Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Cardiovascular Effects Tachycardia, hypotension, and hypertension have been reported.
QT prolongation and/or ventricular arrhythmias have also been reported, in addition to ECG pattern changes compatible with the polymorphous configuration of Torsades de pointes, and may occur more frequently with high doses and in predisposed patients (see WARNINGS and PRECAUTIONS).
Cases of sudden and unexpected death have been reported in association with the administration of haloperidol.
The nature of the evidence makes it impossible to determine definitively what role, if any, haloperidol played in the outcome of the reported cases.
The possibility that haloperidol caused death cannot, of course, be excluded, but it is to be kept in mind that sudden and unexpected death may occur in psychotic patients when they go untreated or when they are treated with other antipsychotic drugs.
CNS Effects Extrapyramidal Symptoms (EPS) EPS during the administration of haloperidol have been reported frequently, often during the first few days of treatment.
EPS can be categorized generally as Parkinson-like symptoms, akathisia, or dystonia (including opisthotonos and oculogyric crisis).
While all can occur at relatively low doses, they occur more frequently and with greater severity at higher doses.
The symptoms may be controlled with dose reductions or administration of antiparkinson drugs such as benztropine mesylate, USP or trihexyphenidyl hydrochloride, USP.
It should be noted that persistent EPS have been reported;
WARNINGS 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.
Haloperidol is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).
Cardiovascular Effects Cases of sudden death, QT-prolongation, and Torsades de pointes have been reported in patients receiving haloperidol.
Higher than recommended doses of any formulation of haloperidol appear to be associated with a higher risk of QT-prolongation and Torsades de pointes.
Although cases have been reported even in the absence of predisposing factors, particular caution is advised in treating patients with other QT-prolonging conditions (including electrolyte imbalance [particularly hypokalemia and hypomagnesemia], drugs known to prolong QT, underlying cardiac abnormalities, hypothyroidism, and familial long QT-syndrome).
Like all medications, Haloperidol can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: