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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

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.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased sexual function; fever; involuntary movements of the tongue, mouth, face, or jaw; irregular heartbeat; muscle stiffness or spasm; trouble sleeping; unusual body movements; vision changes.

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.

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.

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.

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.

Side Effects by Body System

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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