Note: This document contains side effect information about pimozide. Some dosage forms listed on this page may not apply to the brand name Orap.

Summary

Common side effects of Orap include: akathisia, akinesia, sedated state, and visual disturbance. Continue reading for a comprehensive list of adverse effects.

Applies to pimozide: oral tablet.

Serious side effects of Orap

Along with its needed effects, pimozide (the active ingredient contained in Orap) 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 pimozide:

More common

• Difficulty with speaking
• dizziness or fainting
• fast or irregular heartbeat
• lack of facial expression
• loss of balance control
• mood or behavior changes
• restlessness or need to keep moving
• shuffling walk
• slowed movements
• stiffness of the arms and legs
• swelling or soreness of the breasts (less common in males)
• trembling and shaking of the fingers and hands
• unusual secretion of milk (rare in males)

Less common or rare

• Difficulty with swallowing
• inability to move the eyes
• increased blinking or spasms of the eyelid
• lip smacking or puckering
• menstrual changes
• muscle spasms, especially of the face, neck, or back
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• skin rash and itching
• sore throat and fever
• swelling of the face
• uncontrolled chewing movements
• uncontrolled movements of the neck, trunk, arms, or legs, including twisting movements
• unusual bleeding or bruising
• unusual facial expressions or body positions
• yellow eyes or skin

Rare

• Convulsions (seizures)
• difficult or unusually fast breathing
• fast heartbeat or irregular pulse
• fever (high)
• high or low (irregular) blood pressure
• increased sweating
• loss of bladder control
• muscle stiffness (severe)

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

Symptoms of overdose

• Coma
• dizziness (severe)
• muscle trembling, jerking, or stiffness (severe)
• troubled breathing (severe)
• uncontrolled movements (severe)

Other side effects of Orap

Some side effects of pimozide 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:

More common

• Blurred vision or other vision problems
• constipation
• dizziness, lightheadedness, or fainting when getting up from a lying or sitting position
• drowsiness
• dryness of the mouth
• skin discoloration

Less common

• Decreased sexual ability
• diarrhea
• headache
• loss of appetite and weight
• mental depression
• nausea and vomiting
• tiredness or weakness

For Healthcare Professionals

Applies to pimozide: oral tablet.

General

The most common side effects include somnolence, hyperhidrosis, nocturia, and dizziness.^[Ref]

Nervous system

Very common (10% or more): Somnolence (up to 25%), dizziness (up to 11%)

Common (1% to 10%): Extrapyramidal disorder, akathisia, headache, lethargy, tremor, hyperkinesia, limb tremor, torticollis

Uncommon (0.1% to 1%): Bradykinesia, cogwheel rigidity, dyskinesia, dystonia, dysarthria

Frequency not reported: Neuroleptic malignant syndrome, grand mal convulsion, tardive dyskinesia, electroencephalogram abnormal, motor restlessness, hyperreflexia, opisthotonos, drowsiness, sedation, speech disorder, handwriting change, taste change, akinesia, parkinsonism, fainting

Postmarketing reports: Seizure^[Ref]

Extrapyramidal symptoms typically occurred during the first few days of treatment and involved mild to moderate Parkinson-like symptoms. This disorder is usually dose-related, with an increased occurrence and severity of symptoms with high doses; symptoms decreased or disappeared with lower doses. While these symptoms were usually reversible, a few cases of persistent symptoms required discontinuation.

Grand mal seizures occurred at doses greater than 20 mg/day.^[Ref]

Psychiatric

Very common (10% or more): Adverse behavior effect (up to 22.2%)

Common (1% to 10%): Depression, agitation, insomnia, abnormal dreams, restlessness, nervous

Frequency not reported: Libido decreased/lost, excitement^[Ref]

Other

Very common (10% or more): Asthenia (up to 13.8%)

Common (1% to 10%): Extreme exhaustion

Uncommon (0.1% to 1%): Face edema

Frequency not reported: Neonatal drug withdrawal syndrome, body temperature dysregulation, hypothermia

Postmarketing reports: Sudden, unexplained death, hyperpyrexia, thirst^[Ref]

Sudden, unexpected deaths have occurred at doses greater than 20 mg/day.^[Ref]

Dermatologic

Very common (10% or more): Hyperhidrosis (up to 13%)

Common (1% to 10%): Sebaceous gland overactivity, rash

Uncommon (less than 1%): Pruritus

Frequency not reported: Urticaria, skin irritation^[Ref]

Genitourinary

Very common (10% or more): Nocturia (up to 12%)

Common (1% to 10%): Urinary frequency, erectile dysfunction

Uncommon (0.1% to 1%): Amenorrhea

Frequency not reported: Galactorrhea, menstrual disorder, breast secretions, impotence^[Ref]

Gastrointestinal

Gingival hyperplasia occurred in animal models at high doses, but was reversible after discontinuation.^[Ref]

Common (1% to 10%): Constipation, dry mouth, vomiting, increased salivation/salivary hypersecretion, dysphagia

Frequency not reported: Diarrhea, nausea, gastrointestinal distress

Postmarketing reports: Gingival hyperplasia^[Ref]

Musculoskeletal

Common (1% to 10%): Muscle rigidity, myalgia

Uncommon (0.1% to 1%): Muscle spasms

Frequency not reported: Rigidity, neck rigidity, muscle cramps, muscle tightness, stooped posture^[Ref]

Ocular

Common (1% to 10%): Vision blurred, visual disturbance

Uncommon (0.1% to 1%): Oculogyric crisis

Frequency not reported: Sensitivity of eyes to light, decrease accommodation, spots before eyes, periorbital edema, cataracts^[Ref]

Metabolic

Common (1% to 10%): Anorexia, weight increased

Frequency not reported: Hyperglycemia, hyponatremia, appetite increase, weight loss^[Ref]

Hyperglycemia occurred in patients with preexisting diabetes.^[Ref]

Cardiovascular

Electrocardiographic changes include prolongation of the QT interval, flattening/notching/inversion of the T wave, and the appearance of U waves.^[Ref]

Common (1% to 10%): ECG abnormal

Frequency not reported: Torsade de Pointes, ventricular tachycardia/tachycardia, ventricular fibrillation, chest pain, postural hypotension/hypotension, hypertension, palpitations

Postmarketing reports: Cardiac arrest, venous thromboembolism, deep vein thrombosis^[Ref]

Endocrine

Frequency not reported: Blood prolactin increases, gynecomastia^[Ref]

Renal

Frequency not reported: Glycosuria^[Ref]

Hematologic

Postmarketing reports: Hemolytic anemia^[Ref]

Respiratory

Postmarketing reports: Pulmonary embolism^[Ref]