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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.

LACTOBACILLUS ACIDOPHILUS: 458 Adverse Event Reports & Safety Profile

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458
Total FAERS Reports
20 (4.4%)
Deaths Reported
383
Hospitalizations
458
As Primary/Secondary Suspect
34
Life-Threatening
21
Disabilities

First Report: 19911104 · Latest Report: 20250301

What Are the Most Common LACTOBACILLUS ACIDOPHILUS Side Effects?

#1 Most Reported
Somnolence
282 reports (61.6%)
#2 Most Reported
Pneumonia aspiration
280 reports (61.1%)
#3 Most Reported
Gastrooesophageal reflux disease
280 reports (61.1%)

All LACTOBACILLUS ACIDOPHILUS Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Somnolence 282 61.6% 0 272
Coma 280 61.1% 1 269
Gastrooesophageal reflux disease 280 61.1% 0 269
Pneumonia aspiration 280 61.1% 1 269
Underdose 52 11.4% 0 52
Hepatotoxicity 40 8.7% 0 37
Drug-induced liver injury 35 7.6% 1 35
Hepatic cirrhosis 34 7.4% 0 34
Hepatic encephalopathy 34 7.4% 0 34
Hepatic necrosis 34 7.4% 0 34
Drug interaction 33 7.2% 0 33
Off label use 31 6.8% 0 28
Incorrect route of product administration 25 5.5% 0 25
Septic shock 24 5.2% 0 24
Loss of consciousness 22 4.8% 0 21
Beta haemolytic streptococcal infection 21 4.6% 0 21
Necrosis ischaemic 21 4.6% 0 21
Pneumonia streptococcal 21 4.6% 0 21
Nausea 13 2.8% 0 3
Drug ineffective 8 1.8% 0 3

Who Reports LACTOBACILLUS ACIDOPHILUS Side Effects? Age & Gender Data

Gender: 89.9% female, 10.1% male. Average age: 57.1 years. Most reports from: CA. View detailed demographics →

Is LACTOBACILLUS ACIDOPHILUS Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 1 0 1
2009 3 0 0
2011 2 0 1
2013 8 4 3
2014 7 0 1
2015 5 1 3
2016 4 0 4
2017 6 1 3
2018 1 0 1
2019 2 0 2
2020 2 0 2
2021 5 4 5
2023 2 0 1
2024 4 0 3
2025 7 0 0

View full timeline →

What Is LACTOBACILLUS ACIDOPHILUS Used For?

IndicationReports
Product used for unknown indication 369
Diarrhoea 9
Probiotic therapy 8
Colitis ulcerative 5
Product use in unapproved indication 5

LACTOBACILLUS ACIDOPHILUS vs Alternatives: Which Is Safer?

LACTOBACILLUS ACIDOPHILUS vs LACTOBACILLUS RHAMNOSUS LACTOBACILLUS ACIDOPHILUS vs LACTOSE LACTOBACILLUS ACIDOPHILUS vs LACTULOSE LACTOBACILLUS ACIDOPHILUS vs LAMICTAL LACTOBACILLUS ACIDOPHILUS vs LAMIVUDINE LACTOBACILLUS ACIDOPHILUS vs LAMIVUDINE\NEVIRAPINE\ZIDOVUDINE LACTOBACILLUS ACIDOPHILUS vs LAMIVUDINE\TENOFOVIR LACTOBACILLUS ACIDOPHILUS vs LAMIVUDINE\TENOFOVIR DISOPROXIL LACTOBACILLUS ACIDOPHILUS vs LAMIVUDINE\ZIDOVUDINE LACTOBACILLUS ACIDOPHILUS vs LAMOTRIGINE

Official FDA Label for LACTOBACILLUS ACIDOPHILUS

Official prescribing information from the FDA-approved drug label.