Probiotic Supplement

Florastor

41 adverse event reports submitted to the FDA · 2005–2025 · Data current as of June 3, 2026

These are reports submitted to the FDA. A report does not mean the product caused the effect. Counts reflect reporting activity, not how common an effect is.

Most Reported Reactions

Top 10 reactions from 41 reports. One report may include multiple reactions — reaction totals may exceed the report count.

Fungaemia
6
Clostridium difficile infection
6
Sepsis
5
Nausea
5
Pneumonia
5
Malaise
3
Diarrhoea
3
Fungal infection
3
Clostridium difficile colitis
2
Urticaria
2

Reported Outcomes

Outcome categories as recorded in FDA reports. One report may include multiple outcomes.

OutcomeReports
Other Serious or Important Medical Event 17
Other Serious Outcome 15
Hospitalization 9
Visited Emergency Room 5
Visited a Health Care Provider 3
Death 2
Disability 1
Other Outcome 1

Who Reported

Reporter demographics where available. Many reports do not include age or gender data.

Age

Under 18
0
18–34
2
35–49
3
50–64
2
65–79
6
80+
5
Unknown
23

18 reports had age data; 23 unknown.

Gender

Female
24
Unknown/Not Reported
9
Male
8

Reports by Year

Annual report counts from 2005–2025. Spike years may reflect recalls, media coverage, or litigation rather than changes in the product.

'05
'06
'07
'08
'09
'10
'11
'12
'13
'14
'15
'16
'17
'18
'19
'20
'21
'22
'23
'24
'25

Hover bars for exact counts.

Data Source

This page presents data from the FDA's CFSAN Adverse Event Reporting System (CAERS) via the openFDA API. Reports are voluntary and unverified. The FDA has not concluded that this product caused any reported event.

View openFDA CAERS data ↗  ·  About our methodology  ·  How to read this data