BACITRACIN\NEOMYCIN\POLYMYXIN B: 728 Adverse Event Reports & Safety Profile
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Total FAERS Reports
6 (0.8%)
Deaths Reported
31
Hospitalizations
728
As Primary/Secondary Suspect
2
Life-Threatening
3
Disabilities
Active Ingredient: BACITRACIN ZINC\NEOMYCIN SULFATE\POLYMYXIN B SULFATE ·
First Report: 1990 · Latest Report: 20250522
What Are the Most Common BACITRACIN\NEOMYCIN\POLYMYXIN B Side Effects?
#1 Most Reported
Drug hypersensitivity
422 reports (58.0%)
#2 Most Reported
Rash
89 reports (12.2%)
#3 Most Reported
Drug ineffective
47 reports (6.5%)
All BACITRACIN\NEOMYCIN\POLYMYXIN B Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug hypersensitivity | 422 | 58.0% | 0 | 3 |
| Rash | 89 | 12.2% | 0 | 6 |
| Drug ineffective | 47 | 6.5% | 0 | 2 |
| Hypersensitivity | 30 | 4.1% | 1 | 4 |
| Urticaria | 25 | 3.4% | 0 | 3 |
| Pruritus | 24 | 3.3% | 0 | 1 |
| Off label use | 20 | 2.8% | 0 | 1 |
| Erythema | 17 | 2.3% | 0 | 4 |
| Product use in unapproved indication | 17 | 2.3% | 0 | 1 |
| Condition aggravated | 15 | 2.1% | 0 | 0 |
| Ear pain | 15 | 2.1% | 0 | 1 |
| Headache | 15 | 2.1% | 0 | 2 |
| Drug ineffective for unapproved indication | 14 | 1.9% | 0 | 0 |
| Pain | 12 | 1.7% | 0 | 4 |
| Product use issue | 12 | 1.7% | 0 | 0 |
| Swelling | 12 | 1.7% | 0 | 2 |
| Blister | 11 | 1.5% | 0 | 1 |
| Ear discomfort | 11 | 1.5% | 0 | 0 |
| Eye irritation | 11 | 1.5% | 0 | 0 |
| Infection | 11 | 1.5% | 0 | 1 |
Who Reports BACITRACIN\NEOMYCIN\POLYMYXIN B Side Effects? Age & Gender Data
Gender: 80.1% female, 19.9% male. Average age: 60.5 years. Most reports from: US. View detailed demographics →
Is BACITRACIN\NEOMYCIN\POLYMYXIN B Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 0 | 0 |
| 2004 | 1 | 0 | 0 |
| 2005 | 2 | 0 | 0 |
| 2006 | 1 | 0 | 0 |
| 2008 | 1 | 0 | 1 |
| 2009 | 3 | 0 | 0 |
| 2011 | 3 | 1 | 0 |
| 2012 | 4 | 0 | 0 |
| 2013 | 3 | 0 | 0 |
| 2014 | 10 | 1 | 3 |
| 2015 | 15 | 0 | 1 |
| 2016 | 20 | 0 | 2 |
| 2017 | 12 | 0 | 1 |
| 2018 | 9 | 0 | 1 |
| 2019 | 10 | 0 | 4 |
| 2020 | 8 | 0 | 2 |
| 2021 | 8 | 0 | 0 |
| 2022 | 6 | 0 | 4 |
| 2023 | 10 | 0 | 3 |
| 2024 | 5 | 0 | 0 |
| 2025 | 3 | 0 | 0 |
What Is BACITRACIN\NEOMYCIN\POLYMYXIN B Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 112 |
| Ear infection | 21 |
| Rash | 10 |
| Wound | 9 |
| Thermal burn | 8 |
| Acanthamoeba keratitis | 7 |
| Scratch | 6 |
| Conjunctivitis | 5 |
| Infection | 5 |
| Pruritus | 5 |
BACITRACIN\NEOMYCIN\POLYMYXIN B vs Alternatives: Which Is Safer?
BACITRACIN\NEOMYCIN\POLYMYXIN B vs BACITRACIN\POLYMYXIN B
BACITRACIN\NEOMYCIN\POLYMYXIN B vs BACLOFEN
BACITRACIN\NEOMYCIN\POLYMYXIN B vs BACLOFEN INTRATHECAL
BACITRACIN\NEOMYCIN\POLYMYXIN B vs BACTRIM
BACITRACIN\NEOMYCIN\POLYMYXIN B vs BALOXAVIR MARBOXIL
BACITRACIN\NEOMYCIN\POLYMYXIN B vs BALSALAZIDE
BACITRACIN\NEOMYCIN\POLYMYXIN B vs BAMLANIVIMAB
BACITRACIN\NEOMYCIN\POLYMYXIN B vs BAMLANIVIMAB\ETESEVIMAB
BACITRACIN\NEOMYCIN\POLYMYXIN B vs BARACLUDE
BACITRACIN\NEOMYCIN\POLYMYXIN B vs BARICITINIB
Official FDA Label for BACITRACIN\NEOMYCIN\POLYMYXIN B
Official prescribing information from the FDA-approved drug label.