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risperidone

Generic Name: risperidone (oral) (ris PER i done)
Brand Name: RisperDAL, RisperDAL M-Tab

What is risperidone?

Risperidone is a antipsychotic medicine. It works by changing the effects of chemicals in the brain.

Risperidone is used to treat schizophrenia in adults and children who are at least 13 years old.

Risperidone is also used to treat symptoms of bipolar disorder (manic depression) in adults and children who are at least 10 years old.

Risperidone is also used to treat symptoms of irritability in autistic children who are 5 to 16 years old.

Risperidone may also be used for purposes not listed in this medication guide.

Important Information

Risperidone is not approved for use in psychotic conditions related to dementia. Risperidone may increase the risk of death in older adults with dementia-related conditions.

Before taking this medicine

You should not use risperidone if you are allergic to it.

Risperidone is not approved for use in psychotic conditions related to dementia. Risperidone may increase the risk of death in older adults with dementia-related conditions.

To make sure risperidone is safe for you, tell your doctor if you have ever had:

The risperidone orally disintegrating tablet may contain phenylalanine. Talk to your doctor before using this form of risperidone if you have phenylketonuria (PKU).

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking risperidone, do not stop taking it without your doctor's advice.

Risperidone can pass into breast milk and may cause side effects in the nursing baby. You should not breast-feed while using this medicine.

Do not give this medicine to a child without a doctor's advice.

How should I take risperidone?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Risperidone can be taken with or without food.

To take the orally disintegrating tablet (Risperdal M-Tabs):

  • Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.

  • Use dry hands to remove the tablet and place it in your mouth.

  • Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Use risperidone regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not mix the risperidone liquid with cola or tea.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture, heat, and light. Do not liquid medicine to freeze.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe drowsiness, fast heart rate, feeling light-headed, fainting, and restless muscle movements in your eyes, tongue, jaw, or neck.

What should I avoid while taking risperidone?

Risperidone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

While you are taking risperidone, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

Risperidone side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

  • breast swelling or tenderness (in men or women), nipple discharge, impotence, lack of interest in sex, missed menstrual periods;

  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

  • low white blood cells--sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

  • low levels of platelets in your blood--easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or

  • penis erection that is painful or lasts 4 hours or longer.

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Risperidone dosing information

Usual Adult Dose for Schizophrenia:

Oral Formulations:
-Initial dose: 2 mg orally per day
-Titration dose: May increase in increments of 1 to 2 mg per day at interval of 24 hours or more, as tolerated.
-Maintenance dose: 2 to 8 mg orally per day
-Maximum dose: 16 mg orally per day

Oral Formulation Comments:
-May be administered orally once a day or in divided doses twice a day.
-Doses above 12 mg per day were not demonstrated to be more efficacious and were associated with more extrapyramidal symptoms and other adverse effects.
-Patients who respond to acute treatment doses should be maintained on the effective dose beyond the acute episode.
-Patients should be periodically reassessed to determine the continued need for treatment.

Long-acting IM Injection:
-Initial dose: 25 mg IM every 2 weeks
-Titration dose: May increase to 37.5 mg or 50 mg if needed; dose titration should occur no more frequently than every 4 weeks as expected drug release starts 3 weeks after injection.
-Maximum dose: 50 mg IM every 2 weeks

Long-acting IM Injection Comments:
-For patients who have never taken oral risperidone, it is recommended to establish tolerability with the oral formulation prior to initiating treatment with long acting injection.
-This formulation should be administered by a health care professional as deep IM deltoid or gluteal injection; do not administer IV.
-To ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of drug from the injection, oral risperidone (or another antipsychotic drug) should be given for 3 weeks following the first injection.
-Some patients not responding to the 25 mg dose may benefit from a 37.5 mg or 50 mg dose, and some patients who have a history of poor tolerability to psychotropic medications may benefit from a lower initial dose of 12.5 mg, however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Use: Treatment of schizophrenia

Usual Adult Dose for Bipolar Disorder:

Oral Formulations:
-Initial dose: 2 to 3 mg orally per day
-Titration dose: May increase in increments of 1 mg per day at interval of 24 hours or more, as tolerated.
-Maximum dose: 6 mg orally per day

Oral Formulation Comments:
-The effective dose range is 1 to 6 mg orally per day.
-May be administered orally once a day or in divided doses twice a day.
-Patients experiencing somnolence may benefit from twice a day dosing.
-There are no systematically obtained data to support the use of this drug in maintenance treatment.

Long-acting IM Injection:
-Initial dose: 25 mg IM every 2 weeks
-Titration dose: May increase to 37.5 mg or 50 mg if needed; dose titration should occur no more frequently than every 4 weeks as expected drug release starts 3 weeks after injection.
-Maximum dose: 50 mg IM every 2 weeks

Long-acting IM Injection Comments:
-For patients who have never taken oral risperidone, it is recommended to establish tolerability with oral formulation prior to initiating treatment with long acting injection.
-This formulation should be administered by a health care professional as deep IM deltoid or gluteal injection; do not administer IV.
-To ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of drug from the injection, oral risperidone (or another antipsychotic drug) should be given for 3 weeks following the first injection.
-Some patients not responding to the 25 mg dose may benefit from a 37.5 mg or 50 mg dose, and some patients who have a history of poor tolerability to psychotropic medications may benefit from a lower initial dose of 12.5 mg, however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Use: As monotherapy or as adjunctive therapy with lithium or valproate for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder

Usual Geriatric Dose for Schizophrenia:

Oral Formulations:
-Initial dose: 0.5 mg orally twice a day
-Titration dose: May increase in increments of 1 to 2 mg per day at interval of 24 hours or more, as tolerated.
-Maintenance dose: 2 to 8 mg orally per day
-Maximum dose: 16 mg/day

Oral Formulation Comments:
-May be administered orally once a day or in divided doses twice a day.
-Elderly patients exhibit a greater tendency to orthostatic hypotension, careful titration with monitoring of orthostatic vital signs should be considered.
-Doses above 12 mg per day were not demonstrated to be more efficacious and were associated with more extrapyramidal symptoms and other adverse effects.
-Patients who respond to acute treatment doses should be maintained on the effective dose beyond the acute episode.
-Patients should be periodically reassessed to determine the continued need for treatment.

Long-acting IM Injection:
-Initial dose: 25 mg IM every 2 weeks
-Titration dose: May increase to 37.5 mg or 50 mg if needed; dose titration should occur no more frequently than every 4 weeks as expected drug release starts 3 weeks after injection.
-Maximum dose: 50 mg IM every 2 weeks

Long-acting IM Injection Comments:
-For patients who have never taken oral risperidone, it is recommended to establish tolerability with oral formulation prior to initiating treatment with long acting injection.
-Should be administered by a health care professional as deep IM deltoid or gluteal injection; do not administer IV.
-Elderly patients exhibit a greater tendency to orthostatic hypotension, careful titration with monitoring of orthostatic vital signs should be considered.
-To ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of drug from the injection, oral risperidone (or another antipsychotic drug) should be given for 3 weeks following the first injection.
-Some patients not responding to the 25 mg dose may benefit from a 37.5 mg or 50 mg dose, and some patients who have a history of poor tolerability to psychotropic medications may benefit from a lower initial dose of 12.5 mg, however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Use: Treatment of schizophrenia

Usual Geriatric Dose for Bipolar Disorder:

Oral Formulations:
-Initial dose: 0.5 mg orally twice a day
-Titration dose: May increase in increments of 1 mg per day at interval of 24 hours or more, as tolerated.
-Maximum dose: 6 mg/day

Oral Formulation Comments:
-The effective dose range is 1 to 6 mg per day.
-May be administered orally once a day or in divided doses twice a day; patients experiencing somnolence may benefit from twice a day dosing.
-Elderly patients exhibit a greater tendency to orthostatic hypotension, careful titration with monitoring of orthostatic vital signs should be considered.
-There are no systematically obtained data to support the use of this drug in maintenance treatment.

Long-acting IM Injection:
-Initial dose: 25 mg IM every 2 weeks
-Titration dose: May increase to 37.5 mg or 50 mg if needed; dose titration should occur no more frequently than every 4 weeks as expected drug release starts 3 weeks after injection.
-Maximum dose: 50 mg IM every 2 weeks

Long-acting IM Injection Comments:
-For patients who have never taken oral risperidone, it is recommended to establish tolerability with oral formulation prior to initiating treatment with long acting injection.
-Should be administered by a health care professional as deep IM deltoid or gluteal injection; do not administer IV.
-Elderly patients exhibit a greater tendency to orthostatic hypotension, careful titration with monitoring of orthostatic vital signs should be considered.
-To ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of drug from the injection, oral risperidone (or another antipsychotic drug) should be given for 3 weeks following the first injection.
-Some patients not responding to the 25 mg dose may benefit from a 37.5 mg or 50 mg dose, and some patients who have a history of poor tolerability to psychotropic medications may benefit from a lower initial dose of 12.5 mg, however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Use: As monotherapy or as adjunctive therapy with lithium or valproate for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder

Usual Pediatric Dose for Schizophrenia:

13 years or older:
-Initial dose: 0.5 mg orally once a day
-Titration dose: May increase in increments of 0.5 mg to 1 mg per day at interval of 24 hours or more, as tolerated.
-Maintenance dose: 3 mg orally per day
-Maximum dose: 6 mg orally per day

Comments:
-May be administered orally once a day or in divided doses twice a day; patients experiencing somnolence may benefit from twice a day dosing.
-Doses greater than 6 mg per day have not been studied.
-Patients who respond to acute treatment doses should be maintained on the effective dose beyond the acute episode.
-Patients should be periodically reassessed to determine the continued need for treatment.

Use: Treatment of schizophrenia

Usual Pediatric Dose for Bipolar Disorder:

10 years or older:
-Initial dose: 0.5 mg orally once a day
-Titration dose: May increase in increments of 0.5 mg to 1 mg per day at interval of 24 hours or more, as tolerated.
-Maximum dose: 6 mg orally per day

Comments:
-The effective dose range is 1 to 2.5 mg per day.
-May be administered orally once a day or in divided doses twice a day; patients experiencing somnolence may benefit from twice a day dosing.
-There are no systematically obtained data to support the use of this drug in maintenance treatment.

Use: As monotherapy or as adjunctive therapy with lithium or valproate for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder

Usual Pediatric Dose for Autism:

5 to 17 years:
Greater than 15 kg and less than 20 kg:
-Initial dose: 0.25 mg orally once a day
-Titration: after a minimum of 4 days, may increase to 0.5 mg per day; maintain this dose for a minimum of 14 days; subsequent dose increases may be made in increments of 0.25 mg at intervals of 2 weeks or more, as tolerated.
-Maintenance dose: Once sufficient clinical response has been achieved and maintained, healthcare providers should consider gradually reducing the dose to achieve the optimal balance of safety and efficacy.

20 kg or greater:
-Initial dose: 0.5 mg orally once a day
-Titration: After a minimum of 4 days, may increase to 1 mg per day; maintain this dose for a minimum of 14 days; subsequent dose increases in increments of 0.5 mg at intervals of 2 weeks or more, as tolerated.
-Maintenance dose: Once sufficient clinical response has been achieved and maintained, healthcare providers should consider gradually reducing the dose to achieve the optimal balance of safety and efficacy.

Comments:
-Dosing data is not available for children weighing less than 15 kg.
-The effective dose range is 0.5 to 3 mg per day.
-This drug may be administered orally once a day or in divided doses twice a day; patients experiencing somnolence may benefit from twice a day dosing.

Use: Treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods

What other drugs will affect risperidone?

Taking risperidone with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using, especially:

This list is not complete. Other drugs may interact with risperidone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about risperidone.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 20.05.

Date modified: January 03, 2018
Last reviewed: July 11, 2017

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