Applies to prochlorperazine: oral tablet. Other dosage forms:

• rectal suppository

Serious side effects of Prochlorperazine

Along with its needed effects, prochlorperazine 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 Prochlorperazine

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.

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^[Ref]

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.^[Ref]

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^[Ref]

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.^[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, dry mouth

Frequency not reported: Gum/mouth irritation, obstipation, atonic colon, paralytic/adynamic ileus, nausea and vomiting^[Ref]

Ocular

Lenticular and corneal deposits occurred in patients who received large doses over a prolonged duration.^[Ref]

Common (1% to 10%): Blurred vision

Frequency not reported: Oculogyric crisis, ocular changes, miosis, mydriasis, pigmentary retinopathy, lenticular and corneal deposits^[Ref]

Musculoskeletal

Common (1% to 10%): Rigidity

Frequency not reported: Trismus, torticollis, systemic lupus erythematosus-like syndrome^[Ref]

Cardiovascular

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.^[Ref]

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^[Ref]

Hepatic

Elevated bilirubin and hepatic enzyme levels occurred in patients who developed cholestatic jaundice.^[Ref]

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^[Ref]

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)^[Ref]

Mild fever usually occurred after patients were given large IM doses.^[Ref]

Genitourinary

Very rare (less than 0.01%): Galactorrhea, amenorrhea/menstrual irregularities

Frequency not reported: Ejaculation disorder/inhibition, priapism, impotence, lactation, urinary retention^[Ref]

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^[Ref]

Dermatologic

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

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^[Ref]

Psychiatric

Frequency not reported: Insomnia, agitation, activation/reactivation of psychotic processes, catatonia/catatonic-like states^[Ref]

Metabolic

Frequency not reported: Hyponatremia, hyperglycemia, hypoglycemia, increased appetite, increased weight, impaired glucose tolerance^[Ref]

Respiratory

Frequency not reported: Asthma, laryngeal edema, pulmonary embolism/fatal pulmonary embolism, nasal stuffiness/congestion, respiratory depression^[Ref]

Hypersensitivity

Frequency not reported: Angioedema, anaphylactoid reactions, hypersensitivity reactions/type I hypersensitivity reaction^[Ref]

Local

Frequency not reported: Metallic gray-mauve coloration to exposed skin^[Ref]

Renal

Frequency not reported: Glycosuria^[Ref]