Alrex Side Effects

Generic name: loteprednol ophthalmic

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

Some side effects of Alrex 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 loteprednol ophthalmic: ophthalmic gel, ophthalmic ointment, ophthalmic suspension

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

Stop using loteprednol and call your doctor at once if you have:

• signs of a new eye infection such as swelling, redness, irritation, or drainage;

• blurred vision, eye pain, or seeing halos around lights;

• problems with your vision; or

• severe pain, burning or stinging when using the eye drops.

Common side effects may include:

• minor burning when using the eye drops;

• dry, red, itchy, or watery eyes;

• feeling that something is in your eye;

• being more sensitive to light;

• headache; or

• runny nose, sore throat.

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 loteprednol ophthalmic: ophthalmic gel, ophthalmic ointment, ophthalmic suspension

Ocular

Very common (10% or more): Anterior chamber inflammation with ointment (25%), occurring in 5 to 15% of patients: Abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, photophobia
Common (1% to 10%): Anterior chamber inflammation with gel (5%), conjunctival hyperemia, corneal edema, eye pain, foreign body sensation, occurring in less than 5% of patients: conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/discomfort, papillae, uveitis
Frequency not reported: Elevated intraocular pressure (may be associated with infrequent optic nerve damage), visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing, secondary ocular infection (including herpes simplex), perforation of the globe (where there is thinning of the cornea or sclera), keratitis, corneal ulcers, loss of accommodation, ptosis

Randomized studies involving patients treated with loteprednol etabonate therapy for 28 days or longer revealed the incidence of significant elevation in intraocular pressure (>= 10 mmHg) was 2% (15/901) with loteprednol etabonate, 7% (11/164) with 1% prednisolone acetate and 0.5% (3/583) with placebo.

Respiratory

Very common (10% or more): Occurring in less than 15% of patients: rhinitis, pharyngitis

Nervous system

Very common (10% or more): Headache

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