Risperidone (ris-PER-i-done)

Treats schizophrenia, bipolar disorder, and irritability caused by autistic disorder.

Brand Name(s):

RisperDAL, risperiDONE M-Tab

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Tablet, Dissolving Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. You may mix your dose with water, coffee, low-fat milk, or orange juice. Do not mix it with cola or tea.
• Make sure your hands are dry before you handle the disintegrating tablet. Peel back the foil from the blister pack, then remove the tablet. Do not push the tablet through the foil. Place the tablet in your mouth. After it has melted, swallow or take a drink of water.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not freeze the oral liquid.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how risperidone works. Tell your doctor if you are using carbamazepine, clozapine, fluoxetine, furosemide, levodopa, methylphenidate, paroxetine, phenobarbital, phenytoin, quinidine, rifampin, or blood pressure medicine.
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, diabetes, high cholesterol, Parkinson disease, trouble swallowing, or a history of breast cancer or seizures. Tell your doctor if you have heart failure, low blood pressure, or a history of a heart attack or stroke.
• This medicine may cause the following problems:
  • Increased risk of stroke
  • Neuroleptic malignant syndrome (a nerve disorder that could be life-threatening)
  • Tardive dyskinesia (a muscle disorder that could become permanent)
  • High blood sugar levels or high cholesterol levels
  • Increased levels of prolactin hormone
  • Increased risk of seizures
• This medicine may make you dizzy, drowsy, or have trouble with thinking or controlling body movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine may change how your body regulates temperature. Avoid activities that could cause you to become very cold, hot, or dehydrated.
• Talk with your doctor before using this medicine if you plan to have children. Some women who use this medicine have become infertile (unable to have children).
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Risperdal® M-Tab® contains aspartame (phenylalanine). If you have phenylketonuria (PKU), talk to your doctor before using this medicine.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fast, slow, pounding, or uneven heartbeat
• Fever, sweating, confusion, muscle stiffness
• Increased hunger or thirst, change in how much or how often you urinate
• Jerky muscle movements you cannot control (often in your face, tongue, or jaw)
• Lightheadedness, dizziness, or fainting
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Painful, prolonged erection
• Seizures or tremors
• Swelling of the breasts, breast soreness, nipple discharge (in both women and men)
• Trouble swallowing

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, nausea, upset stomach
• Drooling
• Dry mouth, skin rash, runny or stuffy nose
• Drowsiness, trouble sleeping
• Weight gain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088