Pemirox Adverse Reactions

Upon approval: Adverse reactions to this drug were reported in 16 (2.50%) of 639 patients in total. The major adverse reactions were blepharitis in 4 patients (0.63%), eye irritation in 4 patients (0.63%) and conjunctival hyperaemia in 3 patients (0.47%).
At the time of the reexamination completion: Adverse reactions to this drug were reported in 43 (1.01%) of 4,255 patients in total evaluated in drug-use results surveys and special surveys (those on long-term use and spring catarrh) after launching the product. The major adverse reactions were eye irritation in 16 patients (0.38%), blepharitis in 9 patients (0.21%), eyelid itching in 5 patients (0.12%), eye discharge in 5 patients (0.12%) and conjunctival hyperaemia in 5 patients (0.12%). If any adverse reactions are observed, appropriate measures such as discontinuing administration should be taken. (See Table 4.)

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