Fluorometholone Acetate side effects: what 262 FDA adverse event reports show
Who reports
262 reports · 39% serious · 8 with death outcome · 69% female
Used for
Fluorometholone ophthalmic suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
What it is
DESCRIPTION Fluorometholone ophthalmic suspension, USP, 0.1% is a sterile, topical anti-inflammatory agent for ophthalmic use.
Boxed warning
None in the current label
Causality screen of the 7 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.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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. 6 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 |
|---|---|---|---|---|---|---|
| Eye pain | 61 | 88.5 71.0–110.3ROR 115.0 · χ² 5,198 / p <1e-300 | 86.1 EB05 69.4 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 70.0 · 78% consumer | no trial data cached |
| Photophobia (light sensitivity) | 15 | 64.3 39.4–105.2ROR 68.2 · χ² 873 / p 3e-192 | 59.7 EB05 38.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 10 | 62.4 34.0–114.6ROR 64.8 · χ² 544 / p 1e-120 | 56.0 EB05 32.5 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 82.7 | no trial data cached |
| Ocular discomfort | 8 | 59.0 29.8–116.7ROR 60.8 · χ² 400 / p 3e-89 | 52.1 EB05 28.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Eye discharge | 7 | 54.9 26.4–114.0ROR 56.3 · χ² 318 / p 2e-71 | 48.1 EB05 25.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=3 | no trial data cached |
| Eye irritation | 27 | 38.8 27.1–55.4ROR 43.1 · χ² 958 / p 1e-210 | 37.8 EB05 27.3 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 64.2 · 81% consumer | no trial data cached |
| Ocular hyperaemia | 18 | 30.8 19.7–48.2ROR 33.0 · χ² 491 / p 4e-109 | 30.0 EB05 20.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 30.1 | 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 | 61 | 88.5 71.0–110.3ROR 115.0 · χ² 5,198 / p <1e-300 | 86.1 EB05 69.4 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 70.0 · 78% consumer | no trial data cached |
| Eye irritation | 27 | 38.8 27.1–55.4ROR 43.1 · χ² 958 / p 1e-210 | 37.8 EB05 27.3 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 64.2 · 81% consumer | no trial data cached |
| Ocular hyperaemia | 18 | 30.8 19.7–48.2ROR 33.0 · χ² 491 / p 4e-109 | 30.0 EB05 20.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 30.1 | no trial data cached |
| Photophobia (light sensitivity) | 15 | 64.3 39.4–105.2ROR 68.2 · χ² 873 / p 3e-192 | 59.7 EB05 38.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 10 | 62.4 34.0–114.6ROR 64.8 · χ² 544 / p 1e-120 | 56.0 EB05 32.5 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 82.7 | no trial data cached |
| Ocular discomfort | 8 | 59.0 29.8–116.7ROR 60.8 · χ² 400 / p 3e-89 | 52.1 EB05 28.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Eye discharge | 7 | 54.9 26.4–114.0ROR 56.3 · χ² 318 / p 2e-71 | 48.1 EB05 25.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=3 | no trial data cached |
| Eye inflammation | 4 | 33.9 12.8–89.8ROR 34.5 · χ² 97 / p 3e-23 | 27.2 EB05 7.9 · IC025 +1.1 3/3 methods agree | Likely indication confounding term in indications | serious n=2 | no trial data cached |
| Synovitis | 3 | 13.3 4.3–41.0ROR 13.4 · χ² 23 / p 8e-7 | 6.8 EB05 2.1 · IC025 +0.2 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 | no trial data cached |
| Hand deformity | 3 | 18.4 6.0–56.5ROR 18.6 · χ² 33 / p 4e-9 | 10.1 EB05 2.5 · IC025 +0.3 3/3 methods agree | Not in label — unassessed | serious PRR 29.8 | no trial data cached |
| Pemphigus | 3 | 19.3 6.3–59.5ROR 19.5 · χ² 35 / p 1e-9 | 10.9 EB05 2.6 · IC025 +0.3 3/3 methods agree | Not in label — unassessed | serious PRR 28.9 | no trial data cached |
| Product packaging quantity issue | 3 | 22.0 7.1–67.8ROR 22.2 · χ² 41 / p 8e-11 | 13.0 EB05 2.9 · IC025 +0.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Helicobacter infection | 3 | 23.6 7.6–72.6ROR 23.8 · χ² 44 / p 1e-11 | 14.3 EB05 3.1 · IC025 +0.4 3/3 methods agree | Not in label — unassessed | serious PRR 37.2 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.
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 Fluorometholone?
In FDA FAERS, the most frequently co-reported reaction terms for Fluorometholone are eye pain, eye irritation, ocular hyperaemia, photophobia, intraocular pressure increased, ocular discomfort. 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 Fluorometholone have an FDA boxed warning?
No. The FDA label retrieved for Fluorometholone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Fluorometholone 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 c9cbf06e-5413-4c3c-9ded-174c856a4ce1, effective 20260512; matched on
openfda.generic_name.exact:"FLUOROMETHOLONE") - 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, 13 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.