Drug · FAERS side-effect profile with label screen
Fluorometholone side effects: what 3,150 FDA adverse event reports show
Who reports
3,150 reports · 51% serious · 292 with death outcome · 68% female
openFDA FAERS counts, all years, deduplication not applied
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.
FDA label, Indications and Usage
What it is
DESCRIPTION Fluorometholone ophthalmic suspension, USP, 0.1% is a sterile, topical anti-inflammatory agent for 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 40 strongest signals
Labeled adverse reaction 4Labeled (related wording) 3Likely indication confounding 1Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 29
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. 189 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Autoimmune disorder | 107 | 75.2 62.4–90.7ROR 77.8 · χ² 7,678 / p <1e-300 | 73.4 EB05 62.5 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 89.0 · ♀ 100% (drug 68%) · 100% clinician | no trial data cached |
| Helicobacter infection | 107 | 70.6 58.5–85.1ROR 73.0 · χ² 7,196 / p <1e-300 | 69.0 EB05 58.7 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 82.6 · ♀ 100% (drug 68%) · 98% clinician | no trial data cached |
| Folliculitis | 107 | 69.6 57.8–84.0ROR 72.1 · χ² 7,099 / p <1e-300 | 68.1 EB05 58.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 90.7 · ♀ 99% (drug 68%) · 98% clinician | no trial data cached |
| Bursitis | 99 | 55.0 45.3–66.9ROR 56.8 · χ² 5,159 / p <1e-300 | 54.1 EB05 45.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 71.2 · ♀ 100% (drug 68%) · 95% clinician | no trial data cached |
| Hypercholesterolaemia | 75 | 52.6 42.0–65.8ROR 53.8 · χ² 3,715 / p <1e-300 | 51.5 EB05 42.5 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 62.0 · ♀ 100% (drug 68%) · 100% clinician | no trial data cached |
| Hand deformity | 96 | 49.2 40.4–59.9ROR 50.7 · χ² 4,453 / p <1e-300 | 48.4 EB05 40.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 59.4 · ♀ 100% (drug 68%) · 100% clinician | no trial data cached |
| Foot deformity | 79 | 47.7 38.3–59.4ROR 48.9 · χ² 3,542 / p <1e-300 | 46.9 EB05 38.8 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 61.6 · ♀ 100% (drug 68%) · 100% clinician | no trial data cached |
| Pemphigus | 82 | 44.2 35.7–54.7ROR 45.3 · χ² 3,396 / p <1e-300 | 43.5 EB05 36.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 49.3 · ♀ 100% (drug 68%) · 98% clinician | no trial data cached |
| Laryngitis | 68 | 41.9 33.1–53.1ROR 42.8 · χ² 2,661 / p <1e-300 | 41.2 EB05 33.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=68 · ♀ 98% (drug 68%) · 100% clinician | no trial data cached |
| Wound infection | 63 | 38.8 30.4–49.6ROR 39.6 · χ² 2,270 / p <1e-300 | 38.2 EB05 30.9 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 46.3 · ♀ 100% (drug 68%) · 97% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 109 | 32.6 27.1–39.2ROR 33.7 · χ² 3,294 / p <1e-300 | 32.3 EB05 27.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 52.1 · ♀ 100% (drug 68%) · 99% clinician | no trial data cached |
| Pericarditis | 78 | 31.3 25.1–39.0ROR 32.1 · χ² 2,248 / p <1e-300 | 30.9 EB05 25.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 35.1 · ♀ 100% (drug 68%) · 97% clinician | no trial data cached |
| Joint range of motion decreased | 61 | 30.5 23.8–39.1ROR 31.1 · χ² 1,704 / p <1e-300 | 30.1 EB05 24.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 43.3 · ♀ 100% (drug 68%) · 100% clinician | no trial data cached |
| Treatment failure | 364 | 29.6 26.9–32.7ROR 33.4 · χ² 10,039 / p <1e-300 | 29.5 EB05 27.0 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 | no trial data cached |
| Sleep disorder due to a general medical condition | 71 | 29.3 23.3–36.9ROR 30.0 · χ² 1,908 / p <1e-300 | 29.0 EB05 23.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 58.4 · ♀ 97% (drug 68%) · 92% clinician | no trial data cached |
| Hepatic cirrhosis | 82 | 29.3 23.7–36.3ROR 30.1 · χ² 2,207 / p <1e-300 | 29.0 EB05 24.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 33.1 · ♀ 98% (drug 68%) · 98% clinician | no trial data cached |
| Sciatica | 65 | 27.4 21.5–34.8ROR 27.9 · χ² 1,620 / p <1e-300 | 27.1 EB05 22.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 41.0 · ♀ 96% (drug 68%) · 92% clinician | no trial data cached |
| Eye pain | 221 | 26.7 23.5–30.4ROR 28.7 · χ² 5,441 / p <1e-300 | 26.6 EB05 23.8 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.7 · 72% consumer | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 50 | 26.0 19.7–34.3ROR 26.4 · χ² 1,174 / p 2e-257 | 25.7 EB05 20.2 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious PRR 32.6 | no trial data cached |
| Synovitis | 70 | 25.9 20.5–32.7ROR 26.5 · χ² 1,646 / p <1e-300 | 25.7 EB05 21.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 30.3 · ♀ 100% (drug 68%) · 100% clinician | no trial data cached |
| Ocular discomfort | 40 | 24.6 18.1–33.5ROR 24.9 · χ² 879 / p 2e-193 | 24.3 EB05 18.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=6 · 78% consumer | no trial data cached |
| Fibromyalgia | 87 | 23.9 19.4–29.4ROR 24.6 · χ² 1,883 / p <1e-300 | 23.7 EB05 19.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 34.7 · ♀ 99% (drug 68%) · 97% clinician | no trial data cached |
| Irritable bowel syndrome | 74 | 23.1 18.5–29.0ROR 23.7 · χ² 1,540 / p <1e-300 | 22.9 EB05 18.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 32.7 · ♀ 98% (drug 68%) · 99% clinician | no trial data cached |
| Weight fluctuation | 36 | 23.1 16.7–31.9ROR 23.3 · χ² 736 / p 2e-162 | 22.7 EB05 17.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=35 · ♀ 100% (drug 68%) · 100% clinician | no trial data cached |
| Obesity | 54 | 22.6 17.3–29.4ROR 23.0 · χ² 1,090 / p 2e-239 | 22.4 EB05 17.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 29.3 · ♀ 98% (drug 68%) · 100% clinician | no trial data cached |
| Pulmonary fibrosis | 64 | 22.4 17.5–28.5ROR 22.8 · χ² 1,281 / p 7e-281 | 22.2 EB05 18.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 25.2 · ♀ 98% (drug 68%) · 95% clinician | no trial data cached |
| Impaired healing | 108 | 22.0 18.2–26.4ROR 22.7 · χ² 2,135 / p <1e-300 | 21.8 EB05 18.6 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 28.8 · ♀ 97% (drug 68%) · 97% clinician | no trial data cached |
| Ear infection | 87 | 21.9 17.8–26.9ROR 22.5 · χ² 1,709 / p <1e-300 | 21.7 EB05 18.2 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 43.5 · ♀ 99% (drug 68%) · 97% clinician | no trial data cached |
| Eye inflammation | 29 | 20.5 14.3–29.5ROR 20.7 · χ² 518 / p 7e-115 | 20.2 EB05 14.7 · IC025 +3.3 3/3 methods agree | Likely indication confounding term in indications | serious n=13 | no trial data cached |
| Frequent bowel movements | 81 | 20.1 16.2–24.9ROR 20.6 · χ² 1,448 / p <1e-300 | 20.0 EB05 16.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 33.7 · ♀ 98% (drug 68%) · 98% clinician | no trial data cached |
| Eye irritation | 166 | 19.9 17.1–23.0ROR 20.9 · χ² 2,955 / p <1e-300 | 19.8 EB05 17.4 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.7 · 75% consumer | no trial data cached |
| Wound | 82 | 19.7 15.9–24.4ROR 20.2 · χ² 1,433 / p <1e-300 | 19.5 EB05 16.2 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.2 · ♀ 100% (drug 68%) · 100% clinician | no trial data cached |
| Lower limb fracture | 55 | 19.2 14.8–25.0ROR 19.5 · χ² 930 / p 2e-204 | 19.0 EB05 15.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 23.6 · ♀ 100% (drug 68%) · 95% clinician | no trial data cached |
| Liver injury | 67 | 18.5 14.6–23.4ROR 18.9 · χ² 1,089 / p 4e-239 | 18.3 EB05 14.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 21.4 · ♀ 100% (drug 68%) · 97% clinician | no trial data cached |
| Eye discharge | 28 | 18.3 12.6–26.5ROR 18.4 · χ² 439 / p 7e-98 | 18.0 EB05 12.9 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=8 | no trial data cached |
| Delirium | 91 | 17.6 14.3–21.5ROR 18.0 · χ² 1,403 / p <1e-300 | 17.4 EB05 14.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 20.0 · ♀ 94% (drug 68%) · 98% clinician | no trial data cached |
| Photophobia (light sensitivity) | 43 | 15.4 11.4–20.7ROR 15.6 · χ² 562 / p 1e-124 | 15.1 EB05 11.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · 74% consumer | no trial data cached |
| Prescribed overdose | 44 | 15.2 11.3–20.3ROR 15.4 · χ² 567 / p 1e-125 | 14.9 EB05 11.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 28.2 · ♀ 100% (drug 68%) · 95% clinician | no trial data cached |
| Ocular hyperaemia | 105 | 15.0 12.4–18.1ROR 15.5 · χ² 1,357 / p 3e-297 | 14.9 EB05 12.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Lacrimation increased | 67 | 15.0 11.8–19.0ROR 15.3 · χ² 858 / p 8e-189 | 14.8 EB05 12.0 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 · 73% 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 | 364 | 29.6 26.9–32.7ROR 33.4 · χ² 10,039 / p <1e-300 | 29.5 EB05 27.0 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 | no trial data cached |
| Eye pain | 221 | 26.7 23.5–30.4ROR 28.7 · χ² 5,441 / p <1e-300 | 26.6 EB05 23.8 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.7 · 72% consumer | no trial data cached |
| Arthralgia (joint pain) | 167 | 2.7 2.3–3.1ROR 2.8 · χ² 178 / p 6e-41 | 2.7 EB05 2.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · ♀ 92% (drug 68%) | no trial data cached |
| Eye irritation | 166 | 19.9 17.1–23.0ROR 20.9 · χ² 2,955 / p <1e-300 | 19.8 EB05 17.4 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.7 · 75% consumer | no trial data cached |
| Anxiety | 143 | 3.3 2.8–3.9ROR 3.4 · χ² 235 / p 3e-53 | 3.3 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · ♀ 92% (drug 68%) | no trial data cached |
| Decreased appetite (loss of appetite) | 135 | 3.9 3.3–4.6ROR 4.0 · χ² 289 / p 4e-65 | 3.8 EB05 3.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Depression | 133 | 3.9 3.3–4.6ROR 4.0 · χ² 284 / p 6e-64 | 3.8 EB05 3.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · ♀ 92% (drug 68%) | no trial data cached |
| Hypersensitivity (allergic reaction) | 130 | 4.7 3.9–5.5ROR 4.8 · χ² 374 / p 1e-83 | 4.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 · ♀ 96% (drug 68%) | no trial data cached |
| Chest pain | 128 | 4.6 3.9–5.4ROR 4.7 · χ² 359 / p 2e-80 | 4.5 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 94% (drug 68%) | no trial data cached |
| Alopecia (hair loss) | 127 | 4.3 3.6–5.1ROR 4.4 · χ² 321 / p 5e-72 | 4.2 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 · ♀ 98% (drug 68%) | no trial data cached |
| Asthma | 126 | 7.5 6.3–8.9ROR 7.8 · χ² 705 / p 1e-155 | 7.3 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 · ♀ 94% (drug 68%) · 95% clinician | no trial data cached |
| Drug hypersensitivity | 124 | 4.3 3.6–5.1ROR 4.4 · χ² 308 / p 3e-69 | 4.2 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 · ♀ 96% (drug 68%) | no trial data cached |
| Vision blurred (blurred vision) | 123 | 6.0 5.0–7.1ROR 6.2 · χ² 510 / p 3e-113 | 5.9 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Abdominal discomfort | 122 | 4.9 4.1–5.8ROR 5.0 · χ² 373 / p 2e-83 | 4.8 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · ♀ 95% (drug 68%) · 93% clinician | no trial data cached |
| Arthropathy | 121 | 14.5 12.1–17.2ROR 15.0 · χ² 1,504 / p <1e-300 | 14.4 EB05 12.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 19.7 · ♀ 99% (drug 68%) · 96% clinician | 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.
- Autoimmune disorder — n=107, PRR 75.2
- Helicobacter infection — n=107, PRR 70.6
- Folliculitis — n=107, PRR 69.6
- Bursitis — n=99, PRR 55.0
- Hypercholesterolaemia — n=75, PRR 52.6
- Hand deformity — n=96, PRR 49.2
- Foot deformity — n=79, PRR 47.7
- Pemphigus — n=82, PRR 44.2
- Laryngitis — n=68, PRR 41.9
- Glossodynia — n=109, PRR 32.6
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, arthralgia, eye irritation, anxiety, decreased appetite, depression. 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, 229 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.