Haloperidol was the first discovered typical antipsychotic, developed in 1958 and approved by the FDA in 1967 under the brand name Haldol. It works by blocking dopamine D2 receptors in the brain. While effective for treating schizophrenia, bipolar disorder, agitation, and other conditions, it carries risks of extrapyramidal side effects and increased mortality in elderly patients with dementia. Dosing requires consideration of age, weight, renal or hepatic function, and risk/benefit at higher doses above 30 mg per day.

1. Haloperidol
Franklin N. Alier, MD
PGY-2
SIU Psychiatry
Springfield, IL

2. Haloperidol / Haldol
• First discovered by a Belgian physician named Paul Janssen
• It was developed in 1958 by Janssen Pharmaceutica and submitted for its
first clinical trials in Belgium later that year
• It was approved by the FDA in April of 1967 and was later marketed under
the name Haldol by McNeil Laboratories

3. Haloperidol
• First generation (typical) antipsychotic
• Black box warning: “Elderly patients with dementia related psychosis
treated with antipsychotic drugs are at an increased risk of death.”
• Data: 4.5% increased risk of death in exposed group vs 2.6% in placebo
group.
• Most deaths were cardiovascular in nature.

4. Haldol - Adult Dosing:
• Manufacturer’s label:
• Maximum recommended dose is 100 mg per day, however studies have
shown the risk/benefit ratio is not as favorable when doses exceed 30 mg
qday. (Moore 2020)
• Dose dependent QT Prolongation is seen in doses above 2 mg
• Formulations: Oral, IM or IV.
• Short acting injection (Lactate) and Long acting injection (Decanoate)

5. Haldol: Renal Dosing vs Hepatic Dosing
• Renal impairment / Hemodialysis / Peritoneal Dialysis:
No adjustment necessary
• Hepatic impairment:
Manufacturer does not provide dosage adjustments for hepatic impairment.
• However, since Haloperidol is mainly metabolized by the liver, haloperidol
levels may be increased in patients with hepatic impairment.

6. Pediatric dosing:
• Acute agitation:
Children under 40 kg (88 lbs):
6 mg qday maximum
Children over 40 kg (88 lbs):
15 mg qday maximum
• Children: 0.5 mg – 2 mg, repeat every 1 to 2 hours not to exceed daily maximum
• Adolescents: 2 mg – 5 mg, repeat every 1 to 2 hours not to exceed daily maximum

7. Labeled indications:
• Behavioral disorders (non-psychotic):
Treatment of severe behavioral problems in children with combative, explosive
hyper-excitability.
• Hyperactivity:
Short term treatment of children who show excessive motor activity with
accompanying conduct disorders: impulsivity, difficulty sustaining attention,
aggression, mood lability, poor frustration tolerance.
• Schizophrenia
• Tourette Syndrome – Control of tics and vocal utterances in adults and children

8. Off label indications:
• Agitation – severe, acute, associated with psychiatric disorders, substance
intoxication or other organic causes
• Bipolar disorder
• Chemotherapy induced breakthrough nausea and vomiting
• Delirium (hyperactive)

9. Mechanism of action
• Non-selectively blocks post-synaptic dopaminergic D2 receptors in the brain

10. Adverse reactions
• Extrapyramidal symptoms (Acute dystonia, Akathisia, Drug Induced
Parkinsonism,Tardive Dyskinesia)
• Important: Dysphagia/Esophageal dysmotility or pulmonary aspiration have
also been reported and may not initially be recognized as EPS