Bromfenac side effects: what 998 FDA adverse event reports show

Bromfenac · 35 reaction terms · 717 drug–reaction co-reports · data 2026-09-14

Drug class

Nonsteroidal anti-inflammatory drug (nsaid)

FDA label, Indications wording

Who reports

998 reports · 29% serious · 10 with death outcome · 61% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Bromfenac ophthalmic solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac ophthalmic solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. ( 1 )

FDA label, Indications and Usage

What it is

Bromfenac ophthalmic solution, 0.07% is a sterile, nonsteroidal anti-inflammatory drug (NSAID) for topical ophthalmic use.

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 18 strongest signals

Labeled adverse reaction 1Likely indication confounding 1Reporting / coding artifact 9Not in label — unassessed 7

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.
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.
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. 17 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
Product packaging quantity issue	73	141.2 113.1–176.2ROR 152.2 · χ² 9,958 / p <1e-300	135.3 EB05 111.2 · IC025 +5.8 3/3 methods agree	Reporting / coding artifact	74% consumer	no trial data cached
Poor quality product administered	27	55.5 38.3–80.6ROR 57.0 · χ² 1,389 / p <1e-300	53.4 EB05 38.5 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	85% consumer	no trial data cached
Treatment failure	146	37.4 32.2–43.4ROR 43.6 · χ² 5,141 / p <1e-300	37.1 EB05 32.3 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious PRR 2.9 · 74% consumer	no trial data cached
Eye inflammation	12	26.7 15.2–46.9ROR 27.0 · χ² 272 / p 3e-61	25.6 EB05 15.5 · IC025 +2.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=9	no trial data cached
Vitreous floaters	11	23.7 13.2–42.7ROR 24.0 · χ² 217 / p 2e-49	22.6 EB05 13.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Eye pain	62	23.6 18.5–30.0ROR 25.1 · χ² 1,319 / p 4e-289	23.4 EB05 18.9 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 48.3	no trial data cached
Eye irritation	57	21.5 16.7–27.6ROR 22.7 · χ² 1,093 / p 5e-240	21.3 EB05 17.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 44.2 · 73% consumer	no trial data cached
Drug prescribing error	15	16.2 9.8–26.7ROR 16.4 · χ² 198 / p 2e-45	15.4 EB05 9.3 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product physical issue	13	13.7 8.0–23.5ROR 13.9 · χ² 140 / p 1e-32	12.4 EB05 6.9 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Lacrimation increased	19	13.3 8.5–20.8ROR 13.6 · χ² 205 / p 9e-47	12.6 EB05 8.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 46.6	no trial data cached
Ocular hyperaemia	25	11.2 7.6–16.5ROR 11.5 · χ² 223 / p 9e-51	10.5 EB05 7.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 41.5	no trial data cached
Extra dose administered	21	11.0 7.2–16.9ROR 11.3 · χ² 182 / p 8e-42	10.1 EB05 6.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=1 · 81% consumer	no trial data cached
Circumstance or information capable of leading to medication error	17	10.6 6.6–17.0ROR 10.8 · χ² 139 / p 2e-32	9.4 EB05 5.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Product dispensing error	10	9.6 5.2–17.9ROR 9.7 · χ² 69 / p 5e-17	7.6 EB05 4.1 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Impaired healing	15	9.6 5.8–15.8ROR 9.7 · χ² 107 / p 2e-25	8.2 EB05 5.0 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 7.6	no trial data cached
Product storage error	39	9.5 7.0–12.9ROR 9.8 · χ² 288 / p 9e-65	8.9 EB05 6.7 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 5.1	no trial data cached
Product dose omission	23	7.3 4.9–10.9ROR 7.4 · χ² 119 / p 6e-28	6.5 EB05 4.5 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product quality issue	27	4.2 2.9–6.1ROR 4.3 · χ² 63 / p 1e-15	3.9 EB05 2.9 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 1.3 · ♀ 88% (drug 61%) · 78% consumer	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
Treatment failure	146	37.4 32.2–43.4ROR 43.6 · χ² 5,141 / p <1e-300	37.1 EB05 32.3 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious PRR 2.9 · 74% consumer	no trial data cached
Product packaging quantity issue	73	141.2 113.1–176.2ROR 152.2 · χ² 9,958 / p <1e-300	135.3 EB05 111.2 · IC025 +5.8 3/3 methods agree	Reporting / coding artifact	74% consumer	no trial data cached
Eye pain	62	23.6 18.5–30.0ROR 25.1 · χ² 1,319 / p 4e-289	23.4 EB05 18.9 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 48.3	no trial data cached
Eye irritation	57	21.5 16.7–27.6ROR 22.7 · χ² 1,093 / p 5e-240	21.3 EB05 17.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 44.2 · 73% consumer	no trial data cached
Product storage error	39	9.5 7.0–12.9ROR 9.8 · χ² 288 / p 9e-65	8.9 EB05 6.7 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 5.1	no trial data cached
Product quality issue	27	4.2 2.9–6.1ROR 4.3 · χ² 63 / p 1e-15	3.9 EB05 2.9 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 1.3 · ♀ 88% (drug 61%) · 78% consumer	no trial data cached
Poor quality product administered	27	55.5 38.3–80.6ROR 57.0 · χ² 1,389 / p <1e-300	53.4 EB05 38.5 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	85% consumer	no trial data cached
Ocular hyperaemia	25	11.2 7.6–16.5ROR 11.5 · χ² 223 / p 9e-51	10.5 EB05 7.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 41.5	no trial data cached
Product dose omission	23	7.3 4.9–10.9ROR 7.4 · χ² 119 / p 6e-28	6.5 EB05 4.5 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Extra dose administered	21	11.0 7.2–16.9ROR 11.3 · χ² 182 / p 8e-42	10.1 EB05 6.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=1 · 81% consumer	no trial data cached
Lacrimation increased	19	13.3 8.5–20.8ROR 13.6 · χ² 205 / p 9e-47	12.6 EB05 8.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 46.6	no trial data cached
Circumstance or information capable of leading to medication error	17	10.6 6.6–17.0ROR 10.8 · χ² 139 / p 2e-32	9.4 EB05 5.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Impaired healing	15	9.6 5.8–15.8ROR 9.7 · χ² 107 / p 2e-25	8.2 EB05 5.0 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 7.6	no trial data cached
Drug prescribing error	15	16.2 9.8–26.7ROR 16.4 · χ² 198 / p 2e-45	15.4 EB05 9.3 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product physical issue	13	13.7 8.0–23.5ROR 13.9 · χ² 140 / p 1e-32	12.4 EB05 6.9 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious n=1	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.

Poor quality product administered — n=27, PRR 55.5
Eye irritation — n=57, PRR 21.5
Ocular hyperaemia — n=25, PRR 11.2
Extra dose administered — n=21, PRR 11.0

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 Bromfenac?

In FDA FAERS, the most frequently co-reported reaction terms for Bromfenac are eye pain, eye irritation, poor quality product administered, ocular hyperaemia, extra dose administered, lacrimation increased. 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 Bromfenac have an FDA boxed warning?

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

Do FAERS signals prove that Bromfenac 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 2c4eba0d-db55-4b54-a2ad-dfef1da9462f, effective 20250331; matched on openfda.generic_name.exact:"BROMFENAC")
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, 35 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.