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Durezol (Difluprednate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Adverse reactions associated with ophthalmic steroids include 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.

Ocular Surgery

Ocular adverse reactions occurring in 5-15% of subjects in clinical studies with DUREZOL 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 adverse reactions occurring in 1-5% of subjects included reduced visual acuity, punctate keratitis, eye inflammation, and iritis.  Ocular adverse reactions occurring in < 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, sclera hyperemia, and uveitis.  Most of these reactions may have been the consequence of the surgical procedure.

Endogenous Anterior Uveitis

A total of 200 subjects participated in the clinical trials for endogenous anterior uveitis, of which 106 were exposed to DUREZOL.  The most common adverse reactions of those exposed to DUREZOL occurring in 5-10% of subjects included blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis.  Adverse reactions occurring in 2-5% of subjects included anterior chamber flare, corneal edema, dry eye, iridocyclitis, photophobia, and reduced visual acuity.



REPORTS OF SUSPECTED DUREZOL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Durezol. The information is not vetted and should not be considered as verified clinical evidence.

Possible Durezol side effects / adverse reactions in 23 year old male

Reported by a consumer/non-health professional from United States on 2011-11-03

Patient: 23 year old male weighing 72.6 kg (159.7 pounds)

Reactions: Intraocular Pressure Increased, Vision Blurred, Glare

Suspect drug(s):
Durezol



Possible Durezol side effects / adverse reactions in 60 year old female

Reported by a physician from United States on 2011-12-15

Patient: 60 year old female

Reactions: Amniotic Membrane Graft, Ulcerative Keratitis, Corneal Disorder, Graft Complication

Suspect drug(s):
Bromday
    Dosage: 1 gtt;qd;oph
    Indication: Cataract Operation
    Start date: 2011-11-18
    End date: 2011-11-25

Durezol
    Dosage: oph
    Indication: Cataract Operation
    Start date: 2011-11-18
    End date: 2011-11-25



Possible Durezol side effects / adverse reactions in 82 year old female

Reported by a consumer/non-health professional from United States on 2011-12-19

Patient: 82 year old female

Reactions: Palpitations, Cardiac Fibrillation

Suspect drug(s):
Lumigan
    Dosage: 1 gtt, qhs
    Indication: Intraocular Pressure Increased

Durezol
    Dosage: unk
    Indication: Postoperative Care



See index of all Durezol side effect reports >>

Drug label data at the top of this Page last updated: 2013-05-22

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