Diclofenac ophthalmic Side Effects

Not all side effects for diclofenac ophthalmic may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to diclofenac ophthalmic: ophthalmic solution

In addition to its needed effects, some unwanted effects may be caused by diclofenac ophthalmic. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking diclofenac ophthalmic, check with your doctor or nurse immediately:

More common
  • Eye redness, irritation, or pain
  • tearing of the eyes
Less common
  • Blindness
  • blurred vision
  • burning, dry, or itching eyes
  • clear or yellow fluid from the eye
  • decreased vision or any change in vision
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • sensitivity to light
  • sticky or matted eyelashes
  • throbbing pain
Incidence not known
  • Feeling of something in the eye

Some of the side effects that can occur with diclofenac ophthalmic may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Burning and stinging of the eye
Less common
  • Abdominal or stomach pain
  • chills
  • cold flu-like symptoms
  • cough or hoarseness
  • dizziness
  • fever
  • headache
  • lack or loss of strength
  • nausea
  • pain
  • runny nose
  • sleeplessness
  • sneezing
  • stuffy nose
  • swelling or puffiness of the face
  • trouble with sleeping
  • unable to sleep
  • vomiting

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.[Ref]

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.[Ref]

Gastrointestinal

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

Hypersensitivity

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

Nervous system

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

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.[Ref]

References

1. Lin JC, Rapuano CJ, Laibson PR, Eagle RC, Cohen EJ "Corneal melting associated with use of topical nonsteroidal anti-inflammatory drugs alter ocular surgery." Arch Ophthalmol 118 (2000): 1129-32

2. Shimazaki J, Saito H, Yang HY, Toda I, Fujishima H, Tsubota K "Persistent epithelial defect following penetrating keratoplasty: an adverse effect of diclofenac eyedrops." Cornea 14 (1995): 623-7

3. "Product Information. Voltaren (diclofenac)." Ciba Vision Ophthalmics, Duluth, GA.

4. Valsecchi R, Pansera B, Leghissa P, Reseghetti A "Allergic contact dermatitis of the eyelids and conjunctivitis from diclofenac." Contact Dermatitis 34 (1996): 150-1

5. Yamada M, Ogata M, Kawai M, Mochizuki H, Mashima Y "Topical diclofenac sodium decreases the substance P content of tears." Arch Ophthalmol 120 (2002): 51-4

6. Sharir M "Exacerbation of asthma by topical diclofenac." Arch Ophthalmol 115 (1997): 294-5

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