Prochlorperazine Side Effects

Brand Names: Compazine, Compazine Spansule, Compro

Please note - some side effects for Prochlorperazine 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 of Prochlorperazine - for the Consumer

Prochlorperazine

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 Prochlorperazine:

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

Seek medical attention right away if any of these SEVERE side effects occur when using Prochlorperazine:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness; wheezing); chest pain; confusion; decreased coordination; drooling; fainting; fast, slow, or irregular heartbeat; mask-like face; muscle spasms of the face, neck, or back; muscle weakness; new or worsening mental or mood problems; numbness of an arm or leg; prolonged or painful erection; restlessness; seizures; severe or persistent constipation; severe or persistent dizziness, drowsiness, or headache; shuffling walk; sleeplessness; stiff or rigid muscles; sudden shortness of breath or vomiting; swelling of the hands, ankles, or feet; symptoms of infection (eg, fever, chills, persistent sore throat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, stomach pain, or loss of appetite); tremor; trouble urinating; twisting or twitching movements; uncontrolled muscle movements (eg, twitching of the face or tongue; loss of balance; uncontrolled movements of arms or legs; trouble speaking, breathing, or swallowing); unusual bruising or bleeding; unusual eye movements or inability to move eyes; unusual or excessive sweating; unusual tiredness or weakness; unusually pale skin; vision changes (eg, blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Prochlorperazine 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 Prochlorperazine Suppositories:

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

Seek medical attention right away if any of these SEVERE side effects occur when using Prochlorperazine Suppositories:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness; wheezing); chest pain; confusion; decreased coordination; drooling; fainting; fast, slow, or irregular heartbeat; mask-like face; muscle spasms of the face, neck, or back; muscle weakness; new or worsening mental or mood problems; numbness of an arm or leg; prolonged or painful erection; restlessness; seizures; severe or persistent constipation; severe or persistent dizziness, drowsiness, or headache; shuffling walk; sleeplessness; stiff or rigid muscles; sudden shortness of breath or vomiting; swelling of the hands, ankles, or feet; symptoms of infection (eg, fever, chills, persistent sore throat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, stomach pain, or loss of appetite); tremor; trouble urinating; twisting or twitching movements; uncontrolled muscle movements (eg, twitching of the face or tongue; loss of balance; uncontrolled movements of arms or legs; trouble speaking, breathing, or swallowing); unusual bruising or bleeding; unusual eye movements or inability to move eyes; unusual or excessive sweating; unusual tiredness or weakness; unusually pale skin; vision changes (eg, blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Prochlorperazine 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 Prochlorperazine Syrup:

Blurred vision; chills; constipation; dizziness; drowsiness; dry mouth; jitteriness; nasal congestion; sleeplessness.

Seek medical attention right away if any of these SEVERE side effects occur when using Prochlorperazine Syrup:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; altered mental abilities, including lack of response to your surroundings; changes in breasts; changes in menstrual period; changes in vision; difficulty swallowing; drooling; excessive sweating; fever; inability to move eyes; increased body heat; involuntary movements of tongue, face, mouth, or jaw (eg, protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements); irregular or fast heartbeat; mask-like face; muscle stiffness; muscle spasms of face, neck, or back; prolonged or painful erection; restlessness; rigid muscles; shuffling walk; sore throat; tension in legs; tremors; twitching or twisting movements; unusual eye movements; weakness of arms or legs; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Prochlorperazine 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 Prochlorperazine Tablets:

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

Seek medical attention right away if any of these SEVERE side effects occur when using Prochlorperazine Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness; wheezing); chest pain; confusion; decreased coordination; drooling; fainting; fast, slow, or irregular heartbeat; mask-like face; muscle spasms of the face, neck, or back; muscle weakness; new or worsening mental or mood problems; numbness of an arm or leg; prolonged or painful erection; restlessness; seizures; severe or persistent constipation; severe or persistent dizziness, drowsiness, or headache; shuffling walk; sleeplessness; stiff or rigid muscles; sudden shortness of breath or vomiting; swelling of the hands, ankles, or feet; symptoms of infection (eg, fever, chills, persistent sore throat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, stomach pain, or loss of appetite); tremor; trouble urinating; twisting or twitching movements; uncontrolled muscle movements (eg, twitching of the face or tongue; loss of balance; uncontrolled movements of arms or legs; trouble speaking, breathing, or swallowing); unusual bruising or bleeding; unusual eye movements or inability to move eyes; unusual or excessive sweating; unusual tiredness or weakness; unusually pale skin; vision changes (eg, blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Prochlorperazine Side Effects - for the Professional

Prochlorperazine

Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur. Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Cholestatic jaundice has occurred. If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an abnormality, stop treatment. There have been a few observations of fatty changes in the livers of patients who have died while receiving the drug. No causal relationship has been established. Leukopenia and agranulocytosis have occurred. Warn patients to report the sudden appearance of sore throat or other signs of infection. If white blood cell and differential counts indicate leukocyte depression, stop treatment and start antibiotic and other suitable therapy.

Neuromuscular (Extrapyramidal) Reactions
These symptoms are seen in a significant number of hospitalized mental patients. They may be characterized by motor restlessness, be of the dystonic type, or they may resemble parkinsonism. Depending on the severity of symptoms, dosage should be reduced or discontinued. If therapy is reinstituted, it should be at a lower dosage. Should these symptoms occur in children or pregnant patients, the drug should be stopped and not reinstituted. In most cases barbiturates by suitable route of administration will suffice, or injectable diphenhydramine may be useful. In more severe cases, the administration of an anti-parkinsonism agent, except levodopa, usually produces rapid reversal of symptoms. Suitable supportive measures such as maintaining a clear airway and adequate hydration should be employed.

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 antiparkinsonian agents, benzodiazepines or propranolol may be helpful.

Dystonia
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.

Pseudo-parkinsonism
Symptoms may include: mask-like faces; drooling; tremors; pillrolling motion; cogwheel rigidity; and shuffling gait. Reassurance and sedation are important. 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 pseudo-parkinsonism.) Occasionally it is necessary to lower the dosage of Prochlorperazine 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. 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.

Contact Dermatitis
Avoid getting the injection solution on hands or clothing because of the possibility of contact dermatitis.

Adverse Reactions Reported with Prochlorperazine or Other Phenothiazine Derivatives Adverse reactions with different phenothiazines vary in type, frequency and mechanism of occurrence, i.e., some are dose-related, while others involve individual patient sensitivity. Some adverse reactions may be more Iikely 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 of certain phenothiazines.

Not all of the following adverse reactions have been observed with every phenothiazine derivative, but they have been reported with 1 or more and should be borne in mind when drugs of this class are administered: extrapyramidal symptoms (opisthotonos, oculogyric crisis, hyperreflexia, dystonia, akathisia, dyskinesia, parkinsonism) some of which have lasted months and even years -- particularly in elderly patients with previous brain damage; grand mal and petit mal convulsions, particularly in patients with EEG abnormalities or history of such disorders; altered cerebrospinal fluid proteins; cerebral edema; intensification and prolongation of the action of central nervous system depressants (opiates, analgesics, antihistamines, barbiturates, alcohol), atropine, heat, organophosphorus insecticides; autonomic reactions (dryness of mouth, nasal congestion, headache, nausea, constipation, obstipation, adynamic ileus, ejaculatory disorders/impotence, priapism, atonic colon, urinary retention, miosis and mydriasis); reactivation of psychotic processes, catatonic-like states; hypotension (sometimes fatal); cardiac arrest; blood dyscrasias (pancytopenia, thrombocytopenic purpura, leukopenia, agranulocytosis, eosinophilia, hemolytic anemia, aplastic anemia; liver damage (jaundice, biliary stasis); endocrine
disturbances (hyperglycemia, hypoglycemia, glycosuria, lactation, galactorrhea, gynecomastia, menstrual irregularities, false-positive pregnancy tests); skin disorders (photosensitivity, itching, erythema, urticaria, eczema up to exfoliative dermatitis); other allergic reactions (asthma, laryngeal edema, angioneurotic edema, anaphylactoid reactions); peripheral edema; reversed epinephrine effect; hyperpyrexia; mild fever after large I.M. doses; increased appetite; increased weight; a systemic lupus erythematosus-like syndrome; pigmentary retinopathy; with prolonged administration of substantial doses, skin pigmentation, epithelial keratopathy, and lenticular and corneal deposits.

EKG changes -- particularly nonspecific, usually reversible Q and T wave distortions -- have been observed in some patients receiving phenothiazine tranquilizers.

Although phenothiazines cause neither psychic nor physical dependence, sudden discontinuance in long-term psychiatric patients may cause temporary symptoms, e.g., nausea and vomiting, dizziness, tremulousness.

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.

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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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