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Haloperidol Side Effects

The most commonly reported side effects of haloperidol include off label use, drug interaction, and neuroleptic malignant syndrome, based on 42,820 FDA adverse event reports from 2004 to 2025. 6.1% of reports found the drug to be ineffective.

#1 Reported: Off Label UseAll side effects ↓Top Co-Medication: OlanzapineDrug interactions ↓70% of Reports Are AdultDemographics ↓

Haloperidol side effects

Percentages show how often each reaction appears relative to total reports for haloperidol.

1
Drug Ineffective6.1%2,620
2
Off Label Use4.8%2,048
3
Drug Interaction4.5%1,940
4
Neuroleptic Malignant Syndrome3.7%1,600
5
Toxicity To Various Agents3.0%1,283
6
Somnolence2.8%1,214
7
Extrapyramidal Disorder2.5%1,091
8
Weight Increased2.5%1,078
9
Weight Increased2.3%979
10
Agitation2.3%978
11
Confusional State2.3%975
12
Tremor2.3%965
13
Vomiting2.2%940
14
Death2.1%914
15
Diabetes Mellitus2.1%908

These are voluntary reports and do not establish that haloperidol caused these reactions.

Report severity

89.1%Serious38,168 reports
46.7%Hospitalizations19,990 reports
14.8%Fatal6,330 reports

Seriousness is determined by the reporter, not by OpenClaim.

Haloperidol drug interactions

Other drugs that appear in adverse event reports alongside haloperidol. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Olanzapine13.5%5,774
2
Quetiapine-fumarate12.6%5,386
3
Risperidone11.5%4,919
4
Clozapine9.4%4,019
5
Aripiprazole7.3%3,113
6
Lorazepam5.8%2,494
7
Diazepam4.0%1,723
8
Lithium3.2%1,384
9
Paliperidone2.6%1,123
10
Chlorpromazine2.4%1,041
11
Valproic-acid2.4%1,018
12
Clonazepam2.3%978
13
Fluoxetine-hydrochloride2.1%891
14
Sertraline-hydrochloride2.1%887
15
Ziprasidone1.7%737

Taken alongside

1
Lorazepam10.5%4,500
2
Acetaminophen8.5%3,646
3
Risperidone5.2%2,234
4
Olanzapine5.0%2,157
5
Furosemide5.0%2,142
6
Omeprazole4.8%2,058
7
Aspirin4.7%1,997
8
Quetiapine-fumarate4.5%1,942
9
Benztropine-mesylate4.5%1,922
10
Clonazepam4.3%1,835
11
Pantoprazole-sodium4.3%1,832
12
Levothyroxine-sodium4.2%1,809
13
Diazepam3.8%1,638
14
Ondansetron3.4%1,477
15
Albuterol3.4%1,474

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports haloperidol side effects

41.2% of haloperidol adverse event reports involve female patients and 49.8% involve male patients. The largest age group is adult at 70%. These figures reflect who reports side effects, not underlying risk.

Sex

Female41.2%
Male49.8%
Unknown8.9%

Age group

< 20.8%
2–111.5%
12–173.4%
18–6469.7%
65+24.7%

What is haloperidol used for

Conditions and purposes for which patients were taking haloperidol when the adverse event was reported.

Abdominal PainAbdominal Pain UpperAbnormal BehaviourAbnormal DreamsAbstains From AlcoholAccidental Drug Intake By ChildAccidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By ChildActivities Of Daily Living ImpairedAcute Disseminated EncephalomyelitisAcute PsychosisAcute Respiratory Distress SyndromeAdjustment Disorder With Depressed MoodAdverse Drug Reaction

Showing 15 of 853 indications

Haloperidol brand names and reporting trend

Haloperidol is sold under brand names including Haldol, Haloperidol Intensol.

Brand names

Haldol33,695
Haloperidol Intensol584

Quarterly reports (2004–2025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking haloperidol with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.

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