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Optivar Side Effects

Please note - some side effects for Optivar 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 Optivar - for the Consumer

Optivar Drops

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 Optivar Drops:

Bitter taste in mouth; blurred vision; burning; headache; stinging.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips or tongue).

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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Optivar Side Effects - for the Professional

Optivar

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

In controlled multiple-dose studies where patients were treated for up to 56 days, the most frequently reported adverse reactions were transient eye burning/stinging (approximately 30%), headaches (approximately 15%) and bitter taste (approximately 10%). The occurrence of these events was generally mild.

The following events were reported in 1–10% of patients: asthma, conjunctivitis, dyspnea, eye pain, fatigue, influenza-like symptoms, pharyngitis, pruritus, rhinitis and temporary blurring. Some of these events were similar to the underlying disease being studied.

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Side Effects by Body System - for Healthcare Professionals

Ocular

Ocular side effects including transient eye burning/stinging (30%) have been reported. Other ocular side effects reported in 1% to 10% of patients were conjunctivitis, eye pain, and temporary blurring of vision.

General

General side effects including headache (15%), and bitter taste (10%) have been reported. Other side effects including fatigue and influenza-like symptoms have been reported in 1% to 10% of the patients.

Respiratory

Respiratory side effects including dyspnea, pharyngitis, and rhinitis in 1% to 10% of the patients have been reported.

Dermatologic

Dermatologic side effects including pruritus in 1% to 10% of patients have been reported.

Gastrointestinal

Gastrointestinal side effects have included reports of taste perversion in 10% to 20% of study participants.

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