Taflotan Adverse Reactions

The following safety data were based on the clinical study result of tafluprost ophthalmic solution 0.0015% containing benzalkonium chloride.
Upon Approval: Adverse drug reactions (including abnormal change in laboratory test values) were reported in 326 of 483 patients (67.5%) in clinical studies in Japan. 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: Adverse drug reactions were reported in 396 of 3,260 patients (12.1%) in post-marketing surveillance in Japan. 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.
Clinically significant adverse drug 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.
Other adverse drug reactions: If an adverse drug reaction is observed, appropriate measures including discontinuing administration should be taken. (See Table 3.)

Click on icon to see table/diagram/image