Acular LS Side Effects

Please note - some side effects for Acular LS may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Acular LS - for the Consumer

Acular LS Drops

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Acular LS Drops:

Blurred vision; eye irritation; eye redness; headache; inflammation of the eye; stinging and burning of the eye while applying; swelling of the cornea and iris.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); continuous pain, burning, stinging, redness, or swelling around the eyes; infection in the eye; unusual bleeding; vision changes.

Acular LS Side Effects - for the Professional

Acular LS

The most frequently reported adverse reactions for Acular LS® 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.

Side Effects by Body System

Ocular

Ocular side effects have included transient burning and stinging upon instillation in 20% to 40% of patients. Conjunctival hyperemia, corneal infiltrates, and ocular edema have been reported in 1% to 5% of patients. Corneal edema, iritis, ocular inflammation, ocular irritation, ocular pain, superficial keratitis, and superficial ocular infections have been reported in 1% to 10% of patients. Corneal erosion, corneal thinning, and epithelial breakdown have also been reported.

Hypersensitivity

A 44-year-old female with a history of severe asthma was given ophthalmic ketorolac for the treatment of conjunctivitis previously unresponsive to topical antihistamine treatment. Two hours after instillation, she developed coughing and tightness in her chest which worsened over night. The next morning the patient was hospitalized with complaints of coughing, dyspnea at rest and wheezing. Her condition improved after administration of intravenous steroids and albuterol nebulizations.

Hypersensitivity reactions have been reported in 1% to 10% of patients.

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