What the label lists and what reports show
Besifloxacin side effects
Besifloxacin's FDA label: “The most frequently reported ocular adverse reaction was conjunctival redness, reported in approximately 2% of patients.” FAERS holds 967 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 (102 reports).
- No generic listed
Check it at the source: the besifloxacin FDA label on DailyMed (effective January 12, 2026, Bausch & Lomb Americas Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most frequently reported ocular adverse reaction was conjunctival redness, reported in approximately 2% of patients.
From the label: adverse reactions, continuedBecause 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 data described below reflect exposure to besifloxacin ophthalmic suspension in approximately 1,000 patients between 1 and 98 years old with clinical signs and symptoms of bacterial conjunctivitis. The most frequently reported ocular adverse reaction was conjunctival redness, reported in approximately 2% of patients. Other adverse reactions reported in patients receiving besifloxacin ophthalmic suspension occurring in approximately 1-2% of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache. The most common adverse reaction reported in 2% of patients treated with besifloxacin ophthalmic suspension was conjunctival redness. ( 6 ) 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.
Source: FDA drug label, Bausch & Lomb Americas Inc., effective January 12, 2026 (SPL set ff971287-5610-4f15-8392-fc974e6ff646), via openFDA; the full label on DailyMed
What do FAERS reports show?
967 reports list besifloxacin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 67 are coded as a death and 157 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 22 reactions below, 3 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Besifloxacin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions