NAPHAZOLINE\POLYSORBATE 80: 27 Adverse Event Reports & Safety Profile
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27
Total FAERS Reports
0
Deaths Reported
1
Hospitalizations
27
As Primary/Secondary Suspect
Active Ingredient: NAPHAZOLINE HYDROCHLORIDE\POLYSORBATE 80 ·
First Report: 20140227 · Latest Report: 20250311
What Are the Most Common NAPHAZOLINE\POLYSORBATE 80 Side Effects?
#1 Most Reported
Eye irritation
8 reports (29.6%)
#2 Most Reported
Drug dispensing error
7 reports (25.9%)
#3 Most Reported
Accidental overdose
7 reports (25.9%)
All NAPHAZOLINE\POLYSORBATE 80 Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Eye irritation | 8 | 29.6% | 0 | 0 |
| Accidental overdose | 7 | 25.9% | 0 | 1 |
| Drug dispensing error | 7 | 25.9% | 0 | 1 |
| Bradycardia | 6 | 22.2% | 0 | 1 |
| Pallor | 6 | 22.2% | 0 | 1 |
| Somnolence | 5 | 18.5% | 0 | 0 |
Who Reports NAPHAZOLINE\POLYSORBATE 80 Side Effects? Age & Gender Data
Gender: 56.5% female, 43.5% male. Average age: 33.7 years. Most reports from: US. View detailed demographics →
Is NAPHAZOLINE\POLYSORBATE 80 Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 0 | 0 |
| 2015 | 1 | 0 | 0 |
| 2016 | 2 | 0 | 0 |
| 2017 | 4 | 0 | 0 |
| 2018 | 2 | 0 | 0 |
| 2019 | 2 | 0 | 0 |
| 2022 | 1 | 0 | 0 |
| 2023 | 2 | 0 | 0 |
| 2024 | 1 | 0 | 0 |
| 2025 | 1 | 0 | 0 |
What Is NAPHAZOLINE\POLYSORBATE 80 Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 7 |
| Dry eye | 6 |
| Ocular hyperaemia | 5 |
Official FDA Label for NAPHAZOLINE\POLYSORBATE 80
Official prescribing information from the FDA-approved drug label.