BIFIDOBACTERIUM SPP: 40 Adverse Event Reports & Safety Profile

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Total FAERS Reports

5 (12.5%)

Deaths Reported

Hospitalizations

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 20110702 · Latest Report: 20230126

What Are the Most Common BIFIDOBACTERIUM SPP Side Effects?

#1 Most Reported

Constipation

19 reports (47.5%)

#2 Most Reported

Pyrexia

14 reports (35.0%)

#3 Most Reported

Off label use

13 reports (32.5%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Constipation	19	47.5%	1	16
Pyrexia	14	35.0%	0	14
Off label use	13	32.5%	0	13
Anaemia	12	30.0%	0	12
Drug ineffective	12	30.0%	0	12
Haematochezia	12	30.0%	0	12
Nausea	12	30.0%	0	12
Oral candidiasis	12	30.0%	0	12
Paraesthesia oral	12	30.0%	0	12
Therapeutic product effect incomplete	12	30.0%	0	12
Weight decreased	12	30.0%	0	12
Abdominal pain	11	27.5%	0	11
Chronic sinusitis	11	27.5%	0	11
Colitis	11	27.5%	0	11
Colitis ulcerative	11	27.5%	0	11
Dyspepsia	11	27.5%	0	11
Erythema	11	27.5%	0	11
Female genital tract fistula	11	27.5%	0	11
Frequent bowel movements	11	27.5%	0	11
Headache	11	27.5%	0	11

Gender: 62.8% female, 37.2% male. Average age: 57.2 years. Most reports from: JP. View detailed demographics →

Year	Reports	Deaths	Hosp.
2011	1	0	1
2012	3	0	2
2013	2	2	1
2014	2	2	0
2015	2	0	2
2016	9	0	5
2017	1	0	1
2018	7	0	7
2019	1	1	1
2023	1	0	0

Indication	Reports
Product used for unknown indication	21

Official prescribing information from the FDA-approved drug label.