haloperidol
Brand names: Haldol
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 →
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.
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.
How to Take It
Take haloperidol exactly as your doctor tells you. The dose varies for each person. Adults usually start with 0.5 mg to 5 mg, two or three times a day. Your doctor may adjust the dose to best control your symptoms.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. Haloperidol may cause side effects in newborns if taken during pregnancy. Talk to your doctor about the risks and benefits of taking haloperidol while breastfeeding.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store haloperidol at room temperature (68° to 77°F) away from light and moisture.
Side Effects (from patient reports)
Based on 12,521 FDA adverse event reports.
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
Death-Related Reports
3,896
Hospitalization Reports
11,669
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 2,085 |
| 2 | DRUG INTERACTION | 1,663 |
| 3 | NEUROLEPTIC MALIGNANT SYNDROME | 1,577 |
| 4 | OFF LABEL USE | 1,346 |
| 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 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) 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
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 of...
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.
What to do: Your doctor may need to reduce your dose of haloperidol. Monitor yourself closely for any new side effects while taking both medications.
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 con...
Mechanism: Combining these drugs increases the risk of heart rhythm changes and severe movement disorders like Parkinsonism.
What to do: This combination should be avoided because it can lead to heart problems and serious muscle reactions.
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.
What to do: Talk to your doctor about this combination, as haloperidol can make your bromocriptine treatment less effective.
( 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 (e...
Mechanism: Bupropion stops a liver enzyme from breaking down haloperidol, which can cause haloperidol levels to build up in your body.
What to do: Your doctor may need to lower your dose of haloperidol or watch you closely for side effects.
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, olanzapin...
Mechanism: Carbamazepine causes your body to break down haloperidol faster, which lowers the amount of medicine in your system.
What to do: Your doctor may need to adjust your dose or monitor your blood levels closely.
Common Questions
Can I stop taking haloperidol suddenly?
Will haloperidol cure my condition?
How long does it take for haloperidol to work?
Can I drink alcohol while taking haloperidol?
Does haloperidol have any effect on my heart?
Can haloperidol cause weight gain?
What should I do if I experience muscle stiffness?
Can I take haloperidol if I have Parkinson's disease?
Is haloperidol safe for children?
What should I do if I have trouble swallowing the tablet?
What are the common side effects of haloperidol?
Does haloperidol interact with other medications?
What drug class is haloperidol?
Is haloperidol safe during pregnancy?
Has haloperidol been recalled?
Is haloperidol currently in shortage?
Active Recalls
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Safecor Health, LLC
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Amerisource Health Services LLC
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Amerisource Health Services LLC
Lack of Assurance of Sterility: Media fill with bacterial contamination
Somerset Therapeutics Private Limited
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
SOMERSET THERAPEUTICS LLC
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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 12,521 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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: November 15, 2024
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages