Plain-language summary, compiled from the cited regulatory records
Haloperidol is a medication belonging to the butyrophenone derivatives drug class [1]. It is approved for managing symptoms of psychotic disorders [1]. Additionally, haloperidol is indicated for controlling tics and vocal utterances associated with Tourette's Disorder in both children and adults [1]. The medication is also effective for treating severe behavioral problems in children characterized by combative, explosive hyperexcitability, provided these issues are not due to immediate provocation [1]. It is also effective for short-term treatment of certain conditions [1].
In the market, haloperidol is available under various brand names [1]. In the past 12 months, there have been 1314 adverse event reports associated with haloperidol [2]. Among the frequently reported adverse events are drug ineffectiveness, off-label use, neuroleptic malignant syndrome, drug interactions, and extrapyramidal disorders [2].
This is not medical advice. Consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 29, 2026[1]
Adult patients aged 18 years and above • Treatment of schizophrenia and schizoaffective disorder • Acute treatment of delirium when non-pharmacological treatments have failed • Treatment of moderate to severe manic episodes associated with bipolar I disorder • Treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder • 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.
• Treatment of tic disorders, including Tourette’s syndrome, in patients with severe impairment after educational, psychological and other pharmacological treatments have failed • Treatment of mild to moderate chorea in Huntington’s disease, when other medicinal products are ineffective or not tolerated.
Paediatric patients Treatment of: • Schizophrenia in adolescents aged 13 to 17 years when other pharmacological treatments have failed or are not tolerated • Persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have failed or are not tolerated • Tic disorders, including Tourette’s syndrome, in children and adolescents aged 10 to 17 years with severe impairment after educational, psychological and other pharmacological treatments have failed.
CACanada· Health Canada
14 products
How to take
CAOfficial regulatory label· revised March 19, 2026[2]
DO NOT USE INTRAVENOUSLY. As with all parenteral drug products, haloperidol decanoate (intramuscular) should be inspected visually for clarity, particulate matter, precipitation, discolouration and leakage prior to administration whenever solution and container permit.
Solutions showing haziness, particulate matter, precipitate, that does not clear upon warming to room temperature (see STABILITY AND STABILITY), discolouration or leakage should not be used. Do not use if precipitate appears and discard unused portion.
As with all oily injections it is important to ensure, by aspiration before injection, that inadvertent intravascular injection does not occur. A dry syringe and a dry 5 cm needle of 21 gauge should be used for patients with a normal amount of body fat.
5 cm needle in order to ensure that the injection goes into muscle. Adults Administer by deep IM injection, preferably in the gluteus maximus. As a long-acting depot neuroleptic, haloperidol decanoate (intramuscular) has been found useful in the maintenance management of chronic schizophrenic patients.
USUnited States· FDA
7 products
Uses
USOfficial regulatory label· revised April 8, 2026[3]
1 INDICATIONS AND USAGE Haloperidol Decanoate Injection is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product. Haloperidol Decanoate Injection is a typical antipsychotic indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product ( 1 ).
How to take
Drug interactions
Known interactions involving Haloperidol. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[2]Health Canada (DPD) · 02130300 · revised March 19, 2026
[3]FDA DailyMed · 14f40303-9604-4a… · revised April 8, 2026 [PDF]
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
How to take
GBOfficial regulatory label· revised May 29, 2026[1]
Posology Adults A low initial dose is recommended, which subsequently may be adjusted according to the patient’s response. 2). The dose recommendations for Haloperidol Tablets are presented in Table 1.
Table 1:
Haloperidol dose recommendations for adults aged 18 years and above Treatment of schizophrenia and schizoaffective disorder • 2 to 10 mg/day orally, as a single dose or in 2 divided doses. Patients with first-episode schizophrenia generally respond to 2 to 4 mg/day, whereas patients with multiple-episode schizophrenia may need doses up to 10 mg /day.
• Adjustments to the dose may be made every 1 to 7 days. • Doses above 10 mg/day have not demonstrated superior efficacy to lower doses in the majority of patients and may cause an increased incidence of extrapyramidal symptoms. The individual benefit- risk should be assessed when considering doses above 10 mg/day.
• The maximum dose is 20 mg/day because safety concerns outweigh the clinical benefits of treatment at higher doses. 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. Treatment of moderate to severe manic episodes associated with bipolar I disorder • 2 to 10 mg/day orally, as a single dose or in 2 divided doses.
• Adjustments to the dose may be made every 1 to 3 days. • Doses above 10 mg/day have not demonstrated superior efficacy to lower doses in the majority of patients and may cause an increased incidence of extrapyramidal symptoms. The individual benefit- risk should be assessed when considering doses above 10 mg/day.
• The maximum dose is 15 mg/day because safety concerns outweigh the clinical benefits of treatment at higher doses. 4). Treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder • 5 to 10 mg orally, repeated after 12 hours if necessary to a maximum of 20 mg/day.
4). • When switching from haloperidol intramuscular injection, haloperidol orally should be initiated at a 1:1 dose conversion rate followed by dose adjustment according to clinical response. 5 to 5 mg/day orally, as a single dose or in 2 divided doses.
• Adjustments to the dose may be made every 1 to 3 days. • The need for continued treatment must be reassessed after no more than 6 weeks. 5 to 5 mg/day orally, as a single dose or in 2 divided doses. • Adjustments to the dose may be made every 1 to 7 days.
• The need for continued treatment must be reassessed every 6 to 12 months. Treatment of mild to moderate chorea in Huntington’s disease, when other medicinal products are ineffective or not tolerated • 2 to 10 mg/day orally, as a single dose or in 2 divided doses.
• Adjustments to the dose may be made every 1 to 3 days. 4). Missed dose If patients miss a dose, it is recommended that they take the next dose as usual, and do not take a double dose. 5 mg/day. • 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. 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.
Clinical studies with oral haloperidol in the treatment of tic disorders, including Tourette’s syndrome, did not include patients aged 65 years and above. Renal impairment 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. 2). Hepatic impairment The influence of hepatic impairment on the pharmacokinetics of haloperidol has not been evaluated. 2). 5 to 3 mg/day, administered orally in divided doses (2 to 3 times a day).
• It is recommended to assess the […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 29, 2026[1]
The safety of haloperidol was evaluated in 284 haloperidol-treated patients who participated in 3 placebo-controlled clinical studies and in 1295 haloperidol-treated patients who participated in 16 double-blind active comparator-controlled clinical studies.
Based on pooled safety data from these clinical studies, the most commonly reported adverse reactions were: 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%).
In addition, the safety of haloperidol decanoate was evaluated in 410 patients who participated in 3 comparator studies (1 comparing haloperidol decanoate versus fluphenazine and 2 comparing the decanoate formulation to oral haloperidol), 9 open label studies and 1 dose response study.
Table 3 lists adverse reactions as follows: • Reported in clinical studies with haloperidol • Reported in clinical studies with haloperidol decanoate and relate to the active moiety • From postmarketing experience with haloperidol and haloperidol decanoate Adverse reaction frequencies are based on (or estimated from) clinical trials or epidemiology studies with haloperidol, and classified using the following convention: Very common: ≥1/10 Common: ≥1/100 to <1/10 Uncommon: ≥1/1,000 to <1/100 Rare: ≥1/10,000 to <1/1,000 Very rare: <1/10,000 Not known: cannot be estimated from the available data.
The adverse reactions are presented by System Organ Class and in order of decreasing seriousness within each frequency category. 6) Reproducti ve system and breast disorders Erectile dysfunctio n Amenorrho ea Galactorrh oea Dysmenorr hoea Breast pain Breast discomfort Menorrhagia Menstrual disorder Sexual dysfunction Priapism Gynaecomast ia General disorders and administra tion site conditions Hyperther mia Oedema Gait disturbance Sudden death Face oedema Hypothermia Investigati ons Weight increased Weight decreased Electrocardi ogram QT prolonged Electrocardiogram QT prolonged, ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia), torsade de pointes and sudden death have been reported with haloperidol.
Class effects of antipsychotics Cardiac arrest has been reported with antipsychotics. Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis, have been reported with antipsychotics. The frequency is unknown.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised May 29, 2026[1]
Increased mortality in elderly people with dementia. 8). Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. 7 times the risk of death in placebo-treated patients. 6% in the placebo group.
g. g. pneumonia) in nature. Observational studies suggest that treatment of elderly patients with haloperidol is also associated with increased mortality. This association 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.
The extent to which this association is attributable to the medicinal product, as opposed to being confounded by patient characteristics, has not yet been elucidated. 8). The risk of these events appears to increase with high doses, high plasma concentrations, in predisposed patients or with parenteral use, particularly intravenous administration.
Caution is advised in patients with bradycardia, cardiac disease, family history of QTc prolongation or history of heavy alcohol exposure. 4, Poor metabolisers of CYP2D6). 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 for all patients.
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. 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. 8). Caution is recommended when haloperidol is administered to patients manifesting hypotension or orthostatic hypotension. Cerebrovascular events In randomised, placebo controlled clinical studies in the dementia population there was an approximately 3-fold increased risk of cerebrovascular adverse events with some atypical antipsychotics.
Observational studies comparing the stroke rate in elderly patients exposed to any antipsychotic to the stroke rate in those not exposed to such medicinal products found an increased stroke rate among exposed patients. This increase may be higher with all butyrophenones, including haloperidol.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 29, 2026[1]
1 • Comatose state • Central nervous system (CNS) depression • Parkinson’s disease • Dementia with Lewy bodies • Progressive supranuclear palsy • Known QTc interval prolongation or congenital long QT syndrome • Recent acute myocardial infarction • Uncompensated heart failure • History of ventricular arrhythmia or torsades de pointes • Uncorrected hypokalaemia • Concomitant treatment with medicinal products that prolong the QT interval.
5)
This is not medical advice. Consult a qualified healthcare professional.
These patients have been stabilized with other medications, and might benefit from a transfer to longer acting injectable therapy. The changeover to haloperidol decanoate (intramuscular) should aim at maintaining a clinical outcome similar to or better than that obtained with previous therapy in patients who cannot be relied upon to take oral medication regularly.
It is suggested that previous antipsychotic medication be discontinued before instituting therapy with haloperidol decanoate (intramuscular). Continuous supervision is required during the initial period of dosage adjustment in order to minimize the risk of overdosage or insufficient suppression of psychotic symptoms before the next injection.
Supplemental oral haloperidol may be required in diminishing dosage during this period. The selection of the initial dose of haloperidol decanoate (intramuscular) should be based on the patient’s symptomatology and previous oral neuroleptic dosage.
A ratio of 20:1 of haloperidol decanoate (intramuscular) to oral haloperidol appears to produce comparable steady-state plasma levels of haloperidol with both dosage forms. Control of psychotic symptoms, however, has also been achieved with doses based on lower ratios (10 to 15 times the daily maintenance dose of oral haloperidol).
In order to reduce the possible occurrence of adverse effects, it is advisable to initiate therapy with haloperidol decanoate (intramuscular) at lower doses and adjust the dose upwards as needed. There is limited experience with patients transferred to haloperidol decanoate (intramuscular) from other oral neuroleptics.
If such a transfer is deemed desirable, it is suggested that the patient be converted initially from the previous antipsychotic medication to oral Haloperidol LA Page 16 of 29 haloperidol in order to exclude the possibility of an unexpected adverse sensitivity to haloperidol.
The average duration of haloperidol decanoate (intramuscular) is 4 weeks. The frequency of administration and the dosage must, however, be individually determined for each patient. The dose should not be increased with the intent of prolonging the interval between injections beyond 4 weeks, since higher doses may increase the incidence of extrapyramidal symptoms and other adverse effects.
Occasionally, patients may require higher dosages and/or shorter injection intervals, such as 3 or even 2 weeks. Clinical experience with haloperidol decanoate (intramuscular) at doses greater than 300 mg has been limited and much lower doses are usually adequate to achieve symptom control.
In order to minimize the possible occurrence of serious and potentially irreversible adverse effects, the lowest neuroleptic dosage should be used which is consistent with effective management of the patient. After appropriate dosage adjustment is achieved, regular reassessment is considered essential to allow additional adjustments which will ensure that the lowest effective individual doses are used.
Patients who require higher doses of haloperidol decanoate (intramuscular) and/or those who complain of discomfort with a large injection volume may be administered haloperidol decanoate (intramuscular) 100 mg/mL in preference to haloperidol decanoate (intramuscular) 50 mg/mL.
As with all oily injections it is important to insure, by aspiration before injection, that inadvertent intravascular injection does not occur. A dry syringe and a dry 5 cm needle of 21 gauge should be used for patients with a normal amount of body fat.
5 cm needle in order to ensure that the injection goes into muscle. Pediatrics The safety and efficacy of Haloperidol LA (Haloperidol Decanoate Injection (intramuscular)) in children have not been established (see CONTRAINDICATIONS).
Geriatrics Lower initial doses and more gradual titration are recommended in elderly and debilitated patients. Haloperidol LA Page 17 of 29 PHARMACEUTICAL INFORMATION Drug Substance Proper Name: Haloperidol decanoate (USP, USAN, BAN) Chemical Names: 1.
Decanoic acid, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4- (oxobutyl)]-4-piperidinyl ester. 2. Decanoic acid, ester with 4-[4-(p-chlorophenyl)-4- hydroxypiperidino]-4'-fluorobutyrophenone. 12 g/mol Physiochemical properties: A white to faintly yellowish crystalline powder, odourless or almost odourless.
Slightly soluble in water, soluble in ethanol, ether, acetone and chloroform. Melts at about 42C. STORAGE AND STABILITY Haloperidol LA should be protected from light and stored between 15 and 30C. As with other depot neuroleptics, precipitation may occur if the drug is stored for long periods in the cold.
The precipitate should clear on storage at room temperature. DOSAGE FORMS, COMPOSITION AND PACKAGING Each mL of oily limpid liquid of clear, […]
This is not medical advice. Consult a qualified healthcare professional.
USOfficial regulatory label· revised April 8, 2026[3]
2 DOSAGE AND ADMINISTRATION Administer haloperidol decanoate injection by deep intramuscular injection every 4 weeks by a healthcare provider. 1 ). 1 ). 2 ). 1 Recommended Dosage and Administration Administer haloperidol decanoate injection by deep intramuscular injection every 4 weeks by a health care professional.
Do not administer haloperidol decanoate injection intravenously. When injecting haloperidol decanoate injection, use a 21-gauge needle. The maximum volume per injection site is 3 mL. Table 1 below describes the recommended dosage for haloperidol decanoate injection.
The maximum recommended initial dose is 100 mg. If the calculated first recommended dose of haloperidol decanoate injection is greater than 100 mg, then administer two deep intramuscular injections as follows: 100 mg on the first day Remainder of the amount 3 to 7 days later.
Table 1:
Haloperidol Decanoate Injection Recommended Dosage Population First Recommended Dose Maintenance Dosage 1 Adult patients less than 65 years old stabilized on ≤ 10 mg of daily immediate-release oral haloperidol with normal hepatic function.
10–15 times previous daily dose of immediate-release oral haloperidol. 10–15 times previous daily dose of immediate-release oral haloperidol administered every 4 weeks. The dosage may be increased by increments of 50 mg or less every 4 weeks until an optimal therapeutic effect is obtained.
The typical effective dosage range is between 50 and 200 mg every 4 weeks. Adult patients less than 65 years old stabilized on ≤ 10 mg of daily immediate-release oral haloperidol with hepatic impairment OR Adult patients 65 years and older 10–15 times previous daily dose of immediate-release oral haloperidol.
3) ]. Adult patients less than 65 years old stabilized on >10 mg of daily immediate-release oral haloperidol 10–20 times previous daily dose of immediate-release oral haloperidol 10–15 times previous daily dose of immediate-release oral haloperidol administered every 4 weeks.
The dosage may be increased by increments of 50 mg or less every 4 weeks until an optimal therapeutic effect is obtained. 1 Clinical experience with haloperidol decanoate injection at a dosage greater than 450 mg every 4 weeks has been limited.
2 Recommended Supplemental Immediate-release Oral Haloperidol Therapy If schizophrenia symptoms worsen during dosage modification of haloperidol decanoate injection, consider administering an immediate-release oral haloperidol product in addition to haloperidol decanoate injection therapy.
3 Preparation Instructions Visually inspect haloperidol decanoate injection for particulate matter and discoloration prior to administration. Do not use if the solution has debris or is not clear or not colorless to pink or amber in color.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 1,314 reports total. [4]
Drug Ineffective 170
Off Label Use 163
Neuroleptic Malignant Syndrome 111
Drug Interaction 99
Extrapyramidal Disorder 62
Condition Aggravated 61
Catatonia 60
Tardive Dyskinesia 55
Tremor 51
Serotonin Syndrome 50
Dystonia 49
Toxicity To Various Agents 49
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised April 8, 2026[3]
1 ). To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals, Inc. gov/medwatch . 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
7 times the maximum recommended dosage) of haloperidol decanoate injection monthly in 13 clinical trials of 410 adult patients with schizophrenia or an unapproved condition. These clinical trials comprised of: 1 double-blind, active comparator-controlled trial with fluphenazine decanoate (Trial 1).
2 trials comparing haloperidol decanoate injection to oral haloperidol (Trials 2 and 3). 9 open-label trials. 1 dose-response trial. The most common adverse reactions that occurred in ≥5% of haloperidol decanoate injection-treated patients in Trial 1 were Parkinsonism and oculogyric crisis.
Adverse reactions that occurred in ≥1% of haloperidol decanoate injection-treated patients in Trial 1 are shown in Table 2. Trial 1 was not designed to evaluate meaningful comparisons of the incidence of adverse reactions in the haloperidol decanoate injection and fluphenazine decanoate treatment groups.
Table 2:
Adverse Reactions that Occurred in ≥1% of Haloperidol Decanoate Injection-treated Patients and Fluphenazine Decanoate-treated Patients in Trial a Haloperidol Decanoate Injection (n=36) Fluphenazine decanoate (n=36) Extrapyramidal disorder: Parkinsonism 31% 44% Oculogyric crisis 6% 0% Akinesia 3% 22% Akathisia 3% 14% Tremor 3% 0% Abdominal pain 3% 0% Headache 3% 0% a The study was not designed to evaluate meaningful comparisons of the incidence of adverse reactions in the haloperidol decanoate injection and the fluphenazine decanoate treatment groups.
Less common adverse reactions (<1%) that occurred in Trial 1 and other adverse reactions that occurred in Trials 2 and 3, and open-label and dose-response clinical trials of haloperidol decanoate injection are listed below. 2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of haloperidol, including haloperidol decanoate injection.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders:
Pancytopenia, Agranulocytosis, Thrombocytopenia, Leukopenia, Neutropenia Cardiac Disorders: Ventricular fibrillation, Torsade de pointes, Ventricular tachycardia, Extrasystoles, QTc interval prolongation Endocrine Disorders: Inappropriate antidiuretic hormone secretion Gastrointestinal Disorders: Vomiting, Nausea General Disorders and Administration Site Conditions: Sudden death, Face edema, Edema, Hyperthermia, Hypothermia, Injection site abscess, Weight decreased Hepatobiliary Disorders: Acute hepatic failure, Hepatitis, Cholestasis, Jaundice, Liver function test abnormal Immune System Disorders: Anaphylactic reaction, Hypersensitivity Metabolic and Nutritional Disorders: Hypoglycemia Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis Nervous System Disorders: Convulsion, Opisthotonus, Tardive dystonia Pregnancy, Puerperium and Perinatal Conditions: Neonatal drug withdrawal syndrome Psychiatric Disorders: Agitation, Confusional state, Depression, Insomnia Renal and Urinary Disorders: Urinary retention Reproductive System and Breast Disorders: Priapism, Gynecomastia Respiratory, Thoracic and Mediastinal Disorders: Laryngeal edema, Bronchospasm, Laryngospasm, Dyspnea Skin and Subcutaneous Tissue Disorders: Angioedema, Dermatitis exfoliative, Hypersensitivity vasculitis, Photosensitivity reaction, Urticaria, Pruritus, Rash, Hyperhidrosis
USOfficial regulatory label· Warnings and precautions· revised April 8, 2026[3]
5 WARNINGS AND PRECAUTIONS Sudden Death, Torsades de Pointes (TdP), and QTc Interval Prolongation: Avoid use of haloperidol decanoate injection in patients who are at risk of developing TdP. Avoid concomitant use of haloperidol decanoate injection with drugs that may increase risk of QTc interval prolongation or increase haloperidol exposure.
2 ). 3 ). 4 ). 5 ). 6 ).
Seizures:
Haloperidol decanoate injection is generally not recommended in patients receiving antiseizure drugs or who have a history of seizures or EEG abnormalities. 8 ). 11 ). 12 ).
Leukopenia, Neutropenia, and Agranulocytosis:
Perform complete blood counts (CBC) in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Consider discontinuing haloperidol decanoate injection if clinically significant decline in WBC occurs in absence of other causative factors.
13 ). 14 ). 1 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. 7 times the risk of death in placebo-treated patients.
6% in placebo-treated patients. , pneumonia) in nature. Haloperidol decanoate injection is not approved for the treatment of patients with dementia-related psychosis [see Indications and Usage (1) ] . 2) ] . Cases have been reported even in the absence of predisposing factors.
Higher than recommended haloperidol dosages were associated with a higher risk of TdP and QTc interval prolongation. Avoid use of haloperidol decanoate injection in patients who are at significant risk of developing TdP including those with congenital long QT syndrome, uncontrolled or significant cardiac disease, recent myocardial infarction, ischemic cardiomyopathy, unstable angina, bradyarrhythmias, uncontrolled hypertension, high degree atrioventricular block, severe aortic stenosis, or uncontrolled hypothyroidism.
Avoid the concomitant use of haloperidol decanoate injection with drugs that may increase the risk of the QTc interval prolongation or increase haloperidol exposure. Assess the QTc interval via an ECG at baseline, and during treatment as clinically indicated.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised April 8, 2026[3]
4 CONTRAINDICATIONS Haloperidol decanoate injection is contraindicated in patients with: Severe toxic central nervous system depression or comatose states from any cause. Known hypersensitivity to haloperidol or any components of haloperidol decanoate injection.
2) ] . 7) ]. 7) ] . Severe toxic central nervous system depression or comatose states from any cause ( 4 ). Known hypersensitivity to haloperidol or any components of haloperidol decanoate injection ( 4 ). 1 ). 7 ).
This is not medical advice. Consult a qualified healthcare professional.
The mechanism for this increased risk is not known. An increased risk cannot be excluded for other patient populations. Haloperidol must be used with caution in patients with risk factors for stroke. Neuroleptic malignant syndrome Haloperidol has been associated with neuroleptic malignant syndrome: a rare idiosyncratic response characterised by hyperthermia, generalised muscle rigidity, autonomic instability, altered consciousness and increased serum creatine phosphokinase levels.
Hyperthermia is often an early sign of this syndrome. Antipsychotic treatment must be withdrawn immediately and appropriate supportive therapy and careful monitoring instituted. Tardive dyskinesia Tardive dyskinesia may appear in some patients on long-term therapy or after discontinuation of the medicinal product.
The syndrome is mainly characterised by rhythmic involuntary movements of the tongue, face, mouth or jaw. The manifestations may be permanent in some patients. The syndrome may be masked when treatment is reinstituted, when the dose is increased or when a switch is made to a different antipsychotic.
If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including haloperidol, must be considered. g. tremor, rigidity, hypersalivation, bradykinesia, akathisia, acute dystonia). The use of haloperidol has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move, often accompanied by an inability to sit or stand still.
This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental. Acute dystonia may occur during the first few days of treatment with haloperidol, but later onset as well as onset after dose increases has been reported.
Dystonic symptoms can include, but are not limited to, torticollis, facial grimacing, trismus, tongue protrusion, and abnormal eye movements, including oculogyric crisis. Males and younger age groups are at higher risk of experiencing such reactions.
Acute dystonia may necessitate stopping the medicinal product. Antiparkinson medicinal products of the anticholinergic type may be prescribed as required to manage extrapyramidal symptoms, but it is recommended that they are not prescribed routinely as a preventive measure.
If concomitant treatment with antiparkinson medicinal product is required, it may have to be continued after stopping haloperidol if its excretion is faster than that of haloperidol in order to […]
Obtain serum electrolytes (including potassium, calcium, phosphorus, and magnesium) at baseline and during treatment as clinically indicated, and correct electrolyte abnormalities. 1) ] . , geriatric patients, patients with dehydration, hypovolemia, and concomitantly treated with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and patients with cerebrovascular disease.
Should hypotension occur and a vasopressor be required, epinephrine must not be used since haloperidol decanoate injection may block its vasopressor activity, and paradoxically lower blood pressure. Instead, metaraminol, phenylephrine or norepinephrine should be used.
, stroke, transient ischemic attack) including fatalities, compared to those treated with placebo. The mechanism for this increased risk is not known. Haloperidol decanoate injection is not approved for the treatment of patients with dementia-related psychosis.
Haloperidol decanoate injection should be used with caution in patients with schizophrenia who have risk factors for cerebrovascular adverse reactions. 1) ] . TD can develop after a relatively brief treatment period at low dosages and may also occur after discontinuation of treatment.
If antipsychotic treatment is discontinued, TD may partially or completely remit. Antipsychotic treatment, however, may suppress or partially suppress the signs and symptoms of TD and may mask the underlying process. The effect that symptomatic suppression has upon the long-term course of TD is unknown.
The TD risk in patients treated with antipsychotic drugs appears to be highest among the elderly, especially elderly women, but it is not possible to predict, which patients are likely to develop TD. The TD risk and the likelihood that TD will become irreversible increase with the duration of antipsychotic drug treatment and the cumulative dosage.
In patients who require chronic antipsychotic treatment, use the lowest dosage and the shortest duration of treatment that produces a satisfactory clinical response. Periodically reassess the need for continued treatment. If signs and symptoms of TD appear in haloperidol decanoate injection-treated patients, consider drug discontinuation.
However, some patients may require haloperidol decanoate injection treatment despite the presence of TD. 1) ] . Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, delirium, and autonomic instability, and additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
If NMS is suspected, immediately discontinue haloperidol decanoate injection and provide intensive symptomatic treatment and monitoring. 7 Neurological Adverse Reactions in Patients with Parkinson's Disease or Dementia with Lewy Bodies Patients with Parkinson's disease or Dementia with Lewy bodies may experience increased sensitivity to haloperidol.
, tremor, rigidity, bradykinesia), confusion, sedation, and falls. Haloperidol decanoate injection is contraindicated in patients with Dementia with Lewy bodies and in patients with Parkinson's disease. 8 Seizures Haloperidol decanoate injection may lower the seizure threshold.
Haloperidol decanoate injection is generally not recommended in patients receiving antiseizure drugs or have a history of seizures or EEG abnormalities. If clinically indicated, maintain patients taking haloperidol decanoate injection on adequate antiseizure therapy.
2) ] . Haloperidol decanoate injection is contraindicated in patients with known hypersensitivity to haloperidol or any components of haloperidol decanoate injection. 10 Falls Antipsychotics, including haloperidol decanoate injection, may cause somnolence, orthostatic hypotension, motor instability and sensory abnormality, which may lead to falls and, consequently, fractures and other injuries.
If patients have a condition (or take concomitant drugs) that could exacerbate these effects, complete fall risk assessments when initiating haloperidol decanoate injection treatment and periodically during long-term treatment. 11 Potential for Cognitive and Motor Impairment Haloperidol decanoate injection may impair judgement, thinking, or motor skills.
Inform patients of the risk and advise them to not drive a motor vehicle or operate hazardous machinery until they are reasonably certain that treatment with haloperidol decanoate injection does not impair their cognitive and motor functions.
12 Risk of Encephalopathic Syndrome with Concomitant Use of Lithium An encephalopathic syndrome, characterized by weakness, lethargy, fever, tremulousness, confusion, extrapyramidal symptoms, leukocytosis, and elevated serum enzymes (AST, ALT, GGT, alkaline phosphatase, CK, and LDH), BUN, and fasting blood sugar, followed by irreversible brain damage has occurred in a few patients treated with concomitant haloperidol and lithium.
Monitor patients who concomitantly use haloperidol decanoate injection and lithium closely for early signs of neurological toxicity, and discontinue haloperidol decanoate injection or both haloperidol decanoate injection and lithium promptly if such signs appear.
2) ] . Possible risk factors for antipsychotic drug-associated leukopenia and neutropenia include pre-existing low WBC and history of drug-induced leukopenia and neutropenia. Perform frequent complete blood count (CBC) monitoring during the first few months of haloperidol decanoate injection therapy in patients with a history of a clinically significant low WBC, drug-induced leukopenia or neutropenia.
Consider discontinuing haloperidol decanoate injection in patients who have a clinically significant decline in their WBC in the absence of other causative factors. Discontinue haloperidol decanoate injection in patients with clinically significant neutropenia or an absolute neutrophil count of <1,000/mm 3 and monitor closely until the neutropenia resolves.
3) ] . 1) ] . 15 Risk of Severe Neurotoxicity in Patients with Thyrotoxicosis Severe neurotoxicity (rigidity, inability to walk or talk) may occur in patients with thyrotoxicosis who are also receiving antipsychotic drugs, including haloperidol decanoate injection.