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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.

BCG LIVE: 48 Adverse Event Reports & Safety Profile

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48
Total FAERS Reports
6 (12.5%)
Deaths Reported
25
Hospitalizations
48
As Primary/Secondary Suspect
3
Life-Threatening

First Report: 2010 · Latest Report: 20250703

What Are the Most Common BCG LIVE Side Effects?

#1 Most Reported
Bacillus calmette-guerin infection
11 reports (22.9%)
#2 Most Reported
Drug ineffective
6 reports (12.5%)
#3 Most Reported
Sepsis
5 reports (10.4%)

All BCG LIVE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Bacillus calmette-guerin infection 11 22.9% 1 4
Drug ineffective 6 12.5% 2 1
Bladder cancer recurrent 5 10.4% 2 1
Decreased appetite 5 10.4% 0 1
Dysuria 5 10.4% 0 3
Sepsis 5 10.4% 2 5

Who Reports BCG LIVE Side Effects? Age & Gender Data

Gender: 14.3% female, 85.7% male. Average age: 64.2 years. Most reports from: US. View detailed demographics →

Is BCG LIVE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2010 1 0 1
2012 1 1 1
2014 1 0 1
2021 1 0 0
2022 2 1 2
2023 3 0 2
2024 5 0 3
2025 4 0 4

View full timeline →

What Is BCG LIVE Used For?

IndicationReports
Bladder cancer 15
Bladder transitional cell carcinoma 6

Official FDA Label for BCG LIVE

Official prescribing information from the FDA-approved drug label.