Drug Information for Ketorolac Tromethamine Ophthalmic Solution, 0.4% (Akorn Inc.): ADVERSE REACTIONS

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  • The most frequently reported adverse reactions for Ketorolac Ophthalmic Solution occurring in approximately 1 to 5% of the overall study population were conjunctival hyperemia, corneal infiltrates, headache, ocular edema and ocular pain.

    The most frequent adverse events reported with the use of ketorolac tromethamine ophthalmic solutions have been transient stinging and burning on instillation. These events were reported by 20% - 40% of patients participating in these other clinical trials.

    Other adverse events occurring approximately 1%-10% of the time during treatment with ketorolac tromethamine ophthalmic solutions included allergic reactions, corneal edema, iritis, ocular inflammation, ocular irritation, ocular pain, superficial keratitis, and superficial ocular infections.

  • Clinical Practice: The following events have been identified during postmarketing use of ketorolac tromethamine ophthalmic solutions 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 solutions, or a combination of these factors, include corneal erosion, corneal perforation, corneal thinning and epithelial breakdown (see PRECAUTIONS, General).

  • Drug Information Provided by National Library of Medicine (NLM).
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