Taflotan-S Adverse Reactions

Following safety data were derived from tafluprost ophthalmic solution 0.0015% containing benzalkonium chloride.
At the time of approval: Adverse drug reactions (including abnormal change in laboratory test values) were reported in 326 of 483 patients (67.5%). The major adverse drug reactions were conjunctival hyperaemia in 151 patients (31.3%), abnormality in eyelashes in 93 patients (19.3%), itching in 85 patients (17.6%), eye irritation in 65 patients (13.5%), iris pigmentation in 39 patients (8.1%), etc.
Post-marketing surveillance (Upon issuance of the 5th Periodic Safety Update Report): Adverse drug reactions were reported in 396 of 3,260 patients (12.1%). The major adverse drug reactions were blepharal pigmentation in 93 patients (2.9%), conjunctival hyperaemia in 74 patients (2.3%), corneal epithelium disorder including corneal erosion in 58 patients (1.8%), hypertrichosis of eyelids in 40 patients (1.2%), abnormality in eyelashes in 39 patients (1.2%), etc.
1) Clinically significant adverse reactions: Iris pigmentation (8.1%): Since iris pigmentation may occur, patients should be examined periodically, and administration should be discontinued depending on the clinical status when iris pigmentation is observed.
2) Other adverse reactions: If an adverse drug reaction is observed, appropriate measures including discontinuing administration should be taken. (See Table 4.)

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Incidence was calculated based on the clinical study results up to the approval of tafluprost ophthalmic solution 0.0015% containing benzalkonium chloride.