Brizagan Adverse Reactions

The most commonly reported ADRs are oral dryness, ocular hyperaemia and burning/stinging, all occurring in 22 to 25% of patients. They are usually transient and not commonly of a severity requiring discontinuation of treatment.
Symptoms of ocular allergic reactions occurred in 12.7% of subjects (causing withdrawal in 11.5% of subjects) in clinical trials with the onset between 3 and 9 months in the majority of patients.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The following terminologies have been used in order to classify the occurrence of undesirable effects: Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000), not known (cannot be estimated from the available data).
Immune system disorders: Uncommon: systemic allergic reactions.
Psychiatric disorders: Uncommon: depression.
Very rare: insomnia.
Nervous system disorders: Very common: headache, drowsiness.
Common: dizziness, abnormal taste.
Very rare: syncope.
Eye disorders: Very common: ocular irritation (hyperaemia, burning and stinging, pruritus, foreign body sensation, conjunctival follicles), blurred vision, allergic blepharitis, allergic blepharoconjunctivitis, allergic conjunctivitis, ocular allergic reaction, and follicular conjunctivitis.
Common: local irritation (eyelid hyperaemia and oedema, blepharitis, conjunctival oedema and discharge, ocular pain and tearing), photophobia, corneal erosion and staining, ocular dryness, conjunctival blanching, abnormal vision, conjunctivitis.
Very rare: iritis, miosis.
Cardiac disorders: Uncommon: palpitations/arrhythmias (including bradycardia and tachycardia).
Vascular disorders: Very rare: hypertension, hypotension.
Respiratory, thoracic and mediastinal disorders: Common: upper respiratory symptoms.
Uncommon: nasal dryness.
Rare: dyspnoea.
Gastrointestinal disorders: Very common: oral dryness.
Common: gastrointestinal symptoms.
General disorders and administration site conditions: Very common: fatigue.
Common: asthenia.
The following adverse reactions have been identified during post-marketing use of Brizagan in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
Not known: Eye disorders: iridocyclitis (anterior uveitis), eyelid pruritus.
Skin and subcutaneous tissue disorders: Skin reaction including erythema, face oedema, pruritus, rash and vasodilatation.
In cases where brimonidine has been used as part of the medical treatment of congenital glaucoma, symptoms of brimonidine overdose such as loss of consciousness, lethargy, somnolence, hypotension, hypotonia, bradycardia, hypothermia, cyanosis, pallor, respiratory depression and apnoea have been reported in neonates and infants receiving brimonidine (see Contraindications).
In a 3-month, phase 3 study in children aged 2-7 years with glaucoma, inadequately controlled by beta-blockers, a high prevalence of somnolence (55%) was reported with Brizagan as adjunctive treatment. In 8% of children, this was severe and led to discontinuation of treatment in 13%. The incidence of somnolence decreased with increasing age, being least in the 7-year-old age group (25%), but was more affected by weight, occurring more frequently in those children weighing ≤20 kg (63%) compared to those weighing >20 kg (25%) (see Precautions).