Orap Side Effects

Generic Name: pimozide

Please note - some side effects for Orap may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Orap - for the Consumer

Orap

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Orap:

Constipation; drowsiness; dry mouth; restlessness.

Seek medical attention right away if any of these SEVERE side effects occur when using Orap:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain; confusion; decreased sexual desire or ability; difficulty urinating; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; inability to move the eyes or unusual eye movements; mental or mood changes (eg, abnormal thinking, depression); muscle stiffness; rigid muscles; seizures; severe or persistent dizziness, headache, or light-headedness; severe restlessness or trouble sitting still; trouble walking, speaking, or swallowing; twitching or twisting movements; uncontrolled muscle spasms or unusual body movements (eg, of the arms, legs, tongue, jaw, cheeks, neck; lip smacking or puckering; puffing of the cheeks; tremors); trouble sleeping.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Orapred ODT

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Orapred ODT:

Dizziness; facial flushing; headache; increased appetite; increased sweating; lightheadedness; nausea; nervousness; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur when using Orapred ODT:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in body fat; changes in menstrual period; changes in skin color; depression; fever, chills, or sore throat; lesions in the mouth or throat; mental or mood changes; muscle pain or weakness; seizures; severe nausea or vomiting; severe stomach or back pain; sudden severe dizziness or headache; swelling of the ankles, feet, or hands; tendon or bone pain; thinning of skin; trouble sleeping; unusual weight gain; vision changes or other eye problems; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Orapred Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Orapred Solution:

Acne; clumsiness; dizziness; facial flushing; feeling of a whirling motion; general body discomfort; headache; increased appetite; increased sweating; nausea; nervousness; sleeplessness; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur when using Orapred Solution:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in body fat; changes in menstrual period; changes in skin color; chest pain; easy bruising or bleeding; infection (eg, fever, chills, sore throat); mental or mood changes (eg, depression); muscle pain, weakness, or wasting; seizures; severe nausea or vomiting; sudden severe dizziness or headache; swelling of feet or legs; tendon or bone pain; thinning of skin; unusual skin sensation; unusual weight gain; vision changes or other eye problems; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Orap Side Effects - for the Professional

Orap

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.

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	Drug-Related Events
	(N=36)	(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

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Side Effects by Body System - for Healthcare Professionals

Musculoskeletal

Musculoskeletal side effects including Parkinson-like symptoms have been reported frequently. Motor restlessness, dystonia, hyperreflexia, akathisia, and opisthotonos have been reported far less frequently. Pimozide has also been associated with persistent dyskinesia.

Parkinson-like symptoms were usually mildly to moderately severe and usually reversible. Generally, the occurrence and severity of most extrapyramidal symptoms are felt to be dose related. Administration of antiparkinson drugs such as benztropine mesylate or trihexyphenidyl hydrochloride may be required to control Parkinson-like symptoms.

The risk of developing tardive dyskinesia has been reported to be greater among elderly patients on high-dose therapy, especially females. 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.

Other

It is not known whether gradual withdrawal of antipsychotic drugs will reduce the rate of occurrence of withdrawal emergent neurological signs. However, until further evidence becomes available, it is recommended to gradually withdraw the use of pimozide.

Other side effects including neuroleptic malignant syndrome (NMS) and hyperpyrexia (not associated with NMS) have been reported. Transient dyskinetic signs after abrupt withdrawal from a maintenance treatment have also been reported.

Cardiovascular

Cardiovascular side effects have included prolongation of the QT interval, flattening, notching, and inversion of the T wave, and the appearance of U waves. Sudden, unexpected deaths have been reported at higher dosages.

Nervous system

Nervous system side effects including grand mal seizures have been reported at higher dosages.

Ocular

Ocular side effects including oculogyric crisis have been reported.

Oncologic

Oncologic side effects have been reported in animal studies. Animal studies have reported a dose related increase in pituitary and mammary tumors.

Gastrointestinal

The gingival hyperplasia was reversible after withdrawal of the drug.

Gastrointestinal side effects have been reported in animal studies. Chronic animal studies have reported that pimozide caused gingival hyperplasia.

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