In clinical studies, the overall incidence of adverse drug reactions following Relestat was <10%. No serious adverse reactions occurred. Most were ocular and mild.
The most common adverse reaction was burning sensation in eye (mostly mild); all other adverse reactions were uncommon.
The following adverse drug reactions were reported during clinical trials with Relestat [common (>1/100, <1/10), uncommon (>1/1000, <1/100)]: Eye Disorders: Common: Burning sensation. Uncommon: Allergic conjunctivitis, blepharoptosis, conjunctival oedema, conjunctival hyperaemia, eye discharge, eye dryness, irritation, itching, increased sensitivity, photophobia, visual disturbance.
Nervous System Disorders: Uncommon: Headache.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Asthma, nasal irritation, rhinitis.
Gastrointestinal Disorders: Uncommon: Oral dryness, taste alteration.
Skin and Subcutaneous Tissue Disorders: Uncommon: Pruritus.