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Haloperidol: Drug information

Copyright 1978-2021 Lexicomp, Inc. All rights reserved.

(For additional information see "Haloperidol: Patient drug information" and see "Haloperidol: Pediatric drug
information")

For abbreviations and symbols that may be used in Lexicomp ( show table)

ALERT: US Boxed Warning

Increased mortality in elderly patients with dementia-related psychosis:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an
increased risk of death. Analyses of 17 placebo-controlled trials (modal duration, 10 weeks),
largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-
treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients.
Over the course of a typical 10-week controlled trial, the rate of death in drug-treated
patients was approximately 4.5%, compared with a rate of approximately 2.6% in the
placebo group. Although the causes of death were varied, most of the deaths appeared to
be cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature.
Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with
conventional antipsychotic drugs may increase mortality. The extent to which the findings
of increased mortality in observational studies may be attributed to the antipsychotic drug
as opposed to some characteristic(s) of the patients is not clear. Haloperidol is not
approved for the treatment of patients with dementia-related psychosis.

Brand Names: US
Haldol;
Haldol Decanoate

Brand Names: Canada

APO-Haloperidol;
Haloperidol-LA Omega;
PMS-Haloperidol;
PMS-Haloperidol LA;
TEVA-
Haloperidol
Pharmacologic Category
First Generation (Typical) Antipsychotic

Dosing: Adult
Note: Dose: Although manufacturer's labeling includes a maximum dose of up to 100 mg/day,
doses >30 mg/day are in general not recommended (Moore 2020). Safety: IV administration is
associated with dose-dependent QT prolongation at doses >2 mg and the risk of rare, but
potentially fatal, cardiac arrhythmia; increased monitoring is necessary prior to and during
administration (Drew 2010; Jibson 2019; Meyer-Massetti 2010). Concomitant IM or IV
antiparkinsonism medications (eg, benztropine, diphenhydramine) may be useful for
preventing acute dystonic reactions to IM/IV haloperidol (Holloman 1997; Kane 1996;
Kreyenbuhl 2010). Formulations: Available as oral tablets (as base), an oral solution and short-
acting injection (as lactate), and an ER suspension for IM injection (as decanoate). All doses are
expressed as the equivalent amounts of haloperidol base.

Agitation/aggression (severe, acute) associated with psychiatric disorders (eg,

schizophrenia), substance intoxication, or other organic causes (off-label use): Note:
Antipsychotics are appropriate when psychosis is suspected to be the primary cause of
agitation/aggression (WFSBP [Hasan 2012]; Wilson 2012a). Avoid in suspected or confirmed
intoxications with anticholinergic substances; other agents are used preferentially in some
intoxications (eg, stimulants) or alcohol withdrawal. Depending on presentation, may
combine with a benzodiazepine (Moore 2020; Suh 2019; Wilson 2012a).

IM, IV (off-label route) (lactate injection): 2 to 10 mg; repeat dose every ≥15 minutes
until acute symptoms are controlled; once acute symptoms are controlled, may repeat
every 0.5 to 6 hours as needed; up to 30 mg/day (Clinton 1987; Klein 2018; MacDonald
2012; Moore 2020; Ostinelli 2017; Wilson 2012a; Wilson 2012b).

Oral: 2 to 10 mg; repeat dose every 6 hours as needed; up to 30 mg/day. A lower initial
dose of 0.5 to 1 mg may be sufficient for some patients (Moore 2020).

Bipolar disorder:

Acute mania, episodes with mixed features and acute hypomania (either as
monotherapy or as adjunctive therapy) (off-label use): Note: Haloperidol may
worsen depressive symptoms. It is not recommended for the treatment of acute
bipolar major depression or for maintenance in bipolar disorder (Stovall 2019).
 Oral: Initial: 2 to 15 mg/day or 0.2 mg/kg/day (up to 15 mg/day), in 1 or 2 divided
doses. May increase dose based on response and tolerability in increments of ≤5 mg as
frequently as every 2 days up to 30 mg/day (Goikolea 2013; McElroy 1996; Sachs 2002;
Stovall 2021).

Chemotherapy-induced breakthrough nausea and vomiting (alternative therapy) (off-

label use): Note: May be used as an adjunct to standard antiemetic regimens for
breakthrough nausea/vomiting (Hesketh 2019; Lohr 2008).

Oral, IV (off-label route) (lactate injection): 0.5 to 1 mg every 6 hours as needed (Lohr
2008).

Delirium, hyperactive (treatment): Note: Nonpharmacologic interventions and treatment

of underlying conditions are initial steps to prevent and manage delirium. Antipsychotics
may be used as short-term adjunctive treatment if distressing symptoms (eg, agitation,
anxiety, combative behavior) are present (SCCM [Devlin 2018]). Reassess daily for continued
need; consider discontinuation and/or taper as symptoms resolve, especially at transitions
of care to prevent unnecessary continuation of therapy (D’Angelo 2019; Marshall 2016;
Tietze 2020).

ICU (off-label use): IV (off-label route), IM (lactate injection): Initial range: 0.5 to 20 mg
depending on degree of agitation (mild: 0.5 to 2.5 mg; moderate: 2 to 5 mg; severe: 10
to 20 mg); if inadequate response, may repeat or increase bolus dose every 15 to 30
minutes until calm achieved, then administer a maintenance dose (~25% of total
loading dose needed to achieve calm) every 6 hours if needed (Tesar 1988; Tietze 2020).
Note: Continuous infusions have been used for refractory symptoms; regimens vary.
One regimen includes an optional loading dose of 2.5 mg, followed by 0.5 to 2 mg/hour
(Reade 2009).

Non-ICU (off-label use): IM, IV (off-label route) (lactate injection), Oral: Initial: 0.5 to 1
mg; if needed, may repeat every 30 minutes until calm. Maximum 5 mg/day (Francis
2019; Maneeton 2013).

Nausea and vomiting in advanced or terminal illness (palliative care) (alternative

agent) (off-label use): Note: Identify and treat potentially reversible causes; used in
conjunction with other agents/treatments in bowel obstruction-associated symptoms (Del
Fabbro 2020).

IV, SubQ (off-label routes) (lactate injection), Oral: 0.5 to 2 mg every 6 to 8 hours; for
nausea associated with bowel obstruction, may titrate up to 20 mg/day IV in divided
 doses if needed. (Del Fabbro 2020; Harman 2020).

Continuous SubQ infusion (off-label route) (lactate injection): Typical range for initial
treatment: 1 to 5 mg per 24 hours (Glare 2008; Mercadante 2020).

Postoperative nausea and vomiting, prevention, moderate- to high-risk patients

(alternative agent) (off-label use): Note: In general, combined with one or more other
prophylactic interventions.

IV (off-label route) (lactate injection): 0.5 to 2 mg as a single dose after induction of

anesthesia or at the end of surgery (ASER/SAMBA [Gan 2020]; Büttner 2004; Feinleib
2019).

Schizophrenia:

Oral, IM, IV (lactate injection; off-label route [IV]): Initial: 2 to 10 mg/day in 1 to 3

divided doses; adjust dose based on response and tolerability to a usual dose of 2 to 20
mg/day (typically ≤10 mg/day). Doses >30 mg/day are not recommended (Rosenheck
2003; Stroup 2019a; WFSBP [Hasan 2013]). Note: In a first psychotic episode, a lower
dose (eg, 1 to 4 mg/day) may be sufficient (WFSBP [Hasan 2013]).

IM (decanoate ER suspension): Note: Establish tolerability using oral haloperidol prior

to initiating IM decanoate injection.

Regimen with overlapping of oral haloperidol:

Initial: 10 to 20 times the daily oral dose. If the initial dose conversion requires
>100 mg ER injection, administer the dose in 2 injections with a maximum of
100 mg for first injection and the remainder given in 3 to 7 days. Maximum
total initial dose: 450 mg.

Oral overlap: Following the first ER decanoate dose, taper the oral dose by
~25% at weekly intervals during the second or third month of decanoate
treatment. Adjust oral dose and rate of tapering based on clinical response
and tolerability (Lauriello 2020; McEvoy 2006).

Maintenance dose: Adjust dose based on response and tolerability; usual

maintenance dose is 10 to 15 times the previous daily oral dose administered
at 4-week intervals. Maximum dose: 450 mg every 4 weeks.

Alternative regimen without overlap of oral haloperidol: Note: Discontinue oral

haloperidol immediately prior to the first injection when using this regimen.
 Initial: 20 times the daily oral dose. If the initial dose conversion requires >100
mg ER injection, administer the dose in 2 injections with a maximum of 100
mg for the first injection and the remainder given in 3 to 7 days.

Maintenance dose: Reduce the ER decanoate dose during the second and third
months (eg, by ~25% each month), then continue to adjust based on response
and tolerability. (Ereshefsky 1990; Ereshefsky 1993). Usual maintenance dose is
10 to 15 times the previous daily oral dose administered at 4-week intervals.
Maximum dose: 450 mg every 4 weeks (manufacturer's labeling).

Tourette syndrome, management of tics (alternative agent): Oral: Initial: 1 to 2 mg/day

in 1 to 3 divided doses; may increase dose based on response and tolerability in increments
of 0.5 to 2 mg every 2 to 3 days up to 12 mg/day. Note: Although manufacturer's labeling
includes a maximum dose of up to 100 mg/day, doses ≥12 mg/day are not recommended
(AAN [Pringsheim 2019]).

Dosing conversion:

IM (lactate injection) to oral: Use the total IM (as lactate) dose administered in the
preceding 24 hours as an initial approximation of the total daily dose requirement for
the oral formulation. Initiate the first oral dose within 12 to 24 hours of the last IM (as
lactate) dose. Adjust dose based on response and tolerability. Note: Bioavailability of
oral administration is about 60% to 70% relative to short-acting lactate injection; dose
adjustment may be needed when switching from short-acting injection to oral (Jibson
2019).

Oral to IM (as decanoate): See Schizophrenia dosing.

Discontinuation of therapy:

Oral: In the treatment of chronic psychiatric disease, switching therapy rather than
discontinuation is generally advised if side effects are intolerable or treatment is not
effective. If patient insists on stopping treatment, gradual dose reduction (ie, over
several weeks to months) is advised to detect a re-emergence of symptoms and to
avoid withdrawal reactions (eg, agitation, alternating feelings of warmth and chill,
anxiety, diaphoresis, dyskinesias, GI symptoms, insomnia, irritability, myalgia,
paresthesia, psychosis, restlessness, rhinorrhea, tremor, vertigo) unless
discontinuation is due to significant adverse effects. Monitor closely to allow for
detection of prodromal symptoms of disease recurrence (APA [Keepers 2020]; Lambert
2007; Moncrieff 2020; Post 2020).