondary outcomes
✓ The study showed what it set out to show
Who was studied
Leucht 15-drug multiple-treatments meta-analysis
How many people
43049
Study design
Bayesian network meta-analysis of 212 blinded randomised trials
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Amisulpride standardised mean difference 0.66 (95% CrI 0.53 to 0.78), second of fifteen; all-cause discontinuation odds ratio 0.43, the most favourable of the fifteen; sedation odds ratio 1.42, the most favourable of the fifteen
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. These results describe a use that has no United States approval. The evidence is European and the ranking has no bearing on what an American prescriber can write.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. In the United States, an intravenous injection of 5 or 10 mg given as a single dose over one to two minutes. Elsewhere, an oral tablet taken daily.
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
NCT02337062 — phase 3 combination prophylaxis trial of intravenous amisulpride against postoperative nausea and vomiting, posted results (NCT02337062) · a recorded source, not a stored snapshot
NCT02646566 — treatment of established postoperative nausea and vomiting after failed prophylaxis, posted results showing p=0.109 for the 5 mg arm (NCT02646566) · a recorded source, not a stored snapshot
Change in overall symptoms against placebo in adults with multi-episode schizophrenia, with positive symptoms, negative symptoms, discontinuation, weight, prolactin and QTc as further outcomes
✓ The study showed what it set out to show
Who was studied
Huhn 32-drug network meta-analysis
How many people
53463
Study design
Network meta-analysis of 402 studies
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Amisulpride standardised mean difference for positive symptoms -0.69 (95% CrI -0.86 to -0.52), the strongest of the 32 drugs, against -0.17 for brexpiprazole at the weakest
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 authors state that confidence in the evidence was often low or very low and that efficacy differences between antipsychotics are mostly gradual rather than discrete.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. In the United States, an intravenous injection of 5 or 10 mg given as a single dose over one to two minutes. Elsewhere, an oral tablet taken daily.
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
NCT02337062 — phase 3 combination prophylaxis trial of intravenous amisulpride against postoperative nausea and vomiting, posted results (NCT02337062) · a recorded source, not a stored snapshot
NCT02646566 — treatment of established postoperative nausea and vomiting after failed prophylaxis, posted results showing p=0.109 for the 5 mg arm (NCT02646566) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 5 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
Amisulpride
What a person takes: In the United States, an intravenous injection of 5 or 10 mg given as a single dose over one to two minutes. Elsewhere, an oral tablet taken daily..
The measurement behind this step
The United States product is a hospital-administered injection, which is why it has no pharmacy acquisition price in the CMS survey that prices the other drugs on this page. Elimination is substantially renal. There is no United States oral product and no long-acting form. The two forms of this molecule serve two different specialties in two different regulatory worlds, and only the injection has an American licence.
Getting in
In America, one injection into a vein over one to two minutes
The only form approved in the United States is a single injection of 5 or 10 mg given slowly into a vein, around the time of an operation. Everywhere else the drug is a tablet taken daily.
──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 approved United States route recorded in the openFDA product data is intravenous. Elimination is substantially renal, which matters in perioperative patients whose kidney function may be transiently reduced.
NCT02337062 — phase 3 combination prophylaxis trial of intravenous amisulpride against postoperative nausea and vomiting, posted results (NCT02337062) · a recorded source, not a stored snapshot
Reaching the cell
It reaches the brainstem region that triggers vomiting
There is a small area at the base of the brain that sits outside the usual blood-brain barrier and detects circulating chemicals. When it senses dopamine, it triggers vomiting.
╌╌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
D2 receptors in the chemoreceptor trigger zone respond to dopamine released from nerve endings, and activation relays stimuli to the vomiting centre. The label adds that studies in multiple species indicate D3 receptors in the area postrema also play a role in emesis, and reports that amisulpride inhibits apomorphine-induced emesis in ferrets with an estimated ED50 below 1 microgram per kilogram subcutaneously.
NCT02337062 — phase 3 combination prophylaxis trial of intravenous amisulpride against postoperative nausea and vomiting, posted results (NCT02337062) · a recorded source, not a stored snapshot
What it acts on
It blocks dopamine D2 and D3, and almost nothing else
Unlike most drugs in this family, amisulpride does not also block histamine, acetylcholine or the adrenaline receptors. That is why it is not sedating and does not cause dry mouth or a drop in blood pressure.
╌╌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 states it is a selective D2 and D3 antagonist with no appreciable affinity for any other receptor types apart from low affinities for 5-HT2B and 5-HT7. In the fifteen-drug analysis this showed up directly: least sedation of the fifteen at an odds ratio of 1.42, and the most favourable all-cause discontinuation at 0.43.
NCT02337062 — phase 3 combination prophylaxis trial of intravenous amisulpride against postoperative nausea and vomiting, posted results (NCT02337062) · a recorded source, not a stored snapshot
The change it makes
The same blockade deeper in the brain is the antipsychotic effect
Further into the brain, blocking the same receptors reduces hallucinations and delusions. That is what the rest of the world prescribes this drug for, and it is not approved for it in America.
╌╌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
Standardised mean difference against placebo of 0.66 (95% CrI 0.53 to 0.78) for overall symptom change, second of fifteen, and -0.69 (95% CrI -0.86 to -0.52) for positive symptoms, first of thirty-two. The selectivity that makes it non-sedating also concentrates its adverse effects into the ones D2 blockade produces: prolactin elevation and movement effects.
NCT02337062 — phase 3 combination prophylaxis trial of intravenous amisulpride against postoperative nausea and vomiting, posted results (NCT02337062) · a recorded source, not a stored snapshot
What that does for a person
Sickness stops, and the electrocardiogram lengthens with the amount given
After surgery, adding it to a standard anti-sickness drug raised the proportion of people with no vomiting and no need for rescue treatment from 47% to 58%. The trade is a measurable effect on the heart tracing.
──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
Complete response 330 of 572 (57.7%) against 268 of 575 (46.6%), p<0.001, in the 1,147-patient combination prophylaxis trial. QT prolongation is stated in the label to be dose- and concentration-dependent, with use avoided in congenital long QT syndrome and alongside droperidol, and electrocardiographic monitoring recommended with ondansetron and in several other defined situations.
NCT02337062 — phase 3 combination prophylaxis trial of intravenous amisulpride against postoperative nausea and vomiting, posted results (NCT02337062) · a recorded source, not a stored snapshot
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
In the United States, adults having surgery. Across Europe and much of the rest of the world, people with schizophrenia, for whom it is a routine first-line option.
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 · ab23bc6e-b6a8-165f-e053-2a95a90ab144 · read 2026-08-30
On older people, the label states: “Of the total number of patients enrolled in controlled clinical trials who received BARHEMSYS 5 mg for prevention of PONV or 10 mg for treatment of PONV, 235 (17%) were 65 years of age and older, while 59 (4%) were 75 years of age and older.”
US prescribing information · ab23bc6e-b6a8-165f-e053-2a95a90ab144 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Available data with amisulpride use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.”
US prescribing information · ab23bc6e-b6a8-165f-e053-2a95a90ab144 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Based on case reports in published literature, amisulpride is present in human milk at concentrations that are 11- to 20-fold higher than human plasma in patients taking multiple oral doses of amisulpride (200 to 400 mg/day).”
US prescribing information · ab23bc6e-b6a8-165f-e053-2a95a90ab144 · read 2026-08-30
Where the result stopped carrying
The 5 mg arm of NCT02646566 did not separate from placebo, at p=0.109, while remaining on the label
No dose-response relationship is visible across the two treatment trials
No sponsor has run a United States registration programme for the psychiatric indication in which the drug ranks second of fifteen
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
In the United States, an intravenous injection of 5 or 10 mg given as a single dose over one to two minutes. Elsewhere, an oral tablet taken daily.
✎ 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 United States product is a hospital-administered injection, which is why it has no pharmacy acquisition price in the CMS survey that prices the other drugs on this page. Elimination is substantially renal. There is no United States oral product and no long-acting form. The two forms of this molecule serve two different specialties in two different regulatory worlds, and only the injection has an American licence.
✎ 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 United States label for BARHEMSYS carries no boxed warning. Its principal warning is QT prolongation, described as dose- and concentration-dependent, with use to be avoided in congenital long QT syndrome and in patients taking droperidol, and electrocardiographic monitoring recommended with pre-existing arrhythmias or conduction disorders, electrolyte abnormalities including hypokalaemia and hypomagnesaemia, congestive heart failure, and other QT-prolonging medicines including ondansetron. The adverse-effect profile of sustained antipsychotic use — prolactin elevation, movement disorders, tardive dyskinesia — is not described in the American label because the American label does not cover that use, and a reader should not take its absence there as evidence of absence.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
NCT02337062 — phase 3 combination prophylaxis trial of intravenous amisulpride against postoperative nausea and vomiting, posted results (NCT02337062) · 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
In the United States, an intravenous injection of 5 or 10 mg given as a single dose over one to two minutes. Elsewhere, an oral tablet taken daily.
✎ 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
Elimination is substantially renal. There is no United States oral product and no long-acting form. The two forms of this molecule serve two different specialties in two different regulatory worlds, and only the injection has an American licence.
✎ 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
2 products list this as an active ingredient in the United States drug directory. 2 of them contain it and nothing else.
FDA National Drug Code directory · 51604-1156 · read 2026-08-29
They are sold as injection, solution and powder, taken intravenous.
FDA National Drug Code directory · 51604-1156 · read 2026-08-29
The regulator's established pharmacologic class for it is dopamine d2 antagonists [moa] and dopamine-2 receptor antagonist [epc].
FDA National Drug Code directory · 51604-1156 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · ab23bc6e-b6a8-165f-e053-2a95a90ab144 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · ab23bc6e-b6a8-165f-e053-2a95a90ab144 · read 2026-08-29
Barhemsys is intravenous at 3 DOSAGE FORMS AND STRENGTHS Injection: 5 mg/2 mL (2.5 mg/mL) or 10 mg/4 mL (2.5 mg/mL) as a clear, colorless sterile solution in a single-dose vial., recorded as fda label in effect 2026-06-17 in the United States.
US prescribing information · ab23bc6e-b6a8-165f-e053-2a95a90ab144 · read 2026-08-30
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 Amisulpride 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 antipsychotics available in a country are the ones the evidence ranks highest — the second-ranked drug of fifteen has no United States psychiatric approval
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 perioperative safety record transfers to sustained psychiatric use — the two evidence bases differ in route, amount, duration, population and endpoint
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 higher is better within the approved antiemetic range — one trial found the two amounts numerically identical and another found the lower one non-significant
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 receptor promiscuity is what makes an antipsychotic effective — the most selective drug in the ranking placed second
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 Amisulpride 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.
Second of fifteen antipsychotics, and America approved it as an anti-sickness shot
In plain words
In the largest pooled comparison of antipsychotics ever published, amisulpride came second of fifteen, ahead of olanzapine and risperidone. The only version of it approved in the United States is a single injection given after an operation to stop nausea.
What was measured
That the antipsychotics available in a country are the ones the evidence ranks highest — the second-ranked drug of fifteen has no United States psychiatric approval, for commercial rather than evidential reasons
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In the Leucht multiple-treatments meta-analysis of 212 blinded trials and 43,049 participants, amisulpride's standardised mean difference against placebo for overall symptom change was 0.66 (95% CrI 0.53 to 0.78), second only to clozapine at 0.88 and ahead of olanzapine 0.59, risperidone 0.56, paliperidone 0.50, haloperidol 0.45, quetiapine 0.44 and aripiprazole 0.43. In the same analysis it had the most favourable all-cause discontinuation of the fifteen at an odds ratio of 0.43, where haloperidol was worst at 0.80, and the least sedation of the fifteen at an odds ratio of 1.42, where clozapine was worst at 8.82. The only United States approval for the molecule is BARHEMSYS, NDA 209510, approved 26 February 2020, for prevention and treatment of postoperative nausea and vomiting as a single 5 or 10 mg intravenous dose. There is no United States psychiatric indication. This is not a statement that the drug should be approved there — no sponsor has run the United States registration programme that would be required, and that commercial fact is the reason, not a regulatory finding against the drug. It does mean an American reader searching for the second-ranked antipsychotic in the published literature finds an antiemetic.
Written into the record, not signed off as a reviewed claim
First of thirty-two drugs on reduction of positive symptoms
In plain words
A later network meta-analysis of 402 studies and 53,463 patients ranked 32 antipsychotics on how much they reduce hallucinations and delusions. Amisulpride came first.
What was measured
Standardised mean difference against placebo for positive symptom reduction: -0.69 (95% CrI -0.86 to -0.52), strongest of 32 drugs
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In the Huhn network meta-analysis, standardised mean differences against placebo for reduction of positive symptoms across 31,179 participants ranged from -0.69 (95% CrI -0.86 to -0.52) for amisulpride at the strongest end to -0.17 (95% CrI -0.31 to -0.04) for brexpiprazole at the weakest. Across the same network, overall symptom reduction ran from -0.89 for clozapine to -0.03 for levomepromazine, with six drugs not reaching statistical significance. The authors' interpretation is that efficacy differences between antipsychotics exist but are mostly gradual rather than discrete, that side-effect differences are more marked, and that confidence in the evidence was often low or very low. Amisulpride heading the positive-symptom ranking in one analysis and placing second overall in another, seven years apart and with different methods and datasets, is about as close to independent replication as this literature offers.
Written into the record, not signed off as a reviewed claim
The most selective drug in the group, and the "atypical" label does not fit it
In plain words
The second-generation antipsychotics are usually described as working by hitting many receptors at once. Amisulpride hits two, and outperformed all of the multi-receptor drugs except clozapine.
What was measured
Receptor selectivity per the label, alongside an efficacy rank of second, a discontinuation rank of first and a sedation rank of first among fifteen drugs
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The United States label states that amisulpride is a selective dopamine D2 and D3 antagonist and has no appreciable affinity for any other receptor types apart from low affinities for 5-HT2B and 5-HT7. That profile is closer to haloperidol's than to olanzapine's or clozapine's, and it is the opposite of the receptor promiscuity the term "atypical" was originally used to describe. Yet amisulpride ranked second of fifteen on efficacy, best of fifteen on all-cause discontinuation and least sedating of fifteen — the last two following directly from what it does not bind. Taken with the finding that haloperidol placed seventh, above eight newer drugs, the generational framework does not survive contact with the ranking. The Leucht authors said as much: their findings challenge the straightforward classification of antipsychotics into first-generation and second-generation groupings.
Written into the record, not signed off as a reviewed claim
In one antiemetic trial the lower approved amount did not beat placebo
In plain words
Two trials tested 5 mg and 10 mg injections for treating sickness that had already started. In one of them the 5 mg arm did not separate from placebo. Both amounts are on the label.
What was measured
Complete response: 33.8% on 5 mg (p=0.109) and 41.7% on 10 mg (p=0.003) against 28.5% on placebo in one trial; 31.4% on both arms against 21.5% (p=0.016) in the other
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
NCT02646566 randomised 705 patients with established postoperative nausea and vomiting who had already received prophylaxis. Complete response — no vomiting and no rescue medication — occurred in 80 of 237 on 5 mg (33.8%), 96 of 230 on 10 mg (41.7%) and 67 of 235 on placebo (28.5%), with p=0.003 for 10 mg against placebo and p=0.109 for 5 mg. NCT02449291 randomised 568 patients who had not received prophylaxis, giving 60 of 191 on 5 mg (31.4%), 59 of 188 on 10 mg (31.4%) and 39 of 181 on placebo (21.5%), with p=0.016 for both active arms. So across the two treatment trials, the 5 mg arm succeeded in one and failed in the other, and in the trial where both succeeded the two amounts were numerically identical. That is not a dose-response relationship. The label recommends 5 or 10 mg as a single intravenous dose without distinguishing between them by efficacy.
Source
NCT02646566 and NCT02449291 — randomised double-blind placebo-controlled trials of intravenous amisulpride for established postoperative nausea and vomiting, posted results, Acacia Pharma
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
Prophylaxis added eleven percentage points on top of a standard antiemetic
In plain words
The largest American trial gave amisulpride alongside a standard anti-sickness drug in 1,147 patients. Complete response rose from 47% to 58%.
What was measured
Complete response 330/572 (57.7%) against 268/575 (46.6%), p<0.001
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
NCT02337062, a phase 3 randomised double-blind placebo-controlled combination prophylaxis trial in 1,147 patients, gave 5 mg intravenous amisulpride or placebo alongside a standard antiemetic. Complete response occurred in 330 of 572 (57.7%) against 268 of 575 (46.6%), p<0.001. That is an absolute difference of about eleven percentage points, or roughly one additional complete response for every nine patients treated. It is a real and clearly significant result on a hard, patient-relevant endpoint, achieved on top of existing therapy rather than instead of it, and it is a good deal more convincing than the treatment trials of the same drug.
Source
NCT02337062 — phase 3 combination prophylaxis trial of intravenous amisulpride against postoperative nausea and vomiting, posted results, Acacia Pharma
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
QT prolongation that rises with the amount given, and a named drug to avoid
In plain words
Amisulpride stretches the heart's electrical recovery time, and does so more at higher amounts. The label says to avoid it in people with an inherited long QT and in anyone taking droperidol.
What was measured
Dose- and concentration-dependent QT prolongation, with named contraindicated and monitored combinations
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Section 5.1 states that BARHEMSYS causes dose- and concentration-dependent prolongation of the QT interval, that the recommended amount is 5 or 10 mg as a single intravenous dose infused over one to two minutes, and that use should be avoided in patients with congenital long QT syndrome and in patients taking droperidol. Electrocardiographic monitoring is recommended in patients with pre-existing arrhythmias or cardiac conduction disorders, with electrolyte abnormalities such as hypokalaemia or hypomagnesaemia, with congestive heart failure, and in patients taking other QT-prolonging medicines, with ondansetron named explicitly. Ondansetron is the drug amisulpride is most often given alongside, and that combination is the design of the trial that produced its strongest result.
Source
United States prescribing information for BARHEMSYS (amisulpride), sections 5.1 and 7.2, via the openFDA drug label endpoint
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
Two evidence bases for one molecule, and they do not speak to each other
In plain words
Everything known about amisulpride as an antipsychotic comes from European trials of daily tablets. Everything the American label rests on comes from single injections after surgery. Neither body of evidence tells you much about the other.
What was measured
That the safety and efficacy record of one use transfers to the other — the two evidence bases differ in route, amount, duration, population and endpoint, and no bridging study connects them
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The efficacy rankings that place amisulpride second of fifteen and first of thirty-two are built on European randomised trials of oral treatment in schizophrenia, sustained over weeks. The United States approval rests on three trials totalling 2,420 patients receiving a single intravenous injection of 5 or 10 mg around the time of surgery. The receptor pharmacology is shared, the exposure and duration are not remotely comparable, and no bridging study joins them. Two consequences follow. An American clinician cannot use the antiemetic evidence to reason about psychiatric use, and the safety experience accumulating from single perioperative injections says nothing about the long-term prolactin, movement and cardiac consequences of sustained blockade. The molecule is the same; the evidence is two separate literatures that share a chemical name.
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What is not here
7 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A selective dopamine D2 and D3 blocker that ranked second of fifteen antipsychotics on pooled symptom reduction (standardised mean difference 0.66), first of thirty-two on reduction of positive symptoms (-0.69), best of fifteen on all-cause discontinuation and least sedating of fifteen — and whose only United States approval is a single 5 or 10 mg intravenous dose to stop nausea after surgery.
Recorded evidence blocks (10)
Q1
On the Amisulpride label: indicated for what?
"BARHEMSYS ® is indicated in adults for: prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class. treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis. BARHEMSYS…": indications and usage on Amisulpride's label. DailyMed label · ab23bc6e-b6a8-165f-e053-2a95a90ab144 · 2026-06-17
Q2
55 registered trials of Amisulpride — at which phases?
Registered studies posting no result
45 of 55
55 registered studies of Amisulpride: 16 phase4, 12 na, 8 phase1, 8 phase3, 5 phase2, 4 na or unstated, 3 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
242 with a PubMed record
Show the evidence
phase4
16
na
12
phase1
8
phase3
8
phase2
5
na or unstated
4
6 more recorded rows
early phase1
3
completed
38
unknown
8
not yet recruiting
3
terminated
3
withdrawn
3
recorded 2026-09-01 · last checked 2026-09-04
Q3
3 of Amisulpride's trials stopped: accrual/recruitment, sponsor decision unspecified, other?
accrual/recruitment (1), sponsor decision unspecified (1) and other (1): Amisulpride's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"Recruitment issues"; 3 of 55 registered studies
Show the evidence
Trial
NCT00419653
terminated; "Recruitment issues"
NCT04954365
withdrawn; "Sponsor terminated prior to initiation."
NCT05956600
withdrawn; "Action of PI. Loss of sponsor"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Amisulpride used APD421 5 mg — over how long?
Human studies of Amisulpride used "APD421 5 mg". ClinicalTrials.gov · 2026-09-01
7 recorded entries; human; also "Amisulpride 5mg", "APD421 40 mg", "Amisulpride 40mg"
Show the evidence
human
NCT02661594
APD421 5 mg
NCT02661594
Amisulpride 5mg
NCT02661594
APD421 40 mg
NCT02661594
Amisulpride 40mg
NCT03863691
Amisulpride 300 MG
NCT04674670
Amisulpride 400 MG
1 more recorded row
humanNCT05956600
Amisulpride 50 MG
recorded 2026-09-01 · last checked 2026-09-04
Q5
Amisulpride's half-life is 4 to 5 hours — which schedules were studied?
4 to 5 hours; Elimination The mean elimination half-life is approximately 4 to 5 hours and similar between healthy subjects and surgical patients.
tmaxpharmacokinetics
15 minutes; After an intravenous infusion, the peak plasma concentration of amisulpride is achieved at the end of the infusion period and the plasma concentration decreases to about 50% of the peak value within approximately 15 minutes.
metabolismpharmacokinetics
Metabolism In a mass balance study, no metabolites were detectable in plasma while four metabolites were identified in urine and feces.
recorded 2026-06-17 · last checked 2026-09-04
Q6
Which 23 trials of Amisulpride posted no result?
Posted no result
23 of 23 completed trials
Registrations
NCT00204061, NCT01160991, NCT00471588, NCT00926965, NCT00628290 and NCT01185418, and 17 more
Completion dates
oldest 2005-06; newest 2023-07-31
Show the evidence
Trial
NCT00204061
2005-06
NCT01160991
2006-10
NCT00471588
2007-12
NCT00926965
2007-12
NCT00628290
2008-03
NCT01185418
2009-07
14 further recorded trials
NCT01303978
2012-07
NCT00956189
2012-10
NCT01795183
2013-12
NCT02557984
2014-04
NCT01246232
2015-03
NCT01972711
2015-07
NCT01154829
2016-05
NCT02307396
2016-06-22
NCT01555814
2016-10
NCT02051387
2017-08
NCT01446328
2017-12
NCT01498770
2017-12-21
NCT03583489
2018-08-13
NCT01609153
2019-04
Q7
At the median, Amisulpride's trials enrolled 85 people — anything larger?
Median enrolment
85
Largest enrolment
1147
Registered trials counted
55
Q8
What do 1151 spontaneous reports say about Amisulpride — 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.
Amisulpride appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1151 reaction mentions were counted: weight increased 157; suicide attempt 132; akathisia 126; electrocardiogram qt prolonged 126. FAERS via Open Targets · CHEMBL243712 · 2026-06-24
Show the evidence
weight increased
157
suicide attempt
132
akathisia
126
electrocardiogram qt prolonged
126
toxicity to various agents
119
extrapyramidal disorder
110
4 more recorded rows
leukopenia
101
schizophrenia
97
neuroleptic malignant syndrome
95
neutropenia
88
recorded 2026-06-24 · last checked 2026-09-04
Q9
Which 10 reactions does Amisulpride's label not list?
In vitro amisulpride is not metabolized by major cytochrome P450 enzymes.
pharmacokinetics
In Vitro Studies Cytochrome P450-Related Metabolism In vitro , amisulpride did not inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2D6, or CYP3A4, or induce CYP1A2, CYP2C9, CYP2C19, or CYP3A4.
pharmacokinetics
In vitro , amisulpride was not a substrate of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4.
pharmacokinetics
Transporters Amisulpride inhibits MATE1 and MATE2-K transporters.
pharmacokinetics
Amisulpride does not inhibit P-gp, BCRP, OCT1, OCT2, OAT1, OAT3, OATP1B1, OATP1B3 at therapeutic concentrations.
pharmacokinetics
Amisulpride is a substrate for P-gp, BCRP, OCT1, MATE1 and MATE2-K, but not a substrate for OATP1B1, OATP1B3, OAT1, OAT3 and OCT2.
2 more recorded rows
Interaction statementclinical_pharmacology
In vitro amisulpride is not metabolized by major cytochrome P450 enzymes.
Interaction statementclinical_pharmacology
In Vitro Studies Cytochrome P450-Related Metabolism In vitro , amisulpride did not inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2D6, or CYP3A4, or induce CYP1A2, CYP2C9, CYP2C19, or CYP3A4.
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
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 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
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.