Besifloxacin side effects: what 967 FDA adverse event reports show

Besifloxacin · Besivance · 30 reaction terms · 747 drug–reaction co-reports · data 2026-09-14

Drug class

Quinolone Antimicrobial

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Besivance

openFDA label

Who reports

967 reports · 44% serious · 67 with death outcome · 61% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Besifloxacin ophthalmic suspension 0.6% is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: Aerococcus viridans CDC coryneform group G Corynebacterium pseudodiphtheriticum Corynebacter.

FDA label, Indications and Usage

What it is

Besifloxacin ophthalmic suspension 0.6% is a sterile ophthalmic suspension of besifloxacin formulated with DuraSite ®† (polycarbophil, edetate disodium dihydrate, sodium chloride, sodium hydroxide, and water for injection).

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 19 strongest signals

Labeled adverse reaction 3Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 12

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 11 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Eye inflammation	20	46.1 29.8–71.1ROR 47.0 · χ² 836 / p 4e-184	44.2 EB05 30.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Photophobia (light sensitivity)	35	40.7 29.4–56.4ROR 42.2 · χ² 1,315 / p 3e-288	39.8 EB05 29.9 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 42.1	no trial data cached
Eye discharge	19	40.4 25.9–63.1ROR 41.2 · χ² 690 / p 2e-152	38.9 EB05 26.3 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Eye pain	102	40.1 33.4–48.2ROR 44.7 · χ² 3,855 / p <1e-300	39.8 EB05 33.7 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 31.1	no trial data cached
Ocular discomfort	19	38.0 24.3–59.3ROR 38.7 · χ² 647 / p 5e-143	36.7 EB05 24.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Eye irritation	79	30.8 24.9–38.0ROR 33.4 · χ² 2,248 / p <1e-300	30.5 EB05 25.3 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 35.8	no trial data cached
Ocular hyperaemia	60	27.9 21.8–35.6ROR 29.7 · χ² 1,530 / p <1e-300	27.6 EB05 22.2 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 21.5 · 71% consumer	no trial data cached
Intraocular pressure increased (raised eye pressure)	14	23.7 14.1–39.8ROR 24.0 · χ² 282 / p 2e-63	22.9 EB05 14.3 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious PRR 36.2	no trial data cached
Eye infection	12	23.2 13.2–40.8ROR 23.5 · χ² 233 / p 6e-53	22.3 EB05 13.3 · IC025 +2.6 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=6	no trial data cached
Impaired healing	34	22.5 16.2–31.3ROR 23.3 · χ² 677 / p 2e-149	22.2 EB05 16.6 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 3.2 · 100% clinician	no trial data cached
Eye swelling	27	15.8 10.9–23.0ROR 16.3 · χ² 361 / p 8e-81	15.5 EB05 11.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.3 · 93% consumer	no trial data cached
Vision blurred (blurred vision)	81	12.9 10.4–15.8ROR 13.9 · χ² 880 / p 1e-193	12.7 EB05 10.5 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.8	no trial data cached
Chronic kidney disease	42	11.9 8.8–16.0ROR 12.4 · χ² 409 / p 3e-91	11.5 EB05 8.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 15.9	no trial data cached
Eye pruritus	18	11.8 7.5–18.7ROR 12.1 · χ² 168 / p 9e-39	10.8 EB05 6.8 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.9	no trial data cached
Visual acuity reduced	18	11.7 7.4–18.4ROR 11.9 · χ² 165 / p 4e-38	10.6 EB05 6.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 18.4	no trial data cached
Lacrimation increased	16	11.6 7.1–18.9ROR 11.8 · χ² 145 / p 1e-33	10.4 EB05 6.3 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 9.9	no trial data cached
Cardiac disorder	50	11.6 8.8–15.1ROR 12.1 · χ² 473 / p 3e-105	11.2 EB05 8.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 17.2 · ♀ 6% (drug 61%) · 96% clinician	no trial data cached
Cataract	29	10.6 7.4–15.2ROR 10.9 · χ² 243 / p 4e-55	9.9 EB05 7.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 15.2	no trial data cached
Dry eye	22	9.9 6.5–14.9ROR 10.1 · χ² 167 / p 2e-38	8.9 EB05 6.0 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 17.7	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Eye pain	102	40.1 33.4–48.2ROR 44.7 · χ² 3,855 / p <1e-300	39.8 EB05 33.7 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 31.1	no trial data cached
Vision blurred (blurred vision)	81	12.9 10.4–15.8ROR 13.9 · χ² 880 / p 1e-193	12.7 EB05 10.5 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.8	no trial data cached
Eye irritation	79	30.8 24.9–38.0ROR 33.4 · χ² 2,248 / p <1e-300	30.5 EB05 25.3 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 35.8	no trial data cached
Ocular hyperaemia	60	27.9 21.8–35.6ROR 29.7 · χ² 1,530 / p <1e-300	27.6 EB05 22.2 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 21.5 · 71% consumer	no trial data cached
Cardiac disorder	50	11.6 8.8–15.1ROR 12.1 · χ² 473 / p 3e-105	11.2 EB05 8.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 17.2 · ♀ 6% (drug 61%) · 96% clinician	no trial data cached
Chronic kidney disease	42	11.9 8.8–16.0ROR 12.4 · χ² 409 / p 3e-91	11.5 EB05 8.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 15.9	no trial data cached
Photophobia (light sensitivity)	35	40.7 29.4–56.4ROR 42.2 · χ² 1,315 / p 3e-288	39.8 EB05 29.9 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 42.1	no trial data cached
Impaired healing	34	22.5 16.2–31.3ROR 23.3 · χ² 677 / p 2e-149	22.2 EB05 16.6 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 3.2 · 100% clinician	no trial data cached
Cataract	29	10.6 7.4–15.2ROR 10.9 · χ² 243 / p 4e-55	9.9 EB05 7.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 15.2	no trial data cached
Eye swelling	27	15.8 10.9–23.0ROR 16.3 · χ² 361 / p 8e-81	15.5 EB05 11.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.3 · 93% consumer	no trial data cached
Dry eye	22	9.9 6.5–14.9ROR 10.1 · χ² 167 / p 2e-38	8.9 EB05 6.0 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 17.7	no trial data cached
Eye inflammation	20	46.1 29.8–71.1ROR 47.0 · χ² 836 / p 4e-184	44.2 EB05 30.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Ocular discomfort	19	38.0 24.3–59.3ROR 38.7 · χ² 647 / p 5e-143	36.7 EB05 24.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Eye discharge	19	40.4 25.9–63.1ROR 41.2 · χ² 690 / p 2e-152	38.9 EB05 26.3 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Visual acuity reduced	18	11.7 7.4–18.4ROR 11.9 · χ² 165 / p 4e-38	10.6 EB05 6.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 18.4	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Eye inflammation — n=20, PRR 46.1
Photophobia — n=35, PRR 40.7
Ocular hyperaemia — n=60, PRR 27.9
Eye swelling — n=27, PRR 15.8
Chronic kidney disease — n=42, PRR 11.9
Cardiac disorder — n=50, PRR 11.6
Cataract — n=29, PRR 10.6
Dry eye — n=22, PRR 9.9

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Besifloxacin?

In FDA FAERS, the most frequently co-reported reaction terms for Besifloxacin are eye pain, vision blurred, eye irritation, ocular hyperaemia, cardiac disorder, chronic kidney disease. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Besifloxacin have an FDA boxed warning?

No. The FDA label retrieved for Besifloxacin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Besifloxacin causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID f312ddb2-3173-4c2c-bf1b-4ade8fb75d94, effective 20260728; matched on openfda.generic_name.exact:"BESIFLOXACIN")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 30 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.