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Limited Use
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Generic drug name:
haloperidol
(ha loe PER i dole)
Brand name(s):
HALDOL
GENERIC:
available
FAMILY:
Traditional or Typical Antipsychotics
Find the drug label by
searching at DailyMed.
Pregnancy and Breast-feeding Warnings [top]
Pregnancy Warning
Haloperidol (HALDOL) was found to cause harm to developing fetuses in animal studies. It caused undescended testicles, delayed bone formation, decreased weight and survival, and increased stillbirths. You should not use this drug during pregnancy. Tell your doctor if you are pregnant or thinking of becoming pregnant before you take this drug.
The FDA updated the information for the entire class of antipsychotic drugs relating to their potential risk to newborns when used during pregnancy. The drugs’ product labels have been updated to include information that when mothers are treated with these drugs during the third trimester of pregnancy, there is a potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in their newborns.
Breast-feeding Warning
Haloperidol is excreted in human breast milk. Infants should not be nursed during drug treatment with haloperidol.
Safety Warnings For This Drug [top]
FDA BLACK-BOX WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs, like haloperidol, may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Haloperidol is not approved for the treatment of patients with dementia-related psychosis.
Decreased Sweating
This drug may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or in hot weather while you are taking this medication, since overheating may result in heatstroke. Also, hot baths or saunas may make you feel dizzy or faint when you are taking this medication.
Product Warnings
Ask a doctor or pharmacist before use if you are taking antibiotics.
When using this product, tiredness, drowsiness or dizziness may occur. Be careful driving or operating machinery.
Stop using and ask a doctor if symptoms get worse, diarrhea lasts more than two days or you get abdominal swelling or bulging. These may be signs of a serious condition.
If pregnant or breast-feeding, ask a health care professional before use.
Older adults are especially sensitive to the harmful anticholinergic effects of this drug. Drugs in this family should not be used unless absolutely necessary.
Mental Effects: confusion, delirium, short-term memory problems, disorientation and impaired attention.
Physical Effects: dry mouth, constipation, difficulty urinating (especially for a man with an enlarged prostate), blurred vision, decreased sweating with increased body temperature, sexual dysfunction and worsening of glaucoma.
Facts About This Drug [top]
Haloperidol (HALDOL) is effective for treating mental illnesses called psychoses, including schizophrenia. It should not be used to treat anxiety, to treat the loss of mental abilities (due to Alzheimer's disease, for example) in nonpsychotic patients, or to sedate or control restless behavior or any other problems in nonpsychotic patients.
Haloperidol also should be used sparingly, if at all, to treat depression in older people.
There is no clear evidence that the newer atypical...
Haloperidol (HALDOL) is effective for treating mental illnesses called psychoses, including schizophrenia. It should not be used to treat anxiety, to treat the loss of mental abilities (due to Alzheimer's disease, for example) in nonpsychotic patients, or to sedate or control restless behavior or any other problems in nonpsychotic patients.
Haloperidol also should be used sparingly, if at all, to treat depression in older people.
There is no clear evidence that the newer atypical antipsychotics (such as olanzapine [ZYPREXA]) are more effective or are better tolerated than the older conventional antipsychotics, such as haloperidol.[1]
Adverse effects
This class of antipsychotics can cause serious adverse effects, including tardive dyskinesia, drug-induced Parkinsonism, the "jitters," and weakness and muscle fatigue (see Adverse Effects). Up to 60% of older adults with depression who are given antipsychotics experience tardive dyskinesia (involuntary movements of parts of the body), an often disabling adverse effect of this drug. Most studies find that increased age and long duration of therapy are important predictors of increased rates of tardive dyskinesia. Another variable between studies is the differing definitions of tardive dyskinesia.
The "Adverse Effects of Antipsychotic Drugs" table in "Antipsychotic Drugs: Dangerously Overused" shows the major differences among the various antipsychotic drugs. If your doctor has prescribed one of these drugs and it is causing an unwanted adverse effect, use this table to find alternative drugs that cause less of that particular effect.
Regardless of the antipsychotic, older adults should take between one-tenth and one-fifth of the dose used for younger adults.
Studies show ...
A randomized, controlled clinical trial comparing olanzapine with haloperidol "found no statistically or clinically significant advantages of olanzapine for schizophrenia on measures of compliance, symptoms, or overall quality of life, nor did it find evidence of reduced inpatient use or total cost."[2]
A study published in the British Medical Journal evaluated the risk of death associated with specific antipsychotic medications used in elderly residents in nursing homes. The study reviewed information relating to the risk of death when using different drug therapies and found that the risk of death varied according to the specific drug used. The authors of the study concluded:
"The evidence accumulated so far implies that use of haloperidol in this vulnerable population cannot be justified because of the excess harm. Quetiapine might be somewhat safer than other atypical drugs, but these findings will require replication in other studies."[3]
Regulatory actions surrounding haloperidol
2007: The Food and Drug Administration (FDA) updated haloperidol's label to include warnings that torsades de pointes and QT prolongation (both potentially serious problems having to do with irregular heartbeat) have been observed in patients receiving the drug. This is more likely to occur when the drug is administered intravenously or in higher doses than are recommended. Haloperidol is not approved for intravenous use.[4]
2009: The FDA updated the product label of haloperidol to state that the agency had received reports of leukopenia/neutropenia (low white blood cell count). These reports were received in clinical trial and/or post-marketing reports, and the FDA called them short-term events "related to antipsychotic agents." Agranulocytosis (failure of the bone marrow to make enough white blood cells) also has been reported.[5]
2011: The FDA updated information for the entire class of antipsychotic drugs that includes haloperidol to include information stating that when mothers are treated with these drugs during the third trimester of pregnancy, there is a potential risk of abnormal muscle movements (extrapyramidal signs, or EPS) and withdrawal symptoms in their newborns[6].
In August, the FDA issued a warning concerning the use of the combination therapy of haloperidol and lithium (ESKALITH, LITHOBID, LITHONATE). The advisory stated that in a few patients taking this combination, weakness, lethargy, fever, tremulousness and confusion, EPS, leukocytosis, elevated serum enzymes, BUN (urea levels in the blood) and fasting blood sugar (encephalopathic syndrome) followed by irreversible brain damage occurred. The FDA stated that a causal relationship has not been established between these events and the combined drug therapy. However, the FDA recommends that these patients should be monitored closely for early evidence of neurological toxicity.[7]
2017: The FDA approved a new warning for haloperidol’s product label that stated that the drug may cause excessive sleepiness, low blood pressure upon sitting up or standing (postural hypotension) and problems with balance, all of which may increase the risk of falls and fractures in patients taking the drug.[8]
In 2022, the Journal of Clinical Psychopharmacology published a study showing that antipsychotic drugs that caused a high or medium increase in the level of the hormone prolactin in women, which include haloperidol, were associated with an increased risk of breast cancer .[9] See the July 2022 Worst Pills, Best Pills News article “Some Antipsychotics Elevate Breast Cancer Risk, a Large Study Confirms.”
Before You Use This Drug [top]
Do not use if you have or have had:
Tell your doctor if you have or have had:
Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.
When You Use This Drug [top]
How to Use This Drug [top]
Interactions with Other Drugs [top]
The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs.
alcohol, AVELOX, carbamazepine, cabergoline, COGNEX, DOSTINEX, ESKALITH, LARODOPA, levodopa, lithium, LITHOBID, LITHONATE, moxifloxacin, NORVIR, pergolide, PERMAX, PRIFTIN, RIFADIN, rifampin, rifapentine, ritonavir, tacrine, TEGRETOL.
Central nervous system (CNS) depressant drugs, including alcohol, antidepressants, antihistamines, antipsychotics, some blood pressure medications (reserpine, methyldopa, beta-blockers), motion sickness medications, muscle relaxants, narcotics, sedatives, sleeping pills, and tranquilizers.
Adverse Effects [top]
Call your doctor immediately if you experience:
Call your doctor if these symptoms continue:
Signs of overdose:
If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.
Periodic Tests[top]
Ask your doctor which of these tests should be done periodically while you are taking this drug:
last reviewed July 31, 2024
Worst Pills, Best Pills is a project of Public Citizen's Health Research Group Group. As an independent, nonprofit organization, we take no corporate or government contributions and accept no advertising. Copyright © 2024 Public Citizen's Health Research Group. All rights reserved.
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