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Typical Antipsychotic (Butyrophenone) Pregnancy: UK SPC §4.6, verbatim: 'A moderate amount of data on pregnant women (more than 400 pregnancy outcomes) indicate no malformative or foeto/ neonatal toxicity of haloperidol. However, there have been isolated case reports of birth defects following foetal exposure to haloperidol, mostly in combination with other medicinal products. Animal studies have shown reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of haloperidol during pregnancy.' Third trimester: 'Newborn infants exposed to antipsychotics (including haloperidol) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms... There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, it is recommended that newborn infants be monitored carefully.' Breast-feeding: 'Haloperidol is excreted in human milk. Small amounts of haloperidol have been detected in plasma and urine of breast-fed newborns... A decision must be made whether to discontinue breastfeeding or to discontinue haloperidol therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.' Fertility: 'Haloperidol elevates prolactin level. Hyperprolactinaemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This may inhibit reproductive function...'

Haloperidol (Delirium)

Brand names: Haldol, Serenace

Used in: Delirium & Cognitive Impairment

Haloperidol is a first-generation (typical) antipsychotic used in schizophrenia and mania, and short-term for severe agitation or distress in delirium when non-drug measures have failed.

Adult dose

Dose: Acute treatment of delirium when non-pharmacological treatments have failed: 1 to 10 mg/day orally, as a single dose or in 2 to 3 divided doses. In elderly patients the SPC starts at half the lowest adult dose.
Route: Oral. SCOPE - the fetched SPC is Haloperidol 1 mg/ml Oral Solution, so only the oral route is covered; the intramuscular and intravenous routes listed on this page are NOT sourced here and no injectable dose is asserted. SPC note on formulation: 'When small doses and childrens doses are to be prescribed, it may be more appropriate to use the 200micrograms/ml Haloperidol Oral Solution.'
Frequency: As a single dose or in 2 to 3 divided doses. SPC: 'Treatment should be started at the lowest possible dose, and the dose should be adjusted in increments at 2- to 4-hour intervals if agitation continues.'
Max: Maximum 10 mg/day for acute delirium (SPC: 'up to a maximum of 10 mg/day'). On this geriatric page the lower elderly ceiling governs - SPC: 'The maximum dose in elderly patients is 5 mg/day. Doses above 5 mg/day should only be considered in patients who have tolerated higher doses and after reassessment of the patient's individual benefit-risk profile.'
Verbatim, UK SPC §4.2, Table 1: 'Acute treatment of delirium when non-pharmacological treatments have failed - 1 to 10 mg/day orally, as a single dose or in 2 to 3 divided doses. Treatment should be started at the lowest possible dose, and the dose should be adjusted in increments at 2- to 4-hour intervals if agitation continues, up to a maximum of 10 mg/day.' General principle from the same section: 'A low initial dose is recommended, which subsequently may be adjusted according to the patient's response. Patients must always be maintained on the minimal effective dose.' Elderly special population, verbatim: 'The following initial haloperidol doses are recommended in elderly patients: ... All other indications - half the lowest adult dose. The haloperidol dose may be adjusted according to the patient's response. Careful and gradual dose up-titration in elderly patients is recommended. The maximum dose in elderly patients is 5 mg/day.' Withdrawal: 'Gradual withdrawal of haloperidol is advisable.' RELATED BUT DIFFERENT INDICATION, quoted only so it is not confused with the delirium dose - dementia: 'Treatment of persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimer's dementia and vascular dementia when non-pharmacological treatments have failed and when there is a risk of harm to self or others - 0.5 to 5 mg/day orally', with an elderly initial dose of 0.5 mg/day and reassessment 'after no more than 6 weeks'; note the §4.4 warning that 'Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death', an association that 'may be stronger for haloperidol than for atypical antipsychotic medicinal products, is most pronounced in the first 30 days after the start of treatment, and persists for at least 6 months'. PAEDIATRIC: paedDose is null - the fetched SPC gives no paediatric delirium dose (its paediatric table covers schizophrenia in adolescents 13-17 years, '0.5 to 3 mg/day... The maximum recommended dose is 5 mg/day', and was cut mid-entry for aggression in autism aged 6-17), and the US label's paediatric figures are for psychotic disorders and Tourette's, not delirium. Any paediatric use should be checked against a children's formulary.

Dose adjustments

Renal

UK SPC §4.2, verbatim: 'The influence of renal impairment on the pharmacokinetics of haloperidol has not been evaluated. No dose adjustment is recommended, but caution is advised when treating patients with renal impairment. However, patients with severe renal impairment may require a lower initial dose, with subsequent adjustments at smaller increments and at longer intervals than in patients without renal impairment.'

Hepatic

UK SPC §4.2, verbatim: 'The influence of hepatic impairment on the pharmacokinetics of haloperidol has not been evaluated. Since haloperidol is extensively metabolised in the liver, it is recommended to halve the initial dose, and adjust the dose with smaller increments and at longer intervals than in patients without hepatic impairment.'

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

DOSAGE AND ADMINISTRATION There is considerable variation from patient to patient in the amount of medication required for treatment. As with all antipsychotic drugs, dosage should be individualized according to the needs and response of each patient. Dosage adjustments, either upward or downward, should be carried out as rapidly as practicable to achieve optimum therapeutic control. To determine the initial dosage, consideration should be given to the patient's age, severity of illness, previous response to other antipsychotic drugs, and any concomitant medication or disease state. Children, debilitated or geriatric patients, as well as those with a history of adverse reactions to …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2024-11-15. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

  • UK SPC §4.3: 'Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.'
  • UK SPC §4.3: 'Comatose state.'
  • UK SPC §4.3: 'Central nervous system (CNS) depression.'
  • UK SPC §4.3: "Parkinson's disease."
  • UK SPC §4.3: 'Dementia with Lewy bodies.'
  • UK SPC §4.3: 'Progressive supranuclear palsy.'
  • UK SPC §4.3: 'Known QTc interval prolongation or congenital long QT syndrome.'
  • UK SPC §4.3: 'Recent acute myocardial infarction.'
  • UK SPC §4.3: 'Uncompensated heart failure.'
  • UK SPC §4.3: 'History of ventricular arrhythmia or torsades de pointes.'
  • UK SPC §4.3: 'Uncorrected hypokalaemia.'
  • UK SPC §4.3: 'Concomitant treatment with medicinal products that prolong the QT interval.'
  • US label CONTRAINDICATIONS agrees in part: 'contraindicated in severe toxic central nervous system depression or comatose states from any cause and in individuals who are hypersensitive to this drug or have Parkinson's disease.'

Side effects

  • Most commonly reported in pooled clinical studies (UK SPC §4.8): extrapyramidal disorder (34%), insomnia (19%), agitation (15%), hyperkinesia (13%), headache (12%), psychotic disorder (9%), depression (8%), weight increased (8%), tremor (8%), hypertonia (7%), orthostatic hypotension (7%), dystonia (6%) and somnolence (5%)
  • Nervous system (UK SPC §4.8 table): extrapyramidal disorder, hyperkinesia, headache, tardive dyskinesia, akathisia, bradykinesia, dyskinesia, dystonia, hypokinesia, hypertonia, dizziness, somnolence, tremor, convulsion, parkinsonism, sedation, involuntary muscle contractions, neuroleptic malignant syndrome, motor dysfunction, nystagmus, akinesia, cogwheel rigidity, masked facies; oculogyric crisis
  • Cardiac and vascular (UK SPC §4.8 table): tachycardia, ventricular fibrillation, torsade de pointes, ventricular tachycardia, extrasystoles; hypotension, orthostatic hypotension
  • Blood and lymphatic (UK SPC §4.8 table): leukopenia, pancytopenia, agranulocytosis, thrombocytopenia, neutropenia
  • Immune and endocrine (UK SPC §4.8 table): hypersensitivity, anaphylactic reaction; hyperprolactinaemia, inappropriate antidiuretic hormone secretion; hypoglycaemia
  • Psychiatric (UK SPC §4.8 table): agitation, insomnia, psychotic disorder, depression, confusional state, loss of libido, decreased libido, restlessness
  • Respiratory, eye and gastrointestinal (UK SPC §4.8 table): dyspnoea, bronchospasm, laryngeal oedema, laryngospasm; visual disturbance, vision blurred; vomiting, nausea, constipation, dry mouth (the table was cut at the source-fetch limit part-way through the gastrointestinal row)
  • UK SPC §4.4: 'QTc prolongation and/or ventricular arrhythmias, in addition to sudden death, have been reported with haloperidol. The risk of these events appears to increase with high doses, high plasma concentrations, in predisposed patients or with parenteral use, particularly intravenous administration.'
  • UK SPC §4.4: increased mortality in elderly people with dementia-related psychosis treated with antipsychotics - roughly 4.5% versus 2.6% on placebo over a typical 10-week controlled study, with most deaths cardiovascular or infectious
  • US label ADVERSE REACTIONS: 'EPS during the administration of haloperidol have been reported frequently, often during the first few days of treatment... While all can occur at relatively low doses, they occur more frequently and with greater severity at higher doses'; tachycardia, hypotension and hypertension have been reported

Monitoring

  • UK SPC §4.4: 'A baseline ECG is recommended before treatment. During therapy, the need for ECG monitoring for QTc interval prolongation and for ventricular arrhythmias must be assessed in all patients.'
  • UK SPC §4.4: 'Whilst on therapy, it is recommended to reduce the dose if QTc is prolonged, but haloperidol must be discontinued if the QTc exceeds 500 ms.'
  • UK SPC §4.4: 'Electrolyte disturbances such as hypokalaemia and hypomagnesaemia increase the risk for ventricular arrhythmias and must be corrected before treatment with haloperidol is started. Therefore, baseline and periodic electrolyte monitoring is recommended.'
  • UK SPC §4.4: 'Caution is recommended when haloperidol is administered to patients manifesting hypotension or orthostatic hypotension' - tachycardia and hypotension including orthostatic hypotension have been reported.
  • Monitor for extrapyramidal symptoms, which were the most common adverse reaction in pooled trials (34%), and for neuroleptic malignant syndrome.
  • Review the need to continue: for the dementia indication the SPC requires reassessment 'after no more than 6 weeks'; for delirium the dose is titrated at 2- to 4-hour intervals only while agitation continues, and 'Patients must always be maintained on the minimal effective dose.'
  • UK SPC §4.6: newborn infants exposed to antipsychotics in the third trimester 'be monitored carefully' for extrapyramidal and withdrawal symptoms.

Clinical monograph

How it works

It is a potent dopamine D2 antagonist.

Prescribing in practice

  • Extrapyramidal effects (acute dystonia, parkinsonism, akathisia) and QT prolongation are prominent; be alert to neuroleptic malignant syndrome.
  • Avoid in Parkinson's disease and dementia with Lewy bodies (severe sensitivity); in delirium use the lowest dose for the shortest time after addressing causes.
  • Antipsychotics increase stroke and mortality risk in older people with dementia.

Monitoring

Monitor for extrapyramidal effects and (where relevant) ECG/QT; in delirium review the need to continue daily.

Counselling the patient

  • It is used short-term for severe agitation.
  • Report muscle stiffness, abnormal movements, or a high fever.
  • Drowsiness can occur.

Evidence & guidelines

An option for short-term management of distress/agitation in delirium after non-drug measures (NICE CG103); avoided in Parkinson's and Lewy body disease, with EPSE and QT cautions.

Reference: NICE NG212 (delirium); HOPE-ICU trial; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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