Diquas Adverse Reactions

Adverse drug reactions (including abnormal changes in laboratory test values) were reported in 155 of 655 patients (23.7%) in clinical trials 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%), eye itching in 16 patients (2.4%), foreign body sensation in eyes in 14 patients (2.1%) and ocular discomfort in 7 patients (1.1%), etc.
Adverse reactions were reported in 202 of 3,196 patients (6.3%) in post marketing observational study 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.
If an adverse drug reaction is observed, appropriate measures including discontinuing administration should be taken. (See Table 5.)

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Incidence was calculated based on the clinical study results up to approval.
Immune system disorders: Frequency not known: Hypersensitivity including anaphylactic shock.