Difluprednate Ophthalmic
Difluprednate ophthalmic emulsion is a steroid eye drop used to treat inflammation and pain after eye surgery and to treat endogenous anterior uveitis (inflammation inside the eye).
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 12 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Difluprednate Ophthalmic: Patient Information Guide
A plain-language walkthrough of Difluprednate Ophthalmic — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Difluprednate ophthalmic emulsion is a topical corticosteroid (steroid) approved for two uses:
- Post-surgical eye inflammation: Difluprednate ophthalmic emulsion is used to reduce inflammation and pain in the eye following ocular surgery.
- Endogenous anterior uveitis: Difluprednate ophthalmic emulsion is used to treat inflammation at the front of the eye (the anterior chamber) that originates from within the body rather than from an outside infection.
⚙️How it works▾
Difluprednate is a corticosteroid — a type of steroid medicine. It works by prompting the body to produce proteins that block the enzyme phospholipase A2. That enzyme is needed to release arachidonic acid from cell membranes, which the body then converts into prostaglandins and leukotrienes — chemicals that cause swelling, redness, and pain. By interrupting this chain reaction, difluprednate reduces inflammation in the eye. Once absorbed into the eye, the drug is converted in the body to an active form called DFB, which carries out this anti-inflammatory effect.
💊How it's taken▾
Difluprednate ophthalmic emulsion is instilled as eye drops into the affected eye. The frequency and length of treatment depend on what it is being used for — always follow your prescriber's exact directions.
- After eye surgery: One drop 4 times daily starting 24 hours after surgery for 2 weeks, then 2 times daily for one week, then a gradual taper based on your response.
- For anterior uveitis: One drop 4 times daily for 14 days, then tapered as your doctor directs.
- Do not stop or reduce the dose on your own — steroid eye drops need to be tapered carefully.
- If symptoms do not improve within 2 days, contact your doctor rather than continuing treatment unchanged.
🤒Side effects — in detail▾
Like all steroid eye drops, difluprednate can cause side effects in or around the eye. Common ones reported in clinical studies include:
- Eye pain
- Eye redness (hyperemia of the conjunctiva or ciliary body)
- Corneal swelling (corneal edema)
- Sensitivity to light (photophobia)
- Blurred vision
- Eye irritation or itching
- Eyelid irritation and crusting (blepharitis)
- Headache
- Increased eye pressure (IOP)
Serious reactions to watch for include a significant rise in eye pressure (which can lead to glaucoma), new or worsening eye infection, cataract formation, and any persistent sore or ulcer on the cornea. Contact your doctor promptly if any of these develop or if your symptoms aren't getting better within 2 days.
⚠️Warnings & precautions▾
- Increased eye pressure (IOP) and glaucoma: Prolonged steroid use can raise the pressure inside the eye, potentially damaging the optic nerve. If you use difluprednate for 10 days or more, your doctor should monitor your eye pressure regularly.
- Cataract formation: Long-term use of corticosteroid eye drops can cause a type of cataract called a posterior subcapsular cataract to develop.
- Delayed wound healing: Using steroid drops after cataract surgery may slow healing and increase the chance of bleb formation (fluid-filled pockets). In people with thin corneas or sclera, there is a risk of perforation.
- Infection risk: Steroids can suppress the eye's immune defenses, making bacterial, viral, and fungal infections easier to develop or harder to detect. Do not use if you have an active herpes, vaccinia, varicella, mycobacterial, or fungal eye infection.
- Contact lens precaution: The preservative in this medication can be absorbed by soft contact lenses. Always remove lenses before instilling drops and wait at least 10 minutes before reinserting them.
- For topical use only: This medication must not be injected into the eye.
🔀What it interacts with▾
The FDA label for difluprednate ophthalmic emulsion does not identify specific drug-drug interactions. However, keep the following in mind:
- Soft contact lenses: The preservative in difluprednate eye drops can be absorbed by soft contact lenses — always remove lenses before using the drops.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Active eye infections: Do not use if you have an active viral infection of the cornea or conjunctiva (including herpes simplex keratitis, vaccinia, or varicella), a mycobacterial eye infection, or a fungal eye disease — these are contraindications.
- History of eye herpes: If you have ever had herpes simplex in your eye, tell your doctor before using this medication — extreme caution is required.
- Glaucoma or high eye pressure: Tell your doctor, as this medication can raise eye pressure further.
- Pregnancy: There are no human studies confirming safety in pregnancy. Animal studies showed fetal harm at doses higher than typical human exposure. Because eye-drop absorption into the bloodstream is very low, risk to a pregnant woman is expected to be minimal — but discuss with your doctor.
- Breastfeeding: It is not known if the drug passes into breast milk in meaningful amounts after eye-drop use. Talk with your doctor about the risks and benefits.
- Children: Difluprednate ophthalmic emulsion has been studied in children from newborns to 3 years old for post-cataract surgery inflammation and showed a similar safety profile to a comparator steroid drop.
- Older adults: No meaningful differences in safety or effectiveness have been found between older and younger patients.
- Thin cornea or sclera: Let your doctor know, as steroid drops may increase the risk of eye tissue thinning or perforation.
🔬Pharmacokinetics — how your body processes it▾
After difluprednate eye drops are instilled, the drug is converted in the body to an active form called DFB (6α,9-difluoroprednisolone 17-butyrate). Studies measuring blood levels of DFB after repeated dosing found levels below the detectable limit in all subjects, meaning very little of the drug enters the bloodstream after being applied to the eye. This low systemic (whole-body) absorption means the drug works mainly where it is applied — in the eye — with minimal effects elsewhere in the body.
📦How to store it▾
Store at 15° to 25°C (59° to 77°F).
📄 Written from Difluprednate Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Difluprednate Ophthalmic — the kind of thing our pharmacy team would talk through with you at the counter.
What is this eye drop actually for? ▾
How do I use the drops correctly? ▾
What side effects should I expect, and which ones mean I should call my doctor? ▾
I've heard steroid eye drops can raise eye pressure. Should I be worried? ▾
Can I use this drop if I've had eye herpes before? ▾
I'm pregnant — is it safe to use these drops? ▾
Is Difluprednate Ophthalmic available over the counter? ▾
When was Difluprednate Ophthalmic first available? ▾
Who makes Difluprednate Ophthalmic? ▾
💬 Answers drafted from Difluprednate Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Difluprednate Ophthalmic comes
Difluprednate Ophthalmic is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Eye drops
How this form is used
- Difluprednate Ophthalmic Emulsion is used to treat inflammation and pain associated with ocular surgery
- Difluprednate Ophthalmic Emulsion is used to treat endogenous anterior uveitis (inflammation at the front of the eye)
- Difluprednate Ophthalmic Emulsion: instill one drop into the affected eye; remove contact lenses first and wait 10 minutes before reinserting
- Difluprednate Ophthalmic Emulsion: for post-surgical use, begin 24 hours after surgery and use 4 times daily for the first 2 weeks, then taper as directed
- Difluprednate Ophthalmic Emulsion: for anterior uveitis, use 4 times daily for 14 days then taper as clinically directed by your doctor
- Do not allow the dropper tip to touch your eye, eyelids, or any surface to avoid contaminating the emulsion
📊 Difluprednate Ophthalmic across the U.S. market
How Difluprednate Ophthalmic appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Difluprednate Ophthalmic is used
A general measure of how commonly Difluprednate Ophthalmic is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Difluprednate Ophthalmic is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Difluprednate Ophthalmic prescribed? Of the 1,596 medications we measure, Difluprednate Ophthalmic ranks #855 by Medicaid prescriptions — more than 46% of them.
Utilization by Difluprednate Ophthalmic product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
difluprednate 0.5 MG/ML Ophthalmic Suspension
Summed across the 9 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 804544
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Difluprednate Ophthalmic, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 9 of 13 listed Difluprednate Ophthalmic NDCs with Medicaid activity.
🔍 Compare Difluprednate Ophthalmic products
A representative set of FDA-listed product records for Difluprednate Ophthalmic — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Eye drops | ||||
| 0.5 mg/mL | Ophthalmic | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Amneal Pharmaceuticals NY LLC × 3 listings | ANDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Caplin Steriles Limited | ANDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Cipla USA Inc. | ANDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Dr. Reddy's Laboratories Inc. × 2 listings | ANDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Exelan Pharmaceuticals, Inc. | ANDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Leading Pharma, LLC | ANDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Mylan Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Novartis Pharmaceuticals Corporation × 2 listings | NDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Sandoz Inc × 2 listings | NDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Sandoz Inc × 3 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 0.5 mg/mL | Ophthalmic | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
Showing 21 of 21 products — FDA National Drug Code Directory. See every product, package size and price: browse all 21 Difluprednate Ophthalmic NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Difluprednate Ophthalmic — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Difluprednate Ophthalmic in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Difluprednate Ophthalmic went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 23043 1 dose form · 1 strength
-
Dose form (SCDF) Ophthalmic Suspension RxCUI 804543In current FDA listingsClinical drug / strength (SCD) 0.5 MG/MLRxCUI 804544
Look up RxCUI 23043 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Difluprednate Ophthalmic is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Difluprednate Ophthalmic belongs to the Corticosteroids, potent (group III) class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 12 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Sandoz Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.