Drug · FAERS side-effect profile with label screen
Difluprednate side effects: what 3,795 FDA adverse event reports show
Drug class
Corticosteroid
FDA label, Indications wording
Who reports
3,795 reports · 46% serious · 123 with death outcome · 61% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Difluprednate ophthalmic emulsion is a corticosteroid indicated for: The treatment of inflammation and pain associated with ocular surgery ( 1.1 ) The treatment of endogenous anterior uveitis ( 1.2 ) 1.1 Ocular Surgery Difluprednate ophthalmic emulsion 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery.
FDA label, Indications and Usage
What it is
Difluprednate ophthalmic emulsion 0.05% is a sterile, topical anti-inflammatory corticosteroid 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 40 strongest signals
Labeled adverse reaction 7Labeled (related wording) 6Likely indication confounding 2Reporting / coding artifact 7Lab value / disease marker 2Not in label — unassessed 16
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. 63 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 |
|---|---|---|---|---|---|---|
| Intraocular pressure increased (raised eye pressure) | 528 | 237.0 218.6–257.1ROR 275.2 · χ² 118,772 / p <1e-300 | 225.3 EB05 209.7 · IC025 +7.4 3/3 methods agree | Lab value / disease marker | serious PRR 61.3 · 84% consumer | no trial data cached |
| Eye inflammation | 94 | 55.6 45.5–68.0ROR 57.0 · χ² 4,938 / p <1e-300 | 54.5 EB05 45.8 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=51 | no trial data cached |
| Uveitis | 97 | 40.0 32.8–48.7ROR 41.0 · χ² 3,621 / p <1e-300 | 39.4 EB05 33.2 · IC025 +4.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 51.1 | no trial data cached |
| Therapy partial responder | 105 | 38.8 32.1–46.9ROR 39.9 · χ² 3,803 / p <1e-300 | 38.3 EB05 32.5 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 96% consumer | no trial data cached |
| Ocular discomfort | 49 | 25.0 18.9–33.1ROR 25.4 · χ² 1,102 / p 5e-242 | 24.7 EB05 19.4 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=17 | no trial data cached |
| Eye pain | 231 | 23.2 20.5–26.3ROR 24.6 · χ² 4,878 / p <1e-300 | 23.1 EB05 20.7 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.0 | no trial data cached |
| Glaucoma | 69 | 19.9 15.7–25.1ROR 20.2 · χ² 1,213 / p 4e-266 | 19.7 EB05 16.1 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.9 | no trial data cached |
| Blindness unilateral | 50 | 19.7 14.9–25.9ROR 19.9 · χ² 866 / p 2e-190 | 19.5 EB05 15.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 | no trial data cached |
| Vitreous floaters | 31 | 17.6 12.4–25.1ROR 17.8 · χ² 469 / p 3e-104 | 17.4 EB05 12.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Eye infection | 35 | 17.3 12.4–24.1ROR 17.4 · χ² 520 / p 2e-115 | 17.0 EB05 12.7 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | no trial data cached |
| Eye irritation | 167 | 16.6 14.3–19.3ROR 17.3 · χ² 2,431 / p <1e-300 | 16.5 EB05 14.5 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.7 · 70% consumer | no trial data cached |
| Photophobia (light sensitivity) | 53 | 15.7 12.0–20.6ROR 15.9 · χ² 715 / p 9e-158 | 15.6 EB05 12.3 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.6 | no trial data cached |
| Cataract | 158 | 14.8 12.7–17.2ROR 15.4 · χ² 2,013 / p <1e-300 | 14.7 EB05 12.8 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.2 | no trial data cached |
| Eye discharge | 27 | 14.6 10.0–21.3ROR 14.7 · χ² 329 / p 9e-74 | 14.2 EB05 10.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Retinal detachment | 24 | 14.5 9.7–21.5ROR 14.5 · χ² 287 / p 1e-64 | 14.0 EB05 9.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 18.2 | no trial data cached |
| Lacrimation increased | 57 | 10.6 8.2–13.7ROR 10.7 · χ² 484 / p 2e-107 | 10.2 EB05 8.1 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.6 · 76% consumer | no trial data cached |
| Product availability issue | 41 | 10.1 7.5–13.7ROR 10.2 · χ² 328 / p 2e-73 | 9.6 EB05 7.3 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 8.9 · 88% consumer | no trial data cached |
| Ocular hyperaemia | 85 | 10.1 8.2–12.4ROR 10.3 · χ² 686 / p 2e-151 | 9.8 EB05 8.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Blindness | 74 | 10.1 8.0–12.6ROR 10.2 · χ² 595 / p 1e-131 | 9.8 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 · 78% consumer | no trial data cached |
| Eye swelling | 65 | 9.7 7.6–12.4ROR 9.9 · χ² 500 / p 4e-111 | 9.4 EB05 7.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · 76% consumer | no trial data cached |
| Product administration error | 30 | 8.3 5.8–11.9ROR 8.4 · χ² 186 / p 1e-42 | 7.6 EB05 5.5 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 | no trial data cached |
| Eye haemorrhage | 20 | 8.3 5.3–12.8ROR 8.3 · χ² 121 / p 2e-28 | 7.3 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · 75% consumer | no trial data cached |
| Eye disorder | 48 | 8.1 6.1–10.7ROR 8.2 · χ² 292 / p 1e-65 | 7.7 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Vision blurred (blurred vision) | 186 | 7.5 6.5–8.7ROR 7.9 · χ² 1,053 / p 3e-231 | 7.4 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.7 | no trial data cached |
| End stage renal disease | 24 | 7.2 4.8–10.7ROR 7.2 · χ² 122 / p 1e-28 | 6.5 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Visual acuity reduced | 42 | 6.9 5.1–9.4ROR 7.0 · χ² 208 / p 2e-47 | 6.5 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.2 | no trial data cached |
| Visual impairment | 153 | 6.9 5.9–8.0ROR 7.1 · χ² 766 / p 5e-169 | 6.8 EB05 5.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Chronic kidney disease | 87 | 6.3 5.1–7.7ROR 6.4 · χ² 382 / p 3e-85 | 6.1 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Eye pruritus | 36 | 6.0 4.4–8.4ROR 6.1 · χ² 146 / p 5e-34 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Dry eye | 47 | 5.4 4.0–7.1ROR 5.4 · χ² 163 / p 1e-37 | 5.1 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.9 · ♀ 81% (drug 61%) | no trial data cached |
| Product use complaint | 14 | 5.0 3.0–8.4ROR 5.0 · χ² 41 / p 8e-11 | 4.3 EB05 2.8 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious n=3 | no trial data cached |
| Eyelid oedema | 10 | 4.7 2.5–8.8ROR 4.7 · χ² 26 / p 2e-7 | 4.0 EB05 2.3 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.6 | no trial data cached |
| Macular degeneration | 10 | 4.6 2.5–8.6ROR 4.6 · χ² 25 / p 3e-7 | 3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Treatment failure | 65 | 4.4 3.4–5.6ROR 4.4 · χ² 167 / p 2e-38 | 4.3 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 1.1 · 77% consumer | no trial data cached |
| Post procedural complication | 13 | 3.7 2.2–6.4ROR 3.7 · χ² 23 / p 7e-7 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 | no trial data cached |
| Scar | 11 | 3.5 2.0–6.4ROR 3.6 · χ² 18 / p 1e-5 | 3.2 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Blood lactate dehydrogenase increased | 10 | 3.5 1.9–6.4ROR 3.5 · χ² 15 / p 5e-5 | 3.1 EB05 1.8 · IC025 +0.6 | Lab value / disease marker | serious PRR 4.6 | no trial data cached |
| Oral pain | 14 | 3.4 2.0–5.8ROR 3.5 · χ² 22 / p 1e-6 | 3.2 EB05 2.0 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Inflammation | 31 | 3.3 2.4–4.7ROR 3.4 · χ² 49 / p 2e-12 | 3.2 EB05 2.4 · IC025 +1.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 2.2 | no trial data cached |
| Expired product administered | 18 | 3.0 1.9–4.8ROR 3.0 · χ² 22 / p 1e-6 | 2.8 EB05 1.9 · IC025 +0.7 | Reporting / coding artifact | serious n=2 | 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 |
|---|---|---|---|---|---|---|
| Intraocular pressure increased (raised eye pressure) | 528 | 237.0 218.6–257.1ROR 275.2 · χ² 118,772 / p <1e-300 | 225.3 EB05 209.7 · IC025 +7.4 3/3 methods agree | Lab value / disease marker | serious PRR 61.3 · 84% consumer | no trial data cached |
| Eye pain | 231 | 23.2 20.5–26.3ROR 24.6 · χ² 4,878 / p <1e-300 | 23.1 EB05 20.7 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.0 | no trial data cached |
| Vision blurred (blurred vision) | 186 | 7.5 6.5–8.7ROR 7.9 · χ² 1,053 / p 3e-231 | 7.4 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.7 | no trial data cached |
| Eye irritation | 167 | 16.6 14.3–19.3ROR 17.3 · χ² 2,431 / p <1e-300 | 16.5 EB05 14.5 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.7 · 70% consumer | no trial data cached |
| Cataract | 158 | 14.8 12.7–17.2ROR 15.4 · χ² 2,013 / p <1e-300 | 14.7 EB05 12.8 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.2 | no trial data cached |
| Visual impairment | 153 | 6.9 5.9–8.0ROR 7.1 · χ² 766 / p 5e-169 | 6.8 EB05 5.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Therapy partial responder | 105 | 38.8 32.1–46.9ROR 39.9 · χ² 3,803 / p <1e-300 | 38.3 EB05 32.5 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 96% consumer | no trial data cached |
| Uveitis | 97 | 40.0 32.8–48.7ROR 41.0 · χ² 3,621 / p <1e-300 | 39.4 EB05 33.2 · IC025 +4.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 51.1 | no trial data cached |
| Eye inflammation | 94 | 55.6 45.5–68.0ROR 57.0 · χ² 4,938 / p <1e-300 | 54.5 EB05 45.8 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=51 | no trial data cached |
| Chronic kidney disease | 87 | 6.3 5.1–7.7ROR 6.4 · χ² 382 / p 3e-85 | 6.1 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Ocular hyperaemia | 85 | 10.1 8.2–12.4ROR 10.3 · χ² 686 / p 2e-151 | 9.8 EB05 8.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Blindness | 74 | 10.1 8.0–12.6ROR 10.2 · χ² 595 / p 1e-131 | 9.8 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 · 78% consumer | no trial data cached |
| Glaucoma | 69 | 19.9 15.7–25.1ROR 20.2 · χ² 1,213 / p 4e-266 | 19.7 EB05 16.1 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.9 | no trial data cached |
| Treatment failure | 65 | 4.4 3.4–5.6ROR 4.4 · χ² 167 / p 2e-38 | 4.3 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 1.1 · 77% consumer | no trial data cached |
| Eye swelling | 65 | 9.7 7.6–12.4ROR 9.9 · χ² 500 / p 4e-111 | 9.4 EB05 7.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · 76% consumer | 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.
- Blindness unilateral — n=50, PRR 19.7
- Vitreous floaters — n=31, PRR 17.6
- Eye discharge — n=27, PRR 14.6
- Retinal detachment — n=24, PRR 14.5
- Ocular hyperaemia — n=85, PRR 10.1
- Blindness — n=74, PRR 10.1
- Eye swelling — n=65, PRR 9.7
- Eye haemorrhage — n=20, PRR 8.3
- Eye disorder — n=48, PRR 8.1
- End stage renal disease — n=24, PRR 7.2
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 Difluprednate?
In FDA FAERS, the most frequently co-reported reaction terms for Difluprednate are intraocular pressure increased, eye pain, vision blurred, eye irritation, cataract, visual impairment. 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 Difluprednate have an FDA boxed warning?
No. The FDA label retrieved for Difluprednate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Difluprednate 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 ce8c1d56-771e-45da-8a19-5f881f993738, effective 20260216; matched on
openfda.generic_name.exact:"DIFLUPREDNATE") - 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, 103 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.