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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 VACCINE: 418 Adverse Event Reports & Safety Profile

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418
Total FAERS Reports
55 (13.2%)
Deaths Reported
171
Hospitalizations
418
As Primary/Secondary Suspect
15
Life-Threatening
6
Disabilities

First Report: 20010530 · Latest Report: 20240301

What Are the Most Common BCG VACCINE Side Effects?

#1 Most Reported
Disseminated bacillus calmette-guerin infection
87 reports (20.8%)
#2 Most Reported
Immune reconstitution inflammatory syndrome
60 reports (14.4%)
#3 Most Reported
Pyrexia
39 reports (9.3%)

All BCG VACCINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Disseminated bacillus calmette-guerin infection 87 20.8% 15 32
Immune reconstitution inflammatory syndrome 60 14.4% 5 13
Pyrexia 39 9.3% 5 18
Drug ineffective 35 8.4% 15 21
Off label use 35 8.4% 8 8
Granuloma 16 3.8% 1 5
Mycobacterial infection 16 3.8% 5 14
Vaccination complication 15 3.6% 0 5
Lymphadenopathy 14 3.4% 2 1
Disease progression 12 2.9% 2 0
Infection 12 2.9% 1 9
Neutropenia 12 2.9% 1 1
Skin lesion 12 2.9% 3 0
Acute kidney injury 11 2.6% 1 3
Bladder cancer 11 2.6% 0 2
Decreased appetite 11 2.6% 0 9
Hypertension 11 2.6% 1 2
Inflammation 11 2.6% 6 1
Pain 11 2.6% 0 1
Paradoxical drug reaction 11 2.6% 1 11

Who Reports BCG VACCINE Side Effects? Age & Gender Data

Gender: 26.8% female, 73.2% male. Average age: 56.7 years. Most reports from: US. View detailed demographics →

Is BCG VACCINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2006 4 0 0
2008 1 1 0
2010 2 0 2
2011 1 1 1
2013 3 0 2
2014 3 0 0
2015 7 0 2
2016 8 1 3
2017 4 0 1
2018 9 1 6
2019 16 0 13
2020 18 0 15
2021 42 2 21
2022 35 0 30
2023 20 0 12
2024 1 0 0

View full timeline →

What Is BCG VACCINE Used For?

IndicationReports
Bladder cancer 135
Immunisation 98
Bladder transitional cell carcinoma 49
Product used for unknown indication 30
Transitional cell carcinoma 23
Mantle cell lymphoma 9
Prophylaxis 9
Bladder neoplasm 7

BCG VACCINE vs Alternatives: Which Is Safer?

BCG VACCINE vs BEBTELOVIMAB BCG VACCINE vs BECLOMETHASONE BCG VACCINE vs BECLOMETHASONE DIPROPIONATE BCG VACCINE vs BECLOMETHASONE DIPROPIONATE\FORMOTEROL BCG VACCINE vs BECLOMETHASONE\FORMOTEROL BCG VACCINE vs BEDAQUILINE BCG VACCINE vs BELANTAMAB MAFODOTIN BCG VACCINE vs BELANTAMAB MAFODOTIN-BLMF BCG VACCINE vs BELATACEPT BCG VACCINE vs BELIMUMAB

Official FDA Label for BCG VACCINE

Official prescribing information from the FDA-approved drug label.