Netarsudil side effects: what 1,939 FDA adverse event reports show

Netarsudil · Rhopressa · 38 reaction terms · 1,415 drug–reaction co-reports · data 2026-09-14

Drug class

Rho kinase inhibitor

FDA label, Indications wording

Brand names

Rhopressa

openFDA label

Who reports

1,939 reports · 22% serious · 60 with death outcome · 62% female

openFDA FAERS counts, all years, deduplication not applied

Used for

RHOPRESSA is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. RHOPRESSA ® is a Rho kinase inhibitor indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )

FDA label, Indications and Usage

What it is

Netarsudil is a Rho kinase inhibitor.

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 24 strongest signals

Labeled adverse reaction 1Labeled (related wording) 4Likely indication confounding 2Reporting / coding artifact 4Not in label — unassessed 13

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.
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. 14 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
Intraocular pressure increased (raised eye pressure)	93	78.9 64.6–96.2ROR 82.8 · χ² 7,023 / p <1e-300	77.1 EB05 64.8 · IC025 +5.4 3/3 methods agree	Likely indication confounding term in indications	serious PRR 68.6	no trial data cached
Ocular hyperaemia	159	36.9 31.8–42.8ROR 40.1 · χ² 5,512 / p <1e-300	36.6 EB05 32.1 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 49.9	no trial data cached
Lacrimation increased	94	34.1 28.0–41.6ROR 35.8 · χ² 2,983 / p <1e-300	33.8 EB05 28.4 · IC025 +4.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 24.7 · 85% consumer	no trial data cached
Visual acuity reduced	89	28.8 23.5–35.3ROR 30.1 · χ² 2,358 / p <1e-300	28.6 EB05 23.9 · IC025 +4.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.0	no trial data cached
Eye pain	141	27.7 23.6–32.4ROR 29.8 · χ² 3,597 / p <1e-300	27.5 EB05 23.9 · IC025 +4.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 20.2 · 87% consumer	no trial data cached
Eye pruritus	70	23.0 18.3–28.9ROR 23.8 · χ² 1,450 / p <1e-300	22.8 EB05 18.7 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 25.5 · 78% consumer	no trial data cached
Eye irritation	116	22.5 18.9–26.9ROR 23.9 · χ² 2,367 / p <1e-300	22.4 EB05 19.2 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 40.6 · 79% consumer	no trial data cached
Eye discharge	21	22.3 14.5–34.1ROR 22.5 · χ² 405 / p 3e-90	21.8 EB05 15.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=4 · 71% consumer	no trial data cached
Ocular discomfort	20	19.9 12.9–30.8ROR 20.1 · χ² 341 / p 2e-76	19.5 EB05 13.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=4 · 75% consumer	no trial data cached
Product packaging quantity issue	20	19.8 12.8–30.7ROR 20.0 · χ² 339 / p 6e-76	19.4 EB05 13.1 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious n=1 · 90% consumer	no trial data cached
Photophobia (light sensitivity)	28	16.2 11.2–23.5ROR 16.5 · χ² 385 / p 5e-86	15.9 EB05 11.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 17.2 · 79% consumer	no trial data cached
Uveitis	20	16.0 10.4–24.8ROR 16.2 · χ² 267 / p 3e-60	15.5 EB05 10.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 11.2 · 75% consumer	no trial data cached
Eye inflammation	13	14.9 8.7–25.6ROR 15.0 · χ² 155 / p 7e-36	13.8 EB05 7.7 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Vision blurred (blurred vision)	162	12.8 11.1–14.9ROR 13.9 · χ² 1,765 / p <1e-300	12.8 EB05 11.2 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.3 · 81% consumer	no trial data cached
Glaucoma	20	11.2 7.3–17.4ROR 11.3 · χ² 176 / p 2e-40	10.3 EB05 6.6 · IC025 +2.4 3/3 methods agree	Likely indication confounding term in indications	serious PRR 28.5	no trial data cached
Dry eye	43	9.6 7.1–12.9ROR 9.8 · χ² 323 / p 1e-72	9.1 EB05 6.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 9.6 · 86% consumer	no trial data cached
Eye haemorrhage	11	8.9 4.9–16.0ROR 8.9 · χ² 69 / p 4e-17	7.1 EB05 4.0 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.9	no trial data cached
Conjunctivitis	15	8.8 5.3–14.6ROR 8.9 · χ² 96 / p 5e-23	7.5 EB05 4.6 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.9	no trial data cached
Eye swelling	27	7.9 5.4–11.5ROR 8.0 · χ² 156 / p 4e-36	7.2 EB05 5.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 1.6 · 88% consumer	no trial data cached
Blindness unilateral	10	7.7 4.1–14.3ROR 7.7 · χ² 52 / p 3e-13	6.0 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 18.7	no trial data cached
Visual impairment	49	4.3 3.3–5.7ROR 4.4 · χ² 122 / p 1e-28	4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached
Product dose omission issue	92	3.5 2.9–4.3ROR 3.6 · χ² 163 / p 1e-37	3.4 EB05 2.9 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0 · 81% consumer	no trial data cached
Accidental overdose	10	3.0 1.6–5.5ROR 3.0 · χ² 11 / p 4e-4	2.7 EB05 1.6 · IC025 +0.4	Reporting / coding artifact	–	no trial data cached
Product storage error	21	2.6 1.7–4.0ROR 2.6 · χ² 20 / p 5e-6	2.5 EB05 1.8 · IC025 +0.6	Reporting / coding artifact	serious PRR 14.1 · 81% 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
Vision blurred (blurred vision)	162	12.8 11.1–14.9ROR 13.9 · χ² 1,765 / p <1e-300	12.8 EB05 11.2 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.3 · 81% consumer	no trial data cached
Ocular hyperaemia	159	36.9 31.8–42.8ROR 40.1 · χ² 5,512 / p <1e-300	36.6 EB05 32.1 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 49.9	no trial data cached
Eye pain	141	27.7 23.6–32.4ROR 29.8 · χ² 3,597 / p <1e-300	27.5 EB05 23.9 · IC025 +4.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 20.2 · 87% consumer	no trial data cached
Eye irritation	116	22.5 18.9–26.9ROR 23.9 · χ² 2,367 / p <1e-300	22.4 EB05 19.2 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 40.6 · 79% consumer	no trial data cached
Lacrimation increased	94	34.1 28.0–41.6ROR 35.8 · χ² 2,983 / p <1e-300	33.8 EB05 28.4 · IC025 +4.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 24.7 · 85% consumer	no trial data cached
Intraocular pressure increased (raised eye pressure)	93	78.9 64.6–96.2ROR 82.8 · χ² 7,023 / p <1e-300	77.1 EB05 64.8 · IC025 +5.4 3/3 methods agree	Likely indication confounding term in indications	serious PRR 68.6	no trial data cached
Product dose omission issue	92	3.5 2.9–4.3ROR 3.6 · χ² 163 / p 1e-37	3.4 EB05 2.9 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0 · 81% consumer	no trial data cached
Visual acuity reduced	89	28.8 23.5–35.3ROR 30.1 · χ² 2,358 / p <1e-300	28.6 EB05 23.9 · IC025 +4.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.0	no trial data cached
Eye pruritus	70	23.0 18.3–28.9ROR 23.8 · χ² 1,450 / p <1e-300	22.8 EB05 18.7 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 25.5 · 78% consumer	no trial data cached
Visual impairment	49	4.3 3.3–5.7ROR 4.4 · χ² 122 / p 1e-28	4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached
Dry eye	43	9.6 7.1–12.9ROR 9.8 · χ² 323 / p 1e-72	9.1 EB05 6.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 9.6 · 86% consumer	no trial data cached
Photophobia (light sensitivity)	28	16.2 11.2–23.5ROR 16.5 · χ² 385 / p 5e-86	15.9 EB05 11.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 17.2 · 79% consumer	no trial data cached
Eye swelling	27	7.9 5.4–11.5ROR 8.0 · χ² 156 / p 4e-36	7.2 EB05 5.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 1.6 · 88% consumer	no trial data cached
Product storage error	21	2.6 1.7–4.0ROR 2.6 · χ² 20 / p 5e-6	2.5 EB05 1.8 · IC025 +0.6	Reporting / coding artifact	serious PRR 14.1 · 81% consumer	no trial data cached
Eye discharge	21	22.3 14.5–34.1ROR 22.5 · χ² 405 / p 3e-90	21.8 EB05 15.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=4 · 71% 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.

Ocular hyperaemia — n=159, PRR 36.9
Eye pruritus — n=70, PRR 23.0
Eye irritation — n=116, PRR 22.5
Eye discharge — n=21, PRR 22.3
Ocular discomfort — n=20, PRR 19.9
Photophobia — n=28, PRR 16.2
Uveitis — n=20, PRR 16.0
Dry eye — n=43, PRR 9.6
Eye swelling — n=27, PRR 7.9
Visual impairment — n=49, PRR 4.3

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 Netarsudil?

In FDA FAERS, the most frequently co-reported reaction terms for Netarsudil are vision blurred, ocular hyperaemia, eye pain, eye irritation, lacrimation increased, intraocular pressure increased. 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 Netarsudil have an FDA boxed warning?

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

Do FAERS signals prove that Netarsudil 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 7d4f0e3a-5b86-4c43-982a-813b22ae7e22, effective 20260120; matched on openfda.generic_name.exact:"NETARSUDIL")
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, 38 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.