FLUOCINOLONE ACETONIDE\NEOMYCIN\POLYMYXIN B: 21 Adverse Event Reports & Safety Profile
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21
Total FAERS Reports
0
Deaths Reported
11
Hospitalizations
21
As Primary/Secondary Suspect
3
Disabilities
Active Ingredient: FLUOCINOLONE ACETONIDE\NEOMYCIN SULFATE\POLYMYXIN B SULFATE ·
First Report: 20160324 · Latest Report: 20191206
What Are the Most Common FLUOCINOLONE ACETONIDE\NEOMYCIN\POLYMYXIN B Side Effects?
#1 Most Reported
Macular degeneration
17 reports (81.0%)
#2 Most Reported
Drug ineffective
16 reports (76.2%)
#3 Most Reported
Therapeutic product effect incomplete
10 reports (47.6%)
All FLUOCINOLONE ACETONIDE\NEOMYCIN\POLYMYXIN B Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Macular degeneration | 17 | 81.0% | 0 | 11 |
| Drug ineffective | 16 | 76.2% | 0 | 10 |
| Chronic sinusitis | 10 | 47.6% | 0 | 10 |
| Therapeutic product effect incomplete | 10 | 47.6% | 0 | 10 |
| Colitis ulcerative | 9 | 42.9% | 0 | 9 |
| Constipation | 9 | 42.9% | 0 | 9 |
| Dyspepsia | 9 | 42.9% | 0 | 9 |
| Erythema | 9 | 42.9% | 0 | 9 |
| Female genital tract fistula | 9 | 42.9% | 0 | 9 |
| Frequent bowel movements | 9 | 42.9% | 0 | 9 |
| Haematochezia | 9 | 42.9% | 0 | 9 |
| Headache | 9 | 42.9% | 0 | 9 |
| Infusion related reaction | 9 | 42.9% | 0 | 9 |
| Malaise | 9 | 42.9% | 0 | 9 |
| Nausea | 9 | 42.9% | 0 | 9 |
| Off label use | 9 | 42.9% | 0 | 9 |
| Oral candidiasis | 9 | 42.9% | 0 | 9 |
| Pain | 9 | 42.9% | 0 | 9 |
| Paraesthesia oral | 9 | 42.9% | 0 | 9 |
| Procedural pain | 9 | 42.9% | 0 | 9 |
Who Reports FLUOCINOLONE ACETONIDE\NEOMYCIN\POLYMYXIN B Side Effects? Age & Gender Data
Gender: 95.7% female, 4.3% male. Average age: 54.3 years. Most reports from: CA. View detailed demographics →
Is FLUOCINOLONE ACETONIDE\NEOMYCIN\POLYMYXIN B Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2016 | 1 | 0 | 0 |
| 2018 | 1 | 0 | 1 |
| 2019 | 3 | 0 | 0 |
What Is FLUOCINOLONE ACETONIDE\NEOMYCIN\POLYMYXIN B Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 12 |
Official FDA Label for FLUOCINOLONE ACETONIDE\NEOMYCIN\POLYMYXIN B
Official prescribing information from the FDA-approved drug label.