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Orap Side Effects

Generic name: pimozide

Medically reviewed by Drugs.com. Last updated on Mar 6, 2023.

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

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

Less common or rare

Rare

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

Symptoms of overdose

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

Less common

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]

References

1. Product Information. Orap (pimozide). Gate Pharmaceuticals. PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.