Drug Notebook

FDA Alerts

Special Alerts:

[Posted 06/16/2008] FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antipsychotics, http://www.fda.gov/cder/drug/InfoSheets/HCP/antipsychotics_conventional.htm and http://www.fda.gov/bbs/topics/NEWS/2008/NEW01851.html.

[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
(HAL oh PER i dol)

What is haloperidol?
Haloperidol is an antipsychotic medication. It works by changing the actions of chemicals in your brain. Haloperidol is used to treat schizophrenia. It is also used to control motor and speech tics in people with Tourette's syndrome. Haloperidol may also be used for other purposes not listed in this medication guide.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Haldol Decanoate 100MG/ML Solution MCNEIL5/$378.99 or 15/$1133.9
Haloperidol 0.5MG Tablets MYLAN90/$17 or 180/$22
Haloperidol 1MG Tablets MYLAN90/$19.99 or 180/$27.97
Haloperidol 10MG Tablets SANDOZ60/$72.26 or 180/$202.57
Haloperidol 2MG Tablets MYLAN90/$18.99 or 270/$39.96
Haloperidol 20MG Tablets SANDOZ60/$124.07 or 180/$342.41
Haloperidol 5MG Tablets SANDOZ90/$25.99 or 270/$55.97
Haloperidol Decanoate 100MG/ML Solution APOTEX USA5/$184.99 or 15/$551.94

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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.

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How should I take haloperidol?
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Taking too much of this medication can cause a serious heart rhythm disorder or sudden death. Never take more than your prescribed dose. Take haloperidol with a full glass of water. Haloperidol can be taken with or without food.

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What is the most important information I should know about haloperidol?
Haloperidol is not for use in psychotic conditions related to dementia. Haloperidol may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. 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.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

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What other drugs will affect haloperidol?
Before using haloperidol, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by haloperidol. The following drugs can interact with haloperidol. Tell your doctor if you are using any of these: lithium (Eskalith, Lithobid, others); a blood thinner such as warfarin (Coumadin); or rifampin (Rifadin, Rifamate, Rimactane).

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Haloperidol has not been formally assigned to a pregnancy category by the FDA. Several cases of limb reduction malformations occurring in infants whose mothers took haloperidol during the first trimester have been reported. Other workers have not found an association with limb reductions. Haloperidol has been used in the second and third trimesters for control of chorea gravidarum and psychiatric disorders. There are no controlled data in human pregnancy. Haloperidol should only be given during pregnancy when benefit outweighs the risk.

Haloperidol is excreted into human milk. The American Academy of Pediatrics describes haloperidol as a drug "whose effect on nursing infants in unknown but may be of concern".

One study has reported that levels of haloperidol excreted into human breast milk were 5 ng/mL after an average maternal dose of 30 mg/day.

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Who should NOT use this medication?

  • Severe toxic CNS depression or comatose states from any cause.
  • Parkinsonian syndrome.
  • Hypersensitivity to haloperidol.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. An overdose of haloperidol can be fatal. Overdose symptoms may include extreme drowsiness, feeling like you might pass out, tremors, and uncontrolled muscle movements in your eyes, tongue, jaw, or neck.

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What should I discuss with my healthcare provider before taking haloperidol?
Haloperidol is not for use in psychotic conditions related to dementia. Haloperidol may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. You should not use this medication if you are allergic to haloperidol, or have certain conditions. Be sure your doctor knows if you have Parkinson's disease. Before taking haloperidol, tell your doctor if you are allergic to any drugs, or if you have: liver disease; kidney disease; heart disease, angina (chest pain);

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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