Propylene Glycol Emulsion side effects: what 125 FDA adverse event reports show

Propylene Glycol Emulsion · Systane Complete Pf · 7 reaction terms · 116 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Systane Complete Pf

openFDA label

Who reports

125 reports · 38% serious · 0 with death outcome · 76% female

openFDA FAERS counts, all years, deduplication not applied

Used for

for the temporary relief of burning and irritation due to dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun for use as a protectant against further irritation or to relieve dryness of the eye for use as a lubricant to prevent further irritation or to relieve dryness of the eye

FDA label, Indications and Usage

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 6 strongest signals

Reporting / coding artifact 1No label text to screen 5

What the badges mean

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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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. 1 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
Ocular discomfort	10	154.6 85.3–280.2ROR 168.0 · χ² 1,376 / p <1e-300	119.8 EB05 69.5 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1	no trial data cached
Eye pain	49	149.0 119.7–185.3ROR 244.4 · χ² 7,067 / p <1e-300	140.8 EB05 110.7 · IC025 +5.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 75.2 · 96% consumer	no trial data cached
Eye discharge	5	82.1 34.8–193.9ROR 85.5 · χ² 324 / p 1e-72	63.2 EB05 28.9 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2	no trial data cached
Eye irritation	23	69.2 47.9–100.2ROR 84.6 · χ² 1,483 / p <1e-300	65.6 EB05 46.0 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 160.9 · 91% consumer	no trial data cached
Ocular hyperaemia	19	68.2 45.1–103.3ROR 80.3 · χ² 1,195 / p 4e-262	64.0 EB05 43.3 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 129.3	no trial data cached
Device use issue	6	58.2 26.6–127.0ROR 61.0 · χ² 282 / p 1e-63	49.5 EB05 24.3 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious n=1	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	49	149.0 119.7–185.3ROR 244.4 · χ² 7,067 / p <1e-300	140.8 EB05 110.7 · IC025 +5.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 75.2 · 96% consumer	no trial data cached
Eye irritation	23	69.2 47.9–100.2ROR 84.6 · χ² 1,483 / p <1e-300	65.6 EB05 46.0 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 160.9 · 91% consumer	no trial data cached
Ocular hyperaemia	19	68.2 45.1–103.3ROR 80.3 · χ² 1,195 / p 4e-262	64.0 EB05 43.3 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 129.3	no trial data cached
Ocular discomfort	10	154.6 85.3–280.2ROR 168.0 · χ² 1,376 / p <1e-300	119.8 EB05 69.5 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1	no trial data cached
Device use issue	6	58.2 26.6–127.0ROR 61.0 · χ² 282 / p 1e-63	49.5 EB05 24.3 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Eye discharge	5	82.1 34.8–193.9ROR 85.5 · χ² 324 / p 1e-72	63.2 EB05 28.9 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2	no trial data cached
Poor quality product administered	4	65.7 25.0–172.2ROR 67.8 · χ² 194 / p 2e-44	50.0 EB05 20.2 · IC025 +1.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=4	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Propylene Glycol Emulsion?

In FDA FAERS, the most frequently co-reported reaction terms for Propylene Glycol Emulsion are eye pain, eye irritation, ocular hyperaemia, ocular discomfort, eye discharge, poor quality product administered. 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 Propylene Glycol Emulsion have an FDA boxed warning?

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

Do FAERS signals prove that Propylene Glycol Emulsion 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 798ffdde-1dba-4a3f-a0b6-937f9e958cca, effective 20251103; matched on openfda.generic_name.exact:"PROPYLENE GLYCOL EMULSION")
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, 7 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.