Difluprednate
Active ingredient · 2 therapeutic classes
Sold as DUREZOL
- Drug class
- Corticosteroids, Potent (Group Iii)
- Availability
- Prescription only
- Routes
- Ophthalmic
- Markets covered
- 2
- Products on record
- 5
- FDA reports (12 mo)
- 147
Overview
Plain-language summary, compiled from the cited regulatory records
Difluprednate is a potent topical corticosteroid [1]. It is classified as a Group III corticosteroid [1].
Difluprednate ophthalmic emulsion is approved for two main uses: treating inflammation and pain associated with ocular surgery, and treating endogenous anterior uveitis [1].
In the last 12 months, there have been 147 adverse event reports associated with difluprednate [2]. The most frequently reported adverse reactions include eye pain, the perception of the drug being ineffective, eye irritation, hallucination, and off-label use [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 4 | September 24, 2025 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
USUnited States· FDA
4 products
Uses
05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery. 2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion is also indicated for the treatment of endogenous anterior uveitis.
05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery. 2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion is also indicated for the treatment of endogenous anterior uveitis.
How to take
CACanada· Health Canada
1 product
Uses
AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS .................................................................................
4 ADVERSE REACTIONS ................................................................................................... 8 DRUG INTERACTIONS .................................................................................................
13 DOSAGE AND ADMINISTRATION ............................................................................. 13 OVERDOSAGE................................................................................................................
14 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 14 STORAGE AND STABILITY ......................................................................................... 15 SPECIAL HANDLING INSTRUCTIONS ......................................................................
Sources & citations
- [1]FDA DailyMed · 054ca798-454a-41… · revised February 8, 2025 [PDF]
- [2]Health Canada (DPD) · 02415534 · revised March 22, 2025
- [3]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.