Procot Side Effects

Generic name: prochlorperazine

Medically reviewed by Drugs.com. Last updated on Sep 4, 2024.

Note: This document provides detailed information about Procot Side Effects associated with prochlorperazine. Some dosage forms listed on this page may not apply specifically to the brand name Procot.

Applies to prochlorperazine: oral tablet.

Other dosage forms:

• rectal suppository

Important warnings This medicine can cause some serious health issues

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.

Serious side effects of Procot

Along with its needed effects, prochlorperazine (the active ingredient contained in Procot) 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

• agitation
• black, tarry stools
• chest pain
• clay-colored stools
• constipation
• dark urine
• decrease in how much or how often you urinate
• diarrhea
• difficulty in swallowing and breathing
• dizziness, faintness, or lightheadedness when suddenly getting up from a lying or sitting position
• drooling
• drowsiness
• dryness of the mouth
• fever and chills
• headache
• inability to have or keep an erection
• loss of appetite
• mask-like face
• nasal congestion
• nausea
• painful or difficult urination
• shuffling walk
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain
• swollen glands
• tightness of the throat
• trembling and shaking of the fingers and hands
• uncontrolled chewing movements and movements of the arms and legs
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking prochlorperazine:

Symptoms of overdose

• change in consciousness
• fast, slow, or irregular heartbeat
• loss of consciousness
• seizures
• severe sleepiness

Other side effects of Procot

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

• blurred vision
• increased sensitivity of the skin to sunlight
• irregular menstrual periods
• itching, rash, redness, or discoloration of the skin
• jitteriness
• trouble sleeping

For healthcare professionals

Applies to prochlorperazine: compounding powder, injectable solution, oral capsule extended release, oral syrup, oral tablet, rectal suppository.

General adverse events

The most commonly reported adverse effects in greater than 1% of patients included constipation, dry mouth, mild leukopenia, rigidity, blurred vision, drowsiness, dyskinesia, akathisia, parkinsonism, and tremor/tremulousness.^[Ref]

Cardiovascular

• 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 from serious dystonic tractions.

Hypotension occurred more frequently in patients who received IM doses of this drug.

Dermatologic

• 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, metallic gray-mauve coloration to exposed skin (especially with long periods of use)

Skin pigmentation and epithelial keratopathy occurred in patients who received large doses over a prolonged duration.

Endocrine

• 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

Gastrointestinal

• Common (1% to 10%): Constipation, dry mouth
• Frequency not reported: Gum/mouth irritation, obstipation, atonic colon, paralytic/adynamic ileus, nausea and vomiting

Genitourinary

• Very rare (less than 0.01%): Galactorrhea, amenorrhea/menstrual irregularities
• Frequency not reported: Ejaculation disorder/inhibition, priapism, impotence, lactation, urinary retention

Hematologic

• 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.

Hepatic

• 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

Hypersensitivity

• Frequency not reported: Angioedema, anaphylactoid reactions, hypersensitivity reactions/type I hypersensitivity reaction

Metabolic

• Frequency not reported: Hyponatremia, hyperglycemia, hypoglycemia, increased appetite, increased weight, impaired glucose tolerance

Musculoskeletal

• Common (1% to 10%): Rigidity
• Frequency not reported: Trismus, torticollis, systemic lupus erythematosus-like syndrome, shuffling gate, mask-like face

Nervous system

• 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.

Ocular

• Common (1% to 10%): Blurred vision
• Frequency not reported: Oculogyric crisis, ocular changes, miosis, mydriasis, pigmentary retinopathy, lenticular and corneal deposits (notably in patients who received large doses)

Other

• 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)

Psychiatric

• Frequency not reported: Insomnia, agitation, anxiety, jitteriness, delirium, activation/reactivation of psychotic processes, catatonia/catatonic-like states

Renal

• Frequency not reported: Glycosuria

Respiratory

• Frequency not reported: Asthma, laryngeal edema, pulmonary embolism/fatal pulmonary embolism, nasal stuffiness/congestion, respiratory depression

Frequently asked questions

• What drugs cause tardive dyskinesia?

Further information

Procot side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer