ADVERSE REACTIONS
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 adverse reactions occurring in 5-15% of patients treated with loteprednol etabonate ophthalmic suspension (0.2% - 0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and photophobia. Other ocular adverse reactions occurring in less than 5% of patients include conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae, and uveitis. Some of these events were similar to the underlying ocular disease being studied.
Non-ocular adverse reactions occurred in less than 15% of patients. These include headache, rhinitis and pharyngitis.
In a summation of controlled, randomized studies of individuals treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (≥10 mm Hg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo. Among the smaller group of patients who were studied with ALREX, the incidence of clinically significant increases in IOP (≥10 mm Hg) was 1% (1/133) with ALREX and 1% (1/135) with placebo.
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REPORTS OF SUSPECTED ALREX SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Alrex. The information is not vetted and should not be considered as verified clinical evidence.
Possible Alrex side effects / adverse reactions in 80 year old female
Reported by a consumer/non-health professional from United States on 2012-05-08
Patient: 80 year old female
Reactions: Rash Generalised
Suspect drug(s):
Alrex
Other drugs received by patient: Actonel /usa/; Xalatan /swe/; Benicar /usa/
Possible Alrex side effects / adverse reactions in 32 year old female
Reported by a consumer/non-health professional from United States on 2012-05-08
Patient: 32 year old female
Reactions: Eye Irritation, Abnormal Sensation in Eye, Eye Pruritus
Suspect drug(s):
Alrex
Indication: OFF Label USE
Start date: 2010-08-01
Alrex
Indication: Pinguecula
Start date: 2010-08-01
Other drugs received by patient: Artificial Tears
Possible Alrex side effects / adverse reactions in 36 year old male
Reported by a consumer/non-health professional from United States on 2012-05-08
Patient: 36 year old male
Reactions: Vitreous Floaters
Suspect drug(s):
Alrex
Other drugs received by patient: Refresh
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