Haloperidol
According to the FDA label: Haloperidol 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).
24,303 adverse event reports submitted to the FDA (1999–2026)
Top Reported Adverse Events
The most frequently reported events in association with Haloperidol in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 2,123 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Drug Interaction 1,708 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Neuroleptic Malignant Syndrome 1,653 reports
A rare but serious reaction, usually to certain mental-health medications, involving high fever, muscle stiffness, and confusion. It needs urgent medical care.
Full definition in the glossary →Off Label Use 1,401 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Extrapyramidal Disorder 1,243 reports
A group of movement problems, such as stiffness, tremor, or restlessness, that can be associated with certain medications.
Full definition in the glossary →Weight Increased 1,224 reports
Toxicity to Various Agents 1,099 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →Agitation 872 reports
A state of restlessness, irritability, or feeling unable to settle.
Full definition in the glossary →Somnolence 829 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Pyrexia 814 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Condition Aggravated 807 reports
A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Full definition in the glossary →- Delirium 777 reports
Confusional State 749 reports
A state of being confused, disoriented, or unable to think clearly.
Full definition in the glossary →Vomiting 731 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Death 724 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 12,219 |
| Female | 9,574 |
| Unknown | 109 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 1,337 |
| 18-34 | 4,352 |
| 35-49 | 4,355 |
| 50-64 | 4,239 |
| 65-74 | 2,358 |
| 75+ | 2,361 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Haloperidol. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 14,040 |
| Hospitalization | 12,154 |
| Death | 4,068 |
| Life-Threatening | 2,690 |
| Non-Serious | 1,639 |
| Disability | 714 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Haloperidol. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 1999 | 2 |
| 2004 | 376 |
| 2005 | 394 |
| 2006 | 437 |
| 2007 | 1,069 |
| 2008 | 401 |
| 2009 | 633 |
| 2010 | 583 |
| 2011 | 827 |
| 2012 | 937 |
| 2013 | 768 |
| 2014 | 875 |
| 2015 | 979 |
| 2016 | 1,150 |
| 2017 | 1,544 |
| 2018 | 1,778 |
| 2019 | 1,674 |
| 2020 | 1,613 |
| 2021 | 1,808 |
| 2022 | 1,580 |
| 2023 | 1,604 |
| 2024 | 1,470 |
| 2025 | 1,473 |
| 2026 (partial) | 328 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Haloperidol
In FDA adverse event reports that mention Haloperidol, these medications appeared most often in the same report.
- Olanzapine (5,144 reports)
- Lorazepam (4,619 reports)
- Quetiapine (4,413 reports)
- Risperidone (4,412 reports)
- Clozapine (3,256 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026