Ketotifen Side Effects

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

Ketotifen 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 Ketotifen Drops:

Burning; dry eyes; eye discharge; eyelid disorder; flu-like syndrome; headache; infection of the mucous membrane around the eye; inflammation of the cornea; itching; nasal congestion; red eyes; runny nose; sensitivity to light; sore throat; stinging; tearing.

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

Side Effects by Body System

Ocular

Ocular side effects have included conjunctival congestion (10% to 25%). There was a significant underlying incidence of conjunctival congestion among treated patients and a causal relationship with use of ketotifen has not been established. Other ocular side effects have included burning or stinging, conjunctivitis, ocular discharge, dry eyes, eyelid disorder, eye pain, itching, keratitis, lacrimation disorder, mydriasis, photophobia, and local rash (< 5%).

Ketotifen instillation was associated with mild to moderate burning or stinging in 98% of patients (n=35) in one trial.

Nervous system

Nervous system side effects including headache have been reported in up to 25% of patients. However, there has been no distinction between headache due to underlying disease and use of the drug such that a causal relationship has been questioned. Headaches associated with the use of this product have generally been mild.

Respiratory

Respiratory side effects have included rhinitis (25%). Other respiratory side effects have included pharyngitis (5%).

General

General side effects have included flu syndrome (5%).

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