POLYETHYLENE GLYCOL 400: 154 Adverse Event Reports & Safety Profile
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Route: OPHTHALMIC · Manufacturer: Alcon Laboratories, Inc. · HUMAN OTC DRUG · FDA Label: Available
First Report: 20010725 · Latest Report: 20250901
What Are the Most Common POLYETHYLENE GLYCOL 400 Side Effects?
All POLYETHYLENE GLYCOL 400 Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Eye irritation | 42 | 27.3% | 0 | 1 |
| Vision blurred | 37 | 24.0% | 1 | 2 |
| Drug ineffective | 19 | 12.3% | 2 | 2 |
| Ocular hyperaemia | 16 | 10.4% | 0 | 0 |
| Condition aggravated | 11 | 7.1% | 6 | 5 |
| Eye pain | 10 | 6.5% | 0 | 0 |
| Headache | 9 | 5.8% | 0 | 2 |
| Off label use | 9 | 5.8% | 7 | 6 |
| Constipation | 8 | 5.2% | 6 | 5 |
| Eye pruritus | 8 | 5.2% | 0 | 0 |
| Nausea | 8 | 5.2% | 6 | 5 |
| Visual impairment | 8 | 5.2% | 0 | 2 |
| Abdominal distension | 7 | 4.6% | 6 | 5 |
| Abdominal pain | 7 | 4.6% | 6 | 5 |
| Anaemia | 7 | 4.6% | 7 | 5 |
| Bacterial infection | 7 | 4.6% | 7 | 5 |
| Diabetes mellitus | 7 | 4.6% | 7 | 5 |
| Drug hypersensitivity | 7 | 4.6% | 6 | 5 |
| Dyspnoea | 7 | 4.6% | 7 | 5 |
| Hypersensitivity | 7 | 4.6% | 0 | 0 |
Who Reports POLYETHYLENE GLYCOL 400 Side Effects? Age & Gender Data
Gender: 38.7% female, 61.3% male. Average age: 75.6 years. Most reports from: CA. View detailed demographics →
Is POLYETHYLENE GLYCOL 400 Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 0 | 1 |
| 2014 | 5 | 0 | 1 |
| 2015 | 35 | 0 | 0 |
| 2016 | 12 | 0 | 0 |
| 2017 | 4 | 0 | 0 |
| 2018 | 3 | 0 | 0 |
| 2019 | 3 | 0 | 0 |
| 2020 | 9 | 7 | 7 |
| 2021 | 2 | 0 | 0 |
| 2022 | 2 | 0 | 0 |
| 2023 | 5 | 0 | 0 |
| 2024 | 7 | 0 | 0 |
| 2025 | 9 | 0 | 1 |
What Is POLYETHYLENE GLYCOL 400 Used For?
| Indication | Reports |
|---|---|
| Dry eye | 93 |
| Product used for unknown indication | 21 |
| Constipation | 18 |
POLYETHYLENE GLYCOL 400 vs Alternatives: Which Is Safer?
Official FDA Label for POLYETHYLENE GLYCOL 400
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or 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 above). Replace cap after use.
Discard
90 days after opening.
Warnings
Warnings For external use only. Ask a doctor before use Ask a doctor before use if you have narrow angle glaucoma. When using this product When using this product pupils may become enlarged temporarily overuse may cause more eye redness remove contact lenses before using replace cap after each use do not use if this solution changes color or becomes cloudy do not touch tip of container to any surface to avoid contamination Stop use and ask a doctor if Stop use and ask a doctor if you feel eye pain redness or irritation of the eye lasts changes in vision occur condition worsens or lasts more than 72 hours If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Active Ingredient
Drug Facts Active ingredients Purpose Polyethylene Glycol 400 0.4%....................... Eye lubricant Propylene Glycol 0.3%....................................Eye lubricant
Inactive Ingredients
Inactive ingredients aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD ® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.