BACILLUS CALMETTE-GUERIN ANTIGEN, UNSPECIFIED SUBSTRAIN: 416 Adverse Event Reports & Safety Profile

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416

Total FAERS Reports

45 (10.8%)

Deaths Reported

163

Hospitalizations

416

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 200611 · Latest Report: 20230807

What Are the Most Common BACILLUS CALMETTE-GUERIN ANTIGEN, UNSPECIFIED SUBSTRAIN Side Effects?

#1 Most Reported

Pyrexia

139 reports (33.4%)

#2 Most Reported

Disseminated bacillus calmette-guerin infection

127 reports (30.5%)

#3 Most Reported

Arthralgia

34 reports (8.2%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Pyrexia	139	33.4%	18	78
Disseminated bacillus calmette-guerin infection	127	30.5%	17	59
Arthralgia	34	8.2%	2	10
Weight decreased	33	7.9%	7	21
Reiter's syndrome	31	7.5%	0	3
Chills	29	7.0%	2	18
Drug ineffective	29	7.0%	3	1
Bladder cancer recurrent	28	6.7%	2	2
Granuloma	24	5.8%	4	8
Back pain	23	5.5%	2	12
Dysuria	23	5.5%	1	7
Haematuria	23	5.5%	5	14
Night sweats	23	5.5%	4	15
Dyspnoea	22	5.3%	4	19
Sepsis	22	5.3%	11	11
Conjunctivitis	20	4.8%	0	4
Infective aneurysm	20	4.8%	4	14
Malaise	20	4.8%	3	10
Asthenia	19	4.6%	4	13
Cough	19	4.6%	3	12

Gender: 11.3% female, 88.7% male. Average age: 70.1 years. Most reports from: JP. View detailed demographics →

Year	Reports	Deaths	Hosp.
2006	2	1	2
2008	1	0	1
2009	1	0	0
2010	3	0	2
2012	1	0	1
2013	3	0	1
2014	5	0	4
2015	8	1	4
2016	5	0	3
2017	4	1	2
2018	5	0	4
2019	2	0	2
2020	10	0	9
2021	9	1	6
2022	7	3	5
2023	2	0	1

Indication	Reports
Bladder cancer	326
Bladder transitional cell carcinoma	33
Transitional cell carcinoma	23
Immunisation	11
Carcinoma in situ	5

Official prescribing information from the FDA-approved drug label.