Bromfenac: uses, dosing, side effects & brands
Bromfenac is a nonsteroidal anti-inflammatory drug sold in the U.S. under 2 brand and generic names, for inflammation, postoperative pain and eye pain. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Nonsteroidal Anti-Inflammatory Drug
- Treats
- Inflammation, Postoperative Pain and Eye Pain
- Available as
- Drops
- Sold as
- 2 products — Bromsite and Prolensa
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- What the pharmacy pays
- about $15 per ml — not your price
How bromfenac is dosed
From the FDA label for Bromsite (application NDA206911). Other bromfenac products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Instill one drop of BromSite to the affected eye twice daily (morning and evening) beginning 1 day prior to surgery, the day of surgery, and 14 days postsurgery. (2.1) 2.1 Recommended Dosing One drop of BromSite should be applied to the affected eye twice daily (morning and evening) 1 day prior to surgery, the day of surgery, and 14 days postsurgery. 2.2 Use with Other Topical Ophthalmic Medications BromSite should be administered at least 5 minutes after instillation of other topical medications. BromSite may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.
Bromfenac side effects
The following serious adverse reactions are described elsewhere in the labeling: Slow or Delayed Healing [see Warnings and Precautions (5.1)] Potential for Cross-Sensitivity [see Warnings and Precautions (5.2)] Increased Bleeding Time of Ocular Tissue [see Warnings and Precautions (5.3)] Keratitis and Corneal Reactions[see Warnings and Precautions (5.4)] Contact Lens Wear [see Warnings and Precautions (5.5)] The most commonly reported adverse reactions in 1-8% of patients were: anterior chamber inflammation, headache, vitreous floaters, iritis, eye pain and ocular hypertension. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 (toll free), or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most commonly reported adverse reactions in 1 to 8% of patients were: anterior chamber inflammation, headache, vitreous floaters, iritis, eye pain and ocular hypertension.
Who shouldn’t take bromfenac
None None (4)
Every bromfenac product we track (2)
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? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Drops | Generic | $15 | View → | |
| 2 | Not yet rated | Prescription | Drops | Generic | $15 | View → |
Bromfenac recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Bromfenac Ophthalmic Solution 0.09%
Failed Impurities/Degradation Specifications
Alembic Pharmaceuticals Limited · May 7, 2025
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension
Lack of Assurance of Sterility
Imprimis NJOF, LLC · May 14, 2024
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution…
Subpotent Drug
Imprimis NJOF, LLC · Apr 10, 2024
How long bromfenac keeps
No bromfenac label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does bromfenac expire? The in-use limits and storage rules from its labelsBromfenac and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for bromfenac: levels in milk, effects in breastfed infants, and the drugs it would consider insteadMilk levels of bromfenac are likely to be low with the usual oral dosage, but milk levels have not been measured after higher injectable dosages. Use caution when using bromfenac in nursing mothers, especially with the injectable drug.
National Institute of Child Health and Human Development, record revised September 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about bromfenac
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 339 reports naming bromfenac, and the FDA flagged 83% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- cataract25 reports
- fall15 reports
- nausea15 reports
- fatigue14 reports
- visual acuity reduced13 reports
- pneumonia12 reports
- diarrhoea11 reports
- endophthalmitis11 reports
Read these as a signal, not a rate. A report does not mean bromfenac caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
Related calculators
Frequently asked questions
What is bromfenac?
BromSite (bromfenac ophthalmic solution) 0.075% is a sterile aqueous, topical NSAID, formulated in DuraSite ® for ophthalmic use. The USAN name for bromfenac sodium sesquihydrate is bromfenac sodium.
What kind of drug is bromfenac?
The FDA classifies bromfenac as a nonsteroidal anti-inflammatory drug. NSAIDs block cyclooxygenase (COX) enzymes that your body uses to make prostaglandins, the chemicals behind pain, swelling, and fever. Lowering prostaglandins eases pain and inflammation and brings down a high temperature. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take bromfenac with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run bromfenac against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is bromfenac sold under?
We track 2 bromfenac-containing products in the U.S.: Bromsite and Prolensa. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does bromfenac come in?
Across the brands we track, bromfenac is currently marketed as drops, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic bromfenac?
We do not currently list a generic-labelled bromfenac product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has bromfenac been recalled?
The FDA's Enforcement database lists 3 recall records whose product description mentions bromfenac. The most recent: Bromfenac Ophthalmic Solution 0.09% (May 7, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Bromfenac: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/bromfenac
- MLA
- “Bromfenac: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/bromfenac.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
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.
Read the full FDA label for bromfenac on DailyMed (NIH) ↗.