Clinical Studies Experience
Because clinical trials are conducted under widely varying
conditions, adverse reaction rates observed in the clinical trials of a drug
cannot be directly compared to rates in the clinical trials of another drug and
may not reflect the rates observed in practice.
Adverse reactions occurring in approximately 10-20% of the
subjects included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritis.
Adverse reactions occurring in approximately 5-9% of the
subjects included: burning sensation, conjunctival folliculosis, hypertension,
ocular allergic reaction, oral dryness, and visual disturbance.
Reactions occurring in approximately 1-4% of subjects
included: allergic reaction, arthralgia, arthritis, asthenia, blepharitis,
blepharoconjunctivitis, blurred vision, bronchitis, cataract, chest pain,
conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness,
diabetes mellitus, 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, insomnia, joint
disorder, keratitis, lid disorder, osteoporosis, 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, nasal dryness, and taste perversion.
The following adverse reactions have been identified during
post-marketing 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, iritis, miosis, skin
reactions (including, eyelid pruritis, and vasodilation), and tachycardia.
Apnea, bradycardia, hypotension, hypothermia, hypotonia, and somnolence have
been reported in infants receiving brimonidine tartrate ophthalmic solutions.