BIFIDOBACTERIUM BIFIDUM: 85 Adverse Event Reports & Safety Profile
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85
Total FAERS Reports
4 (4.7%)
Deaths Reported
80
Hospitalizations
85
As Primary/Secondary Suspect
1
Life-Threatening
First Report: 20130626 · Latest Report: 20220725
What Are the Most Common BIFIDOBACTERIUM BIFIDUM Side Effects?
#1 Most Reported
Somnolence
72 reports (84.7%)
#2 Most Reported
Pneumonia aspiration
72 reports (84.7%)
#3 Most Reported
Gastrooesophageal reflux disease
72 reports (84.7%)
All BIFIDOBACTERIUM BIFIDUM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Coma | 72 | 84.7% | 0 | 72 |
| Gastrooesophageal reflux disease | 72 | 84.7% | 0 | 72 |
| Pneumonia aspiration | 72 | 84.7% | 0 | 72 |
| Somnolence | 72 | 84.7% | 0 | 72 |
| Underdose | 35 | 41.2% | 0 | 35 |
| Off label use | 20 | 23.5% | 0 | 16 |
| Incorrect route of product administration | 15 | 17.7% | 0 | 15 |
| Pneumonia | 6 | 7.1% | 2 | 3 |
Who Reports BIFIDOBACTERIUM BIFIDUM Side Effects? Age & Gender Data
Gender: 98.9% female, 1.1% male. Average age: 63.2 years. Most reports from: CA. View detailed demographics →
Is BIFIDOBACTERIUM BIFIDUM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 1 | 1 | 1 |
| 2020 | 1 | 0 | 1 |
| 2021 | 1 | 1 | 0 |
| 2022 | 2 | 1 | 2 |
What Is BIFIDOBACTERIUM BIFIDUM Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 76 |
Official FDA Label for BIFIDOBACTERIUM BIFIDUM
Official prescribing information from the FDA-approved drug label.