"Feb. 23, 2012 -- The FDA has warned that treatment with antipsychotic drugs increases the risk of death among elderly patients with dementia, and now a new study confirms that some drugs are riskier than others.
Compared to patients t"...
Haldol Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Haldol (haloperidol) is an antipsychotic drug that decreases excitement in the brain. It is used to treat psychotic disorders like schizophrenia, to control motor (movement) and verbal (for example, Tourette's syndrome) tics and is used to treat severe behavior problems in children. Haldol is available as generic haloperidol. Haldol is not approved for use in older adults with dementia because of increased chances of death during treatment. Common side effects of Haldol are nausea, vomiting, diarrhea, dry mouth, nervousness, spontaneous eye movements, mood changes, breast enlargement, difficulty urinating, and occasional movement disorders.
Haldol is available in sterile vials containing 5 mg strength Haldol per 1 ml of fluid used for injection. Usual starting dose is 2.5-5 mg intramuscularly. Dose may vary according to patient response to the drug. Switch to an oral form of this drug is recommended as soon as possible. Severe side effects of Haldol may include death in the elderly, prolongation of the QT heartbeat interval, tardive dyskinesia (involuntary movements), prolonged erection (hours), a symptom complex sometimes referred to as neuroleptic malignant syndrome (NMS) with fever, irregular heartbeats, mental status changes, renal failure, and other symptoms. Haldol may interact with other drugs so the patient needs close observation or monitoring to determine if other side effects develop. Haldol should only be used during pregnancy or in women likely to become pregnant only if the benefit clearly justifies a potential risk to the fetus; fetal abnormalities and fetal exposure to Haldol in the third trimester have shown dependence at birth. Women who are breastfeeding should not take Haldol because the drug may affect the infant. Although reports of use for behavior modification exist, the drug is not approved for use in children.
Our Haldol Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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 Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Haldol in Detail - Patient Information: Side Effects
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 a serious side effect such as:
- 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.
Read the entire detailed patient monograph for Haldol (Haloperidol Injection) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Haldol Overview - Patient Information: Side Effects
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.
Read the entire patient information overview for Haldol (Haloperidol Injection)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Haldol FDA Prescribing Information: Side Effects
Tachycardia, hypotension, and hypertension have been reported. QT prolongation and/or ventricular arrhythmias have also been reported, in addition to ECG pattern changes compatible with the polymorphous configuration of torsade de pointes, and may occur more frequently with high doses and in predisposed patients (see WARNINGS and PRECAUTIONS).
Cases of sudden and unexpected death have been reported in association with the administration of HALDOL. The nature of the evidence makes it impossible to determine definitively what role, if any, HALDOL played in the outcome of the reported cases. The possibility that HALDOL caused death cannot, of course, be excluded, but it is to be kept in mind that sudden and unexpected death may occur in psychotic patients when they go untreated or when they are treated with other antipsychotic drugs.
Extrapyramidal Symptoms (EPS)
EPS during the administration of HALDOL (haloperidol) have been reported frequently, often during the first few days of treatment. EPS can be categorized generally as Parkinson-like symptoms, akathisia, or dystonia (including opisthotonos and oculogyric crisis). While all can occur at relatively low doses, they occur more frequently and with greater severity at higher doses. The symptoms may be controlled with dose reductions or administration of antiparkinson drugs such as benztropine mesylate USP or trihexyphenidyl hydrochloride USP. It should be noted that persistent EPS have been reported; the drug may have to be discontinued in such cases.
Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.
Withdrawal Emergent Neurological Signs
Generally, patients receiving short-term therapy experience no problems with abrupt discontinuation of antipsychotic drugs. However, some patients on maintenance treatment experience transient dyskinetic signs after abrupt withdrawal. In certain of these cases the dyskinetic movements are indistinguishable from the syndrome described below under "Tardive Dyskinesia" except for duration. It is not known whether gradual withdrawal of antipsychotic drugs will reduce the rate of occurrence of withdrawal emergent neurological signs but until further evidence becomes available, it seems reasonable to gradually withdraw use of HALDOL.
As with all antipsychotic agents HALDOL has been associated with persistent dyskinesias. Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may appear in some patients on long-term therapy or may occur after drug therapy has been discontinued. The risk appears to be greater in elderly patients on high-dose therapy, especially females. The symptoms are persistent and in some patients appear irreversible. The syndrome is characterized by rhythmical involuntary movements of tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities and the trunk.
There is no known effective treatment for tardive dyskinesia; antiparkinson agents usually do not alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, this syndrome may be masked.
It has been reported that fine vermicular movement of the tongue may be an early sign of tardive dyskinesia and if the medication is stopped at that time the full syndrome may not develop.
Tardive dystonia, not associated with the above syndrome, has also been reported. Tardive dystonia is characterized by delayed onset of choreic or dystonic movements, is often persistent, and has the potential of becoming irreversible.
Other CMS Effects
Insomnia, restlessness, anxiety, euphoria, agitation, drowsiness, depression, lethargy, headache, confusion, vertigo, grand mal seizures, exacerbation of psychotic symptoms including hallucinations, and catatonic-like behavioral states which may be responsive to drug withdrawal and/or treatment with anticholinergic drugs.
Body as a Whole
Reports have appeared citing the occurrence of mild and usually transient leukopenia and leukocytosis, minimal decreases in red blood cell counts, anemia, or a tendency toward lymphomonocytosis. Agranulocytosis has rarely been reported to have occurred with the use of HALDOL, and then only in association with other medication. (See PRECAUTIONS: Leukopenia, Neutropenia, and Agranulocytosis.)
Impaired liver function and/or jaundice have been reported.
Maculopapular and acneiform skin reactions and isolated cases of photosensitivity and loss of hair.
Laryngospasm, bronchospasm and increased depth of respiration.
Cataracts, retinopathy and visual disturbances.
Hyperammonemia has been reported in a 5% year old child with citrullinemia, an inherited disorder of ammonia excretion, following treatment with HALDOL.
Read the entire FDA prescribing information for Haldol (Haloperidol Injection) »
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