Durezol Side Effects

Generic Name: difluprednate ophthalmic

Note: This page contains information about the side effects of difluprednate ophthalmic. Some of the dosage forms included on this document may not apply to the brand name Durezol.

Not all side effects for Durezol 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 difluprednate ophthalmic: ophthalmic emulsion

In addition to its needed effects, some unwanted effects may be caused by difluprednate ophthalmic (the active ingredient contained in Durezol). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking difluprednate ophthalmic:

More common
  • Blurred vision
  • change in color vision
  • decreased vision or other changes in vision
  • difficulty seeing at night
  • eye discomfort
  • eye pain
  • eye redness
  • increase in blood flow to the whites of the eyes
  • increased sensitivity of the eyes to sunlight
  • painful irritation of the front clear part of the eye
  • sensitivity of the eyes to light
  • swelling or redness of the eye and lining of the eyelid
Less common
  • Eyelid irritation and crusting
  • tearing
  • throbbing eye pain
  • watering of the eyes

Some of the side effects that can occur with difluprednate 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:

Less common
  • Dry eyes
Rare
  • Burning, itching, or soreness of the eye
  • feeling of having something in the eye

For Healthcare Professionals

Applies to difluprednate ophthalmic: ophthalmic emulsion

Ocular

Ocular side effects have included elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. Other side effects have included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis. Other ocular side effects occurring in 1 to 5% of subjects included reduced visual acuity, punctate keratitis, eye inflammation, and iritis. Ocular side effects occurring in less then 1% of subjects included application site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritis, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, scleral hyperemia, and uveitis. Most of these events may have been the consequence of the surgical procedure.[Ref]

References

1. "Product Information. Durezol (difluprednate ophthalmic)." Sirion Therapeutics, Tampa, FL.

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