Chlorpromazine Side Effects

Please note - some side effects for Chlorpromazine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Chlorpromazine - for the Consumer

Chlorpromazine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Chlorpromazine:

Blurred vision; constipation; dizziness; drowsiness; dry mouth; light sensitivity; nasal congestion.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue); changes in breasts; changes in menstrual period; changes in vision; chest pain; chills; confusion; difficulty swallowing; difficulty urinating; drooling; extreme tiredness; fever; inability to move eyes; involuntary movements of the face, mouth, tongue, or jaw; jitteriness; lip smacking or puckering; mask-like face; muscle spasms of the face, neck, or back; prolonged or painful erection; puffing of cheeks; rigid muscles; seizures; shuffling walk; skin discoloration; sleeplessness; sore throat; stiff arms or legs; tremors of hands; twitching or twisting movements; weakness of arms or legs; yellowing of the skin or eyes.

Chlorpromazine Concentrate

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Chlorpromazine Concentrate:

Agitation; dizziness; drowsiness; dry mouth; enlarged pupils; jitteriness; nausea; stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in menstrual period; changes in sexual ability; dark urine; difficulty swallowing; drooling; fainting; fast or irregular heartbeat; fever, chills, or sore throat; involuntary movements or spasms of the arms and legs, tongue, face, mouth, or jaw; mask-like face; muscle restlessness; prolonged or painful erection; restlessness; seizures; shuffling walk; sleeplessness; stiff or rigid muscles; stomach pain; sweating; trouble urinating; unusual eye movements or inability to move eyes; unusual mood or mental changes, including lack of response to your surroundings; vision changes; weakness of arms or legs; yellowing of the skin or eyes.

Chlorpromazine Suppositories

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Chlorpromazine Suppositories:

Agitation; blurred vision; constipation; dizziness; drowsiness; dry mouth; enlarged pupils; excessive hunger, thirst, or urination; fever; jitteriness; nausea; neck spasms; sensitivity to light; sexual problems; sleeplessness; stomach pain; stuffy nose; urination problems.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in breasts; changes in menstrual period; difficulty swallowing; drooling; fast or irregular heartbeat; inability to move eyes; increased body heat; infection (fever, chills, sore throat); involuntary movements of the arms and legs; involuntary movements of tongue, face, mouth, or jaw (eg, sticking out of tongue, puffing of cheeks, puckering of mouth, lip-smacking, chewing movements); mask-like face; mental changes, including lack of response to your surroundings; muscle restlessness; muscle spasms; prolonged or painful erection; restlessness; seizures; shuffling walk; stiff or rigid muscles; sweating; tension in legs; unusual eye movements; weakness of arms or legs; yellowing of the skin or eyes.

Chlorpromazine Syrup

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Chlorpromazine Syrup:

Agitation; dizziness; drowsiness; dry mouth; enlarged pupils; jitteriness; nausea; stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in menstrual period; changes in sexual ability; dark urine; difficulty swallowing; drooling; fainting; fast or irregular heartbeat; fever, chills, or sore throat; involuntary movements or spasms of the arms and legs, tongue, face, mouth, or jaw; mask-like face; muscle restlessness; prolonged or painful erection; restlessness; seizures; shuffling walk; sleeplessness; stiff or rigid muscles; stomach pain; sweating; trouble urinating; unusual eye movements or inability to move eyes; unusual mood or mental changes, including lack of response to your surroundings; vision changes; weakness of arms or legs; yellowing of the skin or eyes.

Chlorpromazine Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Chlorpromazine Tablets:

Agitation; dizziness; drowsiness; dry mouth; enlarged pupils; jitteriness; nausea; stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in menstrual period; changes in sexual ability; dark urine; difficulty swallowing; drooling; fainting; fast or irregular heartbeat; fever, chills, or sore throat; involuntary movements or spasms of the arms and legs, tongue, face, mouth, or jaw; mask-like face; muscle restlessness; prolonged or painful erection; restlessness; seizures; shuffling walk; sleeplessness; stiff or rigid muscles; stomach pain; sweating; trouble urinating; unusual eye movements or inability to move eyes; unusual mood or mental changes, including lack of response to your surroundings; vision changes; weakness of arms or legs; yellowing of the skin or eyes.

Chlorpromazine Side Effects - for the Professional

Chlorpromazine

Note: Some adverse effects of Chlorpromazine may be more likely to occur, or occur with greater intensity, in patients with special medical problems, e.g., patients with mitral insufficiency or pheochromocytoma have experienced severe hypotension following recommended doses.

Drowsiness, usually mild to moderate, may occur, particularly during the first or second week, after which it generally disappears. If troublesome, dosage may be lowered.

Jaundice

Overall incidence has been low, regardless of indication or dosage. Most investigators conclude it is a sensitivity reaction. Most cases occur between the second and fourth weeks of therapy. The clinical picture resembles infectious hepatitis, with laboratory features of obstructive jaundice, rather than those of parenchymal damage. It is usually promptly reversible on withdrawal of the medication; however, chronic jaundice has been reported.

There is no conclusive evidence that preexisting liver disease makes patients more susceptible to jaundice. Alcoholics with cirrhosis have been successfully treated with Chlorpromazine without complications. Nevertheless, the medication should be used cautiously in patients with liver disease. Patients who have experienced jaundice with a phenothiazine should not, if possible, be reexposed to Chlorpromazine or other phenothiazines.

If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an abnormality, stop treatment.

Liver function tests in jaundice induced by the drug may mimic extrahepatic obstruction; withhold exploratory laparotomy until extrahepatic obstruction is confirmed.

Hematological Disorders, including agranulocytosis, eosinophilia, leukopenia, hemolytic anemia, aplastic anemia, thrombocytopenic purpura and pancytopenia have been reported.

Warn patients to report the sudden appearance of sore throat or other signs of infection. If white blood cell and differential counts indicate cellular depression, stop treatment and start antibiotic and other suitable therapy.

Most cases have occurred between the 4th and 10th weeks of therapy; patients should be watched closely during that period.

Moderate suppression of white blood cells is not an indication for stopping treatment unless accompanied by the symptoms described above.

Cardiovascular

Postural hypotension, simple tachycardia, momentary fainting and dizziness may occur after the first injection; occasionally after subsequent injections; rarely, after the first oral dose. Usually recovery is spontaneous and symptoms disappear within 1/2 to 2 hours. Occasionally, these effects may be more severe and prolonged, producing a shock-like condition.

To minimize hypotension after injection, keep patient lying down and observe for at least 1/2 hour. To control hypotension, place patient in head-low position with legs raised. If a vasoconstrictor is required, norepinephrine and phenylephrine are the most suitable. Other pressor agents, including epinephrine, should not be used as they may cause a paradoxical further lowering of blood pressure.

Particularly nonspecific, usually reversible Q and T wave distortions–have been observed in some patients receiving phenothiazine tranquilizers, including Chlorpromazine.

Note: Sudden death, apparently due to cardiac arrest, has been reported.

CNS Reactions

Neuromuscular reactions include dystonias, motor restlessness, pseudo-parkinsonism and tardive dyskinesia, and appear to be dose-related. They are discussed in the following paragraphs:

Dystonias

Symptoms may include spasm of the neck muscles, sometimes progressing to acute, reversible torticollis; extensor rigidity of back muscles, sometimes progressing to opisthotonos; carpopedal spasm, trismus, swallowing difficulty, oculogyric crisis and protrusion of the tongue.

These usually subside within a few hours, and almost always within 24 to 48 hours after the drug has been discontinued.

In mild cases, reassurance or a barbiturate is often sufficient. In moderate cases, barbiturates will usually bring rapid relief. In more severe adult cases, the administration of an anti-parkinsonism agent, except levodopa, usually produces rapid reversal of symptoms. In children (1 to 12 years of age), reassurance and barbiturates will usually control symptoms. (Or, parenteral diphenhydramine may be useful. See diphenhydramine prescribing information for appropriate children’s dosage.) If appropriate treatment with anti-parkinsonism agents or diphenhydramine fails to reverse the signs and symptoms, the diagnosis should be reevaluated.

Suitable supportive measures such as maintaining a clear airway and adequate hydration should be employed when needed. If therapy is reinstituted, it should be at a lower dosage. Should these symptoms occur in children or pregnant patients, the drug should not be reinstituted.

Motor Restlessness

Symptoms may include agitation or jitteriness and sometimes insomnia. These symptoms often disappear spontaneously. At times these symptoms may be similar to the original neurotic or psychotic symptoms. Dosage should not be increased until these side effects have subsided.

If these symptoms become too troublesome, they can usually be controlled by a reduction of dosage or change of drug. Treatment with anti-parkinsonian agents, benzodiazepines or propranolol may be helpful.

Pseudo-parkinsonism

Symptoms may include: mask-like facies, drooling, tremors, pillrolling motion, cogwheel rigidity and shuffling gait. In most cases, these symptoms are readily controlled when an anti-parkinsonism agent is administered concomitantly. Anti-parkinsonism agents should be used only when required. Generally, therapy of a few weeks to 2 or 3 months will suffice. After this time, patients should be evaluated to determine their need for continued treatment. (Note: Levodopa has not been found effective in antipsychotic-induced pseudo-parkinsonism.) Occasionally it is necessary to lower the dosage of Chlorpromazine or to discontinue the drug.

Tardive Dyskinesia

As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or may appear after drug therapy has been discontinued. The syndrome can also develop, although much less frequently, after relatively brief treatment periods at low doses. This syndrome appears in all age groups. Although its prevalence appears to be highest among elderly patients, especially elderly women, it is impossible to rely upon prevalence estimates to predict at the inception of antipsychotic treatment which patients are likely to develop the syndrome. The symptoms are persistent and in some patients appear to be irreversible. The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities. In rare instances, these involuntary movements of the extremities are the only manifestations of tardive dyskinesia. A variant of tardive dyskinesia, tardive dystonia, has also been described.

There is no known effective treatment for tardive dyskinesia; anti-parkinsonism agents do not alleviate the symptoms of this syndrome. If clinically feasible, it is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, the syndrome may be masked. It has been reported that fine vermicular movements of the tongue may be an early sign of the syndrome and if the medication is stopped at that time the syndrome may not develop.

Psychotic symptoms and catatonic-like states have been reported rarely.

Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs.

Cerebral edema has been reported.

Convulsive seizures (petit mal and grand mal) have been reported, particularly in patients with EEG abnormalities or history of such disorders.

Abnormality of the cerebrospinal fluid proteins has also been reported.

Allergic Reactions of a mild urticarial type or photosensitivity are seen. Avoid undue exposure to sun. More severe reactions, including exfoliative dermatitis, have been reported occasionally.

Contact dermatitis has been reported in nursing personnel; accordingly, the use of rubber gloves when administering Chlorpromazine injectable is recommended.

In addition, asthma, laryngeal edema, angioneurotic edema and anaphylactoid reactions have been reported.

Endocrine Disorders

Lactation and moderate breast engorgement may occur in females on large doses. If persistent, lower dosage or withdraw drug. False-positive pregnancy tests have been reported, but are less likely to occur when a serum test is used. Amenorrhea and gynecomastia have also been reported. Hyperglycemia, hypoglycemia and glycosuria have been reported.

Autonomic Reactions

Occasional dry mouth; nasal congestion; nausea; obstipation; constipation; adynamic ileus; urinary retention; priapism; miosis and mydriasis; atonic colon; ejaculatory disorders/impotence.

Special Considerations in Long-Term Therapy

Skin pigmentation and ocular changes have occurred in some patients taking substantial doses of Chlorpromazine for prolonged periods.

Rare instances of skin pigmentation have been observed in hospitalized mental patients, primarily females who have received the drug usually for 3 years or more in dosages ranging from 500 mg to 1500 mg daily. The pigmentary changes, restricted to exposed areas of the body, range from an almost imperceptible darkening of the skin to a slate gray color, sometimes with a violet hue. Histological examination reveals a pigment, chiefly in the dermis, which is probably a melanin-like complex. The pigmentation may fade following discontinuance of the drug.

Ocular changes have occurred more frequently than skin pigmentation and have been observed both in pigmented and nonpigmented patients receiving Chlorpromazine usually for 2 years or more in dosages of 300 mg daily and higher. Eye changes are characterized by deposition of fine particulate matter in the lens and cornea. In more advanced cases, star-shaped opacities have also been observed in the anterior portion of the lens. The nature of the eye deposits has not yet been determined. A small number of patients with more severe ocular changes have had some visual impairment. In addition to these corneal and lenticular changes, epithelial keratopathy and pigmentary retinopathy have been reported. Reports suggest that the eye lesions may regress after withdrawal of the drug. Since the occurrence of eye changes seems to be related to the dosage levels and/or duration of therapy, it is suggested that long-term patients on moderate to high dosage levels have periodic ocular examinations.

The etiology of both of these reactions is not clear, but exposure to light, along with dosage/duration of therapy, appears to be the most significant factor. If either of these reactions is observed, the physician should weigh the benefits of continued therapy against the possible risks and, on the merits of the individual case, determine whether or not to continue present therapy, lower the dosage, or withdraw the drug.

Other Adverse Reactions

Mild fever may occur after large IM doses. Hyperpyrexia has been reported. Increases in appetite and weight sometimes occur. Peripheral edema and a systemic lupus erythematosus-like syndrome have been reported.

Note: There have been occasional reports of sudden death in patients receiving phenothiazines. In some cases, the cause appeared to be cardiac arrest or asphyxia due to failure of the cough reflex.

Chlorpromazine Tablets

Note: Some adverse effects of Chlorpromazine may be more likely to occur, or occur with greater intensity, in patients with special medical problems; e.g., patients with mitral insufficiency or pheochromocytoma have experienced severe hypotension following recommended doses.

Drowsiness

Usually mild to moderate may occur, particularly during the first or second week, after which it generally disappears. If troublesome, dosage may be lowered.

Jaundice

Overall incidence has been low, regardless of indication or dosage. Most investigators conclude it is a sensitivity reaction. Most cases occur between the second and fourth weeks of therapy. The clinical picture resembles infectious hepatitis, with laboratory features of obstructive jaundice, rather than those of parenchymal damage. It is usually promptly reversible on withdrawal of the medication; however, chronic jaundice has been reported.

There is no conclusive evidence that preexisting liver disease makes patients more susceptible to jaundice. Alcoholics with cirrhosis have been successfully treated with Chlorpromazine without complications. Nevertheless, the medication should be used cautiously in patients with liver disease. Patients who have experienced jaundice with a phenothiazine should not, if possible, be reexposed to Chlorpromazine or other phenothiazines.

If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an abnormality, stop treatment.

Liver function tests in jaundice induced by the drug may mimic extrahepatic obstruction; withhold exploratory laparotomy until extrahepatic obstruction is confirmed.

Hematologic Disorders

Including agranulocytosis, eosinophilia, leukopenia, hemolytic anemia, aplastic anemia, thrombocytopenic purpura and pancytopenia have been reported.

Warn patients to report the sudden appearance of sore throat or other signs of infection. If white blood cell and differential counts indicate cellular depression, stop treatment and start antibiotic and other suitable therapy.

Most cases have occurred between the 4th and 10th weeks of therapy; patients should be watched closely during that period.

Moderate suppression of white blood cells is not an indication for stopping treatment unless accompanied by the symptoms described above.

Cardiovascular

Postural hypotension, simple tachycardia, momentary fainting and dizziness may occur rarely, after the first oral dose. Usually recovery is spontaneous and symptoms disappear within 1/2 to 2 hours. Occasionally, these effects may be more severe and prolonged, producing a shock-like condition.

To control hypotension, place patient in head-low position with legs raised. If a vasoconstrictor is required, norepinephrine and phenylephrine are the most suitable. Other pressor agents, including epinephrine, should not be used as they may cause a paradoxical further lowering of blood pressure.

Particularly nonspecific, usually reversible Q and T wave distortions – have been observed in some patients receiving phenothiazine tranquilizers, including Chlorpromazine.

Note: Sudden death, apparently due to cardiac arrest, has been reported.

CNS Reactions

Neuromuscular reactions include dystonias, motor restlessness, pseudo-parkinsonism and tardive dyskinesia, and appear to be dose-related. They are discussed in the following paragraphs:

Class effect:  Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Symptoms may include agitation or jitteriness and sometimes insomnia. These symptoms often disappear spontaneously. At times, these symptoms may be similar to the original neurotic or psychotic symptoms. Dosage should not be increased until these side effects have subsided.

If these symptoms become too troublesome, they can usually be controlled by a reduction of dosage or change of drug. Treatment with anti-parkinsonian agents, benzodiazepines or propranolol may be helpful.

Symptoms may include: mask-like facies, drooling, tremors, pillrolling motion, cogwheel rigidity and shuffling gait. In most cases, these symptoms are readily controlled when an anti-parkinsonism agent is administered concomitantly. Anti-parkinsonism agents should be used only when required. Generally, therapy of a few weeks to 2 or 3 months will suffice. After this time patients should be evaluated to determine their need for continued treatment. (Note: Levodopa has not been found effective in antipsychotic-induced pseudo-parkinsonism.) Occasionally, it is necessary to lower the dosage of Chlorpromazine or to discontinue the drug.

As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or may appear after drug therapy has been discontinued. The syndrome can also develop, although much less frequently, after relatively brief treatment periods at low doses. This syndrome appears in all age groups. Although its prevalence appears to be highest among elderly patients, especially elderly women, it is impossible to rely upon prevalence estimates to predict at the inception of antipsychotic treatment which patients are likely to develop the syndrome. The symptoms are persistent and in some patients appear to be irreversible. The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities. In rare instances, these involuntary movements of the extremities are the only manifestations of tardive dyskinesia. A variant of tardive dyskinesia, tardive dystonia, has also been described.

There is no known effective treatment for tardive dyskinesia; anti-parkinsonism agents do not alleviate the symptoms of this syndrome. If clinically feasible, it is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, the syndrome may be masked.

It has been reported that fine vermicular movements of the tongue may be an early sign of the syndrome and if the medication is stopped at that time, the syndrome may not develop.

Adverse Behavioral Effects

Psychotic symptoms and catatonic-like states have been reported rarely.

Other CNS Effects

Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs.

Cerebral edema has been reported.

Convulsive seizures (petit mal and grand mal) have been reported, particularly in patients with EEG abnormalities or history of such disorders.

Abnormality of the cerebrospinal fluid proteins has also been reported. Allergic Reactions of a mild urticarial type or photosensitivity are seen. Avoid undue exposure to sun. More severe reactions, including exfoliative dermatitis, have been reported occasionally.

Contact dermatitis has been reported in nursing personnel; accordingly, the use of rubber gloves when administering Chlorpromazine liquid or injectable is recommended.

In addition, asthma, laryngeal edema, angioneurotic edema and anaphylactoid reactions have been reported.

Endocrine Disorders

Lactation and moderate breast engorgement may occur in females on large doses. If persistent, lower dosage or withdraw drug. False-positive pregnancy tests have been reported, but are less likely to occur when a serum test is used. Amenorrhea and gynecomastia have also been reported. Hyperglycemia, hypoglycemia and glycosuria have been reported.

Autonomic Reactions

Occasional dry mouth; nasal congestion; nausea; obstipation; constipation; adynamic ileus; urinary retention, priapism, miosis and mydriasis, atonic colon, ejaculatory disorders/impotence.

Special Consideration in Long-Term Therapy

Skin pigmentation and ocular changes have occurred in some patients taking substantial doses of Chlorpromazine for prolonged periods.

Rare instances of skin pigmentation have been observed in hospitalized mental patients, primarily females who have received the drug usually for 3 years or more in dosages ranging from 500 mg to 1500 mg daily. The pigmentary changes, restricted to exposed areas of the body, range from an almost imperceptible darkening of the skin to a slate gray color, sometimes with a violet hue. Histological examination reveals a pigment, chiefly in the dermis, which is probably a melanin-like complex. The pigmentation may fade following discontinuance of the drug.

Ocular changes have occurred more frequently than skin pigmentation and have been observed both in pigmented and nonpigmented patients receiving Chlorpromazine, usually for 2 years or more in dosages of 300 mg daily and higher. Eye changes are characterized by deposition of fine particulate matter in the lens and cornea. In more advanced cases, star-shaped opacities have also been observed in the anterior portion of the lens. The nature of the eye deposits has not yet been determined. A small number of patients with more severe ocular changes have had some visual impairment. In addition to these corneal and lenticular changes, epithelial keratopathy and pigmentary retinopathy have been reported. Reports suggest that the eye lesions may regress after withdrawal of the drug.

Since the occurrence of eye changes seems to be related to dosage levels and/or duration of therapy, it is suggested that long-term patients on moderate to high dosage levels have periodic ocular examinations.

The etiology of both of these reactions is not clear, but exposure to light, along with dosage/duration of therapy, appears to be the most significant factor. If either of these reactions is observed, the physician should weigh the benefits of continued therapy against the possible risks and, on the merits of the individual case, determine whether or not to continue present therapy, lower the dosage, or withdraw the drug.

Other Adverse Reactions

Mild fever may occur after large I.M. doses. Hyperpyrexia has been reported. Increases in appetite and weight sometimes occur. Peripheral edema and a systemic lupus erythematosus-like syndrome have been reported.

Note: There have been occasional reports of sudden death in patients receiving phenothiazines. In some cases, the cause appeared to be cardiac arrest or asphyxia due to failure of the cough reflex..

Side Effects by Body System

General

General side effects have included cases of muscle necrosis after repeated injections of chlorpromazine. 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 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 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 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 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 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 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 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 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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