In clinical trials, the drug with drosolamide in the form of eye drops was prescribed to 1,108 patients as monotherapy or adjunct therapy for treatment with beta-blockers. Approximately 3% of patients had the drug canceled due to local side reactions from the side of the eye, the most frequent of them were conjunctivitis and reactions from the eyelids.
The side effects recorded during the research and during the post-registration period are classified by frequency (very often (≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100 ), rarely (> 1/10000, <1/1000)).
From the nervous system
Often: headache.
Rarely: dizziness, paresthesia.
From the side of the organ of vision
Very often: burning and pain.
Often: superficial punctate keratitis, lacrimation, conjunctivitis, inflammation of the eyelids, itching, eyelid irritation, blurred vision.
Infrequently: iridocyclitis.
Rarely: redness of the eyes, pain, hyperkeratosis of the eyelids, transient myopia (disappearing after withdrawal of the drug), corneal edema, decreased intraocular pressure, detachment of the choroid of the eye after surgical interventions to restore the outflow of intraocular fluid.
On the part of the respiratory system, thorax and mediastinum
Rarely: nosebleeds.
From the gastrointestinal tract
Often: nausea, bitter taste in the mouth.
Rarely: pharyngitis, dry mouth.
From the side of the urinary tract
Rarely: urolithiasis.
From the skin and subcutaneous tissue
Rarely: contact dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis.
General disorders and disorders at the site of administration
Often: asthenia, fatigue.
Rarely: allergic reactions - signs and symptoms of local reactions (eyelid) and systemic allergic reactions, including angioedema, urticaria, pruritus, rash, difficulty breathing, less often - bronchospasm.
Children
During a 3-month, double-blind, multicentre study using an active drug as a control conducted with the participation of 184 children under the age of 6 years,the profile of adverse reactions with dorzolamide in the form of eye drops was comparable with the profile of adverse reactions in adult patients. The most frequent adverse reactions associated with the use of the drug with dorzolamide in in the form of eye drops, in children under 2 years of age, conjunctival injection (5.4%) and discharge from the eyes (3.6%). In children from 2 to 6 years, the most frequent adverse reactions were a burning sensation in the eye (12.1%), conjunctival injection (7.6%), eye pain (3%), inflammation of the eyelids (3%).