Risperidone injection is used in adults to treat schizophrenia.

Risperdal Consta is used in adults alone or in combination with lithium or valproate for the treatment of bipolar disorder.

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

You should not use this medication if you are allergic to risperidone or paliperidone.

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 or have ever had:

• heart disease or a heart attack;
• dizziness, rapid heartbeats, fainting;
• a stroke, a TIA or "mini-stroke";
• Parkinson's disease or a type of dementia called Lewy body dementia;
• trouble swallowing;
• low white blood cell (WBC) counts;
• a severe nervous system reaction while using medicine to treat anxiety, mood disorders, or mental illness such as schizophrenia;
• diabetes (in you or a family member);
• high cholesterol or triglycerides;
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• a seizure;
• low bone mineral density;
• breast cancer;
• dehydration; or
• liver or kidney disease.

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine 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.

It may be harder for you to get pregnant while you are using this medicine.

If you are breastfeeding, tell your doctor if you notice drowsiness, irregular growth, tremors and abnormal muscle movements in the nursing baby.

Use Risperdal Consta (Intramuscular) 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, difficult breathing, swelling of your face, lips, tongue, or throat.

High doses or long-term use of risperidone can cause a serious movement disorder that may not be reversible. The longer you use risperidone, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

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 and tenderness, nipple discharge, loss of interest in sex, impotence, erectile dysfunction, difficulty having an orgasm, missed menstrual periods;
• feeling unusually hot or cold;
• low blood pressure, fast or pounding heartbeats, fluttering in your chest;
• shortness of breath, sudden dizziness (like you might pass out);
• seizure;
• trouble swallowing;
• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
• a painful or prolonged erection.

Common side effects may include:

• headache;
• blurred vision, rash;
• dizziness, drowsiness, tired feeling;
• tremors, twitching or uncontrollable muscle movements, numbness;
• depressed mood, agitation, anxiety, feeling restless;
• back pain, muscle or joint pain, pain in your arms or legs;
• upset stomach, constipation, dry mouth;
• upper stomach pain, nausea, vomiting, diarrhea;
• increased salivation;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• increased appetite, weight gain; or
• itching, bruising, swelling, irritation, warmth, redness, and a hard lump (induration) where the injection was given.

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.

Do not drink alcohol. Dangerous side effects could occur.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Avoid driving or hazardous activity until you know how this medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or drowsiness can cause falls, accidents, or severe injuries.