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

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.

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.

Use Risperdal M-Tab (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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, dry mouth, fruity breath odor; or
• penis erection that is painful or lasts 4 hours or longer.

Common 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.

Avoid drinking alcohol. Dangerous side effects could occur.

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

Avoid driving or hazardous activity until you know how this medicine 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.