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Zioptan Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Zioptan (tafluprost ophthalmic solution) is a fluorinated analog of prostaglandin F2α indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Common side effects of Zioptan include eye redness, eye stinging or irritation, eye itching, cataracts, dry eyes, eye pain, blurred vision, headache, cold symptoms, cough, and urinary tract infections. Other side effects of Zioptan include gradual changes in eyelashes and vellus hair ("peach fuzz" hairs) in the treated eye including darkening, increased length, changes in color, thickness, shape, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.
Zioptan (tafluprost ophthalmic solution) is available in strength of 0.015 mg/mL in a solution. The recommended dose of Zioptan is one drop in the conjunctival sac of the affected eye(s) once daily in the evening. The dose should not exceed once daily. Serious side effects include cataracts. Zioptan should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. It is not known whether Zioptan or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Zioptan is administered to a nursing woman. Use in pediatric patients is not recommended with Zioptan because of potential safety problems related to increased pigmentation.
Our Zioptan Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zioptan FDA Prescribing Information: Side Effects
Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Preservative-containing or preservative-free tafluprost 0.0015% was evaluated in 905 patients in five controlled clinical studies of up to 24-months duration. The most common adverse reaction observed in patients treated with tafluprost was conjunctival hyperemia which was reported in a range of 4% to 20% of patients. Approximately 1% of patients discontinued therapy due to ocular adverse reactions.
Ocular adverse reactions reported at an incidence of ≥ 2% in these clinical studies included ocular stinging/irritation (7%), ocular pruritus including allergic conjunctivitis (5%), cataract (3%), dry eye (3%), ocular pain (3%), eyelash darkening (2%), growth of eyelashes (2%) and vision blurred (2%).
Nonocular adverse reactions reported at an incidence of 2% to 6% in these clinical studies in patients treated with tafluprost 0.0015% were headache (6%), common cold (4%), cough (3%) and urinary tract infection (2%).
The following adverse reactions have been identified during postapproval use of tafluprost. Because postapproval adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed.
Read the entire FDA prescribing information for Zioptan (tafluprost)
Additional Zioptan Information
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