What the label lists and what reports show
Tafluprost side effects
Tafluprost's FDA label: “Most common ocular adverse reaction is conjunctival hyperemia (4% to 20%).” FAERS holds 2,906 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is ocular hyperaemia (464 reports).
- Generic listed
Check it at the source: the tafluprost FDA label on DailyMed (effective April 23, 2026, Thea Pharma Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ZIOPTAN?ZIOPTAN may cause serious side effects including: changes in the color of your eye (iris). Your iris may become more brown in color while using ZIOPTAN. This color change may not go away when you stop using ZIOPTAN. If ZIOPTAN is used in 1 eye only, the color of that eye may always be a different color from the color of your other eye. darkening of the color of the skin around your eye (eyelid). These skin changes usually go away when you stop using ZIOPTAN. increasing the length, thickness, color, shape and number of your eyelashes. These eyelash changes usually go away when you stop using ZIOPTAN. hair growth on your eyelids. This hair growth usually goes away when you stop using ZIOPTAN. inner eye swelling (inflammation). […]
Source: FDA drug label, Thea Pharma Inc., effective April 23, 2026 (SPL set db529b54-2ac7-4020-9791-7333bbe6c90f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common ocular adverse reaction is conjunctival hyperemia (4% to 20%).
From the label: adverse reactions, continuedMost common ocular adverse reaction is conjunctival hyperemia (4% to 20%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Thea Pharma Inc. at 1-833-838-4028 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials 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 trials of another drug and may not reflect the rates observed in practice. Preservative-containing or nonpreserved 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%). …
Source: FDA drug label, Thea Pharma Inc., effective April 23, 2026 (SPL set db529b54-2ac7-4020-9791-7333bbe6c90f), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,906 reports list tafluprost among the medicines taken, each a report of something that happened, not proof the medicine caused it; 330 are coded as a death and 287 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tafluprost: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions