Haloperidol Decanoate 50 mg/mL Injection, 10 vials
Other active recalls for Haloperidol Decanoate (different manufacturers) — 6 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Typical Antipsychotic class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Haloperidol injection and haloperidol extended-release injection are used to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). . Haloperidol is in a class of medications called conventional antipsychotics. It works by changing the activity of certain natural substances in the brain.
Read the full MedlinePlus article ↗- Haloperidol is mainly used to manage symptoms of psychotic disorders — things like hallucinations and severely disorganized thinking. It's also used to control the tics and vocal s...
- The most common things people notice early on are muscle stiffness, tremors, or a restless, can't-sit-still feeling. Some people also feel drowsy or notice their blood pressure dip...
- What side effects should I watch out for when I first start taking it?
- Yes — a few things need prompt attention. If you develop sudden muscle spasms in your neck or jaw, throat tightening, or trouble swallowing or breathing, get help right away. Also...
Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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UNII QX10HYY4QV
Sesame oil is a plant-derived oil from sesame seeds. It's used in medicines as a solvent or carrier to dissolve or suspend active ingredients, helping them mix evenly throughout the formulation.
2 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $6.740 | $67.40 / 10 ml |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $19.84 | $198.37 / 10 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| haloperidol decanoate 50 mg/mL 25021-0831-01 | Sagent | 10 vials | $6.740 | AO | Availability likely | — |
| Haloperidol Decanoate 50 mg/mL 65145-0168-10 | Caplin | 10 vials | $6.740 | AO | Availability likely | — |
| Haloperidol Decanoate 50 mg/mL 67457-0410-13 | Mylan | 10 vials | $6.740 | AO | Availability likely | — |
| Haloperidol Decanoate 50 mg/mL 70069-0866-10 | Somerset | 10 vials | $6.740 | AO | Availability likely | — |
| Haloperidol decanoate 50 mg/mL 70710-1461-06 | Zydus | 10 vials | $6.740 | AO | Availability likely | — |
| Haloperidol Decanoate 50 mg/mL 70756-0615-10 | Lifestar | 10 vials | $6.740 | AO | Availability likely | — |
| Haloperidol Decanoate 50 mg/mL 71288-0502-02 | Meitheal | 10 vials | $6.740 | AO | Availability likely | — |
| Haloperidol Decanoate 50 mg/mLthis 72485-0520-10 | Armas | 10 vials | $6.740 | AO | Availability likely | — |
| Haloperidol decanoate 50 mg/mL 68001-0657-51 | BluePoint | 3 vials | $12.109 | AO | Availability likely | +80% |
| Haloperidol Decanoate 50 mg/mL 63323-0469-01 | Fresenius | 1 vial | $12.467 | AO | Availability likely | +85% |
| Haloperidol Decanoate 50 mg/mL 70069-0381-01 | Somerset | 1 vial | $12.744 | AO | Availability likely | +89% |
| Haloperidol Decanoate 50 mg/mL 68001-0580-41 | BluePoint | 1 vial | $12.748 | AO | Availability likely | +89% |
| Haloperidol Decanoate 50 mg/mL 10147-0921-03 | Patriot | 3 ampules | $20.085 | — | FDA listed | +198% |
| Haloperidol Decanoate 50 mg/mL 68001-0578-48 | BluePoint | 3 ampules | $20.085 | AO | FDA listed | +198% |
| Haloperidol Decanoate 50 mg/mL 70069-0030-03 | Somerset | 3 ampules | $20.598 | AO | Availability likely | +206% |
| Haldol Decanoate 50 mg/mL 50458-0253-03 | Janssen | 3 ampules | — | — | FDA listed | — |
| Haloperidol Decanoate 50 mg/mL 68083-0137-02 | Gland | 1 vial | — | AO | FDA listed | — |
| Haloperidol Decanoate 50 mg/mL 70518-3743-00 | REMEDYREPACK | 10 vials | — | AO | FDA listed | — |
| Haloperidol Decanoate 50 mg/mL 70518-4670-00 | REMEDYREPACK | 10 vials | — | AO | FDA listed | — |
| Haloperidol decanoate 50 mg/mL 70771-1851-06 | Zydus | 10 vials | — | AO | FDA listed | — |
| Haloperidol Decanoate 50 mg/mL 70069-0382-01 | Somerset | 1 vial | — | AO | FDA listed | — |
| Haloperidol decanoate 50 mg/mL 70771-1852-01 | Zydus | 1 vial | — | AO | FDA listed | — |
| Haloperidol decanoate 50 mg/mL 70710-1462-01 | Zydus | 1 vial | — | AO | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72485-0520-10 You're viewing this | 10 VIAL, SINGLE-DOSE in 1 CARTON (72485-520-10) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-520-01) | 2026-05-15 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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 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 decanoate is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).
🎯 Indications and Usage ▾
INDICATIONS & USAGE Haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.
⏱️ Dosage and Administration ▾
DOSAGE & ADMINISTRATION Haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL should be administered by deep intramuscular injection. A 21 gauge needle is recommended. The maximum volume per injection site should not exceed 3 mL.
DO NOT ADMINISTER INTRAVENOUSLY. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL are intended for use in schizophrenic patients who require prolonged parenteral antipsychotic therapy.
These patients must be previously stabilized on antipsychotic medication before considering a conversion to haloperidol decanoate. Furthermore, it is recommended that patients being considered for haloperidol decanoate therapy have been treated with, and tolerate well, short-acting haloperidol in order to reduce the possibility of an unexpected adverse sensitivity to haloperidol. Close clinical supervision is required during the initial period of dose adjustment in order to minimize the risk of overdosage or reappearance of psychotic symptoms before the next injection.
During dose adjustment or episodes of exacerbation of symptoms of schizophrenia, haloperidol decanoate therapy can be supplemented with short-acting forms of haloperidol. The dose of haloperidol decanoate injection, 50 mg/mL or haloperidol decanoate injection, 100 mg/mL should be expressed in terms of its haloperidol content. The starting dose of haloperidol decanoate should be based on the patient's age, clinical history, physical condition, and response to previous antipsychotic therapy.
The preferred approach to determining the minimum effective dose is to begin with lower initial doses and to adjust the dose upward as needed. For patients previously maintained on low doses of antipsychotics (e.g. up to the equivalent of 10 mg/day oral haloperidol), it is recommended that the initial dose of haloperidol decanoate be 10–15 times the previous daily dose in oral haloperidol equivalents; limited clinical experience suggests that lower initial doses may be adequate. Initial Therapy Conversion from oral haloperidol to haloperidol decanoate can be achieved by using an initial dose of haloperidol decanoate that is 10 to 20 times the previous daily dose in oral haloperidol equivalents.
In patients who are elderly, debilitated, or stable on low doses of oral haloperidol (e.g. up to the equivalent of 10 mg/day oral haloperidol), a range of 10 to 15 times the previous daily dose in oral haloperidol equivalents is appropriate for initial conversion. In patients previously maintained on higher doses of antipsychotics for whom a low dose approach risks recurrence of psychiatric decompensation and in patients whose long-term use of haloperidol has resulted in a tolerance to the drug, 20 times the previous daily dose in oral haloperidol equivalents should be considered for initial conversion, with downward titration on succeeding injections.
The initial dose of haloperidol decanoate should not exceed 100 mg regardless of previous antipsychotic dose requirements. If, therefore, conversion requires more than 100 mg of haloperidol decanoate as an initial dose, that dose should be administered in two injections, i.e. a maximum of 100 mg initially followed by the balance in 3 to 7 days. Maintenance Therapy The maintenance dosage of haloperidol decanoate must be individualized with titration upward or downward based on therapeutic response.
The usual maintenance range is 10 to 15 times the previous daily dose in oral haloperidol equivalents dependent on the clinical response of the patient. HALOPERIDOL DECANOATE DOSING RECOMMENDATIONS Patients Monthly 1 st Month Maintenance Stabilized on low daily oral doses (up to 10 mg/day) Elderly or Debilitated 10–15 × Daily Oral Dose 10–15 × Previous Daily Oral Dose High dose Risk of relapse Tolerant to or…
⛔ Contraindications ▾
CONTRAINDICATIONS Since the pharmacologic and clinical actions of haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL are attributed to haloperidol as the active medication, Contraindications, Warnings, and additional information are those of haloperidol, modified only to reflect the prolonged action. Haloperidol is contraindicated in patients with: Severe toxic central nervous system depression or comatose states from any cause. Hypersensitivity to this drug – hypersensitivity reactions have included anaphylactic reaction and angioedema (see WARNINGS, Hypersensitivity Reactions and ADVERSE REACTIONS ).
Parkinson's disease (see WARNINGS , Neurological Adverse Reactions in Patients with Parkinson's Disease or Dementia with Lewy Bodies). Dementia with Lewy bodies (see WARNINGS , Neurological Adverse Reactions in Patients with Parkinson's Disease or Dementia with Lewy Bodies).
⚠️ Warnings ▾
WARNINGS 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. Haloperidol decanoate is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). Cardiovascular Effects Cases of sudden death, QTc interval-prolongation, and Torsades de Pointes have been reported in patients receiving haloperidol (see ADVERSE REACTIONS ).
Higher than recommended doses of any formulation and intravenous administration of haloperidol appear to be associated with a higher risk of QTc interval-prolongation and Torsades de Pointes. Also, a QTc interval that exceeds 500 msec is associated with an increased risk of Torsades de Pointes. Although cases have been reported even in the absence of predisposing factors, particular caution is advised in treating patients with other QTc prolonging conditions (including electrolyte imbalance [particularly hypokalemia and hypomagnesemia], drugs known to prolong QTc, underlying cardiac abnormalities, hypothyroidism, and familial long QT-syndrome).
HALOPERIDOL DECANOATE MUST NOT BE ADMINISTERED INTRAVENOUSLY. Tachycardia and hypotension (including orthostatic hypotension) have also been reported in occasional patients (see ADVERSE REACTIONS ). Cerebrovascular Adverse Reactions In controlled trials, elderly patients with dementia-related psychosis treated with some antipsychotics had an increased risk (compared to placebo) of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities.
The mechanism for this increased risk is not known. An increased risk cannot be excluded for haloperidol decanoate, other antipsychotics, or other patient populations. Haloperidol decanoate should be used with caution in patients with risk factors for cerebrovascular adverse reactions.
Tardive Dyskinesia A syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs (see ADVERSE REACTIONS ). Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.
Both the risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Tardive dyskinesia, may remit, partially or completely, if antipsychotic treatment is discontinued.
Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown. Given these considerations, antipsychotic drugs should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia.
Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that 1) is known to respond to antipsychotic drugs, and 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.
If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered. Ho…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: WARNINGS, Increased mortality in Elderly Patients with Dementia-Related Psychosis WARNINGS, Cardiovascular Effects WARNINGS, Tardive Dyskinesia WARNINGS, Neuroleptic Malignant Syndrome WARNINGS, Hypersensitivity Reactions WARNINGS, Falls WARNINGS, Combined Use of Haloperidol and Lithium WARNINGS, General PRECAUTIONS, Leukopenia, Neutropenia, and Agranulocytosis PRECAUTIONS, Other PRECAUTIONS, Usage in Pregnancy 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.
The data described below reflect exposure to haloperidol in 410 patients who participated in 13 clinical trials with haloperidol decanoate (15 to 500 mg/month) in the treatment of schizophrenia or schizoaffective disorder. These clinical trials comprised: 1 double-blind, active comparator-controlled trial with fluphenazine decanoate. 2 trials comparing the decanoate formulation to oral haloperidol.
9 open-label trials. 1 dose-response trial. The most common adverse reactions in haloperidol decanoate-treated patients in the double-blind, active comparator-controlled clinical trial with fluphenazine decanoate (≥5%) were: Parkinsonism, and oculogyric crisis.
Adverse Reactions Reported at ≥1% Incidence in a Double-Blind Active Comparator-Controlled Clinical Trial Adverse reactions occurring in ≥1% of haloperidol decanoate-treated patients in a double-blind, clinical trial with the active comparator fluphenazine decanoate are shown in Table 1. Table 1. Adverse Reactions Reported by ≥1% of Haloperidol Decanoate-treated Patients in a Double-Blind Active Comparator-Controlled Clinical Trial with Fluphenazine Decanoate S ystem /Organ Class Adverse Reaction Haloperidol decanoate (n=36) % Fluphenazine decanoate (n=36) % Gastrointestinal Disorders Abdominal pain 2.8 0 Nervous System Disorders Extrapyramidal disorder a : Parkinsonism 30.6
44.4Oculogyric crisis 5.6 0 Akinesia 2.8
22.2Akathisia 2.8
13.9Tremor 2.8 0 Headache 2.8 0 a Precise incidence for extrapyramidal disorder cannot be determined; reporting rates of some individual symptoms of extrapyramidal disorder are lower for haloperidol decanoate than for the active comparator, but the terms are included here because the events are considered associated with the drug. Additional Adverse Reactions Reported in Double-Blind, Comparator, Open-Label and Dose-Response Clinical Trials Additional adverse reactions that are listed below were reported by haloperidol decanoate-treated patients in comparator, open-label, and dose-response clinical trials, or at <1% incidence in a double-blind, active comparator-controlled clinical trial with fluphenazine decanoate.
Cardiac Disorders: Tachycardia Endocrine Disorders: Hyperprolactinemia Eye Disorders: Vision blurred Gastrointestinal Disorders: Constipation, Dry mouth, Salivary hypersecretion General Disorders and Administration Site Conditions: Injection site reaction Investigations: Weight increased Musculoskeletal and Connective Tissue Disorders: Muscle rigidity Nervous System Disorders: Dyskinesia, Dystonia, Cogwheel rigidity, Hypertonia, Masked Facies, Sedation, Somnolence Reproductive System and Breast Disorders: Erectile dysfunction Adverse Reactions Identified in Clinical Trials with Haloperidol (Non-Decanoate Formulations) The adverse reactions listed below were identified with non-decanoate formulations, and reflect exposure to the active moiety haloperidol in the following: 284 patients who participated in 3 double-blind, placebo-controlled clinical trials with haloperidol (injection or oral formulation, 2 to 20 mg/day); two trials were in the treatment of schizophrenia and one in the treatment of bipolar disorder.
1295 patients w…
🔄 Drug Interactions ▾
Drug Interactions Drug-drug interactions can be pharmacodynamic (combined pharmacologic effects) or pharmacokinetic (alteration of plasma levels). The risks of using haloperidol in combination with other drugs have been evaluated as described below. Pharmacodynamic Interactions Since QTc interval-prolongation has been observed during haloperidol treatment, caution is advised when prescribing to a patient with QT-prolongation conditions or to patients receiving medications known to prolong the QTc-interval (see WARNINGS, Cardiovascular Effects ).
Examples include (but are not limited to): Class 1A antiarrhythmics (e.g., procainamide, quinidine, disopyramide); Class 3 antiarrhythmics (e.g., amiodarone, sotalol); and other drugs such as citalopram, erythromycin, levofloxacin, methadone, and ziprasidone. Caution is advised when haloperidol decanoate is used in combination with drugs known to cause electrolyte imbalance (e.g., diuretics or corticosteroids) because hypokalemia, hypomagnesemia, and hypocalcemia are risk factors for QT prolongation. As with other antipsychotic agents, it should be noted that haloperidol may be capable of potentiating CNS depressants such as anesthetics, Opioids and alcohol.
Pharmacokinetic Interactions Drugs that May Increase Haloperidol Plasma Concentrations Haloperidol is metabolized by several routes. The major pathways are glucuronidation and ketone reduction. The cytochrome P450 enzyme system is also involved, particularly CYP3A4 and, to a lesser extent, CYP2D6.
Inhibition of these routes of metabolism by another drug or a decrease in CYP2D6 enzyme may result in increased haloperidol concentrations. The effect of CYP3A4 inhibition and of decreased CYP2D6 enzyme may be additive. The haloperidol plasma concentrations increased when a CYP3A4 and/or CYP2D6 inhibitor was coadministered with haloperidol.
Examples include: CYP3A4 inhibitors – alprazolam; itraconazole, ketoconazole, nefazodone, ritonavir. CYP2D6 inhibitors – chlorpromazine; promethazine; quinidine; paroxetine, sertraline, venlafaxine. Combined CYP3A4 and CYP2D6 inhibitors – fluoxetine, fluvoxamine; ritonavir.
Buspirone. Increased haloperidol plasma concentrations may result in an increased risk of adverse events, including QTc interval prolongation (see WARNINGS – Cardiovascular Effects ). Increases in QTc have been observed when haloperidol was given with a combination of the metabolic inhibitors ketoconazole (400 mg/day) and paroxetine (20 mg/day).
It is recommended that patients who take haloperidol concomitantly with such medicinal products be monitored for signs or symptoms of increased or prolonged pharmacologic effects of haloperidol, and the haloperidol decanoate dose be decreased as deemed necessary. Valproate: Sodium valproate, a drug known to inhibit glucuronidation, does not affect haloperidol plasma concentrations. Drugs that May Decrease Haloperidol Plasma Concentrations Coadministration of haloperidol with potent enzyme inducers of CYP3A4 may gradually decrease the plasma concentrations of haloperidol to such an extent that efficacy may be reduced.
Examples include (but are not limited to): carbamazepine, phenobarbital, phenytoin, rifampin, St John's Wort ( Hypericum, perforatum). Rifampin: In a study of 12 patients with schizophrenia coadministered oral haloperidol and rifampin, plasma haloperidol levels were decreased by a mean of 70% and mean scores on the Brief Psychiatric Rating Scale were increased from baseline. In 5 other patients with schizophrenia treated with oral haloperidol and rifampin, discontinuation of rifampin produced a mean 3.3-fold increase in haloperidol concentrations.
Carbamazepine: In a study in 11 patients with schizophrenia coadministered haloperidol and increasing doses of carbamazepine, haloperidol plasma concentrations decreased linearly with increasing carbamazepine concentrations. During combination treatment with inducers of CYP3A4, it is recommended that patients be monitored and the halop…
🤰 Pregnancy ▾
Usage in pregnancy Rats or rabbits administered oral haloperidol at doses of 0.5 to 7.5 mg/kg, which are approximately 0.2 to 7 times the maximum recommended human dose (MRHD) of 20 mg/day based on mg/m 2 body surface area, showed an increase in incidence of resorption, reduced fertility, delayed delivery and pup mortality. No fetal abnormalities were observed at these doses in rats or rabbits. Cleft palate has been observed in mice administered oral haloperidol at a dose of 0.5 mg/kg, which is approximately 0.1 times the MRHD based on mg/m 2 body surface area.
There are no adequate and well-controlled studies in pregnant women. There are reports, however, of cases of limb malformations observed following maternal use of haloperidol along with other drugs which have suspected teratogenic potential during the first trimester of pregnancy. Causal relationships were not established with these cases.
Since such experience does not exclude the possibility of fetal damage due to haloperidol, haloperidol decanoate should be used during pregnancy or in women likely to become pregnant only if the benefit clearly justifies a potential risk to the fetus. Non-Teratogenic Effects Neonates exposed to antipsychotic drugs (including haloperidol) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in these neonates.
These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Haloperidol decanoate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness of haloperidol decanoate in children have not been established.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of haloperidol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not consistently identified differences in responses between the elderly and younger patients. However, the prevalence of tardive dyskinesia appears to be highest among the elderly, especially elderly women (see WARNINGS, Tardive Dyskinesia ).
Also, the pharmacokinetics of haloperidol in geriatric patients generally warrants the use of lower doses (see DOSAGE AND ADMINISTRATION ).
🆘 Overdosage ▾
OVERDOSAGE While overdosage is less likely to occur with a parenteral than with an oral medication, information pertaining to haloperidol is presented, modified only to reflect the extended duration of action of haloperidol decanoate. Manifestations In general, the symptoms of overdosage would be an exaggeration of known pharmacologic effects and adverse reactions, the most prominent of which would be: 1) severe extrapyramidal reactions, 2) hypotension, or 3) sedation. The patient would appear comatose with respiratory depression and hypotension which could be severe enough to produce a shock-like state.
The extrapyramidal reactions would be manifested by muscular weakness or rigidity and a generalized or localized tremor, as demonstrated by the akinetic or agitans types, respectively. With accidental overdosage, hypertension rather than hypotension occurred in a two-year old child. The risk of ECG changes associated with torsade de pointes should be considered.
(For further information regarding torsade de pointes, please refer to ADVERSE REACTIONS.) Treatment Since there is no specific antidote, treatment is primarily supportive. Dialysis is not recommended in the treatment of overdose because it removes only very small amounts of haloperidol. A patent airway must be established by use of an oropharyngeal airway or endotracheal tube or, in prolonged cases of coma, by tracheostomy.
Respiratory depression may be counteracted by artificial respiration and mechanical respirators. Hypotension and circulatory collapse may be counteracted by use of intravenous fluids, plasma, or concentrated albumin, and vasopressor agents such as metaraminol, phenylephrine and norepinephrine. Epinephrine must not be used.
In case of severe extrapyramidal reactions, antiparkinson medication should be administered, and should be continued for several weeks, and then withdrawn gradually as extrapyramidal symptoms may emerge. ECG and vital signs should be monitored especially for signs of Q-Tc interval prolongation or dysrhythmias and monitoring should continue until the ECG is normal. Severe arrhythmias should be treated with appropriate anti-arrhythmic measures.
In case of an overdose, consult a Certified Poison Control Center (1-800-222-1222).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL are the long-acting forms of haloperidol, an antipsychotic. The mechanism of action of haloperidol for the treatment of schizophrenia is unclear. However, its efficacy could be mediated through its activity as an antagonist at central dopamine type 2 receptors.
Haloperidol also binds to alpha-1 adrenergic receptors, but with lower affinity, and displays minimal binding to muscarinic cholinergic and histaminergic (H1) receptors. Administration of haloperidol decanoate in sesame oil results in slow and sustained release of haloperidol. The plasma concentrations of haloperidol gradually rise, reaching a peak at about 6 days after the injection, and falling thereafter, with an apparent half-life of about 3 weeks.
Steady state plasma concentrations are achieved within 2 to 4 months in patients receiving monthly injections. The relationship between dose of haloperidol decanoate and plasma haloperidol concentration is roughly linear for doses below 450 mg. It should be noted, however, that the pharmacokinetics of haloperidol decanoate following intramuscular injections can be quite variable between subjects.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Haloperidol decanoate injection, 50 mg haloperidol as 70.52 mg per mL haloperidol decanoate is supplied as: NDC Number Strength Pack style Code Description 72485-520-10 50 mg/mL* 10 vials per carton 1 mL fill in 2 mL Single-Dose Vial Discard unused portion * as haloperidol Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate or freeze. Protect from light.
Retain in carton until contents are used. Keep out of reach of children. For dosage and other prescribing information, see accompanying product literature.
Dispense in a light-resistant container as defined in the official compendium. Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728 (USA) Manufactured by: Caplin Steriles Limited, Gummidipoondi-601 201, India.
Code: TN/Drugs/TN00003457 Revised: September 2025
📋 Description ▾
DESCRIPTION Haloperidol decanoate is the decanoate ester of the butyrophenone, haloperidol. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection.
The structural formula of haloperidol decanoate, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is: Haloperidol decanoate is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. Each mL of Haloperidol decanoate injection, 50 mg/mL for intramuscular injection contains 50 mg haloperidol (present as haloperidol decanoate 70.52 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative. Each mL of Haloperidol decanoate injection, 100 mg/mL for intramuscular injection contains 100 mg haloperidol (present as haloperidol decanoate 141.04 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative. haloperidol-decanoate-structure
💬 Information for Patients ▾
Information for patients Haloperidol decanoate may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. The ambulatory patient should be warned accordingly. The use of alcohol with this drug should be avoided due to possible additive effects and hypotension.