Compazine Side Effects

Generic name: prochlorperazine

Note: This document contains side effect information about prochlorperazine. Some of the dosage forms listed on this page may not apply to the brand name Compazine.

Some side effects of Compazine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to prochlorperazine: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking prochlorperazine (the active ingredient contained in Compazine) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using prochlorperazine and call your doctor at once if you have a serious side effect such as:

• twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

• tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;

• feeling restless, jittery, or agitated;

• high fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing;

• feeling like you might pass out;

• seizure (black-out or convulsions);

• decreased night vision, tunnel vision, watery eyes, increased sensitivity to light;

• nausea and stomach pain, skin rash, and jaundice (yellowing of the skin or eyes);

• pale skin, easy bruising or bleeding, fever, sore throat, flu symptoms;

• urinating less than usual or not at all;

• joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color; or

• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

Less serious side effects of prochlorperazine may include:

• dizziness, drowsiness, anxiety;

• sleep problems (insomnia), strange dreams;

• dry mouth, stuffy nose;

• blurred vision;

• constipation;

• breast swelling or discharge;

• a missed menstrual period;

• weight gain, swelling in your hands or feet;

• impotence, trouble having an orgasm;

• mild itching or skin rash; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to prochlorperazine: compounding powder, injectable solution, oral capsule extended release, oral syrup, oral tablet, rectal suppository

Nervous system

Nervous system side effects have been associated with the use of prochlorperazine (the active ingredient contained in Compazine) 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 (the active ingredient contained in Compazine) 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 (the active ingredient contained in Compazine)

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 (the active ingredient contained in Compazine)

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 (the active ingredient contained in Compazine) have included at least two cases of recurrent lip ulceration.

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