Voltaren Ophthalmic Side Effects

Generic name: diclofenac ophthalmic

Note: This document contains side effect information about diclofenac ophthalmic. Some of the dosage forms listed on this page may not apply to the brand name Voltaren Ophthalmic.

Some side effects of 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.

For the Consumer

Applies to diclofenac ophthalmic: ophthalmic solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking diclofenac ophthalmic (the active ingredient contained in Voltaren Ophthalmic) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• severe burning, stinging, or itching of your eyes;

• eye pain, redness, or excessive watering;

• vision changes, increased sensitivity to light;

• white patches on your eyes;

• crusting or drainage of your eyes; or

• dizziness, stomach pain, vomiting, weakness, fever, chills, or flu symptoms (can occur if the medicine is absorbed into your bloodstream).

Less serious side effects of diclofenac ophthalmic may include:

• mild burning, stinging, or itching of your eyes;

• swollen or puffy eyelids;

• nausea, vomiting, stomach pain;

• weakness, fever or chills;

• headache;

• sleep problems (insomnia); or

• runny nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to diclofenac ophthalmic: ophthalmic solution

Ocular

Ocular side effects including transient burning and stinging upon instillation has been reported in approximately 15% of patients.
In cataract surgery studies, keratitis was reported in up to 28% of patients, 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 10% or less of patients: abnormal vision, acute elevated IOP, blurred vision, conjunctivitis, corneal deposits, corneal edema, corneal opacity, corneal lesions, discharge, eyelid swelling, eye pain, injection (redness), iritis, irritation, itching, lacrimation disorder, and ocular allergy.

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. Blurred vision, dry eyes, scotoma, conjunctivitis, corneal deposits, corneal edema, corneal opacity, corneal lesions, discharge, eyelid swelling, eye pain, injection (redness), iritis, irritation, itching, lacrimation disorder, ocular allergy, transient stinging or burning and amblyopia have been reported.

Gastrointestinal

Gastrointestinal side effects include nausea or vomiting in 1% to 3% of patients. Abdominal pain has also been reported.

Hypersensitivity

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

Nervous system

Rarely, headache and insomnia have been reported. Asthenia and dizziness have also been reported.

Hepatic

Hepatic side effects have included reports of drug-induced hepatotoxicity occurring in the first month, and in some cases, the first 2 months of therapy, but have occurred at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.

General

General side effects have included chills, facial edema, fever, pain, and viral infection.

Respiratory

Respiratory side effects have included rhinitis.

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