DIETARY SUPPLEMENT\PROBIOTICS: 61 Adverse Event Reports & Safety Profile
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61
Total FAERS Reports
4 (6.6%)
Deaths Reported
27
Hospitalizations
61
As Primary/Secondary Suspect
5
Life-Threatening
2
Disabilities
First Report: 20040729 · Latest Report: 20221001
What Are the Most Common DIETARY SUPPLEMENT\PROBIOTICS Side Effects?
#1 Most Reported
Somnolence
8 reports (13.1%)
#2 Most Reported
Pneumonia aspiration
8 reports (13.1%)
#3 Most Reported
Gastrointestinal pain
8 reports (13.1%)
All DIETARY SUPPLEMENT\PROBIOTICS Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Gastrointestinal pain | 8 | 13.1% | 0 | 0 |
| Pneumonia aspiration | 8 | 13.1% | 1 | 8 |
| Somnolence | 8 | 13.1% | 0 | 7 |
| Abdominal discomfort | 7 | 11.5% | 0 | 1 |
| Coma | 7 | 11.5% | 0 | 7 |
| Gastrooesophageal reflux disease | 7 | 11.5% | 0 | 7 |
| Anxiety | 6 | 9.8% | 0 | 0 |
| Generalised tonic-clonic seizure | 5 | 8.2% | 0 | 5 |
| Hepatic function abnormal | 5 | 8.2% | 2 | 5 |
| Pyrexia | 5 | 8.2% | 1 | 2 |
Who Reports DIETARY SUPPLEMENT\PROBIOTICS Side Effects? Age & Gender Data
Gender: 71.7% female, 28.3% male. Average age: 50.6 years. Most reports from: US. View detailed demographics →
Is DIETARY SUPPLEMENT\PROBIOTICS Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2004 | 1 | 1 | 0 |
| 2013 | 1 | 0 | 0 |
| 2015 | 1 | 1 | 1 |
| 2017 | 2 | 0 | 1 |
| 2018 | 1 | 0 | 1 |
| 2019 | 10 | 2 | 7 |
| 2020 | 3 | 0 | 1 |
| 2021 | 4 | 0 | 1 |
| 2022 | 2 | 0 | 1 |
What Is DIETARY SUPPLEMENT\PROBIOTICS Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 31 |
Official FDA Label for DIETARY SUPPLEMENT\PROBIOTICS
Official prescribing information from the FDA-approved drug label.