PROPYLENE GLYCOL: 1,519 Adverse Event Reports & Safety Profile
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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?
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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is PROPYLENE GLYCOL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 1,008 |
| Dry eye | 379 |
| Hyperthyroidism | 16 |
| Eye lubrication therapy | 6 |
PROPYLENE GLYCOL vs Alternatives: Which Is Safer?
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.