Diquas-S Adverse Reactions

Adverse drug reactions (including abnormal changes in laboratory test values) were reported in 155 of 655 (23.7%) for diquafosol sodium ophthalmic solution 3% (multi-dose bottles containing preservative) conducted in Japan before approval. The major adverse reactions were eye irritation (6.7%), eye discharge (4.7%), conjunctival hyperaemia (3.7%), eye pain (2.7%), eye itching (2.4%), foreign body sensation in eyes (2.1%) and ocular discomfort (1.1%), etc.
Adverse reactions were reported in 202 of 3,196 (6.3%) in post marketing observational for diquafosol sodium ophthalmic solution 3% (multidose bottles containing preservative) in Japan. The major adverse reactions were eye irritation (0.9%), eye discharge (0.9%), eye pain (0.7%), lacrimation increased (0.6%) and blepharitis (0.6%), etc.
If adverse reactions are observed, appropriate measures including discontinuing administration should be taken. (See table.)

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Incidence was calculated based on the clinical study results up to the approval of diquafosol ophthalmic solution 3% (multi-dose bottles containing preservative).