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Orap

Last reviewed on RxList: 2/8/2017
Orap Side Effects Center

Last reviewed on RxList 01/19/2017

Orap (pimozide) is an antipsychotic medication used to suppress the motor and phonic tics associated with Tourette's disorder. Common side effects of Orap include:

  • drowsiness,
  • dizziness,
  • dry mouth,
  • blurred vision or other vision problems,
  • tiredness,
  • weakness,
  • fever,
  • headache,
  • restlessness, or
  • constipation.

Orap may cause muscle or nervous system problems (extrapyramidal symptoms-EPS). Tell your doctor if you notice side effects of Orap including:

  • stiff muscles,
  • severe muscle spasms or cramping (such as twisting neck, arching back, eyes rolling up),
  • restlessness,
  • constant need to move,
  • shaking (tremor),
  • slow or shuffling walk,
  • drooling,
  • trouble swallowing, or
  • mask-like expression of the face.

Initial dose of Orap is 1 to 2 mg a day in divided doses. The dose may be increased thereafter every other day. Maintenance dose is usually less than 0.2 mg/kg/day, or 10 mg/day, whichever is less. Pediatric initial dose is 0.05 mg/kg, and may be increased every third day to a maximum of 0.2 mg/kg not to exceed 10 mg/day. Orap may interact with antibiotics, antifungal medicines, protease inhibitors, phenothiazines, antidepressants, antiarrhythmics, nefazodone, or zileuton. It may also interact with other medicines that may cause motor and phonic tics including pemoline, methylphenidate, dexmethylphenidate, and amphetamines. Tell your doctor all medications you use. During pregnancy, Orap should be used only when prescribed. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice symptoms in your newborn during their first month, tell the doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Orap (pimozide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Orap Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • seizure (convulsions);
  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs; or
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Less serious side effects may include:

  • fever;
  • headache, dizziness, drowsiness;
  • feeling restless;
  • vision problems;
  • constipation; or
  • dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Orap (Pimozide)

Orap Professional Information

SIDE EFFECTS

General

Extrapyramidal Reactions

Neuromuscular (extrapyramidal) reactions during the administration of ORAP® (pimozide) have been reported frequently, often during the first few days of treatment. In most patients, these reactions involved Parkinson-like symptoms which, when first observed, were usually mild to moderately severe and usually reversible.

Other types of neuromuscular reactions (motor restlessness, dystonia, akathisia, hyperreflexia, opisthotonos, oculogyric crises) have been reported far less frequently. Severe extrapyramidal reactions have been reported to occur at relatively low doses. Generally the occurrence and severity of most extrapyramidal symptoms are dose-related since they occur at relatively high doses and have been shown to disappear or become less severe when the dose is reduced. Administration of antiparkinson drugs such as benztropine mesylate or trihexyphenidyl hydrochloride may be required for control of such reactions. It should be noted that persistent extrapyramidal reactions have been reported and that the drug may have to be discontinued in such cases.

Withdrawal Emergent Neurological Signs

Generally, patients receiving short term therapy experience no problems with abrupt discontinuation of antipsychotic drugs.

However, some patients on maintenance treatment experience transient dyskinetic signs after abrupt withdrawal. In certain of these cases the dyskinetic movements are indistinguishable from the syndrome described below under “Tardive Dyskinesia” except for duration. It is not known whether gradual withdrawal of antipsychotic drugs will reduce the rate of occurrence of withdrawal emergent neurological signs, but until further evidence becomes available, it seems reasonable to gradually withdraw use of ORAP.

Tardive Dyskinesia

ORAP may be associated with persistent dyskinesias. Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may appear in some patients on long-term therapy or may occur after drug therapy has been discontinued. The risk appears to be greater in elderly patients on high-dose therapy, especially females. The symptoms are persistent and in some patients appear irreversible. The syndrome is characterized by rhythmical involuntary movements of tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities and the trunk.

There is no known effective treatment for tardive dyskinesia; antiparkinson agents usually do not alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, this syndrome may be masked.

It has been reported that fine vermicular movement of the tongue may be an early sign of tardive dyskinesia and if the medication is stopped at that time the syndrome may not develop.

Electrocardiographic Changes

Electrocardiographic changes have been observed in clinical trials of ORAP in Tourette's Disorder and schizophrenia. These have included prolongation of the QT interval, flattening, notching and inversion of the T wave and the appearance of U waves. Sudden, unexpected deaths and grand mal seizure have occurred at doses above 20 mg/day.

Neuroleptic Malignant Syndrome

Neuroleptic malignant syndrome (NMS) has been reported with ORAP. (See WARNINGS for further information concerning NMS.)

Hyperpyrexia

Hyperpyrexia has been reported with other antipsychotic drugs.

Clinical Trials

The following adverse reaction tabulation was derived from 20 patients in a 6-week long placebo-controlled clinical trial of ORAP in Tourette's Disorder.

Body System/ Adverse Reaction Pimozide
(N = 20)
Placebo
(N = 20)
Body as a Whole
  Headache 1 2
Gastrointestinal
  Dry Mouth 5 1
  Diarrhea 1 0
  Nausea 0 2
  Vomiting 0 1
  Constipation 4 2
  Eructations 0 1
  Thirsty 1 0
  Appetite increase 1 0
Endocrine
  Menstrual disorder 0 1
  Breast secretions 0 1
Musculoskeletal
  Muscle cramps 0 1
  Muscle tightness 3 0
  Stooped posture 2 0
CNS
  Drowsiness 7 3
  Sedation 14 5
  Insomnia 2 2
  Dizziness 0 1
  Akathisia 8 0
  Rigidity 2 0
  Speech disorder 2 0
  Handwriting change 1 0
  Akinesia 8 0
Psychiatric
  Depression 2 3
  Excitement 0 1
  Nervous 1 0
  Adverse behavior effect 5 0
Special Senses
  Visual disturbance 4 0
  Taste change 1 0
  Sensitivity of eyes to light 1 0
  Decrease accommodation 4 1
  Spots before eyes 0 1
Urogenital
  Impotence 3 0

The following adverse event tabulation was derived from 36 children (age 2 to 12) in a 24-week open trial of ORAP in Tourette's Disorder.

Body System/ Adverse Reaction Number of Patients Experiencing Each Event (%)
All Events
(N=36)
Drug-Related Events
(N=36)
Body as a Whole
  Asthenia 9 (25.0) 5 (13.8)
  Headache 8 (22.2) 1 (2.7)
Gastrointestinal
  Dysphagia 1 (2.7) 1 (2.7)
  Increased Salivation 5 (13.8) 2 (5.5)
Musculoskeletal
  Myalgia 1 (2.7) 1 (2.7)
Central Nervous System
  Dreaming Abnormal 1 (2.7) 1 (2.7)
  Hyperkinesia 2 (5.5) 1 (2.7)
  Somnolence 10 (27.7) 9 (25.0)
  Torticollis 1 (2.7) 1 (2.7)
  Tremor, Limbs 1 (2.7) 1 (2.7)
Psychiatric
  Adverse Behavior Effect 10 (27.7) 8 (22.2)
  Nervous 3 (8.3) 2 (5.5)
Skin
  Rash 3 (8.3) 1 (2.7)
Special Senses
  Visual Disturbance 2 (5.5) 1 (2.7)
Cardiovascular
  ECG Abnormal 1 (2.7) 1 (2.7)

Because clinical investigational experience with ORAP in Tourette's Disorder is limited, uncommon adverse reactions may not have been detected. The physician should consider that other adverse reactions associated with antipsychotics may occur.

Other Adverse Reactions

In addition to the adverse reactions listed above, those listed below have been reported in U.S. clinical trials of ORAP in conditions other than Tourette's Disorder.

Body as a Whole: Asthenia, chest pain, periorbital edema

Cardiovascular/Respiratory: Postural hypotension, hypotension, hypertension, tachycardia, palpitations

Gastrointestinal: Increased salivation, nausea, vomiting, anorexia, GI distress

Endocrine: Loss of libido

Metabolic/Nutritional: Weight gain, weight loss

Central Nervous System: Dizziness, tremor, parkinsonism, fainting, dyskinesia

Psychiatric: Excitement

Skin: Rash, sweating, skin irritation

Special Senses: Blurred vision, cataracts

Urogenital: Nocturia, urinary frequency

Postmarketing Reports

The following experiences were described in spontaneous postmarketing reports. These reports do not provide sufficient information to establish a clear causal relationship with the use of ORAP.

Gastrointestinal: Gingival hyperplasia in one patient

Hematologic: Hemolytic anemia

Metabolic/Nutritional: Hyponatremia

Other: Seizure

Read the entire FDA prescribing information for Orap (Pimozide)

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© Orap Patient Information is supplied by Cerner Multum, Inc. and Orap Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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