This page shows what was measured, who it was measured in, and what that does not settle.
What Haloperidol does in the body
Haloperidol blocks the dopamine receptor and does almost nothing else.
That single-mindedness is why it is powerful against hallucinations and delusions and why it is so hard on movement: the same receptor that carries the psychotic symptoms also runs the circuit that lets a person start, stop and smooth out a movement. Because it barely touches the histamine and acetylcholine receptors, it does not cause the weight gain, the heavy sedation or the dry mouth that most newer drugs in this class do. It trades one kind of side effect for another rather than avoiding side effects.
Why people take it. Psychosis, and the tics of Tourette disorder
What happened in people
A standardised mean difference of 0.45 against placebo for overall symptom change, seventh of fifteen ranked antipsychotics and above eight newer drugs
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
The most widely used drug for agitation and delirium in hospitals worldwide, by a route its own label states in capital letters is not approved
Where it acts
Striatal and mesolimbic dopamine synapses, where near-complete D2 blockade produces both the antipsychotic effect and the movement disorders in the same structure
Kind of result
Symptoms and quality of life
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 · J6292F8L3D · read 2026-08-29
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 127 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Days alive without delirium or coma during the 14-day intervention period, in ICU patients with acute respiratory failure or shock and hypoactive or hyperactive delirium
✗ The study did not show it
Who was studied
NCT01211522 (MIND-USA)
How many people
566
Study design
Randomised double-blind placebo-controlled trial, 14-day intervention period
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Median 7.9 days (95% CI 4.4 to 9.6) on haloperidol, 8.7 (95% CI 5.9 to 10.0) on ziprasidone and 8.5 (95% CI 5.6 to 9.9) on placebo, p=0.26 across groups; haloperidol odds ratio against placebo 0.88 (95% CI 0.64 to 1.21)
Repeated elsewhere
Replicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. 89% of the delirium in this trial was hypoactive rather than the agitated form clinicians most often reach for haloperidol to treat. No significant differences appeared in any secondary endpoint or in extrapyramidal symptoms. The trial was publicly funded.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, oral concentrate solution, short-acting intramuscular injection of the lactate salt, and long-acting intramuscular decanoate injection in sesame oil given about every four weeks
Interval reported. 95% CI 4
Written into the record, not signed off as a reviewed claim.
35.8 days (95% CI 32.9 to 38.6) on haloperidol against 32.9 (95% CI 29.9 to 35.8) on placebo; adjusted mean difference 2.9 days (95% CI -1.2 to 7.0), p=0.22
Repeated elsewhere
Partially Replicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. Ninety-day mortality was 36.3% against 43.3%, adjusted absolute difference -6.9 percentage points (95% CI -13.0 to -0.6). That is a secondary endpoint from a trial whose primary endpoint was negative, and it should be read as a signal to be tested rather than a result established.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, oral concentrate solution, short-acting intramuscular injection of the lactate salt, and long-acting intramuscular decanoate injection in sesame oil given about every four weeks
Interval reported. 95% CI 32
Written into the record, not signed off as a reviewed claim.
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
Haloperidol standardised mean difference 0.45 (95% CrI 0.39 to 0.51), seventh of fifteen; extrapyramidal odds ratio 4.76, the least favourable of the fifteen; weight gain -0.09, the most favourable
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. Efficacy outcomes did not change substantially after removal of haloperidol groups, which addresses the standing objection that haloperidol comparator arms were run at amounts chosen to make newer drugs look better.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, oral concentrate solution, short-acting intramuscular injection of the lactate salt, and long-acting intramuscular decanoate injection in sesame oil given about every four weeks
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Time to discontinuation of assigned antipsychotic for any cause in chronic schizophrenia, with the first-generation drug perphenazine as comparator
✗ The study did not show it
Who was studied
NCT00014001 (CATIE, phase 1)
How many people
1493
Study design
Phase 4 double-blind randomised effectiveness trial, up to 18 months
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
74% of all patients discontinued before 18 months; the efficacy of perphenazine appeared similar to that of quetiapine, risperidone and ziprasidone
Repeated elsewhere
Replicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. CATIE used perphenazine rather than haloperidol as its first-generation arm, specifically to avoid the movement-disorder burden that would have unblinded the comparison. The finding that a first-generation drug matched three second-generation ones is the independent counterpart to the meta-analytic ranking.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, oral concentrate solution, short-acting intramuscular injection of the lactate salt, and long-acting intramuscular decanoate injection in sesame oil given about every four weeks
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 4 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What 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
Haloperidol
What a person takes: Oral tablet, oral concentrate solution, short-acting intramuscular injection of the lactate salt, and long-acting intramuscular decanoate injection in sesame oil given about every four weeks.
The measurement behind this step
The approved route for the injection recorded in the openFDA product data is intramuscular. The Warnings section states in capital letters that haloperidol injection is not approved for intravenous administration and directs electrocardiographic monitoring for QTc prolongation and arrhythmias if it is given that way. The decanoate depot is an inactive ester in sesame oil with benzyl alcohol; release depends on partition out of the oil and subsequent hydrolysis.
Getting in
A tablet, a liquid, an intramuscular injection, or a monthly oil depot
Haloperidol comes as a tablet, an oral solution, a short-acting injection into muscle, and a long-acting version dissolved in sesame oil that lasts about four weeks.
╌╌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 long-acting form is haloperidol decanoate, an inactive ester dissolved in sesame oil with benzyl alcohol. Release is governed by partition of the ester out of the oil depot and subsequent hydrolysis, not by any property of the parent molecule, which is how a drug with a roughly daily oral rhythm becomes a four-weekly injection.
It crosses into the brain and reaches the striatum in force
The drug enters the brain readily and concentrates where dopamine signalling is densest, which is both where the psychotic symptoms are addressed and where the movement problems begin.
╌╌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
Haloperidol reaches striatal D2 occupancy well above the 65 to 80 per cent window in which antipsychotic effect appears without extrapyramidal effect, and at usual clinical amounts it commonly exceeds the upper end of that window. Clearance is hepatic, predominantly by glucuronidation with contributions from CYP3A4 and CYP2D6.
It blocks the dopamine D2 receptor and very little else
It sits on the dopamine receptor and switches it off. Unlike almost every newer drug in this class it does not also block histamine or acetylcholine receptors, so it does not cause the sedation, weight gain and dry mouth those receptors produce.
╌╌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
High-affinity D2 antagonism with lower-affinity alpha-1 adrenergic binding and minimal muscarinic and H1 binding, per the label. This near-selectivity is why haloperidol serves as the neutral-antagonist reference compound in functional assays that characterise partial agonists such as aripiprazole: it defines what switching the receptor fully off looks like.
The dopamine circuit that carries psychotic symptoms is the same circuit that starts, stops and smooths out movement. Blocking it hard produces stiffness, tremor, an inability to sit still, and in some people permanent involuntary movements.
──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
Nigrostriatal D2 blockade without anticholinergic counterweight produces parkinsonism, akathisia and acute dystonia, and with prolonged exposure the postsynaptic supersensitivity implicated in tardive dyskinesia. The pooled odds ratio for extrapyramidal effects against placebo was 4.76, the least favourable of the fifteen drugs ranked, against 0.30 for clozapine. The label describes the tardive syndrome as potentially irreversible and most prevalent among the elderly, especially elderly women.
Psychosis lifts, movement suffers, delirium does not respond
On symptom scales haloperidol performs better than eight newer drugs. Movement side effects are the worst in the class. In critically ill patients with delirium, two large trials found it did not help.
╌╌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 0.45 (95% CrI 0.39 to 0.51) for overall symptom change, seventh of fifteen. Extrapyramidal odds ratio 4.76, weight gain -0.09, all-cause discontinuation odds ratio 0.80. In MIND-USA the odds ratio against placebo for days alive without delirium or coma was 0.88 (95% CI 0.64 to 1.21); in AID-ICU the adjusted difference in days alive and out of hospital at 90 days was 2.9 (95% CI -1.2 to 7.0).
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.
Adults with psychotic disorders, children and adults with Tourette disorder, and, far more often than any label describes, agitated and delirious patients in emergency departments and intensive care units around the world.
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 · b1ad2abd-a9d6-44e3-957b-36a73260f4f5 · read 2026-08-30
On older people, the label states: “Clinical studies of haloperidol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”
US prescribing information · b1ad2abd-a9d6-44e3-957b-36a73260f4f5 · read 2026-08-30
On people who are pregnant, the label states: “Usage in Pregnancy Rats or rabbits administered oral haloperidol at doses of 0.5 to 7.5 mg/kg, which are approximately 0.2 to 7 times the maximum recommended human dose (MRHD) of 20 mg/day based on mg/m 2 body surface area, showed an increase in incidence of resorption, reduced fertility, delayed delivery and pup mortality.”
US prescribing information · b1ad2abd-a9d6-44e3-957b-36a73260f4f5 · read 2026-08-30
On people who are breastfeeding, the label states: “Since haloperidol is excreted in human breast milk, infants should not be nursed during drug treatment with haloperidol.”
US prescribing information · b1ad2abd-a9d6-44e3-957b-36a73260f4f5 · read 2026-08-30
Where the result stopped carrying
MIND-USA, 566 randomised patients, found no effect on delirium duration and none on any secondary endpoint
AID-ICU, 1,000 randomised patients, missed its primary endpoint at p=0.22
Haloperidol had the least favourable all-cause discontinuation of the fifteen drugs ranked, at an odds ratio of 0.80
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral tablet, oral concentrate solution, short-acting intramuscular injection of the lactate salt, and long-acting intramuscular decanoate injection in sesame oil given about every four weeks
✎ 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: S6.
No source is stored against this line.
What is in the pack
The approved route for the injection recorded in the openFDA product data is intramuscular.
✎ 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. The rest of the recorded wording: The Warnings section states in capital letters that haloperidol injection is not approved for intravenous administration and directs electrocardiographic monitoring for QTc prolongation and arrhythmias if it is given that way. The decanoate depot is an inactive ester in sesame oil with benzyl alcohol; release depends on partition out of the oil and subsequent hydrolysis.
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 carries a boxed warning for increased mortality in elderly patients with dementia-related psychosis, and states that haloperidol is not approved for that use. The Warnings section records sudden death, QT prolongation and torsades de pointes, with higher risk at higher-than-recommended amounts and with intravenous administration, and notes that a QTc exceeding 500 msec is associated with increased torsades risk. Tardive dyskinesia is described as potentially irreversible with prevalence highest among the elderly, especially elderly women. Neuroleptic malignant syndrome, parkinsonism, akathisia, acute dystonia, hyperprolactinaemia, orthostatic hypotension and seizures are all in the label. Weight gain and metabolic disturbance are the least of any drug in the fifteen-drug comparison.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral tablet, oral concentrate solution, short-acting intramuscular injection of the lactate salt, and long-acting intramuscular decanoate injection in sesame oil given about every four weeks
✎ 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
A recorded note compares this form with the others that are sold. It is kept below, word for word.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
The recorded note, unchanged: The Warnings section states in capital letters that haloperidol injection is not approved for intravenous administration and directs electrocardiographic monitoring for QTc prolongation and arrhythmias if it is given that way. The decanoate depot is an inactive ester in sesame oil with benzyl alcohol; release depends on partition out of the oil and subsequent hydrolysis.
No source is stored against this line.
What is recorded as being sold
167 products list this as an active ingredient in the United States drug directory. 167 of them contain it and nothing else.
FDA National Drug Code directory · 72162-2624 · read 2026-08-29
They are sold as powder, solution, solution, concentrate and tablet, taken oral.
FDA National Drug Code directory · 72162-2624 · read 2026-08-29
The regulator's established pharmacologic class for it is typical antipsychotic [epc].
FDA National Drug Code directory · 72162-2624 · read 2026-08-29
76 published labels name it as an active ingredient. 76 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 8a1014d0-d917-40b7-bddd-9ac97df91ef4 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 8a1014d0-d917-40b7-bddd-9ac97df91ef4 · read 2026-08-29
1 marketed supplement label lists this ingredient, classed as other combinations.
Those labels carry all other, nutrient and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.
Haloperidol is tablets at 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg, recorded as prescription product; fda label in effect 2024-11-15 in the United States.
US prescribing information · 00bb61c8-db35-4c04-9ef7-47d447d2496b · read 2026-08-27
Recorded price in US: 0.09386–0.37338 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 84 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 Haloperidol 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 newer antipsychotics are more effective than haloperidol — the pooled ranking places it above eight of the fourteen it was compared against
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 haloperidol shortens delirium in critical illness — two large placebo-controlled trials measured that directly and neither found it
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 AID-ICU established a mortality benefit — that is a secondary endpoint in a trial whose primary endpoint did not separate
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 every indication on the label reflects evidence a modern regulator would accept — the paediatric behavioural indication describes a presentation no current diagnostic manual contains
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 Haloperidol are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
The 1967 drug outranked eight of the fourteen newer ones
In plain words
For twenty years the argument for newer antipsychotics was that they worked better than haloperidol. When 212 trials were pooled and ranked, haloperidol came seventh of fifteen, above quetiapine, aripiprazole, ziprasidone, chlorpromazine, asenapine, sertindole, lurasidone and iloperidone.
What was measured
Standardised mean difference against placebo for overall symptom change, ranked across fifteen drugs
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 randomised trials and 43,049 participants, the standardised mean difference against placebo for overall symptom change was 0.45 (95% CrI 0.39 to 0.51) for haloperidol. The full ranking ran clozapine 0.88, amisulpride 0.66, olanzapine 0.59, risperidone 0.56, paliperidone 0.50, zotepine 0.49, haloperidol 0.45, quetiapine 0.44, aripiprazole 0.43, sertindole 0.39, ziprasidone 0.39, chlorpromazine 0.38, asenapine 0.38, lurasidone 0.33, iloperidone 0.33. The authors' stated interpretation is that antipsychotics differed substantially in side-effects, that small but robust differences were seen in efficacy, and that "our findings challenge the straightforward classification of antipsychotics into first-generation and second-generation groupings." Efficacy outcomes did not change substantially after removal of haloperidol groups, or when dose, withdrawals, blinding, industry sponsorship, study duration, chronicity and publication year were accounted for.
Written into the record, not signed off as a reviewed claim
The worst movement-disorder rate of the fifteen, and the least weight gain
In plain words
The same analysis that put haloperidol seventh on symptoms put it last on movement side effects, with odds nearly sixteen times those of clozapine, and first on weight, as the drug that puts on the least.
What was measured
Odds ratio 4.76 for extrapyramidal effects, standardised mean difference -0.09 for weight gain, odds ratio 0.80 for all-cause discontinuation
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Odds ratios against placebo for extrapyramidal side-effects ranged from 0.30 for the best drug, clozapine, to 4.76 for the worst, haloperidol. Standardised mean differences for weight gain ran from -0.09 for the best drug, haloperidol, to -0.74 for the worst, olanzapine. All-cause discontinuation odds ratios ranged from 0.43 for amisulpride to 0.80 for haloperidol, again the least favourable of the fifteen. Haloperidol therefore holds three extremes of the same dataset: it is the least fattening drug, the most movement-disturbing drug, and the drug people were least likely to stay on. Its label separately states that tardive dyskinesia consists of potentially irreversible involuntary dyskinetic movements, and that prevalence appears highest among the elderly, especially elderly women.
Written into the record, not signed off as a reviewed claim
It did not shorten delirium in 566 randomised intensive-care patients
In plain words
Giving haloperidol to critically ill patients with delirium is one of the most common uses of this drug anywhere in medicine. A placebo-controlled trial tested it directly and found no benefit at all.
What was measured
Days alive without delirium or coma over 14 days: median 7.9 on haloperidol against 8.5 on placebo, odds ratio 0.88 (95% CI 0.64 to 1.21)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
MIND-USA, registered as NCT01211522 and funded by the National Institutes of Health and the VA Geriatric Research Education and Clinical Center, enrolled 1,183 patients with acute respiratory failure or shock. Delirium developed in 566 (48%), of whom 89% had the hypoactive form. Those 566 were randomised to placebo (184), haloperidol (192) or ziprasidone (190), given as intravenous boluses with the amount halved or doubled at 12-hour intervals according to delirium status and side effects. The primary endpoint, days alive without delirium or coma during the 14-day intervention period, gave a median of 8.5 days (95% CI 5.6 to 9.9) on placebo, 7.9 days (95% CI 4.4 to 9.6) on haloperidol and 8.7 days (95% CI 5.9 to 10.0) on ziprasidone, p=0.26 across groups. The odds ratio against placebo was 0.88 (95% CI 0.64 to 1.21) for haloperidol. There were no significant differences in secondary endpoints or in extrapyramidal symptoms.
Written into the record, not signed off as a reviewed claim
A second 1,000-patient trial missed its primary endpoint and found a mortality difference anyway
In plain words
A Danish-led trial randomised 1,000 intensive-care patients with delirium. The main measure, days alive and out of hospital, did not separate. Ninety-day deaths were 36% on haloperidol against 43% on placebo, a gap whose confidence interval just excluded zero.
What was measured
Days alive and out of hospital at 90 days: adjusted mean difference 2.9 (95% CI -1.2 to 7.0), p=0.22; 90-day mortality 36.3% against 43.3%
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
AID-ICU, registered as NCT03392376 and funded by Innovation Fund Denmark, randomised 1,000 adult ICU patients with delirium to intravenous haloperidol or placebo, with 987 in the final analyses. The primary outcome, mean days alive and out of hospital at 90 days, was 35.8 (95% CI 32.9 to 38.6) on haloperidol against 32.9 (95% CI 29.9 to 35.8) on placebo, adjusted mean difference 2.9 days (95% CI -1.2 to 7.0), p=0.22. Mortality at 90 days was 36.3% against 43.3%, adjusted absolute difference -6.9 percentage points (95% CI -13.0 to -0.6). Serious adverse reactions occurred in 11 haloperidol patients and 9 placebo patients. This is the difficult shape: a primary endpoint that did not separate alongside a secondary mortality difference whose interval excludes zero by four tenths of a percentage point. The published conclusion states the primary result. Treating the mortality figure as established would be reading a secondary endpoint from a trial whose primary endpoint was negative, which is the specific inferential error this field has made repeatedly.
Written into the record, not signed off as a reviewed claim
Both ICU trials used a route the label states in capitals is not approved
In plain words
Haloperidol is given intravenously in intensive care units everywhere. Its own United States label says, in capital letters, that the injection is not approved for intravenous administration.
What was measured
The text of the approved United States label for haloperidol injection, and the administration route used in both randomised ICU trials
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Warnings section of the United States label for haloperidol injection states: "HALOPERIDOL INJECTION IS NOT APPROVED FOR INTRAVENOUS ADMINISTRATION. If haloperidol is administered intravenously, the ECG should be monitored for QTc prolongation and arrhythmias." The approved route recorded in the openFDA product data for haloperidol lactate injection is intramuscular. The same section states that higher-than-recommended amounts of any formulation and intravenous administration appear to be associated with a higher risk of QTc prolongation and torsades de pointes, and that a QTc exceeding 500 msec is associated with increased risk. Both MIND-USA and AID-ICU administered the drug intravenously. This does not invalidate either trial — off-label routes are lawful and often the right clinical choice — but it means the two definitive trials of haloperidol's commonest hospital use tested an administration route that carries an explicit label warning, and it means every reader of those trials should know the route was off-label.
Written into the record, not signed off as a reviewed claim
A paediatric behavioural indication written in the language of 1967
In plain words
The label still lists haloperidol for severe behaviour problems in children of combative, explosive hyperexcitability. That is not a modern diagnosis, and no boxed warning about dementia mortality existed when it was written.
What was measured
That every indication on a decades-old label reflects evidence a modern regulator would accept — this one describes a behavioural presentation that no current diagnostic manual contains
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Indications section of the United States label for haloperidol tablets reads: "Haloperidol tablets, USP are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation)." The phrasing describes a behavioural presentation rather than a diagnostic entity, and it has no equivalent in any current diagnostic manual. The indication predates the modern requirement for adequate and well-controlled trials in paediatric populations, predates the boxed warning added in the 2000s, and predates the pooled evidence on tardive dyskinesia risk with prolonged exposure. It remains on the label. An indication that survives on a label is not the same thing as an indication supported by evidence a regulator would accept today.
Source
United States prescribing information for haloperidol tablets, Indications and Usage, 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
A boxed warning about dementia built largely on trials of other drugs
In plain words
Haloperidol carries the same boxed warning about deaths in elderly people with dementia that the newer drugs carry. The seventeen trials behind it were largely trials of those newer drugs, not of haloperidol.
What was measured
Death in about 4.5% of drug-treated patients against about 2.6% on placebo across seventeen placebo-controlled dementia trials, largely of atypical antipsychotics
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The boxed warning states that analyses of seventeen placebo-controlled trials with a modal duration of ten weeks, "largely in patients taking atypical antipsychotic drugs," revealed a risk of death 1.6 to 1.7 times that of placebo, with death in about 4.5% of drug-treated patients against about 2.6% on placebo, most deaths cardiovascular or infectious. It then states that observational studies suggest treatment with conventional antipsychotic drugs may increase mortality similarly, and that the extent to which the observational findings can be attributed to the drug rather than to characteristics of the patients is not clear. The warning is therefore honest about its own basis: randomised evidence for the newer drugs, observational evidence with acknowledged confounding for this one. The label states plainly that haloperidol is not approved for the treatment of patients with dementia-related psychosis.
Source
United States prescribing information for haloperidol tablets, Boxed Warning, via the openFDA drug label endpoint
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
Where else this substance is registered
FDA substance identifier (UNII)
J6292F8L3D
CAS registry number
52-86-8
PubChem compound
3559
RxNorm concept
217483
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Suppression classes recorded: S6.
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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
75 approved applications cover products containing this substance. The earliest was NDA015921, approved 19670412 to ORTHO MCNEIL.
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What is not here
7 questions this page could not answer
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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 nearly pure dopamine D2 blocker from 1967 that ranked seventh of fifteen antipsychotics on symptom reduction — above eight newer drugs — while producing the worst movement-disorder rate of the fifteen (odds ratio 4.76 for extrapyramidal effects) and the least weight gain, and which failed to improve delirium in 566 randomised ICU patients and failed its primary endpoint in 1,000 more, in both cases given by a route its own label states in capital letters is not approved.
"Study suspended due to low enrollment"; 17 of 117 registered studies
Show the evidence
Trial
NCT00124930
terminated; "Study suspended due to low enrollment"
NCT00300391
terminated; "Insufficient recruitment to meet aims."
NCT00419653
terminated; "Recruitment issues"
NCT00599287
terminated; "Inclusion rate too low due to a lack of eligible patients and difficulties obtaining informed consent."
NCT00767715
terminated; "Trial discontinued due to low enrollment"
NCT00954603
terminated; "few delirious patients were enrolled."
11 further recorded trials
NCT01140529
terminated; "Slow recruitment"
NCT01684969
withdrawn; "lack of accrual and funding is about to expire."
NCT02057549
terminated; "PI left institution"
NCT02098499
withdrawn; "No recruitment occurred and PI retired"
NCT02343575
terminated; "We did not recruit the research assistant and terminated the study"
NCT02380118
terminated; "Primary endpoint reached based on data projection from interim analysis."
NCT02893371
terminated; "Per PI, this study is not a clinical trial and was inadvertently entered in the system"
NCT02972502
terminated; "PI lapsed institutional training"
NCT03628391
terminated; "The study was stopped because of futility of being able to reach a one-day difference between treatment groups in the primary outcome of DCFD in the intended sample size."
NCT04715230
terminated; "Sponsor decision based on slower than anticipated enrollment leading to fund exhaustion."
NCT05065567
terminated; "Lost too many patients to follow up, unable to enroll enough patients"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Haloperidol used Haloperidol 10mg — over how long?
studies of Haloperidol used the recorded amount. ClinicalTrials.gov · 2026-09-01
8 recorded entries; human; also "Haloperidol 10mg", "Haloperidol 10 mg Tablets (Cord Laboratories)", "Haldol 10 mg Tablets (McNeil Pharmaceuticals)"
Show the evidence
human
NCT00044044
Haloperidol 10mg
NCT00946491
Haloperidol 10 mg Tablets (Cord Laboratories)
NCT00946491
Haldol 10 mg Tablets (McNeil Pharmaceuticals)
NCT01785290
Haloperidol 1 mg/q8h
NCT01785290
Haloperidol 2 mg/q8h
NCT03056482
Haloperidol 0.05mg/kg
2 more recorded rows
humanNCT03056482
Haloperidol 0.1mg/kg
humanNCT06014606
haloperidol 2mg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which 52 trials of Haloperidol posted no result?
Posted no result
52 of 52 completed trials
Registrations
NCT00946491, NCT00253110, NCT00018850, NCT01123408, NCT00009217 and NCT00625170, and 46 more
Completion dates
oldest 1987-05; newest 2024-02-28
Show the evidence
Trial
NCT00946491
1987-05
NCT00253110
1998-09
NCT00018850
2003-06
NCT01123408
2004-07
NCT00009217
2004-12
NCT00625170
2004-12
14 further recorded trials
NCT00485901
2005-01
NCT00625014
2005-07
NCT00191555
2006-05
NCT00156104
2006-09-16
NCT00534183
2006-12
NCT00097266
2007-01
NCT00096863
2007-07
NCT00429676
2007-09
NCT00631722
2008-05
NCT00505804
2008-11
NCT00250237
2009-02
NCT00859872
2009-03
NCT01185418
2009-07
NCT01139463
2009-10
Q7
At the median, Haloperidol's trials enrolled 80 people — anything larger?
Median enrolment
80
Largest enrolment
1234412
Registered trials counted
115
Q8
What do 5871 spontaneous reports say about Haloperidol — 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.
Haloperidol appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 5871 reaction mentions were counted: extrapyramidal disorder 990; neuroleptic malignant syndrome 938; weight increased 797; somnolence 544. FAERS via Open Targets · CHEMBL4297147 · 2026-06-24
Show the evidence
extrapyramidal disorder
990
neuroleptic malignant syndrome
938
weight increased
797
somnolence
544
drug interaction
481
dystonia
447
4 more recorded rows
agitation
442
suicide attempt
432
toxicity to various agents
401
tremor
399
recorded 2026-06-24 · last checked 2026-09-04
Q9
Which 10 reactions does Haloperidol's label not list?
• Combined CYP3A4 and CYP2D6 inhibitors – fluoxetine, fluvoxamine; ritonavir.
Interaction statementdrug_interactions
Drugs that May Decrease Haloperidol Plasma Concentrations Coadministration of haloperidol with potent enzyme inducers of CYP3A4 may gradually decrease the plasma concentrations of haloperidol to such an extent that efficacy may be reduced.
ChEMBL 37 — CC BY-SA 3.0 Unported · 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
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✓ source coverage passed: 6 source rows
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