Risperidone | Drugs | BNF content published by NICE (2023)

Drug action

Drug action For risperidone

Risperidone is a dopamine D₂, 5-HT_2A, alpha₁-adrenoceptor, and histamine-1 receptor antagonist.

Indications and dose

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For risperidone

Acute and chronic psychosis for risperidone

By mouth

Adult: 2mg daily in 1–2 divided doses for day 1, then 4mg daily in 1–2 divided doses for day 2, slower titration is appropriate in some patients, usual dose 4–6mg daily, doses above 10mg daily only if benefit considered to outweigh risk; maximum 16mg per day.
Elderly: Initially 500micrograms twice daily, then increased in steps of 500micrograms twice daily, increased to 1–2mg twice daily.

Mania for risperidone

By mouth

Adult: Initially 2mg once daily, then increased in steps of 1mg daily if required; usual dose 1–6mg daily.
Elderly: Initially 500micrograms twice daily, then increased in steps of 500micrograms twice daily, increased to 1–2mg twice daily.

Short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer's dementia unresponsive to non-pharmacological interventions and when there is a risk of harm to self or others for risperidone

By mouth

Adult: Initially 250micrograms twice daily, then increased in steps of 250micrograms twice a day on alternate days, adjusted according to response; usual dose 500micrograms twice daily (max. per dose 1mg twice daily).

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For Okedi® pre-filled syringes

Schizophrenia [in patients stabilised on oral risperidone 3mg daily] for Okedi® pre-filled syringes

By deep intramuscular injection

Adult: Initially 75mg every 28days, treatment to be initiated about 24 hours after the last oral risperidone dose. Before treatment initiation risperidone-naïve patients should be titrated with oral risperidone for at least 14 days; patients stabilised on other oral antipsychotics, but with previous response to risperidone, should be titrated with oral risperidone for at least 6 days. Those stabilised on oral risperidone may be switched without titration; increased if necessary up to 100mg every 28days, dose to be adjusted at intervals of 28 days; usual maintenance 75mg every 28days, dose may be given up to 3 days before the 28-day time point.

Schizophrenia [in patients stabilised on oral risperidone 4mg daily or more] for Okedi® pre-filled syringes

By deep intramuscular injection

Adult: Initially 100mg every 28days, treatment to be initiated about 24 hours after the last oral risperidone dose. Before treatment initiation risperidone-naïve patients should be titrated with oral risperidone for at least 14 days; patients stabilised on other oral antipsychotics, but with previous response to risperidone, should be titrated with oral risperidone for at least 6 days. Those stabilised on oral risperidone may be switched without titration, dose to be adjusted as necessary at intervals of 28 days; usual maintenance 75mg every 28days, dose may be given up to 3 days before the 28-day time point.

Schizophrenia [in patients switching from intramuscular risperidone 37.5mg every 2 weeks] for Okedi® pre-filled syringes

By deep intramuscular injection

Adult: 75mg every 28days, treatment to be initiated 2 weeks after the last bi-weekly injection, dose may be given up to 3 days before the 28-day time point.

Schizophrenia [in patients switching from intramuscular risperidone 50mg every 2 weeks] for Okedi® pre-filled syringes

By deep intramuscular injection

Adult: 100mg every 28days, treatment to be initiated 2 weeks after the last bi-weekly injection, dose may be given up to 3 days before the 28-day time point.

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For Risperdal Consta® injection

Schizophrenia [in patients stabilised on oral antipsychotics e.g. risperidone up to 4mg daily for 2 weeks or more] for Risperdal Consta® injection

By deep intramuscular injection

Adult: Initially 25mg every 2weeks, oral antipsychotics should be continued during the first 3 weeks of treatment; increased if necessary up to 37.5–50mg every 2weeks, dose to be increased at intervals of at least 4 weeks; usual maintenance 25mg every 2weeks.

Schizophrenia [in patients stabilised on oral antipsychotics e.g. risperidone over 4mg daily] for Risperdal Consta® injection

By deep intramuscular injection

Adult: Initially 37.5mg every 2weeks, oral antipsychotics should be continued during the first 3 weeks of treatment; increased if necessary up to 50mg every 2weeks, dose to be increased at intervals of at least 4 weeks.

Important safety information

Important safety information For risperidone

Safe Practice

Risperidone has been confused with ropinirole; care must be taken to ensure the correct drug is prescribed and dispensed.

MHRA/CHM advice: Clozapine and other antipsychotics: monitoring blood concentrations for toxicity (August 2020)

Following fatal cases involving toxicity of clozapine and other antipsychotic medicines, the MHRA advises that monitoring blood concentration of risperidone may be helpful in certain circumstances, such as patients presenting symptoms suggestive of toxicity, or when concomitant medicines may interact to increase blood concentration of risperidone.

Contra-indications

Contra-indications For risperidone

With intramuscular use

Children

Cautions

Cautions For all antipsychotic drugs

Blood dyscrasias; cardiovascular disease; conditions predisposing to seizures; depression; diabetes (may raise blood glucose); epilepsy; history of jaundice; myasthenia gravis; Parkinson’s disease (may be exacerbated); photosensitisation (may occur with higher dosages); prostatic hypertrophy; severe respiratory disease; susceptibility to angle-closure glaucoma

Cautions, further information

Cardiovascular disease

An ECG may be required, particularly if physical examination identifies cardiovascular risk factors, personal history of cardiovascular disease, or if the patient is being admitted as an inpatient.

Elderly

Prescription potentially inappropriate (STOPP criteria):

for all antipsychotics (other than quetiapine and clozapine) in patients with parkinsonism or Lewy Body Disease (risk of severe extrapyramidal symptoms)
in behavioural and psychological symptoms of dementia (BPSD), unless symptoms are severe and other non-pharmacological treatments have failed (increased risk of stroke)
for use as a hypnotic, unless sleep disorder is due to psychosis or dementia (risk of confusion, hypotension, extrapyramidal side-effects and falls)
in patients prone to falls (may cause gait dyspraxia, parkinsonism)
if prescribed a phenothiazine (other than prochlorperazine for nausea, vomiting or vertigo; chlorpromazine for relief of persistent hiccups; levomepromazine as an antiemetic in palliative care) as first-line treatment (sedative, significant antimuscarinic (anticholinergic) toxicity in older people, and safer and more efficacious alternatives exist)—
if prescribed an antipsychotic drug with moderate or marked antimuscarinic effects (e.g. chlorpromazine, clozapine, flupenthixol, fluphenazine, pipothiazine, promazine and zuclopenthixol) in patients with a history of prostatism or urinary retention (high risk of urinary retention).

Cautions For risperidone

Avoid in Acute porphyrias; cataract surgery (risk of intra-operative floppy iris syndrome); dehydration; dementia with Lewy bodies; prolactin-dependent tumours

Interactions

View interactions for risperidone

Side-effects

Side-effects For all antipsychotic drugs

Common or very common

Agitation; amenorrhoea; arrhythmias; constipation; dizziness; drowsiness; dry mouth; erectile dysfunction; fatigue; galactorrhoea; gynaecomastia; hyperglycaemia; hyperprolactinaemia; hypotension (dose-related); insomnia; leucopenia; movement disorders; muscle rigidity; neutropenia; parkinsonism; postural hypotension (dose-related); QT interval prolongation; rash; seizure; tremor; urinary retention; vomiting; weight increased

Uncommon

Agranulocytosis; confusion; embolism and thrombosis; neuroleptic malignant syndrome (discontinue—potentially fatal)

Rare or very rare

Sudden death; withdrawal syndrome neonatal

Side-effects, further information

For depot antipsychotics—side-effects may persist until the drug has been cleared from its depot site.

Overdose

Phenothiazines cause less depression of consciousness and respiration than other sedatives. Hypotension, hypothermia, sinus tachycardia, and arrhythmias may complicate poisoning. For details on the management of poisoning see Antipsychotics under Emergency treatment of poisoning.

Side-effects For risperidone

Common or very common

Anaemia; anxiety; appetite abnormal; asthenia; chest discomfort; conjunctivitis; cough; depression; diarrhoea; dyspnoea; epistaxis; fall; fever; gastrointestinal discomfort; headache; hypertension; increased risk of infection; joint disorders; laryngeal pain; muscle spasms; nasal congestion; nausea; oedema; oral disorders; pain; sexual dysfunction; skin reactions; sleep disorders; urinary disorders; vision disorders; weight decreased

Uncommon

Alopecia; breast abnormalities; cardiac conduction disorders; cerebrovascular insufficiency; chills; coma; concentration impaired; consciousness impaired; cystitis; diabetes mellitus; dry eye; dysarthria; dysphagia; dysphonia; ear pain; eye disorders; feeling abnormal; flushing; gait abnormal; gastrointestinal disorders; induration; malaise; menstrual cycle irregularities; mood altered; muscle weakness; palpitations; polydipsia; posture abnormal; procedural pain; respiratory disorders; sensation abnormal; syncope; taste altered; thirst; thrombocytopenia; tinnitus; vaginal discharge; vertigo

Rare or very rare

Angioedema; catatonia; dandruff; diabetic ketoacidosis; eyelid crusting; glaucoma; hypoglycaemia; hypothermia; jaundice; pancreatitis; peripheral coldness; rhabdomyolysis; SIADH; sleep apnoea; water intoxication; withdrawal syndrome

Frequency not known

Cardiac arrest; severe cutaneous adverse reactions (SCARs)

Pregnancy

Pregnancy For all antipsychotic drugs

Extrapyramidal effects and withdrawal syndrome have been reported occasionally in the neonate when antipsychotic drugs are taken during the third trimester of pregnancy. Following maternal use of antipsychotic drugs in the third trimester, neonates should be monitored for symptoms including agitation, hypertonia, hypotonia, tremor, drowsiness, feeding problems, and respiratory distress.

Pregnancy For risperidone

Use only if potential benefit outweighs risk.

Breast feeding

Breast feeding For all antipsychotic drugs

There is limited information available on the short- and long-term effects of antipsychotic drugs on the breast-fed infant. Animal studies indicate possible adverse effects of antipsychotic medicines on the developing nervous system. Chronic treatment with antipsychotic drugs whilst breast-feeding should be avoided unless absolutely necessary. Phenothiazine derivatives are sometimes used in breast-feeding women for short-term treatment of nausea and vomiting.

Breast feeding For risperidone

Use only if potential benefit outweighs risk—small amount present in milk.

Hepatic impairment

Hepatic impairment For risperidone

Caution. M

Dose adjustments

With oral use:

Dose reduction to half the usual dose, and slower dose titration. M

Hepatic impairment For Okedi® pre-filled syringes

Caution (no information available)—increased risk of exposure. M

Dose adjustments

Careful titration with oral risperidone, by halving initial doses and slowing titration, is recommended; if an oral dose of at least 3mg daily is tolerated, treatment with 75mg as a deep intramuscular depot injection may be initiated. M

Hepatic impairment For Risperdal Consta® injection

Caution (no information available). M

Dose adjustments

If an oral dose of at least 2mg daily is tolerated, 25mg as a deep intramuscular depot injection can be given every 2 weeks. M

Renal impairment

Renal impairment For risperidone

Caution. M

Dose adjustments

With oral use:

Initial and subsequent doses should be halved, with slower dose titration. M

Renal impairment For Okedi® pre-filled syringes

Avoid in moderate to severe impairment (no information available). M

Renal impairment For Risperdal Consta® injection

Caution (no information available). M

Dose adjustments

If an oral dose of at least 2mg daily is tolerated, 25mg as a deep intramuscular depot injection can be given every 2 weeks. M

Monitoring requirements

Monitoring requirements For all antipsychotic drugs

Monitoring of patient parameters For all antipsychotic drugs

It is advisable to monitor prolactin concentration at the start of therapy, at 6 months, and then yearly. Patients taking antipsychotic drugs not normally associated with symptomatic hyperprolactinaemia should be considered for prolactin monitoring if they show symptoms of hyperprolactinaemia (such as breast enlargement and galactorrhoea).

Patients with schizophrenia should have physical health monitoring (including cardiovascular disease risk assessment) at least once per year.

Monitoring requirements For risperidone

Monitoring of patient parameters For risperidone

With intramuscular use

Treatment requires careful monitoring for optimum effect.

Treatment cessation

Treatment cessation For all antipsychotic drugs

There is a high risk of relapse if medication is stopped after 1–2 years. Withdrawal of antipsychotic drugs after long-term therapy should always be gradual and closely monitored to avoid the risk of acute withdrawal syndromes or rapid relapse. Patients should be monitored for 2 years after withdrawal of antipsychotic medication for signs and symptoms of relapse.

Directions for administration

Directions for administration For risperidone

With oral use:

Orodispersible tablets should be placed on the tongue, allowed to dissolve and swallowed.

Manufacturer advises oral liquid may be diluted with any non-alcoholic drink, except tea.

With intramuscular use:

Use correct injection technique (including the use of z-track technique) and rotate injection sites.

Directions for administration For Okedi® pre-filled syringes

Inject into the deltoid or gluteal muscle. M

Directions for administration For Risperdal Consta® injection

Inject into the deltoid or gluteal muscle. M

Prescribing and dispensing information

Prescribing and dispensing information For all antipsychotic drugs

Patient decision aid

Antipsychotic medicines for treating agitation, aggression and distress in people living with dementia. National Institute for Health and Care Excellence. June 2018.

https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-guidelines/shared-decision-making

Handling and storage

Handling and storage For Risperdal Consta® injection

Store in a refrigerator (2–8℃) and protect from light; may be stored at room temperature (below 25℃) for up to 7 days—consult product literature about storage after reconstitution.

Patient and carer advice

Patient and carer advice For all antipsychotic drugs

As photosensitisation may occur with higher dosages, patients should avoid direct sunlight.

Driving and skilled tasks

Drowsiness may affect performance of skilled tasks (e.g. driving or operating machinery), especially at start of treatment; effects of alcohol are enhanced.

Patient and carer advice For risperidone

With oral use:

Patients or carers should be given advice on how to administer risperidone orodispersible tablets and oral liquid (counselling on use of dose syringe advised).

Medicinal forms

There can be variation in the licensing of different medicines containing the same drug.

Forms available from special-order manufacturers include: oral solution.

View all medicinal forms and pricinginformation

Or jump straight to:

Tablet
Orodispersible tablet
Oral solution
Powder and solvent for suspension for injection
Powder and solvent for prolonged-release suspension for inj

Essential tremor, chorea, tics, and related disorders
Mania and hypomania
Psychoses and related disorders

Other drugs in class

Other drugs in classAntipsychotics, second-generation

Amisulpride
Aripiprazole
Asenapine
Cariprazine
Clozapine
Lurasidone hydrochloride
Olanzapine
Paliperidone
Quetiapine

Other drugs in classAntipsychotics, second-generation (depot injections)

Aripiprazole
Olanzapine embonate
Paliperidone