Risperdal is an antipsychotic medicine that works by changing the effects of chemicals in the brain.

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

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

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

Risperdal is not approved for use in older adults with dementia-related psychosis.

Do not give Risperdal 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 risperidone.

Stop using Risperdal 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.

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

Risperdal can be taken with or without food.

Remove the Risperdal M-Tab 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 Risperdal 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.

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

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 Risperdal M-Tab 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 , 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.

Risperidone 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 Risperdal, 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.

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 Risperdal: 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 Risperdal 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 Risperdal 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.