FECAL MICROBIOTA: 49 Adverse Event Reports & Safety Profile
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49
Total FAERS Reports
12 (24.5%)
Deaths Reported
15
Hospitalizations
49
As Primary/Secondary Suspect
8
Life-Threatening
8
Disabilities
First Report: 20131220 · Latest Report: 20241016
What Are the Most Common FECAL MICROBIOTA Side Effects?
#1 Most Reported
Diarrhoea
9 reports (18.4%)
#2 Most Reported
Probiotic therapy
5 reports (10.2%)
#3 Most Reported
Abdominal distension
5 reports (10.2%)
All FECAL MICROBIOTA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Diarrhoea | 9 | 18.4% | 3 | 3 |
| Abdominal distension | 5 | 10.2% | 2 | 1 |
| Probiotic therapy | 5 | 10.2% | 1 | 1 |
Who Reports FECAL MICROBIOTA Side Effects? Age & Gender Data
Gender: 66.7% female, 33.3% male. Average age: 56.6 years. Most reports from: US. View detailed demographics →
Is FECAL MICROBIOTA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 1 | 0 | 0 |
| 2014 | 5 | 2 | 1 |
| 2015 | 12 | 5 | 5 |
| 2016 | 3 | 1 | 1 |
| 2017 | 4 | 0 | 0 |
| 2018 | 5 | 0 | 4 |
| 2019 | 3 | 1 | 1 |
| 2020 | 10 | 1 | 2 |
| 2021 | 2 | 0 | 0 |
| 2024 | 1 | 0 | 1 |
What Is FECAL MICROBIOTA Used For?
| Indication | Reports |
|---|---|
| Clostridium difficile infection | 27 |
| Clostridium difficile colitis | 9 |
Official FDA Label for FECAL MICROBIOTA
Official prescribing information from the FDA-approved drug label.