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 Compro.
Applies to prochlorperazine: oral tablet
Other dosage forms:
Oral route (Tablet)
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared with placebo. Although the causes of death in clinical trials were varied, most deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Prochlorperazine maleate is not approved for the treatment of patients with dementia-related psychosis.
Along with its needed effects, prochlorperazine (the active ingredient contained in Compro) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking prochlorperazine:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking prochlorperazine:
Symptoms of overdose
Some side effects of prochlorperazine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
Applies to prochlorperazine: compounding powder, injectable solution, oral capsule extended release, oral syrup, oral tablet, rectal suppository
Very common (10% or more): Mild leukopenia (up to 30%)
Rare (0.01% to 0.1%): Blood dyscrasia
Frequency not reported: Agranulocytosis, pancytopenia, thrombocytopenic purpura, thrombocytopenia, leukopenia, eosinophilia, hemolytic anemia, aplastic anemia, atypical lymphocytes
Blood dyscrasias included pancytopenia, thrombocytopenic purpura, leukopenia, agranulocytosis, eosinophilia, hemolytic anemia, and aplastic anemia.
Mild leukopenia occurred in patients given high doses for prolonged durations.
Common (1% to 10%): Drowsiness, dyskinesia, akathisia, parkinsonism, tremor/tremulousness
Frequency not reported: Convulsion, grand mal/petit mal convulsion, seizures, dizziness, altered consciousness, extrapyramidal reactions, dystonia/acute dystonia/acute dystonic reactions, akinesia, tardive dyskinesia, autonomic dysfunction, headache, opisthotonos, hyperreflexia, neuroleptic malignant syndrome, cerebral edema, EEG changes, altered cerebrospinal fluid proteins
Acute dystonia was usually transitory, but was more commonly reported in young adults and children shortly after beginning treatment or increasing the dosage.
Akathisia usually occurred in patients who were given large initial doses.
Autonomic dysfunction included dry mouth, nasal congestion, headache, nausea, constipation, obstipation, adynamic ileus, ejaculatory disorders/impotence, priapism, atonic colon, urinary retention, miosis, and mydriasis.
Extrapyramidal reactions include acute dystonia, akathisia, parkinsonism, and tardive dyskinesia. These reactions have lasted months to years, especially in elderly patients with brain damage.
Grand and petit mal convulsions have occurred in patients with/with a history of EEG abnormalities.
Parkinsonism typically occurred in adults and elderly patients after weeks to months of treatment, and included tremor, rigidity, akinesia, and most commonly, tremor.
Common (1% to 10%): Constipation, dry mouth
Frequency not reported: Gum/mouth irritation, obstipation, atonic colon, paralytic/adynamic ileus, nausea and vomiting
Lenticular and corneal deposits occurred in patients who received large doses over a prolonged duration.
Common (1% to 10%): Blurred vision
Frequency not reported: Oculogyric crisis, ocular changes, miosis, mydriasis, pigmentary retinopathy, lenticular and corneal deposits
Common (1% to 10%): Rigidity
Frequency not reported: Trismus, torticollis, systemic lupus erythematosus-like syndrome
Uncommon (0.1% to 1%): Hypotension, peripheral edema, cardiac arrhythmia, ECG changes, QT prolongation, deep vein thrombosis, venous thromboembolism, cyanosis, sudden death of cardiac origin
Frequency not reported: Fatal hypotension, orthostatic hypotension, ST depression, ventricular/atrial arrhythmias, atrioventricular block, ventricular tachycardia, ventricular fibrillation, cardiac arrest, U-Wave and T-Wave changes/distortions
Cardiovascular side effects may be correlated with higher doses and may occur more frequently in patients with risk factors (e.g., patients with cardiac disease, hypokalemia, receiving tricyclic antidepressants, and/or who are elderly).
Cyanosis occurred in pediatric patients who developed laryngospasm form serious dystonic tractions.
Hypotension occurred more frequently in patients who received IM doses of this drug.
Elevated bilirubin and hepatic enzyme levels occurred in patients who developed cholestatic jaundice.
Uncommon (0.1% to 1%): Elevated bilirubin and hepatic enzyme levels
Rare (0.01% to 0.1%): Jaundice/transient jaundice
Frequency not reported: Liver damage, cholestatic jaundice, cholestasis/biliary stasis
Mild fever usually occurred after patients were given large IM doses.
Uncommon (0.1% to 1%): Sudden death/unexplained sudden death
Frequency not reported: Neonatal drug withdrawal syndrome, hyperthermia, hyperpyrexia, mild fever, reversed epinephrine effect, intensification and prolongation of the action of atropine, heat, organophosphorous insecticides, and central nervous system depressants (e.g., opiates, analgesics, antihistamines, barbiturates, alcohol)
Very rare (less than 0.01%): Galactorrhea, amenorrhea/menstrual irregularities
Frequency not reported: Ejaculation disorder/inhibition, priapism, impotence, lactation, urinary retention
Very rare (less than 0.01%): Hyperprolactinemia/elevated prolactin levels, gynecomastia,
Frequency not reported: Endocrine disturbances, syndrome of inappropriate antidiuretic hormone secretion (SIADH), false-positive pregnancy tests
Frequency not reported: Rash, dermatitis, skin disorders/reaction, photosensitivity, itching, erythema, urticaria, eczema, exfoliative dermatitis, angioneurotic edema, contact skin sensitization/dermatitis, maculopapular eruptions, erythema multiforme, abnormal pigmentation/skin pigmentation and epithelial keratopathy
Skin pigmentation and epithelial keratopathy occurred in patients who received large doses over a prolonged duration.
Frequency not reported: Insomnia, agitation, activation/reactivation of psychotic processes, catatonia/catatonic-like states
Frequency not reported: Hyponatremia, hyperglycemia, hypoglycemia, increased appetite, increased weight, impaired glucose tolerance
Frequency not reported: Asthma, laryngeal edema, pulmonary embolism/fatal pulmonary embolism, nasal stuffiness/congestion, respiratory depression
Frequency not reported: Angioedema, anaphylactoid reactions, hypersensitivity reactions/type I hypersensitivity reaction
Frequency not reported: Metallic gray-mauve coloration to exposed skin
Frequency not reported: Glycosuria
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Compro (www.drugs.com/mtm/compro-rectal.html).
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