Diquas/Diquas-S Adverse Reactions

Adverse drug reactions (including abnormal changes in laboratory test values) were reported in 155 of 655 patients (23.7%) in clinical trials for diquafosol sodium ophthalmic solution 3% (multidose bottles containing preservative) conducted in Japan before approval. The major adverse reactions were eye irritation in 44 patients (6.7%), eye discharge in 31 patients (4.7%), conjunctival hyperaemia in 24 patients (3.7%), eye pain in 18 patients (2.7%), itching in 16 patients (2.4%), foreign body sensation in 14 patients (2.1%) and ocular discomfort in 7 patients (1.1%), etc (upon approval - for Diquas only).
Adverse reactions were reported in 202 of 3,196 patients (6.3%) in post marketing observational study for diquafosol sodium ophthalmic solution 3% (multidose bottles containing preservative) in Japan. The major adverse reactions were eye irritation in 30 patients (0.9%), eye discharge in 30 patients (0.9%), eye pain in 22 patients (0.7%), lacrimation increased in 20 patients (0.6%) and blepharitis in 19 patients (0.6%), etc (Post marketing surveillance, at the time of 6th periodic safety update report - for Diquas only).
If adverse reactions are observed, appropriate measures such as discontinuing administration should be taken. (See table.)

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