Cautions
Contraindications
Warnings/Precautions
Warnings
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Neuroleptic Malignant Syndrome
Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome requiring immediate discontinuance of the drug and intensive symptomatic treatment, has been reported with antipsychotic agents, including haloperidol.
Hyperpyrexia and heat stroke not associated with NMS also reported.
Tardive Dyskinesia
Tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements, may develop in patients receiving antipsychotic agents, including haloperidol. Consider discontinuance.
Fetal/Neonatal Morbidity and Mortality
Cases of limb malformations in offspring of women given haloperidol concurrently with other potentially teratogenic drugs during first trimester of pregnancy reported; causal relationship not established. Teratogenic and fetotoxic in animals.
Use during pregnancy or in women likely to become pregnant only when potential benefits justify possible risks to fetus.
Concomitant Therapy with Lithium
Although most patients receiving lithium and an antipsychotic agent concurrently do not develop unusual adverse effects, an acute encephalopathic syndrome occasionally has occurred, especially when high serum lithium concentrations were present. Observe patients receiving combined therapy for evidence of neurologic effects; promptly discontinue if manifestations appear.
Respiratory Effects
Bronchopneumonia, sometimes fatal, reported with use of antipsychotic agents, including haloperidol. Consider that lethargy and decreased thirst, resulting from centeral inhibition, may cause dehydration, hemoconcentration, and reduced pulmonary ventilation; if such manifestations occur, particularly in geriatric patients, promptly institute appropriate therapy.
Ocular Effects
Ocular changes reported in patients receiving chemically-related drugs, although not reported with haloperidol.
Sensitivity Reactions
Hypersensitivity
Skin reactions (i.e., maculopapular, acneiform) and isolated cases of photosensitivity reported; contact dermatitis reported rarely with skin contact to haloperidol lactate oral solution and injection.
Use with caution in patients with known allergies or with a history of allergic reactions to drugs.
General Precautions
Nervous System Effects
Possible risk of seizures; may lower seizure threshold. Use with caution in patients with a history of seizures or EEG abnormalities or in those receiving anticonvulsant agents. Maintain adequate anticonvulsant therapy.
Possible impairment of ability to perform activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle).
Extrapyramidal symptoms occur frequently; if concomitant therapy with an antiparkinsonian drug is necessary to manage haloperidol-induced extrapyramidal symptoms, it may be necessary to continue the antiparkinsonian drug for a period of time after haloperidol discontinuance to prevent emergence of these symptoms.
Severe neurotoxicity (e.g., rigidity, inability to walk or talk) may occur in patients with thyrotoxicosis who are also receiving antipsychotic agents, including haloperidol.
If used to control mania in patients with bipolar disorder, there may be a rapid mood swing to depression.
Cardiovascular Effects
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Possibile transient hypotension and/or precipitation of angina; use with caution in patients with severe cardiovascular disorders. If hypotension occurs, may use metaraminol, norepinephrine, or phenylephrine; do not use epinephrine since haloperidol causes a reversal of epinephrine’s vasopressor effects and a further lowering of blood pressure.
Tachycardia, hypotension, hypertension, and ECG changes, including those compatible with QT-interval prolongation and the polymorphous configuration of torsades de pointes, may occur. Although many of the reported cases of QT-interval prolongation and torsades de pointes have been in patients receiving relatively high dosages of haloperidol IV (e.g., >35 mg daily), such effects also reported with low-dose IV or oral therapy.
Abrupt Withdrawal
Possible transient dyskinetic signs after abrupt withdrawal in some patients receiving maintenance therapy; in some cases, dyskinetic movements are indistinguishable from tardive dyskinesia except for duration. It is not known whether gradual withdrawal will reduce occurrence of withdrawal emergent neurological signs; pending further evidence, withdraw gradually.
Endocrine and Metabolic Effects
Elevated prolactin concentrations possible.
Decreased serum cholesterol concentrations reported in patients receiving chemically-related agents.
Specific Populations
Pregnancy
Category C. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Lactation
Distributed into milk. Women receiving haloperidol should not breast-feed.
Pediatric Use
Safety and efficacy of IM administration of haloperidol decanoate or lactate not established in children.
Safety and efficacy of orally administered haloperidol or haloperidol lactate not established in children <3 years of age.
Hyperammonemia reported during postmarketing surveillance in a 5.5-year old child with citrullinemia, an inherited disorder of ammonia excretion, following haloperidol therapy.
Geriatric Use
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults. Other reported clinical experience has not consistently identified differences in responses between geriatric and younger patients.
Prevalence of tardive dyskinesia appears to be highest among geriatric patients, particularly geriatric women. Reduced dosage generally recommended. (See Special Populations under Dosage and Administration.)
Common Adverse Effects
Extrapyramidal reactions (e.g., Parkinson-like symptoms, akathisia, dystonia).
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