Loteprednol Etabonate is a corticosteroid sold in the U.S. under 5 brand and generic names, for allergic conjunctivitis, bacterial conjunctivitis and viral conjunctivitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Alrex (application NDA020803). Other loteprednol etabonate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
One drop instilled into the affected eye(s) four times daily.
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…
Loteprednol Etabonate Ophthalmic Suspension, 0.2%, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Loteprednol Etabonate Ophthalmic Suspension, 0.2% is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Drops | Generic | $20 | View → | |
| 2 | Not yet rated | Prescription | Drops | Generic | $20 | View → |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
| 3 | Not yet rated | Prescription | Suspension | Generic | $20 | View → |
| 4 | Not yet rated | Prescription | Topical | Generic | $20 | View → |
| 5 | Not yet rated | Prescription | Topical | Generic | $20 | View → |