BIFIDOBACTERIUM ANIMALIS LACTIS: 95 Adverse Event Reports & Safety Profile
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95
Total FAERS Reports
1 (1.1%)
Deaths Reported
73
Hospitalizations
95
As Primary/Secondary Suspect
First Report: 2012 · Latest Report: 20250301
What Are the Most Common BIFIDOBACTERIUM ANIMALIS LACTIS Side Effects?
#1 Most Reported
Somnolence
66 reports (69.5%)
#2 Most Reported
Pneumonia aspiration
66 reports (69.5%)
#3 Most Reported
Gastrooesophageal reflux disease
66 reports (69.5%)
All BIFIDOBACTERIUM ANIMALIS LACTIS Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Coma | 66 | 69.5% | 0 | 66 |
| Gastrooesophageal reflux disease | 66 | 69.5% | 0 | 66 |
| Pneumonia aspiration | 66 | 69.5% | 0 | 66 |
| Somnolence | 66 | 69.5% | 0 | 66 |
| Underdose | 18 | 19.0% | 0 | 16 |
| Drug ineffective | 13 | 13.7% | 1 | 2 |
| Frequent bowel movements | 8 | 8.4% | 0 | 0 |
| Colitis | 7 | 7.4% | 0 | 0 |
| Diarrhoea | 7 | 7.4% | 0 | 5 |
| Haematochezia | 6 | 6.3% | 0 | 5 |
| Incorrect route of product administration | 6 | 6.3% | 0 | 6 |
| Off label use | 6 | 6.3% | 0 | 6 |
| Product use in unapproved indication | 6 | 6.3% | 0 | 4 |
| Acrochordon | 5 | 5.3% | 0 | 0 |
| Anorectal discomfort | 5 | 5.3% | 0 | 0 |
| Calcinosis | 5 | 5.3% | 0 | 0 |
| Clostridium test positive | 5 | 5.3% | 0 | 5 |
| Colitis ulcerative | 5 | 5.3% | 0 | 0 |
| Dyschezia | 5 | 5.3% | 0 | 0 |
| Dyspnoea | 5 | 5.3% | 0 | 5 |
Who Reports BIFIDOBACTERIUM ANIMALIS LACTIS Side Effects? Age & Gender Data
Gender: 84.0% female, 16.0% male. Average age: 60.3 years. Most reports from: CA. View detailed demographics →
Is BIFIDOBACTERIUM ANIMALIS LACTIS Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 1 | 0 | 1 |
| 2016 | 1 | 0 | 0 |
| 2017 | 1 | 0 | 0 |
| 2018 | 2 | 0 | 0 |
| 2019 | 3 | 0 | 0 |
| 2022 | 1 | 0 | 0 |
| 2023 | 1 | 0 | 0 |
| 2024 | 2 | 0 | 0 |
| 2025 | 2 | 0 | 0 |
What Is BIFIDOBACTERIUM ANIMALIS LACTIS Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 80 |
Official FDA Label for BIFIDOBACTERIUM ANIMALIS LACTIS
Official prescribing information from the FDA-approved drug label.