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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

PROPYLENE GLYCOL: 1,519 Adverse Event Reports & Safety Profile

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1,519
Total FAERS Reports
109 (7.2%)
Deaths Reported
148
Hospitalizations
1,519
As Primary/Secondary Suspect
70
Life-Threatening
91
Disabilities
Wal-Mart Stores, Inc.
Manufacturer

Route: OPHTHALMIC · Manufacturer: Wal-Mart Stores, Inc. · HUMAN OTC DRUG · FDA Label: Available

First Report: 201206 · Latest Report: 20250626

What Are the Most Common PROPYLENE GLYCOL Side Effects?

#1 Most Reported
Eye irritation
503 reports (33.1%)
#2 Most Reported
Vision blurred
248 reports (16.3%)
#3 Most Reported
Eye pain
224 reports (14.7%)

All PROPYLENE GLYCOL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Eye irritation 503 33.1% 0 0
Vision blurred 248 16.3% 0 0
Eye pain 224 14.8% 0 0
Drug ineffective 209 13.8% 21 52
Ocular hyperaemia 201 13.2% 0 2
Product quality issue 164 10.8% 0 0
Eye pruritus 160 10.5% 0 2
Dry eye 158 10.4% 0 1
Foreign body sensation in eyes 131 8.6% 0 0
Asthenopia 100 6.6% 0 0
Nausea 100 6.6% 63 78
Vomiting 99 6.5% 65 81
Dyspnoea 85 5.6% 44 74
Lacrimation increased 84 5.5% 0 1
Chronic obstructive pulmonary disease 80 5.3% 47 77
Off label use 79 5.2% 69 54
Pulmonary embolism 79 5.2% 48 76
Condition aggravated 75 4.9% 60 52
Stress 71 4.7% 70 51
Hyponatraemia 70 4.6% 70 51

Who Reports PROPYLENE GLYCOL Side Effects? Age & Gender Data

Gender: 69.1% female, 30.9% male. Average age: 69.1 years. Most reports from: US. View detailed demographics →

Is PROPYLENE GLYCOL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2012 1 0 1
2013 3 0 1
2014 14 1 5
2015 78 0 2
2016 121 0 0
2017 123 0 5
2018 109 0 0
2019 47 0 4
2020 34 29 28
2021 12 2 4
2022 10 0 1
2023 17 0 2
2024 7 0 1
2025 2 0 0

View full timeline →

What Is PROPYLENE GLYCOL Used For?

IndicationReports
Product used for unknown indication 1,008
Dry eye 379
Hyperthyroidism 16
Eye lubrication therapy 6

PROPYLENE GLYCOL vs Alternatives: Which Is Safer?

PROPYLENE GLYCOL vs PROPYLTHIOURACIL PROPYLENE GLYCOL vs PROTAMINE PROPYLENE GLYCOL vs PROTHIPENDYL PROPYLENE GLYCOL vs PROTIONAMIDE PROPYLENE GLYCOL vs PROTONIX PROPYLENE GLYCOL vs PROTOPIC PROPYLENE GLYCOL vs PROVENGE PROPYLENE GLYCOL vs PROVENTIL PROPYLENE GLYCOL vs PROVERA PROPYLENE GLYCOL vs PROZAC

Official FDA Label for PROPYLENE GLYCOL

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Uses 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

Dosage & Administration

Directions shake well before using put 1 or 2 drops in the affected eye(s) as needed see side of carton for directions for use

Directions for use: Hold the bottle just below the cap and twist the cap to open. BEFORE FIRST USE , hold the bottle upside down and dispense one drop of product to discard. Shake the bottle downward to remove residual product (see picture).

Place

1 or 2 drops in the affected eye(s) as needed and blink. After use, shake the bottle downward to remove residual product that may be left on the tip (see picture on side panel). Replace cap after use.

Discard

30 days after opening.

Warnings

Warnings For external use only Do not use If this product changes color or becomes cloudy If you are sensitive to any ingredient in this product. Do not use if imprinted seal around cap is broken or bottle is damaged When using this product Make sure the tip of container does not touch any surface to avoid contamination. Replace cap after each use Stop use and ask a doctor if you experience any of the following: Eye pain, changes in vision, continued redness or irritation of the eye Condition worsens or persists for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Active Ingredient(s) BENZALKONIUM CHLORIDE 1.2g/pcs. Purpose: Antiseptic

Inactive Ingredients

Inactive ingredients benzalkonium chloride solution, boric acid, calcium chloride, castor oil, disodium edetate, magnesium chloride, polyoxyl 40 hydrogenated castor oil, potassium chloride, purified water, sodium borate, sodium chloride, sodium hyaluronate. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.