PREDNISOLONE\SULFACETAMIDE: 55 Adverse Event Reports & Safety Profile
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55
Total FAERS Reports
0
Deaths Reported
3
Hospitalizations
55
As Primary/Secondary Suspect
1
Disabilities
Active Ingredient: PREDNISOLONE ACETATE\SULFACETAMIDE SODIUM ·
First Report: 20140512 · Latest Report: 20240927
What Are the Most Common PREDNISOLONE\SULFACETAMIDE Side Effects?
#1 Most Reported
Eye irritation
13 reports (23.6%)
#2 Most Reported
Eye swelling
12 reports (21.8%)
#3 Most Reported
Eye pain
11 reports (20.0%)
All PREDNISOLONE\SULFACETAMIDE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Eye irritation | 13 | 23.6% | 0 | 1 |
| Eye swelling | 12 | 21.8% | 0 | 1 |
| Eye pain | 11 | 20.0% | 0 | 0 |
| Ocular discomfort | 9 | 16.4% | 0 | 0 |
| Off label use | 9 | 16.4% | 0 | 0 |
| Drug hypersensitivity | 7 | 12.7% | 0 | 0 |
| Eye pruritus | 7 | 12.7% | 0 | 0 |
| Vision blurred | 7 | 12.7% | 0 | 1 |
| Ocular hyperaemia | 5 | 9.1% | 0 | 1 |
Who Reports PREDNISOLONE\SULFACETAMIDE Side Effects? Age & Gender Data
Gender: 77.4% female, 22.6% male. Average age: 64.0 years. Most reports from: US. View detailed demographics →
Is PREDNISOLONE\SULFACETAMIDE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 3 | 0 | 2 |
| 2015 | 25 | 0 | 1 |
| 2016 | 1 | 0 | 0 |
| 2020 | 1 | 0 | 0 |
| 2021 | 1 | 0 | 0 |
| 2022 | 1 | 0 | 0 |
| 2023 | 1 | 0 | 0 |
| 2024 | 1 | 0 | 0 |
What Is PREDNISOLONE\SULFACETAMIDE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 14 |
| Blepharitis | 6 |
| Eye irritation | 6 |
Official FDA Label for PREDNISOLONE\SULFACETAMIDE
Official prescribing information from the FDA-approved drug label.