Haldol

DRUG DESCRIPTION

Haloperidol is the first of the butyrophenone series of major antipsychotics. The chemical designation is 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula:

HALDOL® (halopcridol) Structural Formula Illustration

HALDOL (haloperidol) is available as a sterile parenteral form for intramuscular injection. The injection provides 5 mg haloperidol (as the lactate) and lactic acid for pH adjustment between 3.0 - 3.6.

What are the possible side effects of haloperidol (Haldol)?

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);
  • seizure (convulsions);
  • pale skin, easy bruising or bleeding, flu symptoms;
  • very stiff (rigid)...

Read All Potential Side Effects and See Pictures of Haldol »

What are the precautions when taking haloperidol injection (Haldol)?

Before taking haloperidol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain severe nervous system problem (severe CNS depression), Parkinson's disease.

This medication should not be given to a patient who is unconscious.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bipolar disorder, difficulty urinating (e.g., due to prostate problems), glaucoma, heart problems (e.g.,...

Read All Potential Precautions of Haldol »


Haldol Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, difficulty urinating, sleep disturbances, headache, and anxiety may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Tell your doctor promptly if any of these side effects occur: muscle spasm/stiffness, shaking (tremor), restlessness, mask-like facial expression, drooling. Your doctor may prescribe another medication for you to take with haloperidol to decrease these side effects.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

In rare cases, haloperidol may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.

For males, in the unlikely event you have a painful or prolonged erection (lasting more than 4 hours), stop using this drug and seek immediate medical attention, or permanent problems may occur.

This medication may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any facial/muscle twitching such as tongue thrusting, chewing movements, puffing or puckering of your mouth, or uncontrollable shaking.

This medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop any of the following symptoms: fever, muscle stiffness, severe confusion, increased sweating, fast/irregular heartbeat.

Tell your doctor immediately if any of these rare but very serious side effects occur: dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing of eyes/skin, seizures, signs of infection (such as fever, persistent sore throat).

Seek immediate medical attention if any of these rare but very serious side effects occur: slow/fast/irregular heartbeat, severe dizziness, chest pain, fainting.

A very severe allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking haloperidol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain severe nervous system problem (severe CNS depression), Parkinson's disease.

This medication should not be given to a patient who is unconscious.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bipolar disorder, difficulty urinating (e.g., due to prostate problems), glaucoma, heart problems (e.g., angina), overactive thyroid (hyperthyroidism), seizures, low white blood cell count.

Haloperidol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using haloperidol, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using haloperidol safely.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, be sure to tell your doctor or dentist that you are taking haloperidol.

This medication can reduce sweating, making you more likely to get heatstroke. Avoid hard work and exercise in hot weather.

Caution is advised when using this drug in elderly people because they may be more sensitive to the effects of the drug, especially drowsiness, difficulty urinating, and the effects on the heart.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Haldol Patient Information Including Side Effects

Brand Names: Haldol

Generic Name: haloperidol (Pronunciation: HAL oh PER i dol)

  • What is haloperidol (Haldol)?
  • What are the possible side effects of haloperidol (Haldol)?
  • What is the most important information I should know about haloperidol (Haldol)?
  • What should I discuss with my healthcare provider before taking haloperidol (Haldol)?
  • How should I take haloperidol (Haldol)?
  • What happens if I miss a dose (Haldol)?
  • What happens if I overdose (Haldol)?
  • What should I avoid while taking haloperidol (Haldol)?
  • What other drugs will affect haloperidol (Haldol)?
  • Where can I get more information?

What is haloperidol (Haldol)?

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.

What are the possible side effects of haloperidol (Haldol)?

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);
  • seizure (convulsions);
  • pale skin, easy bruising or bleeding, flu symptoms;
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
  • stabbing chest pain, feeling short of breath, cough with yellow or green mucus;
  • sudden mood changes, agitation, hallucinations, unusual thoughts or behavior; or
  • jaundice (yellowing of your skin or eyes).

Less serious side effects may include:

  • headache, dizziness, spinning sensation, 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about haloperidol (Haldol)?

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 have liver disease, kidney disease, heart disease, angina (chest pain), a thyroid disorder, epilepsy or other seizure disorder, a personal or family history of "Long QT syndrome," or an electrolyte imbalance such as low potassium or magnesium levels in your blood.

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.

Call your doctor at once if you have tremor (uncontrolled shaking) or restless muscle movements in your eyes, tongue, jaw, or neck.

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