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Orap Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Orap (pimozide) is used to suppress the motor and phonic tics associated with Tourette's disorder. It is an antipsychotic medication. Common side effects include drowsiness, dizziness, dry mouth, blurred vision, tiredness, or weakness.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Orap in Detail - Patient Information: Side Effects
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:
- headache, dizziness, drowsiness;
- feeling restless;
- vision problems;
- constipation; or
- dry mouth.
Read the entire detailed patient monograph for Orap (Pimozide) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Orap Overview - Patient Information: Side Effects
This drug may cause muscle/nervous system problems (extrapyramidal symptoms-EPS). Your doctor may prescribe another medication to decrease these side effects. Therefore, tell your doctor immediately if you notice any of the following side effects: stiff muscles, severe muscle spasms/cramping (such as twisting neck, arching back, eyes rolling up), restlessness/constant need to move, shaking (tremor), slow/shuffling walk, drooling/trouble swallowing, mask-like expression of the face.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Some people using this medication do not have serious side effects.
This medication may cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any involuntary/repetitive muscle movements such as lip smacking/puckering, tongue thrusting, chewing, or finger/toe movements.
In rare cases, pimozide may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.
Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (such as fever, persistent sore throat).
Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/slow/irregular heartbeat, seizures.
This medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop the following: fever, stiff muscles, sweating, fast/irregular heartbeat, sudden mental/mood changes (such as confusion, loss of consciousness), change in the amount of urine.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Orap (Pimozide)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Orap FDA Prescribing Information: Side Effects
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
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.
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 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 has been reported with other antipsychotic drugs.
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)
(N = 20)
|Body as a Whole|
|Adverse behavior effect||5||0|
|Sensitivity of eyes to light||1||0|
|Spots before eyes||0||1|
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 (%)|
|Body as a Whole|
|Asthenia||9 (25.0)||5 (13.8)|
|Headache||8 (22.2)||1 (2.7)|
|Dysphagia||1 (2.7)||1 (2.7)|
|Increased Salivation||5 (13.8)||2 (5.5)|
|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)|
|Adverse Behavior Effect||10 (27.7)||8 (22.2)|
|Nervous||3 (8.3)||2 (5.5)|
|Rash||3 (8.3)||1 (2.7)|
|Visual Disturbance||2 (5.5)||1 (2.7)|
|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.
Gastrointestinal: Increased salivation, nausea, vomiting, anorexia, GI distress
Endocrine: Loss of libido
Metabolic/Nutritional: Weight gain, weight loss
Skin: Rash, sweating, skin irritation
Special Senses: Blurred vision, cataracts
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
Read the entire FDA prescribing information for Orap (Pimozide) »
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