Compazine Spansule Side Effects

Generic Name: prochlorperazine

Please note - some side effects for Compazine Spansule may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects have been associated with the use of prochlorperazine. Most commonly, patients may experience sedation or dizziness. Extrapyramidal reactions may occur in less than 1% of patients receiving prochlorperazine. More commonly patients have reported akathisia and anxiety.

Sedation has been reported in up to 75% of patients treated with prochlorperazine. Extrapyramidal reactions have occasionally included torticollis, opisthotonos, carpopedal spasm, trismus, oculogyric crisis, and tongue protrusion. Dystonias usually resolve after neuroleptic discontinuation, but may require anticholinergic therapy if symptoms are severe.

Patients have also experienced pseudoparkinsonism reactions including mask-like facies, drooling, cogwheel rigidity, and shuffling gait. Pseudoparkinsonism symptoms may respond to judicious use of one or more of the following: benztropine, trihexyphenidyl, biperiden or diphenhydramine.

Occasionally, patients have experienced spasmodic contractions involving the mouth, difficulty swallowing, and pain in the jaw and neck. In a few severe cases, patients have experienced temporal mandibular joint subluxation.

Tardive dyskinesia, as with all phenothiazines, is possible with long-term use of prochlorperazine. Tardive dyskinesia involves involuntary, dyskinetic, repetitive movements and may be more common in elderly women receiving prochlorperazine. Tardive dyskinesia may be irreversible and is related to both the duration of therapy and the total amount of drug consumed.

Gastrointestinal

Gastrointestinal side effects have included mild to moderate diarrhea.

Hepatic

Hepatic side effects have included the development of cholestasis (which has been chronic in at least two patients).

Hematologic

Hematologic side effects associated with prochlorperazine have rarely included leukopenia and agranulocytosis.

Postmarketing safety experience suggests elderly patients may have an increased incidence of agranulocytosis compared to younger patients receiving prochlorperazine.

Cardiovascular

Cardiovascular side effects have occasionally included hypotension during intravenous administration of prochlorperazine.

Elderly patients may experience an increased sensitivity to the hypotensive effects of chlorperazine.

Other

Other side effects have included cases of the neuroleptic malignant syndrome with other phenothiazines and in at least one patient treated with prochlorperazine.

Fever, altered consciousness, autonomic dysfunction, and muscle rigidity are the hallmarks of the neuroleptic malignant syndrome. The neuroleptic malignant syndrome is associated with a case fatality rate of about 20%. Immediate discontinuation of neuroleptic therapy and intensive monitoring and supportive care are indicated.

Dermatologic

Dermatologic side effects associated with prochlorperazine have included at least two cases of recurrent lip ulceration.

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