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Haloperidol

Haloperidol is a typical (older-generation) antipsychotic used to treat schizophrenia and other psychotic disorders, and, in some oral and injection products, Tourette’s Disorder and severe behavior problems in children.

Brand names HaldolHaloperidol DecanoateHaloperidol Lactate
Drug class Typical Antipsychotic
Rx Forms 3
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 80 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

Other forms & routes:
Haloperidol at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Haloperidol is an older antipsychotic, available as a generic and around for decades, that treats schizophrenia and other psychotic disorders (plus Tourette’s Disorder for some products) by blocking dopamine. Newer antipsychotics are usually tried first, but it remains a familiar standby. It causes more movement side effects than most newer antipsychotics, such as stiffness, tremor, slowed movement and akathisia (an inner restlessness that makes sitting still hard). It carries a boxed warning for a higher risk of death in older adults with dementia-related psychosis, and it can cause serious heart rhythm problems. Report fever with severe stiffness, fainting, a racing heartbeat or new uncontrolled movements (possible tardive dyskinesia) promptly.

Clinical pearls

  • Haloperidol decanoate, the long-acting injection, is meant for people already stable on oral haloperidol and is given every 4 weeks.
  • Tell every prescriber you take it, since antibiotics like erythromycin or levofloxacin, plus methadone, can add to its heart rhythm risk.
  • Your prescriber may check an ECG (heart tracing) and potassium and magnesium levels, especially if you take a water pill or steroid.
  • If you also take lithium, report weakness, fever, tremor or confusion promptly, because the combination has caused a serious brain syndrome.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Older adults with dementia-related psychosis who take antipsychotics like haloperidol have a higher risk of death. In trials lasting about 10 weeks, about 4.5% of drug-treated patients died, compared with about 2.6% on placebo. Most deaths were heart-related (such as heart failure or sudden death) or infections (such as pneumonia). Haloperidol decanoate injection is not approved for dementia-related psychosis.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet, Injection, Oral solution
Earliest FDA record1986
Companies listing it with the FDA42
FDA label last updatedNov 15, 2024
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Haloperidol, written from its FDA label.

What Haloperidol is used for

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Haloperidol is used for several conditions, depending on the product.

  • Schizophrenia: Haloperidol injection products, including Haloperidol Lactate.
  • Schizophrenia in adults previously stable on immediate-release oral haloperidol: Haldol Decanoate.
  • Schizophrenia needing prolonged injectable therapy: Haloperidol Decanoate.
  • Psychotic disorders: Haloperidol tablets and oral solution.
  • Tics and vocal utterances of Tourette’s Disorder: Haloperidol tablets and oral solution (children and adults), and one Haloperidol injection product.
  • Severe behavior problems and hyperactivity in children: Haloperidol tablets and oral solution, only after other treatments fail.

How Haloperidol works

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How haloperidol helps in schizophrenia is not fully understood. It may block dopamine type 2 receptors in the brain. It also binds more weakly to alpha-1 adrenergic receptors and barely binds to muscarinic or histamine (H1) receptors.

Haloperidol dosage

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Dosing is individualized and adjusted to your response.

  • Tablets and oral solution are taken by mouth, usually a few times daily.
  • Haldol Decanoate is injected deep into a muscle by a healthcare provider every 4 weeks. It is never given into a vein.
  • Haloperidol injection products are given into a muscle.

Follow your prescriber and the product label.

Dosing details from the FDA-approved label

From the Haloperidol prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Schizophrenic patients requiring prolonged parenteral antipsychotic therapy: initial conversion from oral haloperidol
    • Initial dose of haloperidol decanoate that is 10 to 20 times the previous daily dose in oral haloperidol equivalents, by deep intramuscular injection
    • Maximum: The initial dose should not exceed 100 mg regardless of previous antipsychotic dose requirements; if conversion requires more than 100 mg, give a maximum of 100 mg initially followed by the balance in 3 to 7 days
    • Maximum volume per injection site should not exceed 3 mL; do not administer intravenously
  • 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)
    • 10 to 15 times the previous daily dose in oral haloperidol equivalents for initial conversion (first month)
    • Maximum: The initial dose should not exceed 100 mg
    • Limited clinical experience suggests lower initial doses may be adequate
  • Patients previously maintained on higher doses of antipsychotics (risk of relapse) or tolerant to oral haloperidol
    • 20 times the previous daily dose in oral haloperidol equivalents should be considered for initial conversion, with downward titration on succeeding injections
    • Maximum: The initial dose should not exceed 100 mg
  • Maintenance therapy
    • Individualized with titration upward or downward based on therapeutic response
    • Usual maintenance range is 10 to 15 times the previous daily dose in oral haloperidol equivalents
    • Usually administered monthly or every 4 weeks
    • Maximum: Clinical experience at doses greater than 450 mg per month has been limited
    • Variation in patient response may require adjustment of the dosing interval as well as the dose
Read the label’s full dosing text

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 antipsychotic drugs, may require less haloperidol. The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels, as recommended below. Clinical experience suggests the following recommendations: Oral Administration Initial Dosage Range Adults Moderate Symptomatology - 0.5 mg to 2 mg b.i.d. or t.i.d. Severe Symptomatology - 3 mg to 5 mg b.i.d. or t.i.d. To achieve prompt control, higher doses may be required in some cases. Geriatric or Debilitated Patients - 0.5 mg to 2 mg b.i.d. or t.i.d. Chronic or Resistant Patients - 3 mg to 5 mg b.i.d. or t.i.d. Patients who remain severely disturbed or inadequately controlled may require dosage adjustment. Daily dosages up to 100 mg may be necessary in some cases to achieve an optimal response. Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses. Children The following recommendations apply to children between the ages of 3 and 12 years (weight range 15 kg to 40 kg). Haloperidol is not intended for children under 3 years old. Therapy should begin at the lowest dose possible (0.5 mg per day). If required, the dose should be increased by an increment of 0.5 mg at 5 to 7 day intervals until the desired therapeutic effect is obtained. (See chart below.) The total dose may be divided, to be given b.i.d. or t.i.d. Psychotic Disorders - 0.05 mg/kg/day to 0.15 mg/kg/day Nonpsychotic Behavior Disorders and Tourette's Disorder - 0.05 mg/kg/day to 0.075 mg/kg/day Severely disturbed psychotic children may require higher doses.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Haloperidol side effects

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Reported side effects include:

Common side effects

  • Parkinsonism (stiffness, tremor, slowed movement)
  • Oculogyric crisis (eyes locked in an upward gaze)
  • Akinesia (reduced movement)
  • Akathisia (inner restlessness)
  • Tremor
  • Headache
  • Abdominal pain

When to get medical help

  • Fever with severe muscle stiffness, confusion, or irregular pulse or blood pressure (possible neuroleptic malignant syndrome). Get emergency help.
  • Fainting, a racing or irregular heartbeat, or dizziness (possible QT prolongation or torsades de pointes, a dangerous heart rhythm)
  • Uncontrolled, repetitive muscle movements (possible tardive dyskinesia)
  • Rash, swelling of the face or throat, or trouble breathing (allergic reaction)
  • Signs of infection or a low white blood cell count
  • Weakness, lethargy, fever, tremor, or confusion if you also take lithium
  • Seizures
  • Falls, severe sleepiness, or stroke symptoms

Haloperidol warnings and precautions

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  • Older adults with dementia-related psychosis have a higher risk of death (boxed warning).
  • Sudden death, QT prolongation, and torsades de pointes (a dangerous heart rhythm) have been reported.
  • Tardive dyskinesia may be irreversible.
  • Neuroleptic malignant syndrome is potentially fatal.
  • Low blood pressure, falls, seizures, and low white blood cell counts can occur.
  • It can impair thinking and driving.

Haloperidol interactions

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Several medicines can change haloperidol’s effects.

  • QT-prolonging drugs (amiodarone, sotalol, citalopram, methadone, ziprasidone): higher risk of heart rhythm problems.
  • CYP3A4 or CYP2D6 inhibitors (ketoconazole, paroxetine, fluoxetine, ritonavir): raise haloperidol levels.
  • Carbamazepine, phenytoin, phenobarbital, rifampin, St John’s Wort: lower haloperidol levels.
  • Lithium: rare serious brain toxicity.
  • Alcohol, opioids, anesthetics: added sedation.
  • Levodopa: haloperidol may weaken its effect.

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Haloperidol

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  • Not for Parkinson’s disease, dementia with Lewy bodies, severe CNS depression or coma, or known allergy to haloperidol.
  • Tell your doctor about heart disease, long QT, electrolyte problems, thyroid problems, seizures, or low white blood cells.
  • Pregnancy: newborns exposed in the third trimester may have movement problems or withdrawal symptoms.
  • Breastfeeding: haloperidol passes into milk. Watch the baby for sleepiness and feeding problems.
  • Older adults and people with liver problems may need lower starting doses.
  • Haloperidol decanoate injection is not established for children.

Haloperidol overdose

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Overdose can cause severe muscle rigidity or tremor, very low blood pressure, heavy sedation, and even coma with slowed breathing. Heart rhythm changes are also possible. There is no specific antidote, and care is supportive. Call Poison Control at 1-800-222-1222.

What Haloperidol does in the body

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How haloperidol’s blood levels relate to its safety and effectiveness has not been fully characterized.

How your body processes Haloperidol

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After a haloperidol decanoate injection, blood levels peak at about 6 days. The half-life is about 3 weeks, and steady state takes 2 to 4 months of monthly injections. The liver breaks haloperidol down, mainly through glucuronidation and CYP3A4. Less than 3% leaves unchanged in urine. Levels may be higher in older adults and in people with liver problems.

How to store Haloperidol

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Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) Protect from light.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

211

Supplements & herbs that interact with Haloperidol

211 supplements and herbal products have documented interactions with Haloperidol in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 11
  • Moderate · 157
  • Minor · 43
Every supplement checked against Haloperidol — ranked by severity The full interaction hub: 11 major · 157 moderate · 43 minor · every one linked to its full report. Check Haloperidol against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Haloperidol: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Haloperidol — the kind of thing our pharmacy team would talk through with you at the counter.

What is haloperidol for?

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It treats schizophrenia and other psychotic disorders. The tablets and oral solution are also used for Tourette’s tics and for certain severe behavior problems in children. Your product determines which of these applies.

How do I take it?

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Tablets and oral solution are taken by mouth as your prescriber directs. Injections are given into a muscle by a healthcare provider, and Haldol Decanoate is given every 4 weeks. Never change the schedule on your own.

What side effects should I expect?

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Movement-related effects are the most common, such as stiffness, tremor, restlessness, or slowed movement. Headache and stomach pain can also happen. Tell us about any new movements you can’t control.

When should I call my doctor right away?

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Call for fever with severe stiffness and confusion, fainting or a racing or irregular heartbeat, seizures, or swelling and trouble breathing. These can be serious.

Can I drink alcohol or take other medicines with it?

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Alcohol can add to sleepiness. Many medicines interact, including QT-prolonging drugs, lithium, and carbamazepine, so check with us before adding anything, including St John’s Wort.

Is it safe in pregnancy or for older adults?

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In late pregnancy it can cause movement or withdrawal symptoms in newborns, so talk with your doctor. Older adults with dementia-related psychosis have a higher risk of death, and older adults are more prone to tardive dyskinesia.

Is Haloperidol available over the counter?

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No. Haloperidol is a prescription medicine: every Haloperidol product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Haloperidol first available?

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The earliest FDA record we hold for Haloperidol is from 1986: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Haloperidol was first used.

Who makes Haloperidol?

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42 companies currently list Haloperidol products in the FDA's NDC Directory, including Bryant Ranch Prepack, Remedyrepack Inc., Method Pharmaceuticals, LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Haloperidol on HelloPharmacist

Detailed data & references for Haloperidol Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Haloperidol forms and strengths (how it comes)

Haloperidol is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
How this form is used
What it may be used for
  • Haloperidol tablets are used for psychotic disorders.
  • Haloperidol tablets are used for tics and vocal utterances of Tourette’s Disorder in children and adults.
  • Haloperidol tablets are used for severe behavior problems or hyperactivity in children after other treatments have failed.
Important instructions
  • Haloperidol tablets dosing is individualized and adjusted to response.
  • Haloperidol tablets may need lower doses in children, older adults, and debilitated patients.
Available strengths 6 strengths
289 FDA-listed product records ⓘ

Injection

Into a muscle
Brands Haloperidol Decanoate Haloperidol Lactate
How this form is used
What it may be used for
  • Haldol Decanoate is for schizophrenia in adults previously stable on immediate-release oral haloperidol.
  • Haloperidol Decanoate is for schizophrenia in patients who need prolonged injectable antipsychotic therapy.
  • Haloperidol Lactate and Haloperidol injection are used for schizophrenia.
  • One Haloperidol injection product is also labeled for Tourette’s Disorder.
Important instructions
  • Haldol Decanoate is given by a healthcare provider as a deep intramuscular injection every 4 weeks.
  • Haldol Decanoate and Haloperidol Decanoate must not be given into a vein.
  • Haloperidol Decanoate is for patients already stabilized on antipsychotic medication.
Available strengths 5 strengths
127 FDA-listed product records ⓘ

Oral solution

By mouth
How this form is used
What it may be used for
  • Haloperidol oral solution is used for psychotic disorders.
  • Haloperidol oral solution is used for tics and vocal utterances of Tourette’s Disorder in children and adults.
  • Haloperidol oral solution is used for severe behavior problems or hyperactivity in children after other treatments have failed.
Important instructions
  • Haloperidol oral solution dosing is individualized and adjusted to response.
  • Haloperidol oral solution may need lower doses in children, older adults, and debilitated patients.
Available strengths 1 strength
8 FDA-listed product records ⓘ

Haloperidol on the U.S. market: products, makers and brands

How Haloperidol appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

42 companies list 231 Haloperidol product records with the FDA, mostly as tablet, injection, oral solution; the earliest marketing or approval year on record is 1986. Brand names on the directory include Haldol, Haloperidol Decanoate, Haloperidol Lactate; the rest are generics.

3
Dose forms ⓘ
42
Labelers (makers, repackagers, distributors)
3
Brand names
231
FDA-listed product records ⓘ
1986
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (15) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack11%
Remedyrepack Inc.7%
Method Pharmaceuticals, LLC5%
Coupler LLC4%
Lifestar Pharma LLC4%
Zydus Lifesciences Limited4%
Other makers63%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Haloperidol is used (Medicaid data)

A general measure of how commonly Haloperidol is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Haloperidol is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

821,226
Medicaid prescriptions filled (Q1–Q4 2025)
$19.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Haloperidol prescribed? Of the 1,601 medications we measure, Haloperidol ranks #197 by Medicaid prescriptions — more than 88% of them.

Where Haloperidol ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Haloperidol product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 5 mg oral tablet is the most-dispensed Haloperidol product — about 30% of these Medicaid prescriptions.

haloperidol 5 MG Oral Tablet Most dispensed

250,395 Medicaid prescriptions (Q1–Q4 2025) 30% of Haloperidol prescriptions shown $4.7M gross reimbursement (before rebates) ≈ $19 per prescription (gross)

Summed across the 13 of 73 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310672

1 ML haloperidol decanoate 100 MG/ML Injection

179,954 Medicaid prescriptions (Q1–Q4 2025) 22% of Haloperidol prescriptions shown $6.3M gross reimbursement (before rebates) ≈ $35 per prescription (gross)

Summed across the 21 of 45 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1719803

haloperidol 10 MG Oral Tablet

171,701 Medicaid prescriptions (Q1–Q4 2025) 21% of Haloperidol prescriptions shown $3.6M gross reimbursement (before rebates) ≈ $21 per prescription (gross)

Summed across the 9 of 49 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314035

haloperidol 2 MG Oral Tablet

67,011 Medicaid prescriptions (Q1–Q4 2025) 8% of Haloperidol prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 9 of 53 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314034

1 ML haloperidol 5 MG/ML Injection

36,357 Medicaid prescriptions (Q1–Q4 2025) 4% of Haloperidol prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $35 per prescription (gross)

Summed across the 3 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1719646

haloperidol 1 MG Oral Tablet

34,503 Medicaid prescriptions (Q1–Q4 2025) 4% of Haloperidol prescriptions shown $560,841 gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 9 of 55 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310671

1 ML haloperidol decanoate 50 MG/ML Injection

29,863 Medicaid prescriptions (Q1–Q4 2025) 4% of Haloperidol prescriptions shown $698,663 gross reimbursement (before rebates) ≈ $23 per prescription (gross)

Summed across the 16 of 40 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1719862

haloperidol 20 MG Oral Tablet

22,786 Medicaid prescriptions (Q1–Q4 2025) 3% of Haloperidol prescriptions shown $672,657 gross reimbursement (before rebates) ≈ $30 per prescription (gross)

Summed across the 6 of 41 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197754

haloperidol 0.5 MG Oral Tablet

16,279 Medicaid prescriptions (Q1–Q4 2025) 2% of Haloperidol prescriptions shown $206,813 gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 9 of 48 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310670

haloperidol 2 MG/ML Oral Solution

7,744 Medicaid prescriptions (Q1–Q4 2025) <1% of Haloperidol prescriptions shown $315,772 gross reimbursement (before rebates) ≈ $41 per prescription (gross)

Summed across the 7 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 141935

haloperidol decanoate 100 MG/ML Injectable Solution

4,382 Medicaid prescriptions (Q1–Q4 2025) <1% of Haloperidol prescriptions shown $292,269 gross reimbursement (before rebates) ≈ $67 per prescription (gross)

Summed across the 5 of 31 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 859871

haloperidol 5 MG/ML Injectable Solution

251 Medicaid prescriptions (Q1–Q4 2025) <1% of Haloperidol prescriptions shown $980 gross reimbursement (before rebates) ≈ $3.90 per prescription (gross)

Summed across the 2 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 204416

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Haloperidol, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 109 of 470 listed Haloperidol NDCs with Medicaid activity.

Compare Haloperidol products

A representative set of FDA-listed product records for Haloperidol — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 124 of 231 products — FDA National Drug Code Directory. See every product, package size and price: browse all 231 Haloperidol NDCs →

Haloperidol recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 4 Haloperidol recalls since July 2021, covering 9 product listings. All of them are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Oct 10, 2025 · Safecor Health, LLC
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
  • Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 w… Lots: Lot 25381993 and 25391516, Exp 12/31/2026 FDA record D-0214-2026 →
Ongoing Class II Apr 2, 2025 · Amerisource Health Services LLC
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
  • Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, In… Lots: A240482B, EXP 08/31/2026 FDA record D-0369-2025 →
  • Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka,… Lots: A240482A, EXP 08/31/2026 FDA record D-0368-2025 →
  • Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India,… Lots: A240467B, EXP 07/31/2026 FDA record D-0367-2025 →
Ongoing Class II Mar 21, 2025 · Somerset Therapeutics Private Limited
Lack of Assurance of Sterility: Media fill with bacterial contamination
  • Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10 Lots: A240482D, exp. date 08/2026 FDA record D-0358-2025 →
  • Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (in… Lots: NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026 FDA record D-0357-2025 →
  • Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41 Lots: A240467B, exp. date 07/2026 FDA record D-0356-2025 →
  • Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10… Lots: NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026 FDA record D-0355-2025 →
Ongoing Class II Apr 24, 2024 · SOMERSET THERAPEUTICS LLC
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
  • Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics,… Lots: Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025 FDA record D-0506-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Haloperidol RxCUI 5093 6 dose forms · 21 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 372375 In current FDA listings
    Clinical drug / strength (SCD) decanoate 100 MG/ML RxCUI 859871 decanoate 50 MG/ML RxCUI 859867 5 MG/ML RxCUI 204416 10 MG/ML RxCUI 199953
  2. Dose form (SCDF) Oral Capsule RxCUI 376237 No current FDA listing
    Clinical drug / strength (SCD) 0.5 MG RxCUI 249960
  3. Dose form (SCDF) Oral Solution RxCUI 372376 In current FDA listings
    Clinical drug / strength (SCD) 0.2 MG/ML RxCUI 108873 0.3 MG/ML RxCUI 108375 0.4 MG/ML RxCUI 108872 1 MG/ML RxCUI 310673 2 MG/ML RxCUI 141935
  4. Dose form (SCDF) Oral Tablet RxCUI 372377 In current FDA listings
    Clinical drug / strength (SCD) 0.5 MG RxCUI 310670 1 MG RxCUI 310671 1.5 MG RxCUI 199319 2 MG RxCUI 314034 5 MG RxCUI 310672 10 MG RxCUI 314035 20 MG RxCUI 197754
  5. Dose form (SCDF) Prefilled Syringe RxCUI 1876501 No current FDA listing
    Clinical drug / strength (SCD) 1 ML haloperidol 5 MG/ML RxCUI 1876502

Look up RxCUI 5093 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Haloperidol brand names

Haloperidol is sold under 3 brand names in the FDA directory — Haldol, Haloperidol Decanoate, Haloperidol Lactate. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Haldol Haloperidol Decanoate Haloperidol Lactate

Who makes Haloperidol: manufacturers and labelers

42 companies list Haloperidol products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Remedyrepack Inc., Method Pharmaceuticals, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 26 Remedyrepack Inc. 17 Method Pharmaceuticals, LLC 12 Coupler LLC 10 Lifestar Pharma LLC 10 Zydus Lifesciences Limited 10 Zydus Pharmaceuticals USA Inc. 10 Somerset Therapeutics, LLC 9 BluePoint Laboratories 8 AiPing Pharmaceutical, Inc 6 Ajanta Pharma USA Inc. 6 Amici Pharmaceuticals, LLC 6 Aurobindo Pharma Limited 6 Creekwood Pharmaceuticals LLC 6 Innogenix, Inc. 6 Marlex Pharmaceuticals, Inc. 6 Novadoz Pharmaceuticals LLC 6 PD-Rx Pharmaceuticals, Inc. 6 Upsher-Smith Laboratories, LLC 6 Hikma Pharmaceuticals USA Inc. 5 American Health Packaging 4 Cardinal Health 107, LLC 4 Major Pharmaceuticals 4 Mylan Institutional Inc. 4

…and 18 more on the FDA NDC directory.

Haloperidol drug class (RxNorm)

Haloperidol belongs to the Typical Antipsychotic class.

Pharmacologic class Typical Antipsychotic
Drug family (ATC) Butyrophenone derivatives

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Haloperidol page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 15, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Haloperidol.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Haloperidol after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
80
Finished products in the current FDA directory
231
Companies listing them (makers, repackagers, distributors)
42
FDA labeler codes behind them ⓘ
47
Linked representative label ⓘ
Lifestar Pharma LLC
Linked label effective
Nov 15, 2024
Composite sections available
15
Linked SPL Set ID
00bb61c8-db35-4c04-9ef7-47d447d2496b
Linked SPL Document ID
7b545974-2d39-4106-8975-76c124a6c5ee
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Lifestar Pharma LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →