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What the label lists and what reports show

Bromfenac side effects

Bromfenac's FDA label: “The most commonly reported adverse reactions in 3% to 8% of patients were anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and blurred vision.” FAERS holds 2,405 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is eye pain (169 reports).

  • Generic listed

Check it at the source: the bromfenac FDA label on DailyMed (effective May 5, 2026, Bausch & Lomb Americas Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most commonly reported adverse reactions in 3% to 8% of patients were anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and blurred vision.

From the label: adverse reactions, continued

The most commonly reported adverse reactions in 3% to 8% of patients were anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and blurred vision. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated, at 1-800-553-5340 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 practice. The most commonly reported adverse reactions following use of Bromfenac Ophthalmic Solution following cataract surgery include: anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and vision blurred. These reactions were reported in 3% to 8% of patients.

Source: FDA drug label, Bausch & Lomb Americas Inc., effective May 5, 2026 (SPL set 246e2110-6a2d-4e22-8e37-72d80796b9af), via openFDA; the full label on DailyMed

What do FAERS reports show?

2,405 reports list bromfenac among the medicines taken, each a report of something that happened, not proof the medicine caused it; 48 are coded as a death and 328 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 15 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Off Label Use (a use or a product term, not a reaction)176
  • Eye Pain (named in the label)169
  • Treatment Failure (a use or a product term, not a reaction)153
  • Eye Irritation148
  • Vision Blurred (named in the label)127
  • Drug Ineffective (a use or a product term, not a reaction)118
  • Product Dose Omission Issue (a use or a product term, not a reaction)106
  • Cataract (a use or a product term, not a reaction)105
  • Product Packaging Quantity Issue89
  • Fatigue85
  • Visual Impairment79
  • Dizziness78
  • Headache73
  • Nausea72
  • Ocular Hyperaemia62
  • Product Use Issue (a use or a product term, not a reaction)62
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)61
  • Pruritus59
  • Diarrhoea57
  • Rash49
  • Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)47
  • Product Quality Issue (a use or a product term, not a reaction)46
  • Asthenia44
  • Fall44
  • Condition Aggravated (a use or a product term, not a reaction)43

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Bromfenac: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions