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., aripiprazole, olanzapine, quetiapine, risperidone) 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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ziprasidone
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What is the most important information I should know about ziprasidone?

Ziprasidone is not for use in psychotic conditions related to dementia. Ziprasidone may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. Do not use this medication if you have a personal or family history of "Long QT syndrome," if you have recently had a heart attack, or if you have uncontrolled heart failure.

Stop taking ziprasidone and call your doctor right away if you feel dizzy or light-headed, have a fast or pounding heartbeat, or if you faint. This could be signs of a serious heart rhythm problem.

There are many other medicines that can cause serious or life-threatening medical problems if you take them together with ziprasidone. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

What is ziprasidone?

Ziprasidone is an antipsychotic medication. It works by changing the effects of chemicals in the brain.

Ziprasidone is used to treat schizophrenia and the manic symptoms of bipolar disorder (manic depression).

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

What should I discuss with my healthcare provider before taking ziprasidone?

Ziprasidone is not for use in psychotic conditions related to dementia. Ziprasidone may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. Do not use this medication if you are allergic to ziprasidone, or if you have:
  • a personal or family history of "Long QT syndrome";

  • history of recent heart attack; or

  • uncontrolled or untreated heart failure.

Ziprasidone should never be taken together with any of the following drugs, or a life-threatening heart rhythm disorder could occur:

Before taking ziprasidone, tell your doctor if you are allergic to any drugs, or if you have:

If you have any of these conditions, you may need a dose adjustment or special tests to safely take ziprasidone.

Ziprasidone may cause you to have high blood sugar (hyperglycemia). Talk to your doctor if you have any signs of hyperglycemia such as increased thirst or urination, excessive hunger, or weakness. If you are diabetic, check your blood sugar levels on a regular basis while you are taking ziprasidone.

The ziprasidone orally disintegrating tablet may contain phenylalanine. Talk to your doctor before using this form of ziprasidone if you have phenylketonuria (PKU).

FDA pregnancy category C. It is not known whether ziprasidone is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether ziprasidone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.
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