POLYVINYL ALCOHOL: 73 Adverse Event Reports & Safety Profile
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Route: OPHTHALMIC · Manufacturer: Optics Laboratory, Inc · HUMAN OTC DRUG · FDA Label: Available
First Report: 20120424 · Latest Report: 20250522
What Are the Most Common POLYVINYL ALCOHOL Side Effects?
All POLYVINYL ALCOHOL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Vision blurred | 12 | 16.4% | 0 | 2 |
| Eye irritation | 9 | 12.3% | 0 | 0 |
| Recalled product | 8 | 11.0% | 0 | 2 |
| Recalled product administered | 8 | 11.0% | 0 | 2 |
| Eye pain | 7 | 9.6% | 0 | 1 |
| Adverse event | 5 | 6.9% | 1 | 0 |
| Eye pruritus | 5 | 6.9% | 0 | 0 |
| Muscle spasticity | 5 | 6.9% | 0 | 0 |
| Pain | 5 | 6.9% | 0 | 0 |
| Visual impairment | 5 | 6.9% | 0 | 1 |
Who Reports POLYVINYL ALCOHOL Side Effects? Age & Gender Data
Gender: 55.8% female, 44.2% male. Average age: 59.1 years. Most reports from: US. View detailed demographics →
Is POLYVINYL ALCOHOL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 1 | 0 | 1 |
| 2015 | 2 | 0 | 0 |
| 2016 | 5 | 0 | 1 |
| 2018 | 2 | 0 | 0 |
| 2019 | 2 | 0 | 0 |
| 2020 | 1 | 0 | 0 |
| 2023 | 13 | 0 | 3 |
| 2025 | 4 | 0 | 0 |
What Is POLYVINYL ALCOHOL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 16 |
| Dry eye | 14 |
| Hepatocellular carcinoma | 13 |
Official FDA Label for POLYVINYL ALCOHOL
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses : for use as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun
Dosage & Administration
DOSAGE AND ADMINISTRATION SECTION DIRECTIONS TWIST OFF TAB COMPLETELY TO OPEN. INSTILL 1 TO 2 DROPS IN THE AFFECTED EYE(S) AS NEEDED. DISCARD DROPPER AND DO NOT REUSE.
Warnings
Warnings For external use only Do not use this product if solution changes color or becomes cloudy When using this product remove contact lenses before using to avoid contamination, do not touch tip of container to any surface replace cap after using. Keep container tightly closed. Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Active Ingredient
ACTIVE INGREDIENTS SECTION POVIDONE 0.6% POLYVINYL ALCOHOL 1.4%
Inactive Ingredients
Inactive ingredients dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, purified water, sodium chloride. Phosphoric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride 0.01%