Loteprednol Etabonate
Active ingredient
Sold as ALREX · LOTEMAX
- Drug class
- -
- Availability
- Prescription only
- Routes
- Ophthalmic
- Markets covered
- 3
- Products on record
- 9
- FDA reports (12 mo)
- 457
Overview
Plain-language summary, compiled from the cited regulatory records
Loteprednol etabonate is a medication used to treat steroid-responsive inflammatory conditions affecting the eye [1]. These conditions can involve the conjunctiva, cornea, and the anterior segment of the eye [1]. Approved uses include allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and certain types of infectious conjunctivitis [1]. It is prescribed when the benefits of reducing swelling and inflammation are considered to outweigh the potential risks associated with steroid use [1].
This medication is available under various brand names [1]. In the past 12 months, there have been 457 adverse event reports associated with loteprednol etabonate [2]. The most frequently reported adverse events include eye pain, eye irritation, product dose omission issues, and ocular hyperemia [2]. Off-label use has also been reported [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| CA Canada | Health Canada | 4 | August 1, 2025 |
| US United States | FDA | 3 | March 26, 2026 |
| GB United Kingdom | MHRA | 2 | May 15, 2026 |
CACanada· Health Canada
4 products
Uses
AND CLINICAL USE................................................................ 3 CONTRAINDICATIONS ..................................................................................... 3 WARNINGS AND PRECAUTIONS....................................................................
4 ADVERSE REACTIONS...................................................................................... 7 DRUG INTERACTIONS .................................................................................... 11 DOSAGE AND ADMINISTRATION ................................................................
11 OVERDOSAGE .................................................................................................. 12 ACTION AND CLINICAL PHARMACOLOGY .............................................. 12 STORAGE AND STABILITY............................................................................
12 SPECIAL HANDLING INSTRUCTIONS ......................................................... 13 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................... 13 PART II: SCIENTIFIC INFORMATION .................................................................
USUnited States· FDA
3 products
Uses
INDICATIONS AND USAGE
Loteprednol etabonate ophthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.
How to take
GBUnited Kingdom· MHRA
2 products
Uses
Treatment of post-operative inflammation following ocular surgery.
How to take
Drug interactions
Known interactions involving Loteprednol Etabonate. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]Health Canada (DPD) · 02320924 · revised August 1, 2025
- [2]FDA DailyMed · 1677e1a2-c598-43… · revised March 26, 2026 [PDF]
- [3]MHRA (UK) · PL179470001 · revised October 28, 2022
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.