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.
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.
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.
None None (4)
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? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Drops | Generic | $15 | View → | |
| 2 | Not yet rated | Prescription | Drops | Generic | $15 | View → |
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
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.