Drug · FAERS side-effect profile with label screen
Propylene Glycol side effects: what 2,791 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Systane Complete Pf
openFDA label
Who reports
2,791 reports · 38% serious · 200 with death outcome · 71% 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 40 strongest signals
Reporting / coding artifact 2Lab value / disease marker 2No label text to screen 36
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.
- 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.
- 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. 66 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Eye irritation | 598 | 81.5 75.8–87.5ROR 103.4 · χ² 47,054 / p <1e-300 | 80.4 EB05 75.1 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.5 · 95% consumer | no trial data cached |
| Eye discharge | 95 | 70.5 57.8–86.0ROR 73.0 · χ² 6,383 / p <1e-300 | 68.9 EB05 58.1 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=6 · 91% consumer | no trial data cached |
| Appendicitis | 85 | 69.3 56.2–85.6ROR 71.5 · χ² 5,606 / p <1e-300 | 67.7 EB05 56.5 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 105.7 · ♀ 0% (drug 71%) · 98% clinician | no trial data cached |
| Ventricular fibrillation | 86 | 58.5 47.4–72.0ROR 60.3 · χ² 4,764 / p <1e-300 | 57.3 EB05 47.8 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 88.2 · ♀ 0% (drug 71%) · 98% clinician | no trial data cached |
| Eye pain | 354 | 48.5 44.0–53.4ROR 55.4 · χ² 16,345 / p <1e-300 | 48.0 EB05 44.0 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.7 · 94% consumer | no trial data cached |
| Cardiogenic shock | 82 | 43.4 35.1–53.8ROR 44.7 · χ² 3,338 / p <1e-300 | 42.8 EB05 35.5 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 65.4 · ♀ 1% (drug 71%) · 98% clinician | no trial data cached |
| Ocular hyperaemia | 261 | 42.2 37.6–47.4ROR 46.5 · χ² 10,422 / p <1e-300 | 41.9 EB05 37.8 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.3 · 93% consumer | no trial data cached |
| Eye pruritus | 178 | 40.8 35.4–47.0ROR 43.5 · χ² 6,840 / p <1e-300 | 40.4 EB05 35.7 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.1 · 93% consumer | no trial data cached |
| Ocular discomfort | 49 | 34.0 25.8–45.0ROR 34.6 · χ² 1,533 / p <1e-300 | 33.5 EB05 26.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=8 · 90% consumer | no trial data cached |
| Dry eye | 217 | 33.8 29.7–38.4ROR 36.6 · χ² 6,858 / p <1e-300 | 33.6 EB05 30.0 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.8 · 88% consumer | no trial data cached |
| Lacrimation increased | 115 | 29.0 24.3–34.7ROR 30.2 · χ² 3,076 / p <1e-300 | 28.8 EB05 24.6 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 · 96% consumer | no trial data cached |
| Incorrect route of product administration | 64 | 28.7 22.5–36.6ROR 29.4 · χ² 1,679 / p <1e-300 | 28.4 EB05 23.0 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 84.0 · ♀ 5% (drug 71%) · 95% clinician | no trial data cached |
| Bacterial infection | 64 | 26.0 20.4–33.1ROR 26.6 · χ² 1,508 / p <1e-300 | 25.7 EB05 20.8 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.7 · ♀ 0% (drug 71%) · 97% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 92 | 24.8 20.3–30.4ROR 25.7 · χ² 2,078 / p <1e-300 | 24.7 EB05 20.7 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.5 · ♀ 0% (drug 71%) · 98% clinician | no trial data cached |
| Hyperlipidaemia | 36 | 22.6 16.3–31.3ROR 22.9 · χ² 721 / p 4e-159 | 22.3 EB05 16.8 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.7 · ♀ 6% (drug 71%) · 92% clinician | no trial data cached |
| Neuralgia | 71 | 22.1 17.5–27.8ROR 22.6 · χ² 1,404 / p <1e-300 | 21.9 EB05 17.9 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.8 · ♀ 3% (drug 71%) · 97% clinician | no trial data cached |
| Ascites | 86 | 22.0 17.9–27.1ROR 22.7 · χ² 1,703 / p <1e-300 | 21.9 EB05 18.3 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.8 · ♀ 1% (drug 71%) · 97% clinician | no trial data cached |
| Vision blurred (blurred vision) | 323 | 17.8 16.1–19.7ROR 20.0 · χ² 5,127 / p <1e-300 | 17.7 EB05 16.2 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 · 94% consumer | no trial data cached |
| Ulcer | 37 | 17.5 12.7–24.1ROR 17.7 · χ² 558 / p 1e-123 | 17.3 EB05 13.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.4 · ♀ 0% (drug 71%) · 92% clinician | no trial data cached |
| Gastroenteritis | 33 | 17.0 12.1–23.9ROR 17.2 · χ² 482 / p 4e-107 | 16.8 EB05 12.4 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.7 · ♀ 7% (drug 71%) | no trial data cached |
| Blood test abnormal | 31 | 16.6 11.7–23.6ROR 16.8 · χ² 439 / p 9e-98 | 16.3 EB05 11.9 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 38.5 · ♀ 3% (drug 71%) · 97% clinician | no trial data cached |
| Photophobia (light sensitivity) | 41 | 16.5 12.2–22.4ROR 16.8 · χ² 582 / p 7e-129 | 16.3 EB05 12.5 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.9 · 88% consumer | no trial data cached |
| Gout | 39 | 16.3 12.0–22.3ROR 16.6 · χ² 546 / p 5e-121 | 16.1 EB05 12.2 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.4 · ♀ 8% (drug 71%) · 97% clinician | no trial data cached |
| End stage renal disease | 39 | 15.9 11.7–21.8ROR 16.2 · χ² 531 / p 1e-117 | 15.7 EB05 11.9 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.1 · ♀ 3% (drug 71%) · 92% clinician | no trial data cached |
| Eye inflammation | 19 | 15.2 9.7–23.7ROR 15.3 · χ² 237 / p 9e-54 | 14.5 EB05 9.4 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=8 | no trial data cached |
| Chronic obstructive pulmonary disease | 105 | 15.2 12.6–18.3ROR 15.7 · χ² 1,375 / p <1e-300 | 15.1 EB05 12.8 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.8 · ♀ 36% (drug 71%) · 94% clinician | no trial data cached |
| Aspiration | 21 | 14.6 9.5–22.3ROR 14.7 · χ² 252 / p 5e-57 | 14.0 EB05 9.2 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.7 · 95% clinician | no trial data cached |
| Eosinophilia | 33 | 14.2 10.1–20.0ROR 14.4 · χ² 392 / p 2e-87 | 13.9 EB05 10.1 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.5 · ♀ 100% (drug 71%) | no trial data cached |
| Full blood count abnormal | 19 | 13.6 8.7–21.2ROR 13.6 · χ² 208 / p 2e-47 | 12.8 EB05 8.1 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 25.8 | no trial data cached |
| Eyelid oedema | 20 | 12.9 8.3–19.9ROR 12.9 · χ² 207 / p 3e-47 | 12.1 EB05 7.8 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 · 80% consumer | no trial data cached |
| Presyncope (near-fainting) | 39 | 12.1 8.9–16.6ROR 12.3 · χ² 387 / p 2e-86 | 11.7 EB05 8.8 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.9 · ♀ 100% (drug 71%) | no trial data cached |
| Eye infection | 18 | 12.1 7.6–19.1ROR 12.1 · χ² 172 / p 2e-39 | 11.1 EB05 6.9 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 | no trial data cached |
| Hypercholesterolaemia | 15 | 11.8 7.1–19.5ROR 11.9 · χ² 137 / p 5e-32 | 10.5 EB05 6.2 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.0 | no trial data cached |
| Hyponatraemia (low sodium) | 87 | 11.6 9.5–14.3ROR 12.0 · χ² 837 / p 3e-184 | 11.5 EB05 9.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.1 · ♀ 3% (drug 71%) · 98% clinician | no trial data cached |
| Blood cholesterol increased | 69 | 11.1 8.8–14.1ROR 11.4 · χ² 627 / p 1e-138 | 10.9 EB05 8.8 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 25.2 · ♀ 3% (drug 71%) · 97% clinician | no trial data cached |
| Eye swelling | 54 | 11.0 8.4–14.3ROR 11.2 · χ² 480 / p 9e-107 | 10.7 EB05 8.4 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 · 89% consumer | no trial data cached |
| Lower respiratory tract infection | 66 | 11.0 8.6–13.9ROR 11.2 · χ² 588 / p 4e-130 | 10.7 EB05 8.6 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.6 | no trial data cached |
| Obstructive airways disorder | 16 | 10.8 6.6–17.6ROR 10.8 · χ² 132 / p 7e-31 | 9.5 EB05 5.8 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.0 | no trial data cached |
| Micturition urgency | 16 | 10.6 6.5–17.3ROR 10.7 · χ² 130 / p 2e-30 | 9.3 EB05 5.7 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.6 | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 65 | 10.6 8.3–13.5ROR 10.8 · χ² 556 / p 4e-123 | 10.3 EB05 8.3 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.1 | 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 irritation | 598 | 81.5 75.8–87.5ROR 103.4 · χ² 47,054 / p <1e-300 | 80.4 EB05 75.1 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.5 · 95% consumer | no trial data cached |
| Eye pain | 354 | 48.5 44.0–53.4ROR 55.4 · χ² 16,345 / p <1e-300 | 48.0 EB05 44.0 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.7 · 94% consumer | no trial data cached |
| Vision blurred (blurred vision) | 323 | 17.8 16.1–19.7ROR 20.0 · χ² 5,127 / p <1e-300 | 17.7 EB05 16.2 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 · 94% consumer | no trial data cached |
| Ocular hyperaemia | 261 | 42.2 37.6–47.4ROR 46.5 · χ² 10,422 / p <1e-300 | 41.9 EB05 37.8 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.3 · 93% consumer | no trial data cached |
| Dry eye | 217 | 33.8 29.7–38.4ROR 36.6 · χ² 6,858 / p <1e-300 | 33.6 EB05 30.0 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.8 · 88% consumer | no trial data cached |
| Eye pruritus | 178 | 40.8 35.4–47.0ROR 43.5 · χ² 6,840 / p <1e-300 | 40.4 EB05 35.7 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.1 · 93% consumer | no trial data cached |
| Product quality issue | 169 | 9.4 8.1–10.9ROR 10.0 · χ² 1,272 / p 8e-279 | 9.3 EB05 8.2 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 · 96% consumer | no trial data cached |
| Lacrimation increased | 115 | 29.0 24.3–34.7ROR 30.2 · χ² 3,076 / p <1e-300 | 28.8 EB05 24.6 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 · 96% consumer | no trial data cached |
| Pulmonary embolism (lung blood clot) | 108 | 8.5 7.1–10.2ROR 8.8 · χ² 710 / p 8e-157 | 8.3 EB05 7.0 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.0 · ♀ 35% (drug 71%) · 93% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 105 | 15.2 12.6–18.3ROR 15.7 · χ² 1,375 / p <1e-300 | 15.1 EB05 12.8 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.8 · ♀ 36% (drug 71%) · 94% clinician | no trial data cached |
| Sepsis (blood infection) | 104 | 7.0 5.8–8.5ROR 7.2 · χ² 532 / p 5e-118 | 6.8 EB05 5.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.7 · ♀ 12% (drug 71%) · 96% clinician | no trial data cached |
| Somnolence (drowsiness) | 103 | 3.9 3.2–4.7ROR 4.0 · χ² 216 / p 3e-49 | 3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.3 · ♀ 20% (drug 71%) | no trial data cached |
| Drug hypersensitivity | 102 | 3.9 3.3–4.8ROR 4.1 · χ² 223 / p 8e-51 | 3.9 EB05 3.3 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.8 · ♀ 28% (drug 71%) | no trial data cached |
| Stress | 98 | 10.2 8.4–12.5ROR 10.6 · χ² 810 / p 1e-178 | 10.1 EB05 8.4 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.0 · ♀ 12% (drug 71%) | no trial data cached |
| Eye discharge | 95 | 70.5 57.8–86.0ROR 73.0 · χ² 6,383 / p <1e-300 | 68.9 EB05 58.1 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=6 · 91% consumer | 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?
In FDA FAERS, the most frequently co-reported reaction terms for Propylene Glycol are eye irritation, eye pain, vision blurred, ocular hyperaemia, dry eye, eye pruritus. 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 have an FDA boxed warning?
No. The FDA label retrieved for Propylene Glycol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Propylene Glycol 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 7eaa93ca-c843-4c89-921b-c76659410dce, effective 20231214; matched on
openfda.generic_name.exact:"PROPYLENE GLYCOL") - 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, fieldpatient.drug.openfda.generic_name.exact, 106 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.