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Risperidone

  • Prescription medicine
  • Given by a clinician
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Risperidone does in the body

Schizophrenia, bipolar mania and severe irritability or aggression in autistic children.

Risperidone blocks two receptors at once: the dopamine receptor that antipsychotics act on, and a serotonin receptor that softens the movement side effects dopamine blockade usually causes. It binds both tightly. The pituitary gland, which controls hormones, sits outside the barrier that protects the brain, so it is exposed to more risperidone than the brain is, and the dopamine block there releases the brake on prolactin. That is why breast tissue growth, milk production and sexual side effects are more common with this drug than with most of its alternatives.

What happened in people

In autistic children, severe irritability fell by 57% versus 14% without it.

Reviewed first-read answer

Where this came from

A person wrote this and a reviewer approved it against this exact record. It carries no effect size.

A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.

No source is stored against this line.

The limit that matters most

Its main active breakdown product is sold separately but has not proved more effective.

Where it acts
Mesolimbic dopamine synapses in the brain, and the pituitary lactotroph cells that sit outside the blood-brain barrier
Kind of result
The kind of result is not recorded
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 · L6UH7ZF8HC · read 2026-08-29

  • Its recorded molecular formula is C23H27FN4O2, weighing 410.49.

    US prescribing information · 390904c2-fcfa-466e-e063-6394a90a03af · read 2026-08-30

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

The limit a reviewer approved as the one that matters most here.

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.

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 peopleRead 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.

Aberrant Behavior Checklist Irritability subscale score and Clinical Global Impressions-Improvement rating at 8 weeks in children aged 5 to 17 with autistic disorder

The study showed what it set out to show

Who was studied
RUPP Autism Network risperidone trial (McCracken 2002)
How many people
101
Study design
Multisite randomised double-blind placebo-controlled trial, 8 weeks
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
P < 0.001 for a 56.9% versus 14.1% reduction in irritability, and for a 69% versus 12% positive response rate
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. Weight gain of 2.7 kg against 0.8 kg on placebo over eight weeks, with increased appetite, fatigue, drowsiness, dizziness and drooling all significantly more common. The authors state the trial was too short to say anything about tardive dyskinesia.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, orally disintegrating tablet, oral solution, and several long-acting injectable depots including intramuscular microspheres and subcutaneous formulations

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Change in Clinician-Administered PTSD Scale score from baseline to 24 weeks with adjunctive risperidone in antidepressant-resistant military-related PTSD

The study did not show it

Who was studied
VA Cooperative Study No. 504 (Krystal 2011)
How many people
296
Study design
Randomised double-blind placebo-controlled multicentre trial, 6 months, 23 VA centres
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Mean difference 3.74 on a 0-136 scale (95% CI -0.86 to 8.35), t = 1.6, P = 0.11
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. No benefit on depression (P = 0.11), anxiety (P = 0.09) or quality of life either. Only the observer-rated Clinical Global Impression reached nominal significance (P = 0.04) among many secondary measures.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, orally disintegrating tablet, oral solution, and several long-acting injectable depots including intramuscular microspheres and subcutaneous formulations

Interval reported. 95% CI -0

Written into the record, not signed off as a reviewed claim.

Time to discontinuation of assigned antipsychotic for any cause

The study did not show it

Who was studied
CATIE phase 1 (NCT00014001)
How many people
1493
Study design
Phase 4 independent randomised double-blind 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
P = 0.002 for shorter time to discontinuation on risperidone than olanzapine; 74% of the risperidone arm discontinued within 18 months
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. Risperidone did not separate from perphenazine, a first-generation drug approved in 1957 and costing about seventeen cents a tablet.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, orally disintegrating tablet, oral solution, and several long-acting injectable depots including intramuscular microspheres and subcutaneous formulations

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Time to discontinuation for any reason, and improvement on the Clinical Global Impression of Change at 12 weeks in Alzheimer disease

The study did not show it

Who was studied
CATIE-AD (NCT00015548)
How many people
421
Study design
Independent randomised double-blind placebo-controlled trial, up to 36 weeks
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
CGIC improvement 29% on risperidone versus 21% on placebo, P = 0.22 across arms; median time to discontinuation for lack of efficacy 26.7 weeks versus 9.0 on placebo, P = 0.002
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. Discontinuation for intolerability was 18% on risperidone against 5% on placebo (P = 0.009). The efficacy advantage and the intolerability disadvantage cancelled on the primary endpoint.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, orally disintegrating tablet, oral solution, and several long-acting injectable depots including intramuscular microspheres and subcutaneous formulations

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Adjusted rate ratio for incident gynaecomastia diagnosis in current risperidone users versus non-users

The study showed what it set out to show

Who was studied
Etminan gynaecomastia case-control study
How many people
1556
Study design
Nested case-control analysis within a claims cohort of 401,924 males aged 15 to 25
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Rate ratio 3.91 (95% CI 2.01 to 7.62) overall; 5.44 (95% CI 1.50 to 19.74) in those aged 18 and under
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. Observational claims data. Confounding by indication cannot be excluded, and gynaecomastia is identified by diagnostic code rather than by examination.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, orally disintegrating tablet, oral solution, and several long-acting injectable depots including intramuscular microspheres and subcutaneous formulations

Interval reported. 95% CI 2

Written into the record, not signed off as a reviewed claim.

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 bodyRead 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.

  1. Start

    Risperidone

    What a person takes: Oral tablet, orally disintegrating tablet, oral solution, and several long-acting injectable depots including intramuscular microspheres and subcutaneous formulations.

    The measurement behind this step

    The oral form is taken daily. Risperdal Consta releases risperidone from polymer microspheres over about two weeks after a three-week lag, so oral cover is needed at the start; the newer subcutaneous depots have different onset profiles. The injectable range exists because non-adherence is the commonest route to relapse in schizophrenia, and a depot converts a daily decision into a monthly one.

  2. Getting in

    A tablet, a dissolving wafer, or an injection lasting two weeks to a month

    Risperidone is taken daily by mouth, or given as an injection that releases slowly over two weeks or a month. The injectable versions exist because taking a tablet every day is the step that most often fails.

    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

    Oral half-life of about 3 hours for risperidone and 21 hours for 9-hydroxyrisperidone, so the active moiety behaves as a once-daily drug. Risperdal Consta releases from polymer microspheres over roughly two weeks with a three-week lag; Perseris and Uzedy are subcutaneous depots with different release kinetics.

  3. Reaching the cell

    The liver converts part of it into a second drug that does the same job

    CYP2D6, a liver enzyme whose activity varies a great deal between people, converts risperidone into 9-hydroxyrisperidone. That second molecule is just as active, so the total effect is more consistent than the enzyme variation would suggest.

    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

    CYP2D6-mediated 9-hydroxylation produces paliperidone. Poor metabolisers have higher risperidone and lower paliperidone concentrations; extensive metabolisers the reverse. Because both are active and roughly equipotent, the sum, referred to as the active moiety, varies far less than either component, which is why CYP2D6 genotyping has not become routine for this drug.

  4. What it acts on

    It blocks serotonin and dopamine receptors, serotonin first

    Risperidone blocks a serotonin receptor at lower concentrations than it blocks the dopamine receptor. The serotonin block is what softens the stiffness and tremor that pure dopamine blockade produces, up to a point.

    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

    Higher affinity for 5-HT2A than for D2, with sustained D2 occupancy at licensed exposures. Above roughly 80% striatal D2 occupancy the extrapyramidal threshold is crossed regardless of 5-HT2A blockade, which is why risperidone is dose-dependently more parkinsonian than quetiapine and required more antiparkinson medication than several newer drugs in the 32-drug network meta-analysis.

  5. The change it makes

    The pituitary is outside the brain's protective barrier, and it gets a full dose

    The gland that controls hormones sits outside the barrier that keeps most molecules out of the brain, so it is exposed to more risperidone than the brain is. Dopamine normally holds prolactin down; blocking it there lets prolactin rise.

    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

    Risperidone is a P-glycoprotein substrate, so central exposure is attenuated relative to plasma, while anterior pituitary lactotrophs lie outside the blood-brain barrier and see unattenuated concentrations. D2 blockade at those lactotrophs removes tonic dopaminergic inhibition of prolactin secretion. The clinical consequences are gynaecomastia, galactorrhoea, amenorrhoea and sexual dysfunction, and the measured consequence in claims data is a rate ratio of 3.91 for gynaecomastia in males aged 15 to 25.

  6. What that does for a person

    Symptoms and irritability scores fall, and prolactin rises

    On the scales the trials use, risperidone is among the more effective antipsychotics, and in children with autism it produced the largest measured reduction in irritability of any drug tested. The hormonal effect runs alongside, not instead.

    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 of 0.56 (95% CrI 0.50 to 0.63) against placebo for overall symptom change in acute schizophrenia, fourth of fifteen. In autism-associated irritability, a 56.9% reduction in the Aberrant Behavior Checklist Irritability subscale against 14.1% on placebo over eight weeks, with 2.7 kg of weight gain against 0.8 kg.

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 unclearRead 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 schizophrenia and bipolar disorder; children and adolescents with autism-associated irritability; and, off-label and against the evidence below, veterans with post-traumatic stress disorder and elderly people with dementia.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “Safety and effectiveness of risperidone in children less than 13 years of age with schizophrenia have not been established.”

    US prescribing information · 390904c2-fcfa-466e-e063-6394a90a03af · read 2026-08-30

  • On older people, the label states: “Clinical studies of risperidone in the treatment of schizophrenia did not include sufficient numbers of patients aged 65 and over to determine whether or not they respond differently than younger patients.”

    US prescribing information · 390904c2-fcfa-466e-e063-6394a90a03af · read 2026-08-30

  • On people who are pregnant, the label states: “Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including risperidone, during pregnancy.”

    US prescribing information · 390904c2-fcfa-466e-e063-6394a90a03af · read 2026-08-30

  • On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential Infertility Females Based on the pharmacologic action of risperidone (D 2 receptor antagonism), treatment with risperidone may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential [see Warnings and Precautions ( 5.6 )].”

    US prescribing information · 390904c2-fcfa-466e-e063-6394a90a03af · read 2026-08-30

  • On people with reduced liver function, the label states: “While the pharmacokinetics of risperidone in subjects with liver disease were comparable to those in young healthy subjects, the mean free fraction of risperidone in plasma was increased by about 35% because of the diminished concentration of both albumin and α 1 -acid glycoprotein.”

    US prescribing information · 390904c2-fcfa-466e-e063-6394a90a03af · read 2026-08-30

  • On people with reduced kidney function, the label states: “In patients with moderate to severe (Clcr 59 to 15 mL/min) renal disease, clearance of the sum of risperidone and its active metabolite decreased by 60%, compared to young healthy subjects.”

    US prescribing information · 390904c2-fcfa-466e-e063-6394a90a03af · read 2026-08-30

Where the result stopped carrying

  • VA Cooperative Study No. 504 found no benefit in PTSD on the PTSD scale, on depression, on anxiety or on quality of life
  • CATIE-AD found no significant advantage over placebo on global improvement in Alzheimer disease, with more than three times the intolerability dropout
  • Risperidone did not separate from perphenazine, a 1957 first-generation drug, in the independent effectiveness trial
  • 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 takeRead 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 takeRead 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, orally disintegrating tablet, oral solution, and several long-acting injectable depots including intramuscular microspheres and subcutaneous formulations

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, S9.

No source is stored against this line.

What is in the pack

The oral form is 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.

Recorded notes on how this is sold. The rest of the recorded wording: Risperdal Consta releases risperidone from polymer microspheres over about two weeks after a three-week lag, so oral cover is needed at the start; the newer subcutaneous depots have different onset profiles. The injectable range exists because non-adherence is the commonest route to relapse in schizophrenia, and a depot converts a daily decision into a monthly one.

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 takeRead 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. Prolactin elevation is the defining class-distinguishing effect, producing gynaecomastia, galactorrhoea, amenorrhoea and sexual dysfunction. Extrapyramidal effects are dose-dependent and more frequent than with quetiapine or clozapine. Weight gain, orthostatic hypotension, sedation, tardive dyskinesia and neuroleptic malignant syndrome all apply.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

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 unclearRead 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, orally disintegrating tablet, oral solution, and several long-acting injectable depots including intramuscular microspheres and subcutaneous formulations

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: Risperdal Consta releases risperidone from polymer microspheres over about two weeks after a three-week lag, so oral cover is needed at the start; the newer subcutaneous depots have different onset profiles. The injectable range exists because non-adherence is the commonest route to relapse in schizophrenia, and a depot converts a daily decision into a monthly one.

No source is stored against this line.

What is recorded as being sold

  • 205 products list this as an active ingredient in the United States drug directory. 205 of them contain it and nothing else.

    FDA National Drug Code directory · 71610-246 · read 2026-08-29

  • They are sold as injection, powder, for solution, injection, suspension, injection, suspension, extended release, powder, solution and tablet, taken oral and subcutaneous.

    FDA National Drug Code directory · 71610-246 · read 2026-08-29

  • The regulator's established pharmacologic class for it is atypical antipsychotic [epc].

    FDA National Drug Code directory · 71610-246 · read 2026-08-29

  • 74 published labels name it as an active ingredient. 74 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 390904c2-fcfa-466e-e063-6394a90a03af · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 390904c2-fcfa-466e-e063-6394a90a03af · read 2026-08-29

  • RISPERIDONE is tablets at Tablets: 1 mg, recorded as prescription product; fda label in effect 2026-06-25 in the United States.

    US prescribing information · 03d3b52d-3a7d-4595-84c9-332da6ca9171 · read 2026-08-27

  • Recorded price in US: 0.03329–2.54743 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 106 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

  • Recorded price in US: 0.48527 USD per one millilitre, across 5 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 takeRead 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 Risperidone 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 unclearRead 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 risperidone helps post-traumatic stress disorder — a 296-veteran six-month randomised trial found a non-significant 3.74-point difference on a 136-point scale

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 it treats autism — the indication is for irritability, aggression and self-injury occurring alongside autism, and no trial has shown an effect on the core features of the condition

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 paliperidone is an improvement on it — the metabolite ranks slightly lower on pooled efficacy, higher on prolactin, and sixteen times higher on price

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 antipsychotic treatment of agitation in dementia is supported by evidence — the pooled randomised data show an odds ratio of 1.54 for death

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 unclearRead 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 Risperidone 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 peopleRead 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 one convincing antipsychotic result in childhood autism-related irritability
In plain words
In 101 children aged five to seventeen with autism and severe tantrums, aggression or self-injury, eight weeks of risperidone cut the irritability score by 57% against 14% on a dummy pill. Two-thirds of those who improved were still improved at six months.
What was measured
Percentage change in the Aberrant Behavior Checklist Irritability subscale at 8 weeks, and positive response rate
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Research Units on Pediatric Psychopharmacology Autism Network randomised 101 children (82 boys, 19 girls, mean age 8.8 years) to risperidone (n=49) or placebo (n=52) for eight weeks, with the Irritability subscale of the Aberrant Behavior Checklist and the Clinical Global Impressions-Improvement rating as co-primary outcomes. Irritability fell 56.9% on risperidone against 14.1% on placebo (P<0.001). Positive response, defined as at least a 25% fall in irritability plus a rating of much or very much improved, occurred in 69% (34 of 49) against 12% (6 of 52), P<0.001. Weight gain averaged 2.7 kg (SD 2.9) against 0.8 kg (SD 2.2) on placebo, P<0.001, and increased appetite, fatigue, drowsiness, dizziness and drooling were all more common on drug. In 23 of the 34 responders the benefit was maintained at six months. The authors state explicitly that the short trial duration limits inference about tardive dyskinesia.
Source
McCracken JT et al., N Engl J Med 2002;347:314-321 (RUPP Autism Network)
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
A 296-veteran VA trial found nothing at all in post-traumatic stress disorder
In plain words
Risperidone was widely added to antidepressants for veterans whose PTSD had not responded. A six-month randomised trial across 23 Veterans Administration centres found no benefit on the PTSD scale, none on depression, and none on quality of life.
What was measured
Change in Clinician-Administered PTSD Scale score from baseline to 24 weeks
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Veterans Affairs Cooperative Study No. 504 randomised veterans with chronic military-related PTSD and persistent symptoms despite at least two adequate serotonin reuptake inhibitor trials to adjunctive risperidone up to 4 mg daily or placebo for six months at 23 VA outpatient centres between February 2007 and February 2010. Of 367 screened, 296 were diagnosed and 247 contributed to the primary analysis. Change in Clinician-Administered PTSD Scale score at 24 weeks was -16.3 (95% CI -19.7 to -12.9) on risperidone and -12.5 (95% CI -15.7 to -9.4) on placebo; the mean difference of 3.74 (95% CI -0.86 to 8.35) was not significant (t=1.6, P=0.11). A mixed model across all time points likewise showed no difference (mean difference 2.73, 95% CI -0.74 to 6.20, P=0.12). Risperidone did not reduce depression (MADRS mean difference 1.19, P=0.11) or anxiety (HAMA mean difference 1.16, P=0.09) and did not increase quality of life.
Source
Krystal JH et al., JAMA 2011;306:493-502 (VA Cooperative Study No. 504)
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
Four times the rate of gynaecomastia in young men taking it
In plain words
Risperidone raises prolactin, the hormone that drives breast tissue growth. In a database study of over 400,000 young men, those currently taking it were diagnosed with breast enlargement about four times as often as non-users, and five times as often among those aged eighteen and under.
What was measured
Adjusted rate ratio for incident gynaecomastia diagnosis in current risperidone users aged 15 to 25
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Etminan and colleagues built a cohort of 401,924 males aged 15 to 25 from the IMS LifeLink claims database and ran a nested case-control analysis, identifying 1,556 incident gynaecomastia diagnoses matched to 15,560 controls by age, follow-up and calendar time. Current risperidone users had an adjusted rate ratio of 3.91 (95% CI 2.01 to 7.62); restricted to those aged 18 and under, the rate ratio was 5.44 (95% CI 1.50 to 19.74). The mechanism is dopamine D2 blockade at pituitary lactotrophs, which sit outside the blood-brain barrier and are therefore fully exposed while central penetration is limited by P-glycoprotein efflux. In the pooled network meta-analysis of 32 antipsychotics, the prolactin elevation range ran to 48.51 ng/mL for paliperidone, risperidone's own active metabolite. This is claims data rather than a randomised trial, so confounding by indication cannot be excluded, but the pharmacological mechanism is not in dispute.
Source
Etminan M, Carleton B, Brophy JM, J Child Adolesc Psychopharmacol 2015;25:671-673
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
Fourth of fifteen on efficacy, and third of five in the independent trial
In plain words
Across 212 randomised trials, risperidone ranked fourth of fifteen antipsychotics on symptom reduction. In the eighteen-month independent trial that compared five drugs head to head, 74% of the risperidone arm stopped taking it.
What was measured
Standardised mean difference against placebo for overall symptom change, and 18-month all-cause discontinuation
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 trials and 43,049 patients, risperidone's standardised mean difference against placebo for overall symptom change was 0.56 (95% CrI 0.50 to 0.63), behind clozapine 0.88, amisulpride 0.66 and olanzapine 0.59, and ahead of paliperidone 0.50, haloperidol 0.45, quetiapine 0.44 and aripiprazole 0.43. In CATIE, 74% of the risperidone arm discontinued within 18 months against 64% on olanzapine (P=0.002 for the difference in time to discontinuation), 75% on perphenazine, 79% on ziprasidone and 82% on quetiapine. In the 2019 network meta-analysis of 32 drugs, risperidone was among those with significantly higher anticholinergic effects than placebo and among those requiring more antiparkinson medication than several newer agents.
Source
Leucht S et al., Lancet 2013;382:951-962; Lieberman JA et al., N Engl J Med 2005;353:1209-1223
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
In dementia, the class went from standard practice to boxed warning
In plain words
Antipsychotics including risperidone were routinely given to agitated residents of care homes. A pooled analysis of fifteen randomised trials found more deaths on drug than on placebo, and the FDA added a boxed warning to the whole class.
What was measured
That antipsychotics are an appropriate routine treatment for agitation in dementia — reversed by pooled randomised mortality data and a boxed warning
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Schneider and colleagues pooled fifteen randomised placebo-controlled trials of atypical antipsychotics in dementia, nine of them unpublished, covering 3,353 patients randomised to drug and 1,757 to placebo, with five of the sixteen drug-placebo contrasts contributed by risperidone. Death occurred in 3.5% on drug against 2.3% on placebo, odds ratio 1.54 (95% CI 1.06 to 2.23, P=0.02), risk difference 0.01 (95% CI 0.004 to 0.02, P=0.01). Sensitivity analyses found no evidence of differential risk between individual drugs. In the separate CATIE-AD trial of 421 outpatients, risperidone had the longest median time to discontinuation for lack of efficacy of any arm (26.7 weeks against 9.0 for placebo, P=0.002 across arms) but no significant advantage on the Clinical Global Impression of Change at 12 weeks (29% improved against 21% on placebo, P=0.22), and 18% discontinued for intolerability against 5% on placebo. The FDA added the class boxed warning for increased mortality in dementia-related psychosis in 2005.
Source
Schneider LS et al., JAMA 2005;294:1934-1943; Schneider LS et al., N Engl J Med 2006;355:1525-1538 (CATIE-AD, NCT00015548)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
The elderly and paediatric uses were promoted, and settled for US$2.2 billion in 2013
In plain words
In November 2013 Johnson & Johnson and Janssen agreed to pay more than two billion dollars to resolve United States criminal and civil investigations, with the promotion of risperidone for uses outside its licence among the conduct at issue.
What was measured
That the observed prescribing pattern in elderly and paediatric populations reflected accumulating clinical evidence
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The United States Department of Justice announced in November 2013 that Johnson & Johnson and its subsidiaries would pay more than US$2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective. Invega is paliperidone, risperidone's own active metabolite. The relevance here is the sequence: the elderly-dementia and paediatric prescribing patterns that the safety literature above was written to evaluate were, in part, produced by promotion that was later found unlawful, rather than by the trials that supported the licence.
Source
United States Department of Justice, Office of Public Affairs, 4 November 2013: "Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations"
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
The metabolite was relaunched as a separate branded drug at sixteen times the price
In plain words
When the body processes risperidone it produces a second active molecule. That molecule was developed and licensed as its own drug, Invega, shortly before risperidone lost patent protection. It is not more effective.
What was measured
That paliperidone is an improvement on risperidone — the pooled efficacy estimate is slightly lower, the prolactin elevation is the largest measured in the class, and the price is roughly sixteen times higher
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Paliperidone is 9-hydroxyrisperidone, the principal active metabolite of risperidone, licensed in 2006 under a separate application. In the 15-drug pooled ranking, paliperidone's standardised mean difference against placebo was 0.50 (95% CrI 0.39 to 0.60), below risperidone's 0.56 (0.50 to 0.63); the credible intervals overlap and neither can be called superior. On prolactin, paliperidone produced the largest elevation of the 32 drugs in the 2019 network meta-analysis, +48.51 ng/mL against placebo (95% CrI 43.52 to 53.51). Current United States pharmacy acquisition cost is about US$1.01 per paliperidone tablet against US$0.0644 per risperidone tablet. What paliperidone genuinely adds is renal rather than CYP2D6-dependent clearance and a monthly and three-monthly injectable range.
Source
Leucht S et al., Lancet 2013;382:951-962; Huhn M et al., Lancet 2019;394:939-951; CMS NADAC file
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

How many documents were read

  • 73 documents were read for this substance.

    RNAWiki source record

  • 67 of them state the same tMax, and they agree.

    RNAWiki source record

  • 69 of them state the same proteinBinding, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
L6UH7ZF8HC
CAS registry number
106266-06-2
PubChem compound
5073
RxNorm concept
35636

Checks this page had to pass

  • Passed

    Identity resolved

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  • Passed

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    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Reviewed first-read answer.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S6, S9.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead 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

  • 57 approved applications cover products containing this substance. The earliest was NDA020272, approved 19931229 to JANSSEN PHARMS.

    Drugs@FDA application register · NDA020272 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA020272 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19931229.

    FDA National Drug Code directory · 71610-246 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

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 tight-binding dopamine and serotonin blocker ranked fourth of fifteen antipsychotics on pooled efficacy, holder of the only convincing randomised result in autism-associated irritability (a 56.9% fall in the irritability score against 14.1% on placebo in 101 children), and the antipsychotic whose prolactin elevation produced a measured four-fold rise in gynaecomastia among males aged 15 to 25.

Recorded evidence blocks (10)

On the Risperidone label: indicated for what?


"Risperidone is an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 )…": indications and usage on Risperidone's label. DailyMed label · 701e1cd8-2868-4d29-85a9-a2212c88165f · 2026-08-20

379 registered trials of Risperidone — at which phases?


Registered studies posting no result
284 of 379

379 registered studies of Risperidone: 121 phase4, 95 phase3, 57 phase2, 49 na, 42 phase1, 26 na or unstated, 2 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

1645 with a PubMed record

Show the evidence
  • phase4
    121
  • phase3
    95
  • phase2
    57
  • na
    49
  • phase1
    42
  • na or unstated
    26
9 more recorded rows
  • early phase1
    2
  • completed
    281
  • terminated
    36
  • unknown
    34
  • withdrawn
    12
  • recruiting
    10
  • not yet recruiting
    3
  • active not recruiting
    2
  • enrolling by invitation
    1

recorded 2026-09-01 · last checked 2026-09-04

39 of Risperidone's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, other?


safety (3), futility/efficacy (3), accrual/recruitment (14), funding/business (3) and other (16): Risperidone's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Unable to recruit adequate number of subjects"; 39 of 379 registered studies

Show the evidence

Trial

  • NCT00000309
    terminated; "Unable to recruit adequate number of subjects"
  • NCT00178854
    withdrawn; "failed recruitment efforts"
  • NCT00256997
    terminated; "Inability to recruit number of planned patients"
  • NCT00287742
    terminated; "A decision was made to discontinue the study due to a change in the strategic direction of the company."
  • NCT00364429
    terminated; "terminated"
  • NCT00418873
    terminated; "Study was stopped due to difficulty in patient enrollment"
14 further recorded trials
  • NCT00511628
    terminated; "Due to the achievement of minimum required sample size and new changes in local regulations."
  • NCT00515489
    terminated; "Due to the achievement of minimum required sample size and new changes in local regulations."
  • NCT00629252
    terminated; "Not enough subjects have been recruited in the expected period."
  • NCT00645515
    terminated; "This study was terminated on November 20, 2003 because of poor recruitment. This study was not terminated due to safety/efficacy."
  • NCT00660595
    terminated; "To difficult to recruit patients in the acute setting"
  • NCT00712270
    terminated; "Study terminated due to failure to meet sufficient enrollment for valid analysis"
  • NCT00746252
    terminated; "Due low rate of participation and lack of funding"
  • NCT00910780
    withdrawn; "Study was not funded."
  • NCT00931996
    terminated; "Study was terminated due to low accrual."
  • NCT00946985
    terminated; "The recruitment rate for the study was inadequate to achieve its enrollment goals."
  • NCT00998608
    terminated; "terminated"
  • NCT01129674
    terminated; "The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population."
  • NCT01193166
    withdrawn; "This study was stopped due to an internal reconsideration of priorities of the product portfolio."
  • NCT01363349
    terminated; "pre-planned interim analysis of the Phase II/III CLARITY trial of BL-1020 indicate that the trial would not meet the pre-specified primary efficacy endpoint."

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Risperidone used Risperidone 2 mg — over how long?


studies of Risperidone used the recorded amount. ClinicalTrials.gov · 2026-09-01

12 recorded entries; human; capsule; also "Risperidone 2 mg", "Risperdal® Tablets, 1 mg", "Risperidone Tablet 1 mg"

Show the evidence

human

  • NCT00174200
    Risperidone 2 mg
  • NCT01064232
    Risperdal® Tablets, 1 mg
  • NCT01618760
    Risperidone Tablet 1 mg
  • NCT01625000
    Risperidone 4mg
  • NCT02100540
    capsule; RCN3028 0.3mg capsule
  • NCT02100540
    capsule; RCN3028 0.6mg capsule
6 more recorded rows
  • human NCT03227562
    RisperiDONE 0.5 MG
  • human NCT03713658
    Risperidone 3 mg
  • human NCT05179525
    Risperidone ISM® 100 mg
  • human NCT05179525
    Risperdal 4mg Tablet
  • human NCT05710237
    Risperidone 1 MG
  • human NCT06161792
    0.8 mg RCN3028

recorded 2026-09-01 · last checked 2026-09-04

Risperidone's half-life is 3 hours — which schedules were studied?


3 hours, the half-life Risperidone's label states: "The apparent half-life of risperidone was 3 hours (CV=30%) in extensive metabolizers and 20 hours (CV=40%) in poor metabolizers." DailyMed label · 701e1cd8-2868-4d29-85a9-a2212c88165f · 2026-08-20

tmax 1 hour; bioavailability 70 %.

Show the evidence
  • half life pharmacokinetics
    3 hours; The apparent half-life of risperidone was 3 hours (CV=30%) in extensive metabolizers and 20 hours (CV=40%) in poor metabolizers.
  • tmax pharmacokinetics
    1 hour; Following oral administration of solution or tablet, mean peak plasma concentrations of risperidone occurred at about 1 hour.
  • bioavailability pharmacokinetics
    70 %; The absolute oral bioavailability of risperidone is 70% (CV=25%).
  • metabolism pharmacokinetics
    Peak concentrations of 9-hydroxyrisperidone occurred at about 3 hours in extensive metabolizers, and 17 hours in poor metabolizers.

recorded 2026-08-20 · last checked 2026-09-04

Which 184 trials of Risperidone posted no result?


Posted no result
184 of 184 completed trials
Registrations
NCT00249132, NCT00249119, NCT00249145, NCT00253123, NCT00000342 and NCT00000347, and 178 more
Completion dates
oldest 1991-07; newest 2024-04-16
Show the evidence

Trial

  • NCT00249132
    1991-07
  • NCT00249119
    1991-12
  • NCT00249145
    1996-12
  • NCT00253123
    1997-03
  • NCT00000342
    1997-09
  • NCT00000347
    1998-09
14 further recorded trials
  • NCT00253110
    1998-09
  • NCT00266552
    1998-10
  • NCT00253149
    1999-04
  • NCT00000317
    1999-07
  • NCT00250354
    1999-08
  • NCT00250367
    1999-11
  • NCT00004393
    2000-09
  • NCT00253136
    2000-12
  • NCT00005014
    2001-02
  • NCT00249158
    2001-02
  • NCT00065273
    2001-06
  • NCT00829894
    2001-07
  • NCT00000267
    2001-12
  • NCT00158028
    2001-12

At the median, Risperidone's trials enrolled 96 people — anything larger?


Median enrolment
96
Largest enrolment
1037352
Registered trials counted
370

What do 11576 spontaneous reports say about Risperidone — 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.

Risperidone appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 11576 reaction mentions were counted: somnolence 1452; extrapyramidal disorder 1392; weight increased 1366; drug interaction 1329. FAERS via Open Targets · CHEMBL85 · 2026-06-24

Show the evidence
  • somnolence
    1452
  • extrapyramidal disorder
    1392
  • weight increased
    1366
  • drug interaction
    1329
  • suicide attempt
    1234
  • neuroleptic malignant syndrome
    1171
4 more recorded rows
  • aggression
    1034
  • psychotic disorder
    970
  • sedation
    868
  • dyskinesia
    760

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Risperidone's label not list?


aggression, drug interaction and dyskinesia and 7 more reported for Risperidone, absent from its label. FAERS via Open Targets · CHEMBL85 · 2026-06-24

2 label terms; 10 reported and unlisted; 701e1cd8-2868-4d29-85a9-a2212c88165f

Show the evidence
  • aggression
    count not stated
  • drug interaction
    count not stated
  • dyskinesia
    count not stated
  • extrapyramidal disorder
    count not stated
  • neuroleptic malignant syndrome
    count not stated
  • psychotic disorder
    count not stated
4 more recorded rows
  • sedation
    count not stated
  • somnolence
    count not stated
  • suicide attempt
    count not stated
  • weight increased
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Risperidone and CYP 2D6, CYP2D6 and CYP3A: shared by which compounds?


CYP 2D6, CYP2D6 and CYP3A appear in Risperidone's recorded interaction sentences, 8 in all. DailyMed label · 701e1cd8-2868-4d29-85a9-a2212c88165f · 2026-08-20

CYP2D6, CYP2D6, CYP3A, CYP3A, P-gp; 5 shared nodes; drug_interactions, pharmacokinetics

Show the evidence

Interaction statement

  • drug_interactions
    ( 7.1 ) Fluoxetine, paroxetine, and other CYP 2D6 enzyme inhibitors increase plasma concentrations of risperidone.
  • drug_interactions
    ( 7.1 ) 7.1 Pharmacokinetic-related Interactions The dose of risperidone should be adjusted when used in combination with CYP2D6 enzyme inhibitors (e.g., fluoxetine, and paroxetine) and enzyme inducers (e.g., carbamazepine) [see Table 18 and Dosage and Administration (2.5) ] .
  • drug_interactions
    Summary of Effect of Coadministered Drugs on Exposure to Active Moiety (Risperidone + 9-Hydroxy-Risperidone) in Healthy Subjects or Patients with Schizophrenia Coadministered Drug Dosing Schedule Effect on Active Moiety (Risperidone + 9-Hydroxy-Risperidone (Ratio Change relative to reference ) Risperidone Dose Recommendation Coadministered Drug Risperidone AUC C max Enzyme (CYP2D6) Inhibitors…
  • drug_interactions
    Do not exceed 8 mg/day 20 mg/day 4 mg/day 1.6 - 40 mg/day 4 mg/day 1.8 - Enzyme (CYP3A/ PgP inducers) Inducers Carbamazepine 573 ± 168 mg/day 3 mg twice daily 0.51 0.55 Titrate dose upwards.
  • drug_interactions
    Do not exceed twice the patient's usual dose Enzyme (CYP3A) Inhibitors Ranitidine 150 mg twice daily 1 mg single dose 1.2 1.4 Dose adjustment not needed Cimetidine 400 mg twice daily 1 mg single dose 1.1 1.3 Dose adjustment not needed Erythromycin 500 mg four times daily 1 mg single dose 1.1 0.94 Dose adjustment not needed Other Drugs Amitriptyline 50 mg twice daily 3 mg twice daily 1.2 1.1 Dose…
  • pharmacokinetics
    The main metabolic pathway is through hydroxylation of risperidone to 9-hydroxyrisperidone by the enzyme, CYP 2D6.
2 more recorded rows
  • Interaction statement pharmacokinetics
    CYP 2D6, also called debrisoquin hydroxylase, is the enzyme responsible for metabolism of many neuroleptics, antidepressants, antiarrhythmics, and other drugs.
  • Interaction statement pharmacokinetics
    CYP 2D6 is subject to genetic polymorphism (about 6%–8% of Caucasians, and a very low percentage of Asians, have little or no activity and are "poor metabolizers") and to inhibition by a variety of substrates and some non-substrates, notably quinidine.

CYP2D6

  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine

CYP3A

  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • P-gp
    FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine

recorded 2026-08-20 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL85
PubChem CID
5073
CAS number
106266-06-2
RxCUI
35636
InChIKey
RAPZEAPATHNIPO-UHFFFAOYSA-N
Development code
LY-03004, LY03004, N05AX08, NSC-759895, R 64 766, R-64766, RCN-3028, RCN3028
Trade name
Okedi, Perseris kit, Risperdal, Risperdal consta, Risperdal consta long acting, Risperdal m, Risperdal m-tab, Risperdal quicklet
Also called
Perseris, Risperidona, Risvan, Rykindo, Uzedy, atypical antipsychotic, ir risperidone, lai risperidone, long-acting injectable risperidone, long-acting risperidone, lyn-005, ris
Salt form
oral antipsychotic, oral antipsychotic medication, oral risperidone, risperidone long-acting injection, risperidone tablets
Sources (6)

Sources

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

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • 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

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