Drug · FAERS side-effect profile with label screen

Oxymetazoline Ophthalmic side effects: what 1,740 FDA adverse event reports show

Oxymetazoline Hydrochloride Ophthalmic · 27 reaction terms · 1,629 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Oxymetazoline Hydrochloride Ophthalmic (Upneeq)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

1,740 reports · 6% serious · 2 with death outcome · 88% female

openFDA FAERS counts, all years, deduplication not applied

Used for

UPNEEQ is indicated for the treatment of acquired blepharoptosis in adults. UPNEEQ is indicated for the treatment of acquired blepharoptosis in adults. ( 1 )

FDA label, Indications and Usage

What it is

UPNEEQ (oxymetazoline hydrochloride ophthalmic solution), 0.1% contains oxymetazoline hydrochloride, an alpha adrenoceptor agonist. UPNEEQ is an aseptically prepared, sterile, non-preserved ophthalmic solution.

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 21 strongest signals

Labeled adverse reaction 4Labeled (related wording) 1Reporting / coding artifact 3Not 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.
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. 6 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
Mydriasis	119	112.9 94.9–134.4ROR 121.1 · χ² 12,973 / p <1e-300	109.9 EB05 94.3 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious PRR 36.2	no trial data cached
Ocular hyperaemia	211	54.7 48.2–62.1ROR 62.1 · χ² 11,038 / p <1e-300	54.2 EB05 48.3 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 45.1	no trial data cached
Eye irritation	221	48.0 42.4–54.3ROR 54.8 · χ² 10,101 / p <1e-300	47.6 EB05 42.5 · IC025 +5.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 85.6	no trial data cached
Dry eye	142	35.4 30.2–41.5ROR 38.5 · χ² 4,712 / p <1e-300	35.2 EB05 30.6 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 47.1	no trial data cached
Ocular discomfort	31	34.5 24.3–48.9ROR 35.1 · χ² 973 / p 8e-214	33.8 EB05 24.9 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Eye pain	150	32.8 28.2–38.3ROR 35.8 · χ² 4,595 / p <1e-300	32.6 EB05 28.5 · IC025 +4.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 35.0 · 79% consumer	no trial data cached
Eye pruritus	89	32.6 26.6–39.9ROR 34.3 · χ² 2,693 / p <1e-300	32.3 EB05 27.1 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 13.5 · 73% consumer	no trial data cached
Eye discharge	27	31.9 21.9–46.4ROR 32.4 · χ² 777 / p 3e-171	31.2 EB05 22.5 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Lacrimation increased	77	31.1 25.0–38.7ROR 32.5 · χ² 2,213 / p <1e-300	30.8 EB05 25.5 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 10.4	no trial data cached
Eyelid ptosis	20	23.7 15.3–36.7ROR 24.0 · χ² 413 / p 5e-92	23.2 EB05 15.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Vision blurred (blurred vision)	255	22.5 20.1–25.2ROR 26.2 · χ² 5,251 / p <1e-300	22.5 EB05 20.2 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 25.1	no trial data cached
Drug effect less than expected	26	22.3 15.2–32.6ROR 22.6 · χ² 506 / p 2e-112	21.9 EB05 15.7 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Eyelid oedema	20	20.6 13.3–31.9ROR 20.9 · χ² 354 / p 3e-79	20.2 EB05 13.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 15.0	no trial data cached
Photophobia (light sensitivity)	31	20.0 14.1–28.4ROR 20.4 · χ² 541 / p 5e-120	19.8 EB05 14.5 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 20.8	no trial data cached
Eye swelling	61	19.9 15.6–25.5ROR 20.6 · χ² 1,077 / p 2e-236	19.8 EB05 15.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 27.3 · 73% consumer	no trial data cached
Vitreous floaters	14	17.3 10.3–29.2ROR 17.5 · χ² 199 / p 1e-45	16.5 EB05 9.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Eye inflammation	11	14.1 7.8–25.4ROR 14.1 · χ² 121 / p 2e-28	12.5 EB05 6.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Product administration error	19	11.5 7.3–18.0ROR 11.6 · χ² 171 / p 2e-39	10.5 EB05 6.7 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Therapeutic product effect decreased	35	9.5 6.9–13.2ROR 9.7 · χ² 258 / p 2e-58	8.9 EB05 6.6 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Diplopia (double vision)	14	6.5 3.9–10.9ROR 6.5 · χ² 60 / p 5e-15	5.5 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 25.2	no trial data cached
Eye disorder	17	6.3 3.9–10.0ROR 6.3 · χ² 70 / p 3e-17	5.4 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.2	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
Vision blurred (blurred vision)	255	22.5 20.1–25.2ROR 26.2 · χ² 5,251 / p <1e-300	22.5 EB05 20.2 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 25.1	no trial data cached
Eye irritation	221	48.0 42.4–54.3ROR 54.8 · χ² 10,101 / p <1e-300	47.6 EB05 42.5 · IC025 +5.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 85.6	no trial data cached
Ocular hyperaemia	211	54.7 48.2–62.1ROR 62.1 · χ² 11,038 / p <1e-300	54.2 EB05 48.3 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 45.1	no trial data cached
Eye pain	150	32.8 28.2–38.3ROR 35.8 · χ² 4,595 / p <1e-300	32.6 EB05 28.5 · IC025 +4.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 35.0 · 79% consumer	no trial data cached
Dry eye	142	35.4 30.2–41.5ROR 38.5 · χ² 4,712 / p <1e-300	35.2 EB05 30.6 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 47.1	no trial data cached
Mydriasis	119	112.9 94.9–134.4ROR 121.1 · χ² 12,973 / p <1e-300	109.9 EB05 94.3 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious PRR 36.2	no trial data cached
Eye pruritus	89	32.6 26.6–39.9ROR 34.3 · χ² 2,693 / p <1e-300	32.3 EB05 27.1 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 13.5 · 73% consumer	no trial data cached
Lacrimation increased	77	31.1 25.0–38.7ROR 32.5 · χ² 2,213 / p <1e-300	30.8 EB05 25.5 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 10.4	no trial data cached
Eye swelling	61	19.9 15.6–25.5ROR 20.6 · χ² 1,077 / p 2e-236	19.8 EB05 15.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 27.3 · 73% consumer	no trial data cached
Therapeutic product effect decreased	35	9.5 6.9–13.2ROR 9.7 · χ² 258 / p 2e-58	8.9 EB05 6.6 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Photophobia (light sensitivity)	31	20.0 14.1–28.4ROR 20.4 · χ² 541 / p 5e-120	19.8 EB05 14.5 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 20.8	no trial data cached
Ocular discomfort	31	34.5 24.3–48.9ROR 35.1 · χ² 973 / p 8e-214	33.8 EB05 24.9 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Eye discharge	27	31.9 21.9–46.4ROR 32.4 · χ² 777 / p 3e-171	31.2 EB05 22.5 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Drug effect less than expected	26	22.3 15.2–32.6ROR 22.6 · χ² 506 / p 2e-112	21.9 EB05 15.7 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Eyelid oedema	20	20.6 13.3–31.9ROR 20.9 · χ² 354 / p 3e-79	20.2 EB05 13.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 15.0	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.

Mydriasis — n=119, PRR 112.9
Ocular hyperaemia — n=211, PRR 54.7
Ocular discomfort — n=31, PRR 34.5
Eye pruritus — n=89, PRR 32.6
Eye discharge — n=27, PRR 31.9
Lacrimation increased — n=77, PRR 31.1
Eyelid ptosis — n=20, PRR 23.7
Eyelid oedema — n=20, PRR 20.6
Eye swelling — n=61, PRR 19.9

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 Oxymetazoline Ophthalmic?

In FDA FAERS, the most frequently co-reported reaction terms for Oxymetazoline Ophthalmic are vision blurred, eye irritation, ocular hyperaemia, eye pain, dry eye, mydriasis. 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 Oxymetazoline Ophthalmic have an FDA boxed warning?

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

Do FAERS signals prove that Oxymetazoline Ophthalmic 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 cf6c9a1f-2367-46d2-99c3-c7d67ec6f519, effective 20260723; matched on openfda.generic_name.exact:"OXYMETAZOLINE HYDROCHLORIDE OPHTHALMIC")
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, 27 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.