Drug Notebook

FDA Alerts

Special Alerts:

[Posted 09/17/2007] Johnson and Johnson and FDA informed healthcare professionals that the WARNINGS section of the prescribing information for haloperidol has been revised to include a new Cardiovascular subsection regarding cases of sudden death, QT prolongation and Torsades de Pointes(TdP) in patients treated with haloperidol, especially when given intravenously, or at doses higher than recommended. Although injectable haloperidol is only approved by the FDA for intramuscular injection, there is considerable evidence that the intravenous administration of haloperidol is a relatively common off-label clinical practice.

There are at least 28 case reports of QT prolongation and TdP, some with fatal outcome in the context of off-label intravenous haloperidol. Healthcare professionals should consider this new risk information when making individual treatment decisions for their patients. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Haloperidol and http://www.fda.gov/cder/drug/InfoSheets/HCP/haloperidol.htm.

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haloperidol
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(hal oh PER i doll)

What should I avoid while taking haloperidol?

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by haloperidol. Tell your doctor if you regularly use any of these other medicines. Haloperidol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can increase drowsiness or dizziness caused by haloperidol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. You may be more prone to heat stroke while you are taking haloperidol.

What are the possible side effects of haloperidol?

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. Call your doctor at once if you have any of these serious side effects:
  • dizziness, fainting, fast or pounding heartbeat;

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

  • tremor (uncontrolled shaking);

  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;

  • stabbing chest pain, feeling short of breath, cough with yellow or green mucus;

  • sudden mood changes;

  • confusion, agitation, hallucinations, unusual thoughts or behavior; or

  • jaundice (yellowing of your skin or eyes).

Less serious side effects may include:

  • headache, dizziness, drowsiness;

  • sleep problems (insomnia);

  • feeling restless or anxious;

  • mild skin rash or itching;

  • breast enlargement, irregular menstrual periods, loss of interest in sex; or

  • dry mouth, blurred vision, urinating less than usual.

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 haloperidol?

Before taking haloperidol, 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 haloperidol. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about haloperidol.

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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