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warnings
WARNINGS There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. With some nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.
ADVERSE REACTIONS The most frequent adverse events reported with the use of ketorolac ophthalmic solution have been transient stinging and burning on instillation. These events were reported by up to 40% of patients participating in clinical trials. Other adverse events occurring approximately 1% - 10% of the time during treatment with ketorolac ophthalmic solution including allergic reactions, corneal edema, iritis, ocular inflammation, ocular irritation, superficial keratitis, and superficial ocular infections. Other adverse events reported rarely with the use of ketorolac tromethamine ophthalmic solutions included corneal infiltrates, corneal ulcer, eye dryness, headaches, and visual disturbance (blurry vision). Clinical Practice: The following events have been identified during postmarketing use of ketorolac tromethamine ophthalmic solution 0.5% 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 ketorolac tromethamine ophthalmic solution 0.5%, or a combination of these factors, including corneal erosion, corneal perforation, corneal thinning and epithelial breakdown (see PRECAUTIONS, General ).