How does this medication work? What will it do for me?

Risperidone belongs to the group of medications known as antipsychotic agents. These medications are used to treat mental and emotional disorders such as schizophrenia and bipolar disorder. Schizophrenia can cause symptoms such as hallucinations (e.g., hearing, seeing, or sensing things that are not there), delusions, unusual suspiciousness, and emotional withdrawal. People with this condition may also feel depressed, anxious, or tense. Bipolar disorder was previously referred to as manic depressive illness; it causes alternating episodes of mania and depression.

Risperidone is also used for the short-term treatment of behavioural problems (such as verbal or physical aggression, suspiciousness, and agitation) in people with severe dementia of the Alzheimer type that has not responded to non-drug approaches and when there is a risk of harm to self or others.

Medications like risperidone are thought to work by correcting the function of nerve pathways in certain areas of the brain.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

0.25 mg
Each yellow, oval, biconvex, film-coated tablet debossed "RI 0.25" on one side and "G" on the other contains 0.25 mg of risperidone. Nonmedicinal ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch sodium lauryl sulfate, hydroxypropyl methylcellulose, purified water, titanium dioxide, propylene glycol, talc, and iron oxide.

0.5 mg
Each brownish-red, capsule-shaped, biconvex, film-coated tablet debossed with “M” on one side and “RI” score line “2” on the other contains 0.5 mg of risperidone. Nonmedicinal ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch sodium lauryl sulfate, hydroxypropyl methylcellulose, purified water, titanium dioxide, propylene glycol, talc, and iron oxide red.

1 mg
Each white, capsule-shaped, biconvex, film-coated tablet debossed with “M” on one side and “RI” score line “3” on the other contains 1 mg of risperidone. Nonmedicinal ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch sodium lauryl sulfate, hydroxypropyl methylcellulose, purified water, titanium dioxide, propylene glycol, and talc.

2 mg
Each orange, capsule-shaped, biconvex, film-coated tablet debossed with “M” on one side and “RI” score line “4” on the other contains 2 mg of risperidone. Nonmedicinal ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch sodium lauryl sulfate, hydroxypropyl methylcellulose, purified water, titanium dioxide, propylene glycol, talc, and FD&C Yellow No. 6/Sunset Yellow FCF Aluminum Lake.

3 mg
Each yellow, capsule-shaped, biconvex, film-coated tablet debossed with “M” on one side and “RI” score line “5” on the other contains 3 mg of risperidone. Nonmedicinal ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch sodium lauryl sulfate, hydroxypropyl methylcellulose, purified water, titanium dioxide, propylene glycol, talc, D&C Yellow No. 10 Aluminum Lake.

4 mg
Each green, capsule-shaped, biconvex, film-coated tablet debossed with “M” on one side and “RI” score line “6” on the other contains 4 mg of risperidone. Nonmedicinal ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch sodium lauryl sulfate, hydroxypropyl methylcellulose, purified water, titanium dioxide, propylene glycol, talc, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2/indigo carmine FCF aluminum.

How should I use this medication?

The dose of risperidone varies according to needs and the condition being treated.

For adults with schizophrenia, the dose is usually started at 1 mg to 2 mg per day (given either once or twice per day) and increased slowly over several days to 4 mg to 6 mg per day. Lower doses are often used for people with low blood pressure, kidney problems, or liver disease. The safety of risperidone has not been established beyond a maximum dose of 16 mg per day (8 mg given twice daily).

For seniors with schizophrenia, the dose is usually 0.25 mg given twice daily to a maximum daily dose of 3 mg.

For behavioural problems in people with severe Alzheimer type dementia, the usual starting dose is 0.25 mg twice a day. This dose is slowly increased every 2 to 4 days to a usual dose of 1 mg per day (0.5 mg twice a day). This dose may be increased to a maximum of 2 mg per day (1 mg twice a day).

For adults with mania associated with bipolar disorder, risperidone should be taken once daily, starting with 2 mg or 3 mg daily. This dose may be increased to a maximum of 6 mg daily.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Risperidone can be taken with or without meals. The oral solution should not be taken with cola or tea. Risperdal M-Tabs® should be used whole and not split into halves.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store risperidone at room temperature in a dry place (not the bathroom), protect it from light, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Risperidone should not be taken by anyone who is allergic to risperidone or to any of the ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • agitation
  • anxiety
  • constipation
  • difficulty sleeping and staying asleep
  • dizziness
  • diarrhea
  • dry mouth
  • headache
  • increased amount of saliva
  • indigestion
  • joint aches
  • muscle stiffness
  • nausea
  • restlessness
  • runny nose
  • trembling
  • unusual tiredness
  • vomiting
  • weight gain

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abnormal movements of the face, tongue or body
  • abdominal pain
  • anxiety
  • breast enlargement (men)
  • changes in sexual function
  • changes in vision
  • depression
  • difficulty concentrating
  • difficulty moving eyes
  • dizziness
  • fainting
  • faster heart rate
  • flu-like symptoms
  • high blood pressure
  • increased heart rate
  • infection of the lungs (pneumonia)
  • infection of the eye
  • infection of the ear
  • infection of the urinary tract
  • irritability
  • leakage of milk from breasts (women)
  • loss of balance control
  • mask-like face
  • menstrual changes
  • mood or mental changes
  • muscle twitching or spasms (of the face, neck, or body)
  • rigid muscles
  • skin rash
  • sleep disorder
  • slight muscle stiffness
  • slowed movements
  • swelling of the body, arms or legs
  • symptoms of a blood clot (e.g., swelling, pain and redness in an arm or leg; sudden chest pain, difficulty breathing or pounding heart beat)
  • tingling/prickling/numbness of skin
  • trembling
  • trouble speaking or swallowing
  • twisting movements of the body

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • confusion
  • complications of uncontrolled diabetes:
    • shortness of breath
    • confusion
    • loss of consciousness
  • dark urine with muscle tenderness or aching
  • an erection that lasts more than 4 hours without sexual stimulation
  • fast or irregular heartbeat
  • high fever
  • increased sweating
  • large changes in body temperature
  • loss of bladder control
  • reduced consciousness
  • seizures
  • severe muscle stiffness
  • signs of a heart attack:
    • discomfort or pain in the chest, back, neck, jaw, arms, or stomach
    • sweating
    • shortness of breath
    • nausea
    • lightheadedness
    • feeling of impending doom
  • signs of a stroke:
    • sudden weakness or numbness in the face, arms, or legs (often on one side of the body)
    • speech problems
    • vision problems
    • balance problems or dizziness
    • confusion
    • sudden severe headache with no known cause
  • suicidal thoughts
  • symptoms of a severe allergic reaction such as hives, itching, difficulty breathing, or swelling of the face, mouth, tongue or throat
  • symptoms of inflammation of pancreas:
    • severe abdominal pain
    • fever
    • nausea and vomiting
  • unusually high or low blood pressure
  • unusually pale skin

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

HEALTH CANADA ADVISORY

February 18, 2015

Health Canada has issued new information concerning the use of risperidone. To read the full report, visit Health Canada's website at www.hc-sc.gc.ca.

A previous advisory on Apo-Risperidone, Ava-Risperidone, CO Risperidone, Dom-Risperidone, Jamp-Risperidone, Mar-Risperidone, Mint-Risperidon, Mylan-Risperidone, phl-Risperidone, pms-Risperidone, pms-Risperidone ODT, Pro-Risperidone, RAN-Risperidone, Risperdal, Risperdal M-Tab, Risperidone by Meliapharm, Risperidone by Sanis Health, Riva-Risperidone, Sandoz Risperidone, and Teva-Risperidone (risperidone) was issued on November 14, 2013. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Body temperature regulation: Risperidone can cause body temperature changes. If you are taking this medication you should take precautions when there is a risk of exposure to extreme heat or cold, strenuous exercise, or dehydration, or if you are also taking anticholinergic medication. Discuss with your doctor about how to prevent body temperature issues.

Diabetes: A risk of aggravating pre-existing diabetes has been linked to risperidone and other antipsychotic medications. If you have diabetes or are at risk for diabetes (e.g., family history of diabetes, obesity), discuss with your doctor how this medication may affect your medical condition and whether any special monitoring is needed.

Drowsiness/reduced alertness: Risperidone may interfere with activities requiring mental alertness. Those taking this medication should not drive or operate machinery until they are reasonably certain that risperidone does not affect their ability to carry out these activities safely.

Heart conditions: If you have a heart condition such as angina, heart failure, irregular heartbeat, and if you have had a heart attack, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney problems: If you have kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver problems: If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Low blood pressure: Risperidone may cause a lowering of blood pressure when rising from a sitting or lying position, or a racing heart rate, especially during the few weeks of treatment. If you feel dizzy or lightheaded or feel your pulse is racing, and this feeling does not go away after a few minutes, call your doctor. Because this medication can cause dizziness or lightheadedness, do not get up too quickly after you have been sitting or lying for prolonged periods.

Low white blood cells: Risperidone may cause a lowering of white blood cells. If you have a history of low white blood cells or are on medication (e.g., chemotherapy) that can cause low white blood cells, monitor for any signs of fever or infection and seek medical attention if symptoms occur.

Neuroleptic malignant syndrome (NMS): Risperidone, like other antipsychotic medications, can cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS, get immediate medical attention. Symptoms include high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, and fainting.

Parkinson's disease: Risperidone may cause deterioration in the condition of people with Parkinson's disease. If you have Parkinson's disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Phenylalanine: Orally disintegrating risperidone tablets contain phenylalanine.

Seizures: Risperidone may increase the risk of seizures, especially in people who have had seizures in the past. If you have a seizure disorder or a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Tardive dyskinesia (TD): This syndrome consists of potentially irreversible, involuntary, and repetitive movements of the face and tongue muscles that may develop in people who take certain antipsychotic medications. Although TD appears most commonly in seniors (especially women), it is impossible to predict who will develop TD. The risk of developing TD increases with higher doses and long-term treatment. If signs and symptoms of TD develop during treatment with risperidone, contact your doctor as soon as possible.

Weight gain: With long-term treatment, weight gain (averaging 2.3 kg) has occurred in those who take this medication.

Pregnancy: The safety of risperidone for use during pregnancy has not been established. Risperidone should not be used during pregnancy unless the expected benefits outweigh the potential risks. If you become pregnant while taking risperidone, contact your doctor immediately.

Breast-feeding: Risperidone passes into breast milk. Women should not breast-feed while taking risperidone.

Children and adolescents: The safety and effectiveness of risperidone have not been established for use by children and adolescents under 18 years of age.

Seniors: There may be a higher risk of strokes, heart attacks, and deaths associated with the use of risperidone by people with dementia. Talk to your doctor about the risks and benefits of using this medication. If you notice the following signs and symptoms, get medical attention immediately:

  • signs of a stroke: sudden weakness or numbness in the face, arms or legs (often on one side of the body); speech problems; vision problems; balance problems or dizziness; confusion; sudden severe headache with no known cause
  • signs of a heart attack: discomfort or pain in the chest, back, neck, jaw, arms, or stomach; sweating; shortness of breath; nausea; lightheadedness; feeling of impending doom

What other drugs could interact with this medication?

There may be an interaction between risperidone and any of the following:

  • alcohol
  • amiodarone
  • blood-pressure-lowering medications
  • bromocriptine
  • buprenorphine
  • bupropion
  • carbamazepine
  • certain "azole" antifungal medications (e.g., fluconazole, ketoconazole, voriconazole)
  • cimetidine
  • chloroquine
  • clozapine
  • darunavir
  • divalproex
  • domperidone
  • donepezil
  • dopamine agonists (e.g., pramipexole, ropinirole)
  • fluoroquinolone antibiotics (e.g., ciprofloxacin, norfloxacin)
  • fluphenazine
  • furosemide
  • haloperidol
  • ipratropium
  • levodopa
  • lithium
  • certain HIV medications (e.g., lopinavir, ritonavir)
  • macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
  • metoclopramide
  • opioid pain relievers (e.g., codeine, morphine, oxycodone)
  • propafenone
  • quetiapine
  • quinidine
  • quinine
  • ritonavir
  • rivastigmine
  • sedating medications
  • SSRI antidepressants (e.g., citalopram, fluoxetine, sertraline)
  • terbinafine
  • thioridazine
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine)
  • topiramate
  • valproic acid
  • venlafaxine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.