Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most commonly reported adverse reactions in 2-7% of patients were abnormal sensation in eye, conjunctival hyperemia and eye irritation (including burning/stinging) ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Inc.
at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience The most commonly reported adverse experiences reported following use of bromfenac after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache, and iritis.
These events were reported in 2-7% of patients.
6.2 Post-Marketing Experience The following events have been identified during post-marketing use of bromfenac ophthalmic solution 0.09% in clinical practice.
Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical bromfenac ophthalmic solution 0.09% or a combination of these factors, include corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown.
[ see Warnings and Precautions (5) ]
5 WARNINGS AND PRECAUTIONS Sulfite Allergic Reactions ( 5.1 ) Slow or Delayed Healing ( 5.2 ) Potential for cross-sensitivity ( 5.3 ) Increase bleeding of ocular tissues ( 5.4 ) Corneal effects including keratitis ( 5.5 ) Contact Lens Wear ( 5.6 ) 5.1 Sulfite Allergic Reactions Contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.
Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
5.2 Slow or Delayed Healing All topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing.
Topical corticosteroids are also known to slow or delay healing.
Like all medications, Bromfenac Ophthalmic Solution 0.09% can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: