Prescription medication · Typical Antipsychotic

haloperidol

Also sold as Haldol. Haloperidol is used to manage symptoms of psychotic disorders.

Data updated 2026-05-15

23,495
FDA reportsModerately reported
14
InteractionsSeveral interactions
In shortage
FDA status

What the data shows

haloperidol (Haldol) is a prescription Typical Antipsychotic, reported at a middle-of-the-pack volume (23,495 FDA reports), with 14 documented drug interactions.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

haloperidol (Haldol) is a prescription Typical Antipsychotic. Haloperidol is used to manage symptoms of psychotic disorders.

Haloperidol is a medicine used to treat mental disorders. It can help reduce symptoms like hallucinations and confused thinking.

Drug Shortage Alert

haloperidol is currently listed as to be discontinued by the FDA. Affected manufacturer: Janssen Pharmaceuticals.

View all drug shortages →

Drug Pricing (NADAC)

Generic Price

$0.13/unit

Generic Available

Yes (25 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

NADAC price trail: HALOPERIDOL 0.5 MG TABLET

Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -21.4% vs prior release.

Effective NADAC / unit vs prior NDCs
April 17, 2024 $0.1704/EA - 1
December 18, 2024 $0.1340/EA -21.4% 12
View Alternatives → Compare with Another Drug → Full Side Effects Report →

What it does

Haloperidol is used to manage symptoms of psychotic disorders.

Common side effects

Muscle stiffness, Shaking, Slow movement

Key warnings

Haloperidol may increase the risk of death in elderly patients with dementia-related psychosis.

The sections below are summarized in plain English from haloperidol's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Haloperidol works by changing the effect of certain natural chemicals in the brain. These chemicals, called neurotransmitters, affect mood and behavior. By blocking dopamine, haloperidol helps to reduce psychotic symptoms.

Side Effects (from patient reports)

Based on 23,495 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for haloperidol, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for haloperidol each year to the FDA Adverse Event Reporting System (FAERS).

05001,0001,5002,000 199920062009201220152018202120242025 1,436

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where haloperidol sits

haloperidol has more FDA adverse-event reports than 58% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is haloperidol; the line is the median (50th percentile).

FDA Adverse Event Report Analysis

Detailed analysis of 23,495 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1999–2025.

Total Reports

23,495

Reports Mentioning Death

3,896

16.6% of reports — not proof of cause

Hospitalization Reports

11,669

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 9,261 (44%)
Male 11,824 (56%)

Age Distribution

0–17 1,280
18–44 6,954
45–64 5,549
65–74 2,286
75+ 2,297

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
2 DRUG INTERACTION 1,663
3 NEUROLEPTIC MALIGNANT SYNDROME 1,577
5 WEIGHT INCREASED 1,216
6 EXTRAPYRAMIDAL DISORDER 1,201
7 TOXICITY TO VARIOUS AGENTS 999
8 AGITATION 839
9 SOMNOLENCE 802
10 PYREXIA 794
11 CONDITION AGGRAVATED 783
12 DELIRIUM 754
13 CONFUSIONAL STATE 729
14 VOMITING 702
15 DEATH 701
16 TREMOR 678
17 NAUSEA 648

Reactions in Death Reports

DEATH 697
COMPLETED SUICIDE 417
TOXICITY TO VARIOUS AGENTS 323
PNEUMONIA 269
CARDIAC ARREST 250
CARDIO-RESPIRATORY ARREST 192
NAUSEA 187
DRUG INTERACTION 184
DIARRHOEA 180
NEUROLEPTIC MALIGNANT SYNDROME 165

Reactions in Hospitalization Reports

NEUROLEPTIC MALIGNANT SYNDROME 1,126
DRUG INTERACTION 919
TOXICITY TO VARIOUS AGENTS 686
PYREXIA 580
AGITATION 528
CONDITION AGGRAVATED 516
DELIRIUM 508
CONFUSIONAL STATE 482
SOMNOLENCE 466
VOMITING 456

Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Haloperidol may increase the risk of death in elderly patients with dementia-related psychosis. Haloperidol is not approved to treat dementia-related psychosis.

Known Drug Interactions

moderate fluoxetine

Monoamine Oxidase Inhibitors (MAOIs): ( 2.9 , 2.10 , 4.1 , 5.2 ) Drugs Metabolized by CYP2D6: Fluoxetine is a potent inhibitor of CYP2D6 enzyme pathway ( 7.7 ) Tricyclic Antidepressants (TCAs): Monitor TCA levels during coadministration with fluoxetine or when fluoxetine has been recently discontinued ( 5.2 , 7.7 ) CNS Acting Drugs: Caution should be used when taken in combination with other centrally acting drugs ( 7.2 ) Benzodiazepines: Diazepam – increased t½, alprazolam - further psychomotor performance decrement due to increased levels ( 7.7 ) Antipsychotics: Potential for elevation...

Mechanism: Fluoxetine slows down the process that clears haloperidol from your system. This can cause the level of the antipsychotic drug to rise in your blood.

7.5 Drugs That Cause QTc Prolongation Tetrabenazine causes a small prolongation of QTc (about 8 msec), concomitant use with other drugs that are known to cause QTc prolongation should be avoided, these including antipsychotic medications (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), Class 1A (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic medications or any other medications known to prolong the QTc interval. 7.6 Neuroleptic Drugs The risk for Parkinsonism, NMS, and akathisia may be increased by...

Mechanism: Combining these drugs increases the risk of heart rhythm changes and severe movement disorders like Parkinsonism.

Compounds in these categories result in a decreased efficacy of bromocriptine mesylate: phenothiazines, haloperidol, metoclopramide, and pimozide.

Mechanism: Haloperidol blocks the effects of bromocriptine in the body. This prevents the medicine from working correctly.

( 7.1 ) Drugs metabolized by CYP2D6: Bupropion inhibits CYP2D6 and can increase concentrations of: antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, flecainide). Such drugs include certain antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, and sertraline), antipsychotics (e.g., haloperidol, risperidone, and thioridazine), beta-blockers...

Mechanism: Bupropion stops a liver enzyme from breaking down haloperidol, which can cause haloperidol levels to build up in your body.

In addition, carbamazepine causes, or would be expected to cause, decreased levels of the following drugs, for which monitoring of concentrations or dosage adjustment may be necessary: acetaminophen, albendazole, alprazolam, aprepitant, buprenorphone, bupropion, citalopram, clonazepam, clozapine, corticosteroids (e.g., prednisolone, dexamethasone), cyclosporine, dicumarol, dihydropyridine calcium channel blockers (e.g., felodipine), doxycycline, ethosuximide, everolimus, haloperidol, imatinib, itraconazole, lamotrigine, levothyroxine, methadone, methsuximide, mianserin, midazolam,...

Mechanism: Carbamazepine causes your body to break down haloperidol faster, which lowers the amount of medicine in your system.

Check all your medications →

This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I stop taking haloperidol suddenly?
Do not stop taking haloperidol without talking to your doctor. Stopping suddenly can cause withdrawal symptoms.
Will haloperidol cure my condition?
Haloperidol helps manage the symptoms of your condition. It is not a cure.
How long does it take for haloperidol to work?
It may take several weeks to see the full effects of haloperidol.
Can I drink alcohol while taking haloperidol?
Avoid drinking alcohol while taking haloperidol, as it can worsen side effects.
Does haloperidol have any effect on my heart?
Haloperidol can cause changes in heart rhythm. Your doctor may monitor your heart with an EKG.
Can haloperidol cause weight gain?
Yes, haloperidol can cause weight gain in some people.
What should I do if I experience muscle stiffness?
Tell your doctor if you experience muscle stiffness, as it could be a side effect of the medication.
Can I take haloperidol if I have Parkinson's disease?
No, you should not take haloperidol if you have Parkinson's disease.
Is haloperidol safe for children?
Haloperidol can be used in children for certain conditions, but only under the guidance of a doctor.
What should I do if I have trouble swallowing the tablet?
Talk to your doctor or pharmacist. There may be liquid forms of haloperidol available.
What are the common side effects of haloperidol?
The registry lists Muscle stiffness, Shaking, Slow movement, Restlessness, Changes in heart rhythm among the most-reported FAERS reaction terms for haloperidol. The compiled record contains 23,495 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does haloperidol interact with other medications?
The registry has 14 documented interaction rows for haloperidol. Notable source-record pairings include fluoxetine, tetrabenazine, bromocriptine. These rows are not a complete medication review.
What drug class is haloperidol?
haloperidol belongs to the Typical Antipsychotic drug class. It requires a prescription (Rx). Haloperidol is used to manage symptoms of psychotic disorders.
What pregnancy or breastfeeding source fields are listed for haloperidol?
The FDA label for haloperidol contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.
Has haloperidol been recalled?
There are 5 recalls associated with haloperidol products. Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm. Check the recalls section below for full details and affected products.
Is haloperidol currently in shortage?
Yes, haloperidol is currently listed as to be discontinued by the FDA. Affected manufacturer: Janssen Pharmaceuticals. Visit the FDA Drug Shortages database for the latest updates.

Active Recalls

Class II October 10, 2025

Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

Safecor Health, LLC

Class II April 2, 2025

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Amerisource Health Services LLC

Class II April 2, 2025

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Amerisource Health Services LLC

Class II March 21, 2025

Lack of Assurance of Sterility: Media fill with bacterial contamination

Somerset Therapeutics Private Limited

Class II April 24, 2024

Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).

SOMERSET THERAPEUTICS LLC

Other drugs grouped near haloperidol - same-class peers and common alternatives.

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Compare beyond drug class

Nationwide peers by FAERS volume & death-report share

Two PlainMeds-derived comparison paths for haloperidol: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.

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What the FDA Data Shows for haloperidol

The FDA label for haloperidol (sold under brand names such as Haldol) classifies it as a prescription-only medication in the Typical Antipsychotic class. Haloperidol is used to manage symptoms of psychotic disorders. Official labeling lists 5 commonly reported side effects, including Muscle stiffness, Shaking, Slow movement.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 23,495 voluntary reports. The database also lists 14 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.13.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 5 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: November 15, 2024

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page