Risperidone is an antipsychotic medicine that 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 is not approved for use in older adults with dementia-related psychosis.

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

While you are taking this medicine, 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. It is easier to become dangerously overheated and dehydrated while you are taking this medication.

Risperidone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of this medicine.

Stop using this medicine and call your doctor at once if you have fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, feeling light-headed, or fainting.

Before taking this medicine

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

Risperidone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

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

• heart disease, high blood pressure, heart rhythm problems, stroke or heart attack;

• diabetes (or risk factors such as obesity or family history of diabetes);

• low white blood cell (WBC) counts;

• liver or kidney disease;

• seizures;

• breast cancer;

• low bone mineral density;

• trouble swallowing;

• Parkinson's disease; or

• if you are dehydrated.

The risperidone orally disintegrating tablet may contain phenylalanine. Tell your doctor 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.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of risperidone on the baby.

This medicine may temporarily affect fertility (ability to have children) in women.

Risperidone can pass into breast milk and may cause side effects in the baby. If you breast-feed while using this medicine, tell your doctor if the baby has symptoms such as drowsiness, tremors, or involuntary muscle movements.

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

Risperidone comes as a tablet, a solution (liquid), and an orally disintegrating tablet (tablet that dissolves quickly in the mouth) to take by mouth. It is usually taken once or twice a day with or without food. Take risperidone at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take risperidone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Use the oral dosing syringe provided to measure your dose of risperidone oral solution. You can take the oral solution with water, orange juice, coffee, or low-fat milk. Do not take the solution with tea or cola.

Do not try to push the orally disintegrating tablet through the foil. Instead, use dry hands to peel back the foil packaging. Immediately take out the tablet and place it on your tongue. The tablet will quickly dissolve and can be swallowed with or without liquid. Do not chew or crush the tablet.

Your doctor will probably start you on a low dose of risperidone and gradually increase your dose to allow your body to adjust to the medication.

Risperidone may help control your symptoms but will not cure your condition. It may take several weeks or longer before you feel the full benefit of risperidone. Continue to take risperidone even if you feel well. Do not stop taking risperidone without talking to your doctor. If you suddenly stop taking risperidone, your symptoms may return and your illness may become harder to treat.

Take risperidone exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Risperidone can be taken with or without food.

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Do not mix the liquid medicine 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.

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

Risperidone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

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

• heart disease, high blood pressure, heart rhythm problems, stroke or heart attack;

• diabetes (or risk factors such as obesity or family history of diabetes);

• low white blood cell (WBC) counts;

• liver or kidney disease;

• seizures;

• breast cancer;

• low bone mineral density;

• trouble swallowing;

• Parkinson's disease; or

• if you are dehydrated.

The risperidone orally disintegrating tablet may contain phenylalanine. Tell your doctor 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.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of risperidone on the baby.

This medicine may temporarily affect fertility (ability to have children) in women.

Risperidone can pass into breast milk and may cause side effects in the baby. If you breast-feed while using this medicine, tell your doctor if the baby has symptoms such as drowsiness, tremors, or involuntary muscle movements.

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

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Always store the orally disintegrating tablets in their sealed package, and use them immediately after opening the package.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid driving or hazardous activity until you know how risperidone will affect you. Your reactions could be impaired.

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.

Get emergency medical help if you have signs of an allergic reaction to risperidone: 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, dry mouth, fruity breath odor; or

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

Common risperidone side effects may include:

• headache;

• dizziness, drowsiness, feeling tired;

• tremors, twitching or uncontrollable muscle movements;

• agitation, anxiety, restless feeling;

• depressed mood;

• dry mouth, upset stomach, diarrhea, constipation;

• weight gain; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

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 using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• blood pressure medication;

• carbamazepine;

• clozapine;

• fluoxetine (Prozac) or paroxetine (Paxil); or

• levodopa.

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 drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to risperidone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

You’ll probably have to take risperidone for several weeks before you notice the full effects.

Missing a dose of risperidone may cause your symptoms to return. Stopping this medication without appropriately tapering (gradually lessening) may also cause symptoms of withdrawal.

Keep taking this medicine, even if you feel better.

Let your doctor know if you experience any severe or unusual side effects.

Your dosage will depend on your age, medical condition, the formulation you use, and other factors.

Follow the instructions on your prescription label carefully when using this medicine.

Risperidone is sometimes used “off-label” to treat the symptoms of other medical conditions, such as:

• Major depression disorder
• Post-traumatic stress disorder (PTSD)
• Tourette syndrome
• Delusional parasitosis
• Other mental health disorders