Prescription medicine
Haloperidol First approved as Haldol
Haloperidol (Haldol) is a prescription medicine with an FDA approval on record since 1967. FDA's NDC Directory lists it from 41 generic labelers, and pharmacies paid $15.60 per mL (Haloperidol dec 100 mg/mL vial) in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the haloperidol FDA label on DailyMed (effective April 23, 2026, PD-Rx Pharmaceuticals, Inc.); the NDA 15922 record on Drugs@FDA; every haloperidol label on DailyMed.
Highlights of the record
FDA label of April 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).
Used for
From the label: indications and usageHaloperidol tablets are indicated for use in the management of manifestations of psychotic disorders.
Forms and strengths
- 0.5 mg
- 1 mg
- 2 mg
- 5 mg
- 10 mg
- 20 mg
- 2 mg/ml
- 5 mg/ml
- 50 mg/ml
- 100 mg/ml
- 250 mg/5ml
- 500 mg/5ml
Tablet; injection; injection (solution); solution; solution (concentrate).
On the market
- Earliest approval on file
- April 12, 1967 Haldol, Ortho Mcneil; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 80 first June 10, 1986; 33 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 42 of which 41 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $15.60 per mL Haloperidol dec 100 mg/mL vial
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- 18 since 2014 0 Class I among all firms' recalls; latest October 10, 2025
- FAERS reports
- 26,054 through July 30, 2026
What is haloperidol used for?
From the label: indications and usageHaloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). […]
Conditions named in the indications of haloperidol's FDA labels, with every medicine labeled for each:
From other haloperidol labelsSchizophrenia: INDICATIONS Haloperidol injection is indicated for use in the treatment of schizophrenia.
FDA pharmacologic class: Typical Antipsychotic.
Source: FDA drug label (Haloperidol), PD-Rx Pharmaceuticals, Inc., effective April 23, 2026 (SPL set 533b0b4c-cbd6-4ec0-a333-8b04b5b43a1d), via openFDA; the full label on DailyMed
Is there a generic for haloperidol (Haldol)?
The FDA approved the first generic haloperidol on June 10, 1986. 80 generic applications are approved; 33 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists haloperidol from 41 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1967 earliest approval on file
- 1986 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for haloperidol (Haldol)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $15.60 per mL (Haloperidol dec 100 mg/mL vial), about the same as a year earlier. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Haloperidol dec 100 mg/mL vial (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Haloperidol 0.5 mg tablet | Generic | $0.0857 per tablet | $2.57 | -14% |
| Haloperidol 1 mg tablet | Generic | $0.120 per tablet | $3.59 | -24% |
| Haloperidol 10 mg tablet | Generic | $0.146 per tablet | $4.39 | -41% |
| Haloperidol 2 mg tablet | Generic | $0.166 per tablet | $4.97 | -0.5% |
| Haloperidol 20 mg tablet | Generic | $0.371 per tablet | $11.13 | +4% |
| Haloperidol 5 mg tablet | Generic | $0.181 per tablet | $5.42 | -8% |
| Haloperidol dec 100 mg/mL amp | Generic | $33.92 per mL | n/a | +1% |
| Haloperidol dec 100 mg/mL vial | Generic | $15.60 per mL | n/a | no change |
| Haloperidol dec 50 mg/mL ampul | Generic | $20.75 per mL | n/a | +17% |
| Haloperidol dec 50 mg/mL vial | Generic | $6.57 per mL | n/a | -41% |
| Haloperidol dec 500 mg/5 mL vial | Generic | $15.60 per mL | n/a | +17% |
| Haloperidol lac 2 mg/mL conc | Generic | $0.426 per mL | n/a | -13% |
| Haloperidol lac 5 mg/mL vial | Generic | $0.782 per mL | n/a | +1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is haloperidol in shortage?
No haloperidol presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated January 9, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Haloperidol Decanoate, Injection, 50 mg/1 mL (NDC 63323-469-01) | Fresenius Kabi USA, LLC | To Be Discontinued | January 9, 2026 |
| Haloperidol Decanoate, Injection, 50 mg/1 mL (NDC 63323-469-05) | Fresenius Kabi USA, LLC | To Be Discontinued | January 9, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has haloperidol been recalled?
The FDA's Enforcement Report lists 18 recalls naming haloperidol since 2014: 0 Class I (the most serious), 16 Class II, 2 Class III; 9 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 10, 2025 | Class II | Safecor Health, LLC | Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm. |
| April 2, 2025 | Class II | Amerisource Health Services LLC | Lack of assurance of sterility. Bacterial contamination detected in some media fill units |
| March 21, 2025 | Class II | Somerset Therapeutics Private Limited | Lack of Assurance of Sterility: Media fill with bacterial contamination |
| April 24, 2024 | Class II | SOMERSET THERAPEUTICS LLC | Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI). |
| July 29, 2021 | Class II | Teva Pharmaceuticals USA | Lack of Assurance of Sterility |
| April 26, 2021 | Class II | Teva Pharmaceuticals USA | Lack of Assurance of Sterility |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| April 7, 2016 | Class III | Fresenius Kabi USA, LLC | Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the haloperidol label say about other medicines?
The haloperidol label names 29 other medicines in its interaction, contraindication or warning sections. The labels of 34 other medicines name haloperidol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Alprazolam | drug interactions | 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. |
| Amiodarone | drug interactions | Class 3 antiarrhythmics (e.g., amiodarone, sotalol); and other drugs such as citalopram, erythromycin, levofloxacin, methadone, and ziprasidone. |
| Carbamazepine | drug interactions | … 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 ). |
| Chlorpromazine | drug interactions | CYP2D6 inhibitors – chlorpromazine; promethazine; quinidine; paroxetine, sertraline, venlafaxine. |
| Citalopram | drug interactions | Class 3 antiarrhythmics (e.g., amiodarone, sotalol); and other drugs such as citalopram, erythromycin, levofloxacin, methadone, and ziprasidone. |
| Desipramine | drug interactions | Plasma concentrations of CYP2D6 substrates (e, g. tricyclic antidepressants such as desipramine or imipramine) may increase when they are co-administered with haloperidol. |
| Disopyramide | drug interactions | … Effects ). Examples include (but are not limited to): Class 1A antiarrhythmics (e.g., procainamide, quinidine, disopyramide); |
| Erythromycin | drug interactions | Class 3 antiarrhythmics (e.g., amiodarone, sotalol); and other drugs such as citalopram, erythromycin, levofloxacin, methadone, and ziprasidone. |
| Fluoxetine | drug interactions | Combined CYP3A4 and CYP2D6 inhibitors – fluoxetine, fluvoxamine; ritonavir. |
| Fluvoxamine | drug interactions | Combined CYP3A4 and CYP2D6 inhibitors – fluoxetine, fluvoxamine; ritonavir. |
| Imipramine | drug interactions | Plasma concentrations of CYP2D6 substrates (e, g. tricyclic antidepressants such as desipramine or imipramine) may increase when they are co-administered with haloperidol. |
| Itraconazole | drug interactions | 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. |
| Ketoconazole | drug interactions | 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. |
| Levofloxacin | drug interactions | Class 3 antiarrhythmics (e.g., amiodarone, sotalol); and other drugs such as citalopram, erythromycin, levofloxacin, methadone, and ziprasidone. |
Every other medicine the haloperidol label names
| Medicine named | Section | What the label says |
|---|---|---|
| Lithium | warnings | Combined Use of Haloperidol and Lithium An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum … |
| Methadone | drug interactions | Class 3 antiarrhythmics (e.g., amiodarone, sotalol); and other drugs such as citalopram, erythromycin, levofloxacin, methadone, and ziprasidone. |
| Nefazodone | drug interactions | … include: CYP3A4 inhibitors – alprazolam; itraconazole, ketoconazole, nefazodone, ritonavir. |
| Paroxetine | drug interactions | CYP2D6 inhibitors – chlorpromazine; promethazine; quinidine; paroxetine, sertraline, venlafaxine. |
| Phenobarbital | drug interactions | … reduced. Examples include (but are not limited to): carbamazepine, phenobarbital, phenytoin, rifampin, St John's Wort ( Hypericum, perforatum ). |
| Phenytoin | drug interactions | … Examples include (but are not limited to): carbamazepine, phenobarbital, phenytoin, rifampin, St John's Wort ( Hypericum, perforatum ). |
| Procainamide | drug interactions | … include (but are not limited to): Class 1A antiarrhythmics (e.g., procainamide, quinidine, disopyramide); |
| Promethazine | drug interactions | CYP2D6 inhibitors – chlorpromazine; promethazine; quinidine; paroxetine, sertraline, venlafaxine. |
| Quinidine | drug interactions | … are not limited to): Class 1A antiarrhythmics (e.g., procainamide, quinidine, disopyramide); |
| Rifampin | drug interactions | … (but are not limited to): carbamazepine, phenobarbital, phenytoin, rifampin, St John's Wort ( Hypericum, perforatum ). |
| Ritonavir | drug interactions | … CYP3A4 inhibitors – alprazolam; itraconazole, ketoconazole, nefazodone, ritonavir. |
| Sertraline | drug interactions | CYP2D6 inhibitors – chlorpromazine; promethazine; quinidine; paroxetine, sertraline, venlafaxine. |
| Sotalol | drug interactions | Class 3 antiarrhythmics (e.g., amiodarone, sotalol); and other drugs such as citalopram, erythromycin, levofloxacin, methadone, and ziprasidone. |
| Venlafaxine | drug interactions | CYP2D6 inhibitors – chlorpromazine; promethazine; quinidine; paroxetine, sertraline, venlafaxine. |
| Ziprasidone | drug interactions | Class 3 antiarrhythmics (e.g., amiodarone, sotalol); and other drugs such as citalopram, erythromycin, levofloxacin, methadone, and ziprasidone. |
Other labels that name haloperidol
Source: FDA drug label (Haloperidol), PD-Rx Pharmaceuticals, Inc., effective April 23, 2026 (SPL set 533b0b4c-cbd6-4ec0-a333-8b04b5b43a1d), via openFDA; the full label on DailyMed
What do FAERS reports show for haloperidol?
The FDA Adverse Event Reporting System holds 26,054 reports that list haloperidol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,220 are coded as a death and 12,918 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as haloperidol?
16 other medicines are given the same way (oral) and in the same FDA class as haloperidol or labeled mainly for the same use (schizophrenia), the same class first. Schizophrenia lists all 24 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Thiothixene | Schizophrenia | 4 labelers | $1.72 per capsule 10 mg capsule | No current entry |
| Molindone | Schizophrenia | 1 labeler | n/a | No current entry |
| Quetiapine | Schizophrenia | 50 labelers | $0.127 per tablet 300 mg tablet | No current entry |
| Olanzapine | Schizophrenia | 33 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Lurasidone | Schizophrenia | 29 labelers | $0.142 per tablet 20 mg tablet | No current entry |
| Chlorpromazine | Schizophrenia | 22 labelers | $0.552 per tablet 100 mg tablet | No current entry |
| Perphenazine | Schizophrenia | 16 labelers | $0.161 per tablet 4 mg tablet | No current entry |
| Paliperidone | Schizophrenia | 18 labelers | $0.972 per tablet 3 mg tablet | No current entry |
Every medicine labeled for the same conditions as haloperidol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does haloperidol compare with medicines for the same use?
7 side-by-side pages set haloperidol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to haloperidol
- 16 medicines for the same use
- Other typical antipsychotics
- the pharmacologic class, with prices and generics
- Haloperidol side effects
- the label's list beside FAERS reports
- Haloperidol shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other