Drug Notebook

FDA Alerts

    Increased Mortality in Geriatric Patients
  • Substantially higher mortality rate (4.5%) in geriatric patients with dementia-related psychosis† receiving atypical antipsychotic agents (e.g., risperidone, aripiprazole, olanzapine, quetiapine) compared with those receiving placebo (2.6%).
  • Most fatalities resulted from cardiac-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).
  • Atypical antipsychotics are not approved for the treatment of dementia-related psychosis. (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions.)

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risperidone
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(ris PER i done)

What are the possible side effects of risperidone?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using risperidone and call your doctor at once if you have any of these serious side effects:
  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;

  • restless muscle movements in your eyes, tongue, jaw, or neck;

  • tremor (uncontrolled shaking);

  • trouble swallowing; or

  • feeling light-headed, fainting.

Less serious side effects may include:

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect risperidone?

Before taking this medication, tell your doctor if you are taking any of the following medicines:

This list is not complete and there may be other drugs that can interact with risperidone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about risperidone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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