Nepafenac side effects: what 3,181 FDA adverse event reports show

Nepafenac · Ilevro · 79 reaction terms · 2,860 drug–reaction co-reports · data 2026-09-14

Drug class

Nonsteroidal Anti-inflammatory Drug

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Ilevro

openFDA label

Who reports

3,181 reports · 45% serious · 74 with death outcome · 59% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ILEVRO ® 0.3% is indicated for the treatment of pain and inflammation associated with cataract surgery. ILEVRO ® 0.3% is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery ( 1 ).

FDA label, Indications and Usage

What it is

ILEVRO ® 0.3% is a sterile, topical, NSAID prodrug 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 3Labeled (related wording) 2Likely indication confounding 4Reporting / coding artifact 9Lab value / disease marker 2Not in label — unassessed 20

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. 39 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
Eye pain	455	54.8 50.3–59.6ROR 63.7 · χ² 23,821 / p <1e-300	54.2 EB05 50.1 · IC025 +5.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 27.4 · 86% consumer	no trial data cached
Intraocular pressure increased (raised eye pressure)	64	33.0 25.9–42.1ROR 33.7 · χ² 1,946 / p <1e-300	32.6 EB05 26.4 · IC025 +4.3 3/3 methods agree	Lab value / disease marker	serious PRR 54.0	no trial data cached
Eye inflammation	42	29.5 21.8–39.8ROR 29.9 · χ² 1,122 / p 2e-246	29.0 EB05 22.4 · IC025 +3.9 3/3 methods agree	Likely indication confounding term in indications	serious n=27	no trial data cached
Vitreous floaters	36	24.5 17.7–33.9ROR 24.7 · χ² 784 / p 8e-173	24.1 EB05 18.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=31 · ♀ 82% (drug 59%)	no trial data cached
Uveitis	46	22.5 16.9–30.0ROR 22.8 · χ² 922 / p 8e-203	22.3 EB05 17.4 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 30.2 · ♀ 80% (drug 59%)	no trial data cached
Eye discharge	34	22.0 15.7–30.8ROR 22.2 · χ² 659 / p 1e-145	21.7 EB05 16.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=14	no trial data cached
Ocular discomfort	32	19.5 13.8–27.5ROR 19.7 · χ² 541 / p 5e-120	19.2 EB05 14.2 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious n=16	no trial data cached
Treatment failure	230	18.5 16.3–21.0ROR 19.9 · χ² 3,799 / p <1e-300	18.4 EB05 16.5 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 4.8 · 74% consumer	no trial data cached
Visual acuity reduced	93	18.4 15.0–22.4ROR 18.9 · χ² 1,507 / p <1e-300	18.2 EB05 15.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 23.7	no trial data cached
Blindness unilateral	38	17.8 13.0–24.5ROR 18.0 · χ² 586 / p 1e-129	17.6 EB05 13.3 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 23.7	no trial data cached
Glaucoma	45	15.4 11.5–20.6ROR 15.6 · χ² 592 / p 5e-131	15.2 EB05 11.8 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 21.0	no trial data cached
Cataract	129	14.4 12.1–17.0ROR 14.9 · χ² 1,592 / p <1e-300	14.3 EB05 12.3 · IC025 +3.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 20.3	no trial data cached
Photophobia (light sensitivity)	38	13.4 9.8–18.4ROR 13.6 · χ² 425 / p 1e-94	13.1 EB05 9.8 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.5	no trial data cached
Product packaging quantity issue	22	13.3 8.8–20.2ROR 13.4 · χ² 238 / p 5e-54	12.7 EB05 8.4 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious n=6	no trial data cached
Eye irritation	107	12.7 10.5–15.3ROR 13.1 · χ² 1,140 / p 4e-250	12.6 EB05 10.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 25.1	no trial data cached
Vasculitis	22	12.5 8.2–18.9ROR 12.5 · χ² 220 / p 4e-50	11.7 EB05 7.7 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 17.3 · ♀ 95% (drug 59%)	no trial data cached
Retinal detachment	17	12.2 7.6–19.6ROR 12.3 · χ² 164 / p 9e-38	11.1 EB05 6.8 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 15.9	no trial data cached
Therapy partial responder	26	11.4 7.8–16.7ROR 11.5 · χ² 236 / p 1e-53	10.7 EB05 7.4 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 1.4 · 96% consumer	no trial data cached
Vision blurred (blurred vision)	213	10.3 9.0–11.7ROR 11.0 · χ² 1,787 / p <1e-300	10.2 EB05 9.1 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.2	no trial data cached
Ocular hyperaemia	69	9.7 7.7–12.3ROR 9.9 · χ² 533 / p 3e-118	9.4 EB05 7.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 24.6	no trial data cached
Product packaging issue	13	9.2 5.4–15.9ROR 9.3 · χ² 87 / p 4e-21	7.7 EB05 4.5 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious n=4	no trial data cached
Post procedural complication	25	8.6 5.8–12.7ROR 8.6 · χ² 160 / p 7e-37	7.7 EB05 5.4 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 9.6	no trial data cached
Eyelid oedema	15	8.5 5.1–14.0ROR 8.5 · χ² 91 / p 6e-22	7.1 EB05 4.4 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 10.7	no trial data cached
Product administration error	25	8.3 5.6–12.2ROR 8.3 · χ² 152 / p 3e-35	7.4 EB05 5.2 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 14.6 · ♀ 88% (drug 59%)	no trial data cached
Eye haemorrhage	16	7.9 4.8–12.9ROR 7.9 · χ² 90 / p 2e-21	6.7 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 10.7	no trial data cached
End stage renal disease	22	7.9 5.2–12.0ROR 7.9 · χ² 125 / p 2e-29	7.0 EB05 4.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 10.2 · ♀ 38% (drug 59%)	no trial data cached
Eye disorder	37	7.4 5.4–10.3ROR 7.5 · χ² 200 / p 9e-46	6.9 EB05 5.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.8	no trial data cached
Product use complaint	16	6.8 4.2–11.1ROR 6.8 · χ² 74 / p 5e-18	5.8 EB05 3.8 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious n=4	no trial data cached
Visual impairment	124	6.6 5.6–7.9ROR 6.9 · χ² 592 / p 4e-131	6.5 EB05 5.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.5	no trial data cached
Hemiparesis	17	6.6 4.1–10.6ROR 6.6 · χ² 75 / p 2e-18	5.7 EB05 3.7 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Impaired healing	32	6.4 4.6–9.1ROR 6.5 · χ² 141 / p 7e-33	5.9 EB05 4.4 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 4.1 · 97% clinician	no trial data cached
Eye swelling	36	6.4 4.6–8.9ROR 6.5 · χ² 160 / p 7e-37	6.0 EB05 4.5 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.2	no trial data cached
Chronic kidney disease	72	6.2 4.9–7.8ROR 6.3 · χ² 309 / p 1e-69	6.0 EB05 4.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Osteopenia	14	6.1 3.6–10.2ROR 6.1 · χ² 54 / p 1e-13	5.1 EB05 3.2 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Blindness	33	5.3 3.8–7.5ROR 5.4 · χ² 112 / p 1e-26	5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Dry eye	38	5.2 3.8–7.1ROR 5.2 · χ² 124 / p 4e-29	4.9 EB05 3.7 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.6	no trial data cached
Lacrimation increased	23	5.1 3.4–7.6ROR 5.1 · χ² 71 / p 2e-17	4.6 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.9	no trial data cached
Blood pressure systolic increased	14	4.7 2.8–7.9ROR 4.7 · χ² 37 / p 5e-10	4.1 EB05 2.6 · IC025 +1.2 3/3 methods agree	Lab value / disease marker	serious PRR 6.6	no trial data cached
Inflammation	30	3.9 2.7–5.5ROR 3.9 · χ² 61 / p 3e-15	3.7 EB05 2.7 · IC025 +1.3 3/3 methods agree	Likely indication confounding term in indications	serious PRR 4.7	no trial data cached
Therapy non-responder	25	3.7 2.5–5.5ROR 3.7 · χ² 47 / p 4e-12	3.5 EB05 2.5 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 7.8 · ♀ 96% (drug 59%)	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
Eye pain	455	54.8 50.3–59.6ROR 63.7 · χ² 23,821 / p <1e-300	54.2 EB05 50.1 · IC025 +5.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 27.4 · 86% consumer	no trial data cached
Treatment failure	230	18.5 16.3–21.0ROR 19.9 · χ² 3,799 / p <1e-300	18.4 EB05 16.5 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 4.8 · 74% consumer	no trial data cached
Vision blurred (blurred vision)	213	10.3 9.0–11.7ROR 11.0 · χ² 1,787 / p <1e-300	10.2 EB05 9.1 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.2	no trial data cached
Cataract	129	14.4 12.1–17.0ROR 14.9 · χ² 1,592 / p <1e-300	14.3 EB05 12.3 · IC025 +3.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 20.3	no trial data cached
Visual impairment	124	6.6 5.6–7.9ROR 6.9 · χ² 592 / p 4e-131	6.5 EB05 5.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.5	no trial data cached
Eye irritation	107	12.7 10.5–15.3ROR 13.1 · χ² 1,140 / p 4e-250	12.6 EB05 10.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 25.1	no trial data cached
Visual acuity reduced	93	18.4 15.0–22.4ROR 18.9 · χ² 1,507 / p <1e-300	18.2 EB05 15.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 23.7	no trial data cached
Chronic kidney disease	72	6.2 4.9–7.8ROR 6.3 · χ² 309 / p 1e-69	6.0 EB05 4.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Ocular hyperaemia	69	9.7 7.7–12.3ROR 9.9 · χ² 533 / p 3e-118	9.4 EB05 7.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 24.6	no trial data cached
Product quality issue	66	3.2 2.5–4.1ROR 3.3 · χ² 100 / p 8e-24	3.2 EB05 2.6 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 1.8	no trial data cached
Intraocular pressure increased (raised eye pressure)	64	33.0 25.9–42.1ROR 33.7 · χ² 1,946 / p <1e-300	32.6 EB05 26.4 · IC025 +4.3 3/3 methods agree	Lab value / disease marker	serious PRR 54.0	no trial data cached
Uveitis	46	22.5 16.9–30.0ROR 22.8 · χ² 922 / p 8e-203	22.3 EB05 17.4 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 30.2 · ♀ 80% (drug 59%)	no trial data cached
Incorrect dose administered	45	1.3 1.0–1.8ROR 1.3 · χ² 3 / p 0.037	1.3 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 1.1	no trial data cached
Glaucoma	45	15.4 11.5–20.6ROR 15.6 · χ² 592 / p 5e-131	15.2 EB05 11.8 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 21.0	no trial data cached
Eye inflammation	42	29.5 21.8–39.8ROR 29.9 · χ² 1,122 / p 2e-246	29.0 EB05 22.4 · IC025 +3.9 3/3 methods agree	Likely indication confounding term in indications	serious n=27	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.

Vitreous floaters — n=36, PRR 24.5
Uveitis — n=46, PRR 22.5
Eye discharge — n=34, PRR 22.0
Visual acuity reduced — n=93, PRR 18.4
Blindness unilateral — n=38, PRR 17.8
Eye irritation — n=107, PRR 12.7
Vasculitis — n=22, PRR 12.5
Ocular hyperaemia — n=69, PRR 9.7
End stage renal disease — n=22, PRR 7.9
Eye disorder — n=37, PRR 7.4

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 Nepafenac?

In FDA FAERS, the most frequently co-reported reaction terms for Nepafenac are eye pain, vision blurred, cataract, visual impairment, eye irritation, visual acuity reduced. 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 Nepafenac have an FDA boxed warning?

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

Do FAERS signals prove that Nepafenac 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 f089b583-0310-4ca8-8d41-52b06b08d1ed, effective 20260401; matched on openfda.generic_name.exact:"NEPAFENAC")
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, 79 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.