BROMELAINS: 83 Adverse Event Reports & Safety Profile
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83
Total FAERS Reports
20 (24.1%)
Deaths Reported
18
Hospitalizations
83
As Primary/Secondary Suspect
7
Life-Threatening
First Report: 20110226 · Latest Report: 20250818
What Are the Most Common BROMELAINS Side Effects?
#1 Most Reported
Sepsis
10 reports (12.0%)
#2 Most Reported
Coma
7 reports (8.4%)
#3 Most Reported
Pyrexia
6 reports (7.2%)
All BROMELAINS Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Sepsis | 10 | 12.1% | 4 | 7 |
| Coma | 7 | 8.4% | 0 | 7 |
| Death | 6 | 7.2% | 6 | 0 |
| Off label use | 6 | 7.2% | 2 | 0 |
| Pneumonia | 6 | 7.2% | 0 | 6 |
| Pyrexia | 6 | 7.2% | 1 | 1 |
| Application site haemorrhage | 5 | 6.0% | 2 | 0 |
| Multiple organ dysfunction syndrome | 5 | 6.0% | 5 | 0 |
| Septic shock | 5 | 6.0% | 2 | 0 |
Who Reports BROMELAINS Side Effects? Age & Gender Data
Gender: 34.4% female, 65.6% male. Average age: 64.8 years. Most reports from: JP. View detailed demographics →
Is BROMELAINS Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 0 | 1 |
| 2012 | 1 | 0 | 1 |
| 2013 | 6 | 0 | 6 |
| 2016 | 6 | 0 | 4 |
| 2017 | 2 | 0 | 0 |
| 2018 | 1 | 0 | 0 |
| 2022 | 2 | 0 | 0 |
| 2023 | 19 | 7 | 2 |
| 2024 | 13 | 6 | 2 |
| 2025 | 11 | 5 | 0 |
What Is BROMELAINS Used For?
| Indication | Reports |
|---|---|
| Thermal burn | 24 |
| Burns third degree | 16 |
| Burns second degree | 15 |
| Product used for unknown indication | 13 |
| Debridement | 5 |
| Knee operation | 5 |
Official FDA Label for BROMELAINS
Official prescribing information from the FDA-approved drug label.