FDA-filed SPL labeling · retrieved through openFDA

Bromfenac Ophthalmic

Bromfenac ophthalmic is a nonsteroidal anti-inflammatory (NSAID) eye drop used to treat inflammation and reduce eye pain after cataract surgery.

Brand names BromsiteProlensaBromdayXibromBromsite 0.075%
Drug class ⓘ Nonsteroidal Anti-inflammatory Drug
Rx Form 1 Route Ophthalmic
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 19 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 →

At a glance
Linked label effectiveMay 5, 2026
Clinical labels in scope ⓘ19
AvailabilityRx
Earliest approval/marketing year ⓘ2013
FDA-listed product records ⓘ30
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Oct 1, 2026 🚨Recall on record
⭐ Bromfenac Ophthalmic at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Bromfenac ophthalmic solution 0.07% is a once-daily NSAID eye drop for inflammation and pain after cataract surgery. Use it only for the time your surgeon sets, usually through 14 days after surgery. Report worsening eye pain or vision changes right away.

📖 Bromfenac Ophthalmic: Patient Information Guide

A plain-language walkthrough of Bromfenac Ophthalmic — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

What Bromfenac Ophthalmic is used for

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Bromfenac ophthalmic solution 0.07% is used after cataract surgery.

  • Treats inflammation after cataract surgery
  • Reduces eye pain after cataract surgery

How Bromfenac Ophthalmic works

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Bromfenac is an NSAID. It is thought to block the COX-1 and COX-2 enzymes that make prostaglandins. In animal studies, prostaglandins were shown to mediate certain kinds of inflammation inside the eye, so blocking them helps reduce inflammation and pain.

How Bromfenac Ophthalmic is taken (dosage)

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Bromfenac ophthalmic solution 0.07% is an eye drop used once a day in the affected eye.

  • Start 1 day before cataract surgery.
  • Continue on the day of surgery and through the first 14 days afterward.
  • Wait at least 5 minutes between other eye drops.
  • Keep the dropper tip clean and recap the bottle.

Follow your prescriber's directions and the label.

Bromfenac Ophthalmic side effects in detail

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The most common side effects, reported in 3% to 8% of patients in studies, were:

  • Anterior chamber inflammation
  • Foreign body sensation
  • Eye pain
  • Sensitivity to light
  • Blurred vision

Contact your doctor promptly about worsening eye pain, vision changes, signs of corneal damage, unusual eye bleeding, or allergic or asthma-like symptoms.

Bromfenac Ophthalmic warnings and precautions

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  • Corneal problems: keratitis, thinning, erosion, ulcers or perforation can occur and may threaten sight. Stop use if the corneal surface breaks down.
  • Higher risk: complicated or repeat eye surgeries, corneal denervation or defects, diabetes, dry eye or other ocular surface disease, and rheumatoid arthritis.
  • Duration: using it more than 24 hours before surgery or beyond 14 days afterward may raise corneal risk.
  • Slow healing: especially when combined with topical steroids.
  • Bleeding: may increase bleeding of eye tissues around surgery.
  • Sulfite allergy: may cause allergic or asthmatic reactions in sensitive people.
  • Cross-sensitivity: possible with aspirin and other NSAIDs.

Bromfenac Ophthalmic interactions: what it interacts with

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Check with your prescriber about these combinations.

  • Topical steroid eye drops: together with NSAID drops, they may increase healing problems.
  • Medicines that prolong bleeding: may add to bleeding risk.
  • Other eye drops: can be used together, but space them at least 5 minutes apart.
  • Soft contact lenses: may absorb the preservative, so remove them before dosing.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

Before taking Bromfenac Ophthalmic

▾
  • There are no listed contraindications.
  • Tell your doctor about sulfite, aspirin or NSAID sensitivity, or asthma.
  • Tell your doctor about bleeding problems, diabetes, rheumatoid arthritis, dry eye or past corneal problems.
  • Avoid in late pregnancy.
  • Breastfeeding: discuss benefits and risks with your doctor.
  • Not established in children.
  • No overall differences seen in adults 70 and older.

Pharmacodynamics: what Bromfenac Ophthalmic does in the body

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Bromfenac reduces prostaglandin production by inhibiting COX-1 and COX-2. In animal eyes, prostaglandins have been shown to disrupt the blood-aqueous humor barrier, widen blood vessels, increase vessel leakiness and raise eye pressure.

Pharmacokinetics: how your body processes Bromfenac Ophthalmic

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The blood level of bromfenac after Prolensa eye drops in humans is unknown. Based on the maximum dose, the level in the blood is estimated to be below what can be measured. Exposure to the rest of the body is expected to be low.

How to store Bromfenac Ophthalmic

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Store at 20º - 25ºC (68º - 77ºF) .

📄 Written from Bromfenac 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 →

209

Supplements & herbs that interact with Bromfenac Ophthalmic

209 supplements and herbal products have documented interactions with Bromfenac Ophthalmic in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 4
  • Moderate · 186
  • Minor · 19
Every supplement checked against Bromfenac Ophthalmic — ranked by severity The full interaction hub: 4 major · 186 moderate · 19 minor · every one linked to its full report. Check Bromfenac Ophthalmic against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Bromfenac Ophthalmic has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Bromfenac Ophthalmic nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

🩺 Bromfenac Ophthalmic: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Bromfenac Ophthalmic — the kind of thing our pharmacy team would talk through with you at the counter.

What is this eye drop for?

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It treats inflammation and reduces eye pain after cataract surgery. It's an NSAID, the same general drug class as ibuprofen, but made as an eye drop.

How long do I use it?

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It is generally used once a day in the operated eye, starting the day before surgery. You continue on the day of surgery and through the first 14 days afterward. Follow your surgeon's directions, and don't use it longer than told, since longer use may raise the risk of corneal problems.

Can I wear my contacts or use other drops?

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Take out contact lenses before putting the drops in, and wait at least 10 minutes before putting them back. Other eye drops are fine to use with it, but space them at least 5 minutes apart.

What side effects should I expect?

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Some people notice eye pain, blurred vision, light sensitivity, or a feeling like something is in the eye. Call your eye doctor if pain gets worse, your vision changes, or you notice eye bleeding. Also seek help for any allergic or asthma-type symptoms.

Is it safe if I'm pregnant or breastfeeding?

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There are no data in pregnant women, and little of the drug is expected to reach your bloodstream. Still, it should be avoided in late pregnancy. If you're breastfeeding, talk with your doctor, because harm to the baby can't be ruled out.

Who should be extra careful with it?

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Tell your doctor if you have asthma or a sulfite, aspirin or NSAID sensitivity. Also mention bleeding problems, diabetes, rheumatoid arthritis, dry eye or past corneal problems. These can raise the chance of complications.

Is Bromfenac Ophthalmic available over the counter?

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Bromfenac Ophthalmic is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.

When was Bromfenac Ophthalmic first available?

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Bromfenac Ophthalmic has been available in the United States since at least 2013, based on FDA approval history (Drugs@FDA) and product marketing records.

Who makes Bromfenac Ophthalmic?

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Bromfenac Ophthalmic is supplied by 14 manufacturers listed in the FDA NDC Directory, including Lupin Pharmaceuticals, Inc., Alembic Pharmaceuticals Inc., Sun Pharmaceutical Industries, Inc..

💬 Answers drafted from Bromfenac 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 →

🧰 More about Bromfenac Ophthalmic on HelloPharmacist

💊 Bromfenac Ophthalmic forms and strengths (how it comes)

Bromfenac 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

In the eye
Brands Bromsite Prolensa
How this form is used
What it may be used for
  • Bromfenac ophthalmic solution 0.07% is used to treat inflammation and reduce eye pain after cataract surgery.
Important instructions
  • Bromfenac ophthalmic solution 0.07% is given as one drop in the affected eye once daily, starting 1 day before surgery and continuing through the first 14 days after surgery.
  • Bromfenac ophthalmic solution 0.07%: remove contact lenses first and wait at least 10 minutes before putting them back in.
  • Bromfenac ophthalmic solution 0.07%: wait at least 5 minutes between this and other eye drops.
Available strengths 6 strengths
30 FDA-listed product records ⓘ

📊 Bromfenac Ophthalmic on the U.S. market: products, makers and brands

How Bromfenac 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.

1
Dose forms ⓘ
14
Manufacturers
9
Brand names
30
FDA-listed product records ⓘ
2013
First marketed ⓘ
Lupin Pharmaceuticals, Inc.17%
Alembic Pharmaceuticals Inc.13%
Sun Pharmaceutical Industries, Inc.13%
Bausch & Lomb Incorporated10%
Alembic Pharmaceuticals Limited7%
Aurobindo Pharma Limited7%
Other makers33%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Bromfenac Ophthalmic is used (Medicaid data)

A general measure of how commonly Bromfenac 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 Bromfenac 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.

3,370
Medicaid prescriptions filled (Q1–Q4 2025)
$452,007 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Bromfenac Ophthalmic prescribed? Of the 1,599 medications we measure, Bromfenac Ophthalmic ranks #1,106 by Medicaid prescriptions — more than 31% of them.

Where Bromfenac Ophthalmic ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Bromfenac 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.

The 0.7 mg/mL ophthalmic solution is the most-dispensed Bromfenac Ophthalmic product — about 74% of these Medicaid prescriptions.

bromfenac 0.7 MG/ML Ophthalmic Solution Most dispensed

2,510 Medicaid prescriptions (Q1–Q4 2025) 74% of Bromfenac Ophthalmic prescriptions shown $398,779 gross reimbursement (before rebates) ≈ $159 per prescription (gross)

Summed across the 6 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1375917

bromfenac 0.9 MG/ML Ophthalmic Solution

836 Medicaid prescriptions (Q1–Q4 2025) 25% of Bromfenac Ophthalmic prescriptions shown $50,042 gross reimbursement (before rebates) ≈ $60 per prescription (gross)

Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 578018

bromfenac 0.75 MG/ML Ophthalmic Solution

24 Medicaid prescriptions (Q1–Q4 2025) <1% of Bromfenac Ophthalmic prescriptions shown $3,186 gross reimbursement (before rebates) ≈ $133 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1790141

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 Bromfenac 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 10 of 23 listed Bromfenac Ophthalmic NDCs with Medicaid activity.

🔍 Compare Bromfenac Ophthalmic products

A representative set of FDA-listed product records for Bromfenac 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.)

Showing 30 of 30 products — FDA National Drug Code Directory. See every product, package size and price: browse all 30 Bromfenac Ophthalmic NDCs →

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.

Ingredient (IN) Bromfenac Ophthalmic RxCUI 19737 1 dose form · 3 strengths
  1. Dose form (SCDF) Ophthalmic Solution RxCUI 578017 In current FDA listings
    Clinical drug / strength (SCD) 0.7 MG/ML RxCUI 1375917 0.75 MG/ML RxCUI 1790141 0.9 MG/ML RxCUI 578018

Look up RxCUI 19737 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.

🏷️ Bromfenac Ophthalmic brand names

Bromsite Prolensa Bromday Xibrom Bromsite 0.075%

🏭 Who makes Bromfenac Ophthalmic: manufacturers and labelers

Lupin Pharmaceuticals, Inc. 5 Alembic Pharmaceuticals Inc. 4 Sun Pharmaceutical Industries, Inc. 4 Bausch & Lomb Incorporated 3 Alembic Pharmaceuticals Limited 2 Aurobindo Pharma Limited 2 Bausch & Lomb Americas Inc. 2 Fosun Pharma USA Inc. 2 Akorn 1 Amneal Pharmaceuticals NY LLC 1 Apotex Corp. 1 Armas Pharmaceuticals Inc. 1 Dr. Reddy's Laboratories Inc. 1 Gland Pharma Limited 1

Bromfenac Ophthalmic drug class (RxNorm)

Bromfenac Ophthalmic belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Antiinflammatory agents, non-steroids
How it works Cyclooxygenase Inhibitors

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.

🔬 Sources for this Bromfenac Ophthalmic page

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 5, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Bromfenac Ophthalmic.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Bromfenac Ophthalmic after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
19
NDC products indexed
30
Distinct labelers/manufacturers represented
14
Linked representative label ⓘ
Bausch & Lomb Americas Inc.
Linked label effective
May 5, 2026
Composite sections available
20
Linked SPL Set ID
246e2110-6a2d-4e22-8e37-72d80796b9af
Linked SPL Document ID
5114ef85-6052-bb94-e063-6294a90a1abc
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 19 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. Bausch & Lomb Americas 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.