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.
Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur.
Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs (see WARNINGS).
Cholestatic jaundice has occurred.
If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted.
If tests indicate an abnormality, stop treatment.
There have been a few observations of fatty changes in the livers of patients who have died while receiving the drug.
No causal relationship has been established.
Leukopenia and agranulocytosis have occurred.
Warn patients to report the sudden appearance of sore throat or other signs of infection.
If white blood cell and differential counts indicate leukocyte depression, stop treatment and start antibiotic and other suitable therapy.
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.
Prochlorperazine maleate is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).
The extrapyramidal symptoms which can occur secondary to prochlorperazine may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g., Reye’s syndrome or other encephalopathy.
The use of prochlorperazine and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reye’s syndrome.
Tardive Dyskinesia: Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs.
Like all medications, Prochlorperazine Maleate 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: