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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

PROBIOTICS NOS: 482 Adverse Event Reports & Safety Profile

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482
Total FAERS Reports
11 (2.3%)
Deaths Reported
241
Hospitalizations
482
As Primary/Secondary Suspect
16
Life-Threatening
5
Disabilities

First Report: 1990 · Latest Report: 20250501

What Are the Most Common PROBIOTICS NOS Side Effects?

#1 Most Reported
Somnolence
110 reports (22.8%)
#2 Most Reported
Gastrooesophageal reflux disease
101 reports (21.0%)
#3 Most Reported
Pneumonia aspiration
97 reports (20.1%)

All PROBIOTICS NOS Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Somnolence 110 22.8% 0 101
Gastrooesophageal reflux disease 101 21.0% 0 96
Coma 97 20.1% 0 96
Pneumonia aspiration 97 20.1% 0 96
Off label use 92 19.1% 1 75
Drug ineffective 65 13.5% 4 26
Nausea 54 11.2% 0 29
Diarrhoea 53 11.0% 0 16
Abdominal discomfort 48 10.0% 0 37
Rash 46 9.5% 0 37
Constipation 43 8.9% 0 22
Underdose 42 8.7% 0 40
Lower respiratory tract infection 41 8.5% 0 32
Headache 36 7.5% 0 24
Arthropathy 34 7.1% 0 32
Knee arthroplasty 34 7.1% 0 29
Pain 34 7.1% 0 19
Drug abuse 33 6.9% 0 31
Intentional product misuse 33 6.9% 0 32
Product dose omission issue 33 6.9% 0 31

Who Reports PROBIOTICS NOS Side Effects? Age & Gender Data

Gender: 76.2% female, 23.8% male. Average age: 61.4 years. Most reports from: US. View detailed demographics →

Is PROBIOTICS NOS Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 5 0 0
2008 1 0 0
2009 1 0 1
2010 1 0 0
2011 1 0 1
2012 5 0 2
2013 4 0 4
2014 9 0 1
2015 19 3 4
2016 15 0 3
2017 16 0 2
2018 24 1 5
2019 17 0 3
2020 37 1 30
2021 17 1 10
2022 6 0 1
2023 13 0 3
2024 5 0 3
2025 8 0 1

View full timeline →

What Is PROBIOTICS NOS Used For?

IndicationReports
Product used for unknown indication 229
Abdominal discomfort 27
Depression 26
Gastrointestinal disorder 18
Helicobacter infection 9
Colitis ulcerative 7
Probiotic therapy 7
Diarrhoea 6
Pituitary tumour 6
Constipation 5

PROBIOTICS NOS vs Alternatives: Which Is Safer?

PROBIOTICS NOS vs PROBUCOL PROBIOTICS NOS vs PROCAINAMIDE PROBIOTICS NOS vs PROCAINE PROBIOTICS NOS vs PROCARBAZINE PROBIOTICS NOS vs PROCHLORPERAZINE PROBIOTICS NOS vs PROCHLORPERAZINE EDISYLATE PROBIOTICS NOS vs PROCRIT PROBIOTICS NOS vs PROCYCLIDINE PROBIOTICS NOS vs PROGESTERONE PROBIOTICS NOS vs PROGRAF

Official FDA Label for PROBIOTICS NOS

Official prescribing information from the FDA-approved drug label.