POVIDONE: 74 Adverse Event Reports & Safety Profile
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Route: OPHTHALMIC · Manufacturer: Thea Pharma Inc. · HUMAN OTC DRUG · FDA Label: Available
First Report: 20100326 · Latest Report: 20250501
What Are the Most Common POVIDONE Side Effects?
All POVIDONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Nausea | 15 | 20.3% | 0 | 4 |
| Drug hypersensitivity | 13 | 17.6% | 0 | 1 |
| Drug ineffective | 13 | 17.6% | 0 | 1 |
| Headache | 13 | 17.6% | 0 | 0 |
| Eye irritation | 12 | 16.2% | 0 | 0 |
| Cerebrovascular accident | 9 | 12.2% | 0 | 0 |
| Drug intolerance | 9 | 12.2% | 0 | 0 |
| Hypoaesthesia | 9 | 12.2% | 0 | 0 |
| Nervous system disorder | 9 | 12.2% | 0 | 0 |
| Skin reaction | 9 | 12.2% | 0 | 0 |
| Eye pain | 8 | 10.8% | 0 | 2 |
| Ocular hyperaemia | 7 | 9.5% | 0 | 0 |
| Vision blurred | 7 | 9.5% | 0 | 0 |
| Visual impairment | 6 | 8.1% | 0 | 0 |
| Drug reaction with eosinophilia and systemic symptoms | 5 | 6.8% | 0 | 3 |
Who Reports POVIDONE Side Effects? Age & Gender Data
Gender: 64.8% female, 35.2% male. Average age: 62.9 years. Most reports from: US. View detailed demographics →
Is POVIDONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 1 | 0 | 1 |
| 2013 | 1 | 0 | 0 |
| 2014 | 2 | 0 | 0 |
| 2015 | 3 | 0 | 0 |
| 2016 | 5 | 0 | 2 |
| 2017 | 7 | 0 | 3 |
| 2019 | 3 | 0 | 0 |
| 2021 | 4 | 0 | 1 |
| 2022 | 6 | 1 | 0 |
| 2023 | 5 | 0 | 0 |
| 2025 | 2 | 0 | 0 |
What Is POVIDONE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 30 |
| Dry eye | 23 |
Official FDA Label for POVIDONE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses (one or more of these) 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 and 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: Wash hands well before use. Twist cap counterclockwise to break tamper evident seal. Press firmly on bottle sides. Dispensing drops is slower due to preservative-free filter.
Dispense
1-2 drops in the affected eye as needed. Safe with contacts. *To limit blurriness when using contact lenses: remove contacts, apply drops, then insert contacts.
Warnings
Warnings For external use only(in the eye) Do not use if:
- you are allergic to any of the ingredients.
- solution changes color or becomes cloudy.
- To avoid contamination, do not touch the tip of container to any surface. Replace cap after using.
- 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, discontinue use and consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. When using this product Rare possibility of mild eye irritation and ocular redness. In such cases, contact lens wearers should remove their contact lenses. You might experience bothersome symptoms such as a burning sensation, stinging sensation, foreign body sensation in the eye and blurred vision for a short time.
Active Ingredient
Active Ingredient Povidone 0.5%
Inactive Ingredients
Inactive Ingredients Purified water, sodium chloride, sodium hyaluronate, trehalose, tromethamine. May contain hydrochloric acid to adjust pH.