Lotemax Side Effects

Please note - some side effects for Lotemax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lotemax - for the Consumer

Lotemax Drops

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lotemax Drops:

Blurred vision; discharge; dry eyes; eye redness; eye/eyelid swelling; foreign body sensation; headache; increased tearing; itching; runny nose; sensitivity to light; sore throat; stinging when placed in the eye.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; continued or worsening itching; delayed healing after surgery; eye pain; severe redness or swelling.

Lotemax Side Effects - for the Professional

Lotemax

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 mmHg) 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.

Side Effects by Body System

Ocular

Ocular side effects have included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and photophobia in 5% to 15% of patients. Conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation,/pain/discomfort, papillae, and uveitis have been reported in <5% of patients. (Some of the adverse reactions reported were similar to the underlying ocular disease being treated.)

Corticosteroids have also been reported to cause elevated intraocular pressure, optic nerve damage, visual acuity and field defects, cataracts, secondary infections, acute anterior uveitis, perforation of the globe, keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation, and 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

Respiratory system side effects have included rhinitis and pharyngitis (<15%).

Nervous system

Nervous system side effects have included headache (<15%).

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