Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse
reaction rates observed in the clinical studies of a drug cannot be directly
compared to rates in the clinical studies of another drug and may not reflect
the rates observed in practice.
Adverse reactions occurring in approximately 10-20%of the subjects receiving
brimonidine ophthalmic solution (0.1-0.2%) included: allergic conjunctivitis,
conjunctival hyperemia, and eye pruritus. Adverse reactions occurring in approximately
5-9% included: burning sensation, conjunctival folliculosis, hypertension, ocular
allergic reaction, oral dryness, and visual disturbance.
Adverse reactions occurring in approximately 1-4% of the subjects receiving
brimonidine ophthalmic solution (0.1-0.2%) included: abnormal taste, allergic
reaction, asthenia, blepharitis, blepharoconjunctivitis, blurred vision, bronchitis,
cataract, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough,
dizziness, dyspepsia, dyspnea, epiphora, eye discharge, eye dryness, eye irritation,
eye pain, eyelid edema, eyelid erythema, fatigue, flu syndrome, follicular conjunctivitis,
foreign body sensation, gastrointestinal disorder, headache, hypercholesterolemia,
hypotension, infection (primarily colds and respiratory infections), insomnia,
keratitis, lid disorder, pharyngitis, photophobia, rash, rhinitis, sinus infection,
sinusitis, somnolence, stinging, superficial punctate keratopathy, tearing, visual field defect, vitreous detachment, vitreous disorder, vitreous floaters,
and worsened visual acuity.
The following reactions were reported in less than 1% of subjects: corneal erosion, hordeolum, nasal dryness, and taste perversion.
The following reactions have been identified during postmarketing use of brimonidine
tartrate ophthalmic solutions in clinical practice. Because they are reported
voluntarily from a population of unknown size, estimates of frequency cannot
be made. The reactions, which have been chosen for inclusion due to either their
seriousness, frequency of reporting, possible causal connection to brimonidine
tartrate ophthalmic solutions, or a combination of these factors, include: bradycardia,
depression, hypersensitivity, iritis, keratoconjunctivitis sicca, miosis, nausea,
skin reactions (including erythema, eyelid pruritus, rash, and vasodilation),
syncope, and tachycardia. Apnea, bradycardia, coma, hypotension, hypothermia,
hypotonia, lethargy, pallor, respiratory depression, and somnolence have been
reported in infants receiving brimonidine tartrate ophthalmic solutions.