Drug · FAERS side-effect profile with label screen

Proparacaine side effects: what 527 FDA adverse event reports show

Proparacaine Hydrochloride · 16 reaction terms · 330 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Proparacaine Hydrochloride (Proparacaine Hydrochloride)

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

Who reports

527 reports · 92% serious · 35 with death outcome · 55% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Proparacaine Hydrochloride Ophthalmic Solution is indicated for topical anesthesia in ophthalmic practice. Representative ophthalmic procedures in which the preparation provides good local anesthesia include measurement of intraocular pressure (tonomet.

FDA label, Indications and Usage

What it is

DESCRIPTION Proparacaine hydrochloride ophthalmic solution USP, 0.5% is a local anesthetic for ophthalmic instillation.

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 16 strongest signals

Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 2Not in label — unassessed 11

What the badges mean

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. 0 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 inflammation	20	84.5 55.0–130.0ROR 87.8 · χ² 1,566 / p <1e-300	78.3 EB05 53.5 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=19	no trial data cached
Photophobia (light sensitivity)	34	72.6 52.4–100.5ROR 77.5 · χ² 2,327 / p <1e-300	69.7 EB05 52.2 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 71.4 · ♀ 18% (drug 55%) · 94% clinician	no trial data cached
Eyelid oedema	14	47.6 28.4–79.9ROR 48.9 · χ² 593 / p 3e-131	44.9 EB05 28.4 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 43.7	no trial data cached
Eye pain	61	44.0 34.7–55.7ROR 49.6 · χ² 2,524 / p <1e-300	43.4 EB05 35.0 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 60.5	no trial data cached
Intraocular pressure increased (raised eye pressure)	13	40.3 23.6–69.0ROR 41.3 · χ² 460 / p 3e-102	38.2 EB05 23.8 · IC025 +3.1 3/3 methods agree	Likely indication confounding term in indications	serious PRR 31.6	no trial data cached
Visual acuity reduced	33	39.2 28.2–54.6ROR 41.8 · χ² 1,193 / p 1e-261	38.4 EB05 28.6 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 33.1 · 97% clinician	no trial data cached
Lacrimation increased	28	37.3 26.0–53.5ROR 39.4 · χ² 954 / p 8e-210	36.4 EB05 26.5 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 58.6 · ♀ 21% (drug 55%) · 96% clinician	no trial data cached
Mydriasis	10	31.1 16.8–57.4ROR 31.6 · χ² 262 / p 4e-59	29.4 EB05 16.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 20.1	no trial data cached
Vitreous floaters	7	28.6 13.7–59.8ROR 29.0 · χ² 160 / p 6e-37	26.2 EB05 12.8 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=7	no trial data cached
Drug abuse	59	28.1 22.1–35.7ROR 31.5 · χ² 1,519 / p <1e-300	27.8 EB05 22.4 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 17.8 · ♀ 10% (drug 55%) · 98% clinician	no trial data cached
Retinal detachment	6	26.0 11.7–57.6ROR 26.3 · χ² 120 / p 3e-28	23.0 EB05 9.5 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 16.5	no trial data cached
Post procedural complication	10	20.7 11.2–38.2ROR 21.1 · χ² 168 / p 9e-39	19.5 EB05 10.5 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 14.1	no trial data cached
Blindness unilateral	6	17.0 7.7–37.6ROR 17.1 · χ² 75 / p 3e-18	13.5 EB05 5.0 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.0	no trial data cached
Uveitis	5	14.7 6.2–35.3ROR 14.9 · χ² 51 / p 5e-13	10.3 EB05 3.6 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.8	no trial data cached
Anaphylactic shock	8	12.4 6.2–24.7ROR 12.6 · χ² 73 / p 6e-18	9.8 EB05 4.5 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 7.8	no trial data cached
Eye irritation	16	11.4 7.0–18.5ROR 11.7 · χ² 142 / p 4e-33	10.2 EB05 6.2 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 15.6	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	61	44.0 34.7–55.7ROR 49.6 · χ² 2,524 / p <1e-300	43.4 EB05 35.0 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 60.5	no trial data cached
Drug abuse	59	28.1 22.1–35.7ROR 31.5 · χ² 1,519 / p <1e-300	27.8 EB05 22.4 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 17.8 · ♀ 10% (drug 55%) · 98% clinician	no trial data cached
Photophobia (light sensitivity)	34	72.6 52.4–100.5ROR 77.5 · χ² 2,327 / p <1e-300	69.7 EB05 52.2 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 71.4 · ♀ 18% (drug 55%) · 94% clinician	no trial data cached
Visual acuity reduced	33	39.2 28.2–54.6ROR 41.8 · χ² 1,193 / p 1e-261	38.4 EB05 28.6 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 33.1 · 97% clinician	no trial data cached
Lacrimation increased	28	37.3 26.0–53.5ROR 39.4 · χ² 954 / p 8e-210	36.4 EB05 26.5 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 58.6 · ♀ 21% (drug 55%) · 96% clinician	no trial data cached
Eye inflammation	20	84.5 55.0–130.0ROR 87.8 · χ² 1,566 / p <1e-300	78.3 EB05 53.5 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=19	no trial data cached
Eye irritation	16	11.4 7.0–18.5ROR 11.7 · χ² 142 / p 4e-33	10.2 EB05 6.2 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 15.6	no trial data cached
Eyelid oedema	14	47.6 28.4–79.9ROR 48.9 · χ² 593 / p 3e-131	44.9 EB05 28.4 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 43.7	no trial data cached
Intraocular pressure increased (raised eye pressure)	13	40.3 23.6–69.0ROR 41.3 · χ² 460 / p 3e-102	38.2 EB05 23.8 · IC025 +3.1 3/3 methods agree	Likely indication confounding term in indications	serious PRR 31.6	no trial data cached
Post procedural complication	10	20.7 11.2–38.2ROR 21.1 · χ² 168 / p 9e-39	19.5 EB05 10.5 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 14.1	no trial data cached
Mydriasis	10	31.1 16.8–57.4ROR 31.6 · χ² 262 / p 4e-59	29.4 EB05 16.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 20.1	no trial data cached
Anaphylactic shock	8	12.4 6.2–24.7ROR 12.6 · χ² 73 / p 6e-18	9.8 EB05 4.5 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 7.8	no trial data cached
Vitreous floaters	7	28.6 13.7–59.8ROR 29.0 · χ² 160 / p 6e-37	26.2 EB05 12.8 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=7	no trial data cached
Blindness unilateral	6	17.0 7.7–37.6ROR 17.1 · χ² 75 / p 3e-18	13.5 EB05 5.0 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.0	no trial data cached
Retinal detachment	6	26.0 11.7–57.6ROR 26.3 · χ² 120 / p 3e-28	23.0 EB05 9.5 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 16.5	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.

Eye inflammation — n=20, PRR 84.5
Photophobia — n=34, PRR 72.6
Eye pain — n=61, PRR 44.0
Visual acuity reduced — n=33, PRR 39.2

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 Proparacaine?

In FDA FAERS, the most frequently co-reported reaction terms for Proparacaine are eye pain, photophobia, visual acuity reduced, lacrimation increased, eye inflammation, eye irritation. 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 Proparacaine have an FDA boxed warning?

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

Do FAERS signals prove that Proparacaine 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 4ae89863-233f-4015-92da-aad0f2a87677, effective 20260206; matched on openfda.generic_name.exact:"PROPARACAINE HYDROCHLORIDE")
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, 16 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.