Thorazine Side Effects

Generic name: chlorpromazine

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

Some side effects of Thorazine 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 chlorpromazine: oral tablet

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

Stop taking chlorpromazine 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;

• feeling like you might pass out;

• seizure (black-out or convulsions);

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

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

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

• unusual thoughts or behavior;

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

• urinating less than usual or not at all;

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

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

Less serious side effects of chlorpromazine may include:

• dizziness, drowsiness, anxiety, sleep problems (insomnia);

• breast swelling or discharge;

• changes in menstrual periods;

• weight gain, swelling in your hands or feet;

• dry mouth or stuffy nose, blurred vision;

• constipation; or

• impotence, trouble having an orgasm.

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 chlorpromazine: compounding powder, injectable solution, oral capsule extended release, oral concentrate, oral syrup, oral tablet, rectal suppository

General

General side effects have included cases of muscle necrosis after repeated injections of chlorpromazine (the active ingredient contained in Thorazine) The low pH of parenteral chlorpromazine solutions may be responsible for the necrosis. Subcutaneous injections should be avoided.

Nervous system

Nervous system side effects are common and include sedation, drowsiness and rarely seizures. Tardive dyskinesia, dystonia, pseudoparkinsonism, increased neuromuscular excitability, and the neuroleptic malignant syndrome have also been reported.

The drowsiness associated with chlorpromazine therapy may resolve after several doses.

Tardive dyskinesia involves involuntary, dyskinetic, repetitive movements and may be more common in elderly women receiving chlorpromazine. Tardive dyskinesia may be irreversible and is related to both the duration of therapy and the total amount of drug consumed. Frequent discontinuation and resumption of therapy may predispose patients to the development of tardive dyskinesia.

Dystonias frequently involve tongue protrusions, muscle rigidity, torticollis, and opisthotonos. Dystonias usually resolve after neuroleptic discontinuation, but may require antihistamine and antiparkinsonian therapy if symptoms are severe or if respiration is compromised. Treatment of dystonic reactions and extrapyramidal effects, in addition to general supportive measures, may include judicious use of one or more of the following: benztropine, trihexyphenidyl, biperiden or diphenhydramine.

Pseudoparkinsonism involves flat facies, pill- rolling tremor, shuffling gait, and cogwheel rigidity. Pseudoparkinsonism symptoms may respond to judicious use of one or more of the following: benztropine, trihexyphenidyl, biperiden or diphenhydramine.

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.

Seizures associated with chlorpromazine have been reported, but many of the reports involve patients with a history of seizures or underlying organic brain disease.

Psychiatric

Psychiatric side effects including psychotic symptoms, excitability, and reversible catatonic states have been reported. There may also be rare paradoxical psychiatric effects with chlorpromazine (the active ingredient contained in Thorazine) therapy.

Hematologic

Hematologic side effects have included reversible agranulocytosis (which occurs in about one out of 10,000 patients). Hemolytic anemia, thrombocytopenia, and eosinophilia have also been reported.

A 40% decrease in platelet counts was observed in 21% of patients on chlorpromazine in one study. The thrombocytopenia persisted for up to 6 months after discontinuation of chlorpromazine.

Some clinicians have suggested that any sign or symptom of infection in patients on chlorpromazine therapy should be evaluated with a complete blood count and differential.

Cardiovascular

Cases of cardiopulmonary arrest in otherwise healthy young patients have been reported rarely. Edema in association with chlorpromazine (the active ingredient contained in Thorazine) therapy has also been reported rarely.

Hypotension is more likely in patients with intravenous administration.

Cardiovascular side effects have included profound orthostatic hypotension and reflex tachycardia. These effects may subside after several doses. Chlorpromazine has mild negative inotropic properties, which may be important in some patients with a history of congestive heart failure. ECG changes include prolongation of the PR interval, prolongation of QTc segments, diffuse T-wave flattening, and ST segment depression.

Hypersensitivity

Rare cases of anaphylaxis, toxic epidermal necrolysis, and angioedema have been reported. A case of contact dermatitis associated with crushed chlorpromazine (the active ingredient contained in Thorazine) tablets has been reported.

Hypersensitivity side effects to chlorpromazine are usually mild and presents as an urticarial rash. Pustular eruptions, severe anaphylaxis and angioedema have been reported rarely.

Hepatic

Chlorpromazine- induced cholestatic jaundice usually resolves without sequelae 2 to 8 weeks after discontinuation of the drug. However, severe and prolonged jaundice, resembling primary biliary cirrhosis, has been reported in a minority of cases. The prognosis of this condition is generally favorable. However, progression to biliary cirrhosis has been reported.

A case of chronic active hepatitis associated with chlorpromazine (the active ingredient contained in Thorazine) has been reported. A Danish study has reported 5 cases of fatal hepatitis associated with chlorpromazine. A recent study of 10,502 users of chlorpromazine has reported 14 illnesses which were considered to be compatible with drug induced liver disease. The frequency of drug induced liver disease in that group was 1.3 per 1,000 users of chlorpromazine.

Monitoring of liver function tests during chlorpromazine therapy may be helpful in patients with liver disease.

Hepatic side effects including mild reversible elevations of liver function tests have been reported. Cholestatic jaundice has been reported in as many as 1% of patients taking chlorpromazine, however many clinicians believe that the reported frequency of cholestatic jaundice may be referable to impurities in early formulations of the drug. Severe hepatitis has also been reported.

Immunologic

In one study 35% of patients on chlorpromazine (the active ingredient contained in Thorazine) tested positive for the lupus anticoagulant. In another study of 64 patients on chlorpromazine, 45% tested positive for the lupus anticoagulant, 39% for positive ANA titers, 34% for the anticardiolipin antibody, 50% for rheumatoid factor, and 27% for an elevation in IgM.

A case of Henoch-Schonlein purpura has been associated with chlorpromazine.

Chlorpromazine- induced antiphospholipid antibody syndrome developed in a patient after taking chlorpromazine 100 mg daily for a year. Symptoms included encephalopathy, seizures (i.e., generalized tonic-clonic, status epilepticus), confusion, and drowsiness. All symptoms resolved following discontinuation of chlorpromazine.

Immunologic side effects have included a variety of adverse immunologic effects including antiphospholipid antibody syndrome which appear to be related to the total dose consumed.

Gastrointestinal

Gastrointestinal side effects including dry mouth, constipation, and less commonly, diarrhea have been reported.

The gastrointestinal side effects may result from the anticholinergic properties of chlorpromazine.

Endocrine

Endocrine side effects including hyperglycemia, hyperprolactinemia, galactorrhea, amenorrhea, and the syndrome of inappropriate secretion of antidiuretic hormone have been reported.

Dermatologic

Dermatologic side effects including skin hyperpigmentation has been reported in patients after long-term chlorpromazine (the active ingredient contained in Thorazine) therapy (doses of 500 to 1,500 mg over 2 to 3 years). The hyperpigmentation commonly presents as a gray- blue discoloration in exposed areas, including the eyelids.

The hyperpigmentation associated with chlorpromazine therapy appears to be reversible in some patients after discontinuation of chlorpromazine and initiation of alternative neuroleptic therapy. Contact dermatitis has been reported in a person who crushed chlorpromazine tablets for a patient. Leukocytoclastic vasculitis associated with Henoch-Schonlein purpura has been reported during chlorpromazine use.

Genitourinary

Genitourinary side effects including urinary retention, impotence and priapism have been associated with chlorpromazine (the active ingredient contained in Thorazine) therapy.

Ocular

Chlorpromazine may induce lens and corneal pigmentary changes which have produced visual impairment such as halos around lights, hazy vision, photophobia, and watering eyes. One case of orbital cellulitis has been reported following the retrobulbar injection of chlorpromazine (the active ingredient contained in Thorazine) for intractable pain in a patient with irreversible blindness.

Ocular changes seem to be related to dosage levels and/or duration of therapy. Therefore, long term chlorpromazine patients on moderate to high dosage levels should have periodic ocular examinations.

Ocular side effects have been reported primarily in patients receiving chlorpromazine for two or more years in dosages of 300 mg daily or more. Ocular changes are characterized by deposition of fine particulate matter in the lens and cornea. In more advanced cases, star- shaped opacities have also been reported in the anterior portion of the lens. The nature of the deposits has not been reported. Anterior capsular cataracts have also been reported. Some visual impairment has been reported in a small number of patients with more severe ocular changes. Epithelial keratopathy and pigmentary retinopathy have also been reported. Reports suggest that the eye lesions may regress after withdrawal of the drug.

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