Drug

Bacillus Calmette-guerin

45 flagged reaction(s) · 1,760 total co-reports · max PRR 126.3

Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.

	Reaction	Co-reports (a)	PRR	ROR	Signal
1	Product Availability Issue	236	126.3	145.6	signal
2	Product Dose Omission	177	31.8	35.2	signal
3	No Adverse Event	378	25.3	32.0	signal
4	Micturition Urgency	19	19.9	20.1	signal
5	Therapy Non-responder	72	19.2	20.0	signal
6	Bladder Disorder	14	16.7	16.8	signal
7	Incorrect Product Storage	17	15.2	15.3	signal
8	Tuberculosis	16	14.8	14.9	signal
9	Dysuria	43	13.9	14.2	signal
10	Cystitis	37	13.8	14.0	signal
11	Haematuria	39	13.5	13.8	signal
12	Circumstance Or Information Capable Of Leading To Medication Error	36	12.7	13.0	signal
13	Expired Product Administered	30	10.7	10.9	signal
14	Incontinence	8	9.0	9.0	signal
15	Blood Urine Present	14	8.7	8.8	signal
16	Exposure Via Skin Contact	15	7.9	7.9	signal
17	Nocturia	8	7.8	7.9	signal
18	Pollakiuria	25	7.1	7.2	signal
19	Treatment Failure	49	7.1	7.3	signal
20	Prostatic Specific Antigen Increased	8	6.9	6.9	signal
21	Incorrect Route Of Drug Administration	19	6.2	6.3	signal
22	Urinary Incontinence	15	6.0	6.1	signal
23	Injury Associated With Device	10	5.9	5.9	signal
24	Product Preparation Error	10	5.7	5.8	signal
25	Accidental Exposure To Product	46	5.5	5.6	signal
26	Bladder Cancer	25	5.0	5.0	signal
27	Drug Dose Omission	66	4.7	4.8	signal
28	Abscess	6	4.5	4.5	signal
29	Product Dose Omission Issue	107	4.5	4.7	signal
30	No Therapeutic Response	4	3.8	3.8	signal
31	Adverse Event	29	3.7	3.8	signal
32	Product Packaging Quantity Issue	3	3.3	3.3	no signal
33	Metastases To Lung	3	3.1	3.1	no signal
34	Drug Administration Error	8	3.1	3.1	signal
35	Inappropriate Schedule Of Drug Administration	18	3.0	3.0	signal
36	Incorrect Product Administration Duration	5	2.9	2.9	signal
37	Malignant Neoplasm Progression	24	2.8	2.8	signal
38	Erectile Dysfunction	6	2.8	2.8	signal
39	Underdose	17	2.8	2.8	signal
40	Product Physical Issue	4	2.4	2.4	no signal
41	Product Quality Issue	27	2.4	2.4	signal
42	Incorrect Dose Administered	44	2.3	2.4	signal
43	Product Storage Error	16	2.2	2.2	signal
44	Drug Exposure During Pregnancy	4	1.4	1.4	no signal
45	Device Leakage	3	0.8	0.8	no signal