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
(ris PER i done)

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

  • carbamazepine (Carbatrol, Tegretol);

  • phenytoin (Dilantin);

  • phenobarbital (Luminal, Solfoton);

  • clozapine (Clozaril);

  • fluoxetine (Prozac) or paroxetine (Paxil);

  • rifampin (Rifadin, Rimactane, Rifater); or

  • medicines used to treat Parkinson's Disease such as levodopa (Dopar, Larodopa, Sinemet, Atamet, others), bromocriptine (Parlodel, others), pergolide (Permax), pramipexole (Mirapex), or ropinirole (Requip).

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.

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:

  • mild restlessness, drowsiness, or tremor;

  • sleepiness, dreaming more than usual;

  • blurred vision;

  • dizziness or headache;

  • weight gain;

  • problems with urination;

  • nausea, dry mouth, constipation; or

  • decreased sex drive, impotence, or difficulty having an orgasm.

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

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