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Chlorpromazine (Chlorpromazine Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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.

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

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.

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

AGRANULOCYTOSIS

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

HYPOTENSIVE EFFECTS

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. /

EKG CHANGES

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

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

CNS Reactions

NEUROMUSCULAR (EXTRAPYRAMIDAL) REACTIONS

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

Dystonia

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. Class effect:

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.

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. (See.) WARNINGS

Cerebral edema has been reported.

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

Abnormality of the cerebrospinal fluid proteins has also been reported.

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

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.

SKIN PIGMENTATION

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

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. /

ETIOLOGY

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.



REPORTS OF SUSPECTED CHLORPROMAZINE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Chlorpromazine. The information is not vetted and should not be considered as verified clinical evidence.

Possible Chlorpromazine side effects / adverse reactions in 6 year old female

Reported by a health professional (non-physician/pharmacist) from Hong Kong on 2011-10-11

Patient: 6 year old female

Reactions: Nervous System Disorder

Adverse event resulted in: death

Suspect drug(s):
Chlorpromazine



Possible Chlorpromazine side effects / adverse reactions in 39 year old male

Reported by a physician from United Kingdom on 2011-11-21

Patient: 39 year old male

Reactions: Blood Creatine Phosphokinase Increased, Neuroleptic Malignant Syndrome

Adverse event resulted in: hospitalization

Suspect drug(s):
Valproate Sodium
    Indication: Schizophrenia, Paranoid Type
    Start date: 2008-02-05
    End date: 2008-03-02

Clozapine
    Indication: Schizophrenia, Paranoid Type
    End date: 2007-12-17

Lithium Carbonate
    Indication: Schizophrenia, Paranoid Type
    Start date: 2008-03-06
    End date: 2008-06-18

Quetiapine Fumarate
    Dosage: at bedtime
    Indication: Schizophrenia, Paranoid Type
    Start date: 2008-01-01
    End date: 2008-01-08

Valproate Sodium
    Start date: 2008-03-06

Depixol
    Indication: Schizophrenia, Paranoid Type
    End date: 2007-12-17

Abilify
    Indication: Schizophrenia, Paranoid Type
    Start date: 2008-02-18
    End date: 2008-02-23

Valproate Sodium
    Start date: 2008-03-03
    End date: 2008-03-05

Chlorpromazine
    Indication: Schizophrenia, Paranoid Type
    End date: 2007-12-17

Clozapine
    Start date: 2008-01-29
    End date: 2008-02-05

Procyclidine Hydrochloride 2MG TAB
    Indication: Schizophrenia, Paranoid Type
    End date: 2007-12-17

Clozapine
    Start date: 2008-03-26

Other drugs received by patient: Lorazepam; Antibiotics; Hyoscine Hydrobromide



Possible Chlorpromazine side effects / adverse reactions in 5 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-23

Patient: 5 year old male

Reactions: Movement Disorder, Developmental Delay, Mood Swings, Attention Deficit/hyperactivity Disorder, Sydenham's Chorea

Adverse event resulted in: hospitalization

Suspect drug(s):
Lisdexamfetamine
    Dosage: 30 mg, unk

Amphetamine Sulfate

Aripiprazole
    Dosage: unk

Valproic Acid
    Dosage: 125 mg, qam

Atomoxetine Hydrochloride
    Dosage: 18 mg, qam

Clonidine
    Dosage: 0.05 mg, 3x/day

Quetiapine Fumarate
    Dosage: 12.5 mg, 2x/day

Ziprasidone HCL
    Dosage: 40 mg, unk

Chlorpromazine
    Dosage: 200 mg, 1x/day
    Indication: Abnormal Behaviour

Valproic Acid
    Dosage: 250 mg, qhs

Carbamazepine
    Dosage: unk

Clonidine
    Dosage: 0.05 unk, 2x/day

Methylphenidate
    Dosage: unk

Iloperidone
    Dosage: 6 mg, unk

Lithium
    Dosage: 150 mg, 2x/day

Valproic Acid
    Dosage: 125 mg, 1x/day

Dextroamphetamine
    Dosage: 2.5 mg, 3x/day

Valproic Acid
    Dosage: 125 mg, 2x/day



See index of all Chlorpromazine side effect reports >>

Drug label data at the top of this Page last updated: 2012-06-13

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