Haldol (haloperidol) is a first-generation, typical antipsychotic medication belonging to the butyrophenone class, widely recognized for its potent dopamine D2 receptor antagonism. It is primarily indicated for the management of manifestations of psychotic disorders, including schizophrenia, and is also utilized in the control of tics and vocal utterances of Tourette’s syndrome, as well as severe behavioral problems in children. Its high efficacy in managing acute agitation and chronic psychotic symptoms has established it as a cornerstone in psychiatric pharmacotherapy for decades. Available in oral tablets, oral concentrate, and immediate-release intramuscular formulations, Haldol offers flexibility in administration tailored to clinical urgency and patient compliance.

Features

• Contains haloperidol as the active pharmaceutical ingredient
• Available in multiple formulations: oral tablets (0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg, 20 mg), oral concentrate (2 mg/mL), and immediate-release intramuscular injection (5 mg/mL with 1 mg/mL lactic acid, and 0.2% methylparaben and 0.02% propylparaben as preservatives)
• Exhibits high affinity for dopamine D2 receptors with additional activity at alpha-1 adrenergic receptors
• Rapid absorption with oral bioavailability of approximately 60-70% due to significant first-pass metabolism
• Peak plasma concentrations achieved within 2-6 hours for oral administration and 20-40 minutes for intramuscular injection
• Extensive hepatic metabolism primarily via CYP3A4 and CYP2D6 isoenzymes
• Elimination half-life of approximately 20 hours (range 14-36 hours) allowing for once-daily dosing in maintenance therapy

Benefits

• Provides rapid control of acute psychotic agitation and aggression through dopaminergic pathway modulation
• Effectively reduces positive symptoms of schizophrenia including hallucinations, delusions, and thought disorder
• Demonstrates reliable efficacy in long-term maintenance therapy to prevent psychotic relapse
• Offers flexible dosing formulations allowing for individualized treatment plans across care settings
• Cost-effective therapeutic option compared to many second-generation antipsychotics
• Established safety profile with extensive clinical experience spanning over five decades

Common use

Haldol is predominantly prescribed for the treatment of schizophrenia, providing symptomatic control of both acute episodes and chronic manifestations. It is also FDA-approved for the management of tics and vocal utterances in patients with Tourette’s disorder who require pharmacologic intervention. In clinical practice, it is frequently utilized off-label for the treatment of severe behavioral problems in children characterized by combativeness and explosive hyperexcitable behavior, though this requires careful risk-benefit assessment. Additionally, it finds application in emergency psychiatry for rapid tranquilization of acutely agitated patients, often in combination with benzodiazepines. The medication may be used as an antiemetic in palliative care settings, particularly when other antiemetics are ineffective or contraindicated.

Dosage and direction

Dosage must be individualized based on symptom severity, patient response, and tolerability. For schizophrenia in adults: initial oral dosage typically ranges from 0.5 mg to 5 mg two or three times daily, with maintenance doses usually between 2 mg and 20 mg daily, though severely ill patients may require up to 100 mg daily. For IM administration in acutely agitated patients: initial dose of 2-5 mg, with subsequent doses every 60 minutes as needed, monitoring for hypotension. For Tourette’s syndrome in children 3-12 years old: initial dose of 0.5 mg daily, increased by 0.5 mg increments every 5-7 days until satisfactory response is achieved; maintenance doses typically range from 0.05 mg to 0.075 mg/kg/day. Elderly or debilitated patients typically require lower initial doses (0.5-2 mg daily) with gradual titration. Always administer with food or milk to minimize gastrointestinal upset.

Precautions

Haldol carries a black box warning for increased mortality in elderly patients with dementia-related psychosis. Use with extreme caution in patients with cardiovascular disorders due to risk of QT prolongation and torsades de pointes. Regular ECG monitoring is recommended, particularly during dose escalation. Neurologic precautions include monitoring for extrapyramidal symptoms, which may require dosage adjustment or antiparkinsonian agents. Avoid abrupt discontinuation after long-term use to prevent withdrawal symptoms or rapid symptom recurrence. Use cautiously in patients with seizure disorders, as haloperidol may lower seizure threshold. Hepatic impairment requires dosage reduction and careful monitoring due to decreased metabolism. Patients should be cautioned about operating machinery or driving until their response to therapy is established.

Contraindications

Haldol is contraindicated in patients with known hypersensitivity to haloperidol or any component of the formulation. It is contraindicated in patients with severe toxic central nervous system depression or comatose states from any cause. Absolute contraindication exists in patients with Parkinson’s disease or dementia with Lewy bodies due to potential exacerbation of parkinsonian symptoms. Should not be used in patients with known prolonged QT interval or history of significant cardiac arrhythmias. Contraindicated in patients with uncorrected electrolyte disturbances, particularly hypokalemia and hypomagnesemia. Not recommended during pregnancy unless potential benefit justifies potential risk to the fetus, particularly in the first trimester.

Possible side effect

Common side effects (≥10%) include extrapyramidal symptoms (dystonia, akathisia, parkinsonism), sedation, and insomnia. Frequent side effects (1-10%) include weight gain, constipation, dry mouth, blurred vision, and urinary retention. Less common but serious adverse effects include neuroleptic malignant syndrome (characterized by hyperthermia, muscle rigidity, autonomic instability), tardive dyskinesia (potentially irreversible involuntary movements), and significant QT prolongation. Endocrine effects may include hyperprolactinemia leading to galactorrhea, gynecomastia, and menstrual irregularities. Dermatological reactions including photosensitivity and skin pigmentation changes may occur with long-term use. Rare cases of sudden cardiac death have been reported, particularly with high-dose therapy.

Drug interaction

Haldol exhibits significant interactions with CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin) which may increase haloperidol concentrations and toxicity. Concurrent use with other QT-prolonging agents (antiarrhythmics, certain antibiotics, methadone) increases risk of torsades de pointes. Carbamazepine and other CYP3A4 inducers may decrease haloperidol levels, potentially reducing efficacy. Enhanced CNS depression may occur with concomitant use of alcohol, benzodiazepines, or opioids. Lithium coadministration may increase risk of neurotoxicity even with therapeutic lithium levels. Anticholinergic agents may reduce haloperidol efficacy while increasing risk of anticholinergic toxicity. Levodopa and dopamine agonists may have their effects antagonized by haloperidol.

Missed dose

If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next scheduled dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not double the dose to make up for a missed one. For patients on once-daily dosing, if remembered within 12 hours of the missed dose, it may be taken; if beyond 12 hours, wait until the next scheduled dose. Consistent timing is important for maintaining stable plasma concentrations, particularly in maintenance therapy. Patients should contact their healthcare provider if multiple doses are missed to discuss potential need for dosage adjustment upon resumption.

Overdose

Haloperidol overdose manifests primarily as extrapyramidal symptoms, severe sedation, hypotension, and QT prolongation. Massive overdose may lead to coma, respiratory depression, and cardiac arrhythmias including torsades de pointes. Management is supportive and symptomatic: ensure adequate airway and ventilation, administer activated charcoal if presentation is early, monitor cardiac function continuously with ECG, and correct electrolyte abnormalities. Hypotension should be treated with IV fluids and vasopressors if necessary. Extrapyramidal symptoms may require anticholinergic agents such as benztropine. There is no specific antidote for haloperidol overdose. Dialysis is not effective due to high protein binding and extensive tissue distribution. Patients should be observed for at least 24 hours due to the drug’s long half-life.

Storage

Store at controlled room temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light and moisture. Keep oral concentrate in the original container; do not transfer to other containers. The intramuscular formulation should be protected from freezing. Keep all medications out of reach of children and pets. Do not use if discoloration or precipitation is observed. Unused portions of oral concentrate should be discarded after the expiration date printed on the container. Do not store in bathroom cabinets where humidity and temperature fluctuations may degrade the product.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Haldol is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Individual response to medication varies, and the prescribing physician will determine the appropriate dosage based on the patient’s specific condition, medical history, and response to therapy. Patients should not adjust their dosage or discontinue medication without consulting their healthcare provider. This summary does not include all possible uses, directions, precautions, or adverse effects. Always consult the official prescribing information and your healthcare provider for complete information about this medication.

Reviews

Clinical studies spanning decades demonstrate Haldol’s efficacy in controlling psychotic symptoms, with response rates of 60-70% in treatment-naïve schizophrenia patients. Systematic reviews confirm its superiority over placebo in acute psychosis (NNT=3-5) and maintenance therapy. However, high rates of extrapyramidal symptoms (30-50% of patients) and tardive dyskinesia (5% annual incidence with long-term use) are frequently noted limitations. Comparative studies show similar efficacy to many second-generation antipsychotics for positive symptoms, though with different side effect profiles. Many clinicians value its rapid action in emergency settings and reliable response in treatment-resistant cases. Patient satisfaction varies considerably, with some appreciating symptom control while others discontinue due to side effects. The drug maintains formulary status in most healthcare systems due to its established efficacy and cost-effectiveness.