Ketorolacside effects

The following serious adverse reactions are described elsewhere in the labeling: Delayed Healing Cross-Sensitivity or Hypersensitivity Increased Bleeding Time Corneal Effects Most common adverse reactions occurring in 1% to 6% of patients were increased intraocular pressure, conjunctival hemorrhage, and vision blurred. To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical

Trials 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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions were reported in 1% to 6% of patients and included increased intraocular pressure, conjunctival hyperemia and/or hemorrhage, corneal edema, ocular pain, headache, tearing and vision blurred. Some of these reactions may be the consequence of the cataract surgical procedure. Other adverse reactions occurring during treatment with ketorolac tromethamine ophthalmic solutions included allergic reactions (including eye swelling, hyperemia, and pruritis).

6.2 Postmarketing

Experience The following adverse reactions have been identified during postapproval use of ketorolac tromethamine ophthalmic solutions in clinical practice. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug.

Eye Disorders: Corneal erosion, corneal perforation, corneal thinning and corneal melt, epithelial breakdown, and ulcerative keratitis. Respiratory, Thoracic and Mediastinal Disorders: Bronchospasm, exacerbation of asthma.