Voltaren Ophthalmic Side Effects

Please note - some side effects for Voltaren Ophthalmic 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).

Voltaren Ophthalmic Side Effects - for the Professional

Voltaren Ophthalmic

Clinical Practice

The following events have been identified during postmarketing use of topical diclofenac sodium ophthalmic solution, 0.1% 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 diclofenac sodium ophthalmic solution, 0.1%, or a combination of these factors, include corneal erosion, corneal infiltrates, corneal perforation, corneal thinning, corneal ulceration, epithelial breakdown, and superficial punctate keratitis,.

Ocular

Transient burning and stinging were reported in approximately 15% of patients across studies with the use of Voltaren Ophthalmic. In cataract surgery studies, keratitis was reported in up to 28% of patients receiving Voltaren Ophthalmic, although in many of these cases keratitis was initially noted prior to the initiation of treatment. Elevated intraocular pressure following cataract surgery was reported in approximately 15% of patients undergoing cataract surgery. Lacrimation complaints were reported in approximately 30% of case studies undergoing incisional refractive surgery.

The following adverse reactions were reported in approximately 5% or less of patients: abnormal vision, acute elevated IOP, blurred vision, conjunctivitis, corneal deposits, corneal edema, corneal opacity, corneal lesions, discharge, eyelid swelling, injection, iritis, irritation, itching, lacrimation disorder, ocular allergy, and redness.

Systemic

The following adverse reactions were reported in 3% or less of patients: abdominal pain, asthenia, chills, cough, dizziness, dyspnea, eczema, erythema, exacerbation of asthma, facial edema, fever, headache, insomnia, itching, nausea, pain, rash, rhinitis, urticaria, viral infection, and vomiting.

Side Effects by Body System

Ocular

Ocular side effects including transient burning and stinging upon instillation has been reported in approximately 15% of patients. Other ocular side effects include keratitis in up to 28%, elevated intraocular pressure (IOP) in 15%, anterior chamber reactions in 1% of patients, and dry eye complaints in 12% of incisional refractive surgery patients. Opportunistic viral infections have been reported in less than 1% of patients. Many cases of keratitis or elevated IOP in cataract surgery were noted prior to diclofenac therapy. Discharge, corneal deposits, corneal lesions, ocular allergy, itching, irritation and blurred vision have been reported in less than 3% of patients. Corneal edema, corneal opacity, eyelid disorder, iritis, and lacrimation disorder have been reported in less than 1% of patients.

Postmarketing reports have included corneal erosion, corneal infiltrates, corneal perforation, corneal thinning, corneal ulceration, epithelial breakdown, and superficial punctate keratitis.

The use of diclofenac eyedrops has been associated with the development of persistent epithelial defects of the cornea (ranging from punctate superficial keratopathy to corneal melt) in patients undergoing ocular surgery. Diclofenac eyedrops should be used with great care in patients with disorders of the corneal epithelium.

Gastrointestinal

Gastrointestinal side effects include nausea or vomiting in 1% to 3% of patients.

Hypersensitivity

Local hypersensitivity reactions have been reported in 1% of patients.

Nervous system

Rarely, headache and insomnia have been reported.

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