Bromfenac Sodium side effects: what 1,418 FDA adverse event reports show
Drug class
Nonsteroidal anti-inflammatory drug (nsaid)
Who reports
1,418 reports · 48% serious · 38 with death outcome · 67% female
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 )
What it is
Bromfenac ophthalmic solution, 0.07% is a sterile, nonsteroidal anti-inflammatory drug (NSAID) for topical ophthalmic use.
Boxed warning
None in the current label
Causality screen of the 28 strongest signals
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.
- 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. 22 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Intraocular pressure increased (raised eye pressure) | 28 | 32.3 22.4–46.6ROR 32.9 · χ² 817 / p 6e-180 | 31.6 EB05 22.9 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious PRR 43.4 | no trial data cached |
| Ocular discomfort | 22 | 30.0 19.8–45.4ROR 30.4 · χ² 587 / p 6e-130 | 29.3 EB05 20.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Eye pain | 108 | 29.0 24.1–34.7ROR 31.3 · χ² 2,889 / p <1e-300 | 28.8 EB05 24.5 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.5 · 74% consumer | no trial data cached |
| Photophobia (light sensitivity) | 34 | 27.0 19.3–37.6ROR 27.6 · χ² 823 / p 2e-181 | 26.6 EB05 19.9 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.3 | no trial data cached |
| Eye irritation | 92 | 24.4 20.0–29.8ROR 26.0 · χ² 2,045 / p <1e-300 | 24.3 EB05 20.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · 79% consumer | no trial data cached |
| Eye inflammation | 15 | 23.5 14.2–38.9ROR 23.8 · χ² 301 / p 9e-68 | 22.8 EB05 14.5 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=12 | no trial data cached |
| Product packaging quantity issue | 16 | 21.7 13.3–35.3ROR 21.9 · χ² 295 / p 2e-66 | 21.1 EB05 13.6 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Cataract | 85 | 21.2 17.3–26.1ROR 22.5 · χ² 1,619 / p <1e-300 | 21.1 EB05 17.6 · IC025 +3.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 28.5 | no trial data cached |
| Eye discharge | 13 | 18.8 11.0–32.3ROR 19.0 · χ² 202 / p 4e-46 | 18.0 EB05 10.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Vitreous floaters | 12 | 18.2 10.4–32.0ROR 18.4 · χ² 178 / p 5e-41 | 17.2 EB05 9.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Retinal detachment | 10 | 16.1 8.7–29.8ROR 16.2 · χ² 127 / p 1e-29 | 14.5 EB05 7.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 19.7 | no trial data cached |
| Product prescribing error | 23 | 14.4 9.6–21.6ROR 14.6 · χ² 273 / p 1e-61 | 13.9 EB05 9.4 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 91% consumer | no trial data cached |
| Eye infection | 10 | 13.2 7.1–24.5ROR 13.3 · χ² 101 / p 5e-24 | 11.2 EB05 5.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Ocular hyperaemia | 37 | 11.7 8.5–16.1ROR 12.0 · χ² 352 / p 7e-79 | 11.3 EB05 8.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · 81% consumer | no trial data cached |
| Lacrimation increased | 23 | 11.4 7.6–17.1ROR 11.6 · χ² 208 / p 2e-47 | 10.6 EB05 7.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Vision blurred (blurred vision) | 103 | 11.1 9.3–13.4ROR 11.9 · χ² 947 / p 3e-208 | 11.0 EB05 9.3 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 · 79% consumer | no trial data cached |
| Visual acuity reduced | 25 | 11.0 7.5–16.3ROR 11.2 · χ² 218 / p 1e-49 | 10.3 EB05 7.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 | no trial data cached |
| Glaucoma | 12 | 9.2 5.2–16.2ROR 9.3 · χ² 80 / p 2e-19 | 7.5 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Dry eye | 29 | 8.8 6.2–12.7ROR 9.0 · χ² 194 / p 2e-44 | 8.1 EB05 5.8 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 · 75% consumer | no trial data cached |
| Eye disorder | 18 | 8.1 5.1–12.8ROR 8.2 · χ² 105 / p 5e-25 | 7.0 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Product prescribing issue | 10 | 7.3 3.9–13.5ROR 7.3 · χ² 48 / p 2e-12 | 5.7 EB05 3.3 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 | no trial data cached |
| Eye swelling | 18 | 7.2 4.5–11.4ROR 7.3 · χ² 90 / p 1e-21 | 6.2 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Eye pruritus | 16 | 7.2 4.4–11.7ROR 7.2 · χ² 79 / p 3e-19 | 6.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Visual impairment | 53 | 6.4 4.9–8.3ROR 6.6 · χ² 236 / p 2e-53 | 6.1 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Expired product administered | 14 | 6.2 3.7–10.5ROR 6.3 · χ² 57 / p 3e-14 | 5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Renal injury | 11 | 5.4 3.0–9.8ROR 5.5 · χ² 35 / p 1e-9 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Drug administration error | 10 | 4.7 2.6–8.8ROR 4.8 · χ² 26 / p 2e-7 | 4.0 EB05 2.3 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Therapy interrupted | 17 | 3.6 2.3–5.8ROR 3.7 · χ² 30 / p 2e-8 | 3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 108 | 29.0 24.1–34.7ROR 31.3 · χ² 2,889 / p <1e-300 | 28.8 EB05 24.5 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.5 · 74% consumer | no trial data cached |
| Vision blurred (blurred vision) | 103 | 11.1 9.3–13.4ROR 11.9 · χ² 947 / p 3e-208 | 11.0 EB05 9.3 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 · 79% consumer | no trial data cached |
| Eye irritation | 92 | 24.4 20.0–29.8ROR 26.0 · χ² 2,045 / p <1e-300 | 24.3 EB05 20.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · 79% consumer | no trial data cached |
| Cataract | 85 | 21.2 17.3–26.1ROR 22.5 · χ² 1,619 / p <1e-300 | 21.1 EB05 17.6 · IC025 +3.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 28.5 | no trial data cached |
| Visual impairment | 53 | 6.4 4.9–8.3ROR 6.6 · χ² 236 / p 2e-53 | 6.1 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Ocular hyperaemia | 37 | 11.7 8.5–16.1ROR 12.0 · χ² 352 / p 7e-79 | 11.3 EB05 8.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · 81% consumer | no trial data cached |
| Photophobia (light sensitivity) | 34 | 27.0 19.3–37.6ROR 27.6 · χ² 823 / p 2e-181 | 26.6 EB05 19.9 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.3 | no trial data cached |
| Dry eye | 29 | 8.8 6.2–12.7ROR 9.0 · χ² 194 / p 2e-44 | 8.1 EB05 5.8 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 · 75% consumer | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 28 | 32.3 22.4–46.6ROR 32.9 · χ² 817 / p 6e-180 | 31.6 EB05 22.9 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious PRR 43.4 | no trial data cached |
| Visual acuity reduced | 25 | 11.0 7.5–16.3ROR 11.2 · χ² 218 / p 1e-49 | 10.3 EB05 7.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 | no trial data cached |
| Lacrimation increased | 23 | 11.4 7.6–17.1ROR 11.6 · χ² 208 / p 2e-47 | 10.6 EB05 7.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Product prescribing error | 23 | 14.4 9.6–21.6ROR 14.6 · χ² 273 / p 1e-61 | 13.9 EB05 9.4 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 91% consumer | no trial data cached |
| Ocular discomfort | 22 | 30.0 19.8–45.4ROR 30.4 · χ² 587 / p 6e-130 | 29.3 EB05 20.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Eye swelling | 18 | 7.2 4.5–11.4ROR 7.3 · χ² 90 / p 1e-21 | 6.2 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Eye disorder | 18 | 8.1 5.1–12.8ROR 8.2 · χ² 105 / p 5e-25 | 7.0 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | 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.
- Ocular discomfort — n=22, PRR 30.0
- Eye irritation — n=92, PRR 24.4
- Ocular hyperaemia — n=37, PRR 11.7
- Lacrimation increased — n=23, PRR 11.4
- Visual acuity reduced — n=25, PRR 11.0
- Visual impairment — n=53, PRR 6.4
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, vision blurred, eye irritation, cataract, visual impairment, ocular hyperaemia. 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, fieldpatient.drug.openfda.generic_name.exact, 50 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.