In controlled clinical studies, conjunctival injection, headaches, and hay fever were reported at an incidence of 10 to 25% among Zaditor users. The occurrence of these side effects was generally mild. Some of these events were similar to the underlying ocular disease being studied. The following reported side effects for Zaditor were reported at an incidence of <5%: Ocular: allergic reactions, burner or stinging, conjunctivitis, discharge, dry eyes, eye pain, eyelid disorder, itching, inflammation of the front part of the eye, abnormal tearing, pupil dilation, photophobia, and rash; Non-Ocular: flu syndrome, pharyngitis.
Safety and efficacy of Zaditor in children under 3 years of age has not been established.
Zaditor is not indicated for treatment of contact lens-related eye irritation.
Zaditor should be used with caution in nursing women. Zaditor is characterized as pregnancy category C.
Zaditor is for ophthalmic use only, and not for injection or oral use. Zaditor should not be used by patients with a known hypersensitivity to any component of this product.
Active ingredient: Ketotifen fumarate.
Inactive ingredients: glycerol, sodium hydroxide/hydrochloric acid (to adjust pH) and purified water. Benzalkonium chloride 0.01% has been added as a preservative.
For more information, please visit the Zaditor Web site at www.zaditor.com.
Full Prescribing Information
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