Bacillus Calmette-Guerin side effects: what 1,767 FDA adverse event reports show

Bacillus Calmette-Guerin · Tice Bcg · 45 reaction terms · 1,760 drug–reaction co-reports · data 2026-09-14

Drug class

Live Attenuated Bacillus Calmette-Guerin Vaccine, Live Attenuated Bacillus Calmette-Guerin Immunotherapy

FDA label (Established Pharmacologic Class)

Brand names

Tice Bcg

openFDA label

Who reports

1,767 reports · 47% serious · 70 with death outcome · 23% female

openFDA FAERS counts, all years, deduplication not applied

Used for

TICE ® BCG is indicated for: the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR) Limitations of Use: TICE BCG is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence.

FDA label, Indications and Usage

What it is

DESCRIPTION TICE ® BCG (BCG LIVE) for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis. 1 The TICE ® seed.

FDA label, Description section

Boxed warning

TICE ® BCG contains live, attenuated mycobacteria. Because of the potential risk for transmission, prepare, handle, and dispose of TICE ® BCG as a biohazard material (see PRECAUTIONS and DOSAGE AND ADMINISTRATION sections).

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 32 strongest signals

Labeled — boxed warning 2Labeled adverse reaction 4Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 20Lab value / disease marker 1Not in label — unassessed 3

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 13 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Product availability issue	236	126.3 112.0–142.3ROR 145.6 · χ² 28,920 / p <1e-300	123.7 EB05 111.0 · IC025 +6.4 3/3 methods agree	Reporting / coding artifact	serious PRR 95.9	no trial data cached
Product dose omission	177	31.8 27.6–36.6ROR 35.2 · χ² 5,252 / p <1e-300	31.6 EB05 27.9 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 16.2	no trial data cached
No adverse event	378	25.3 23.2–27.7ROR 32.0 · χ² 8,871 / p <1e-300	25.3 EB05 23.2 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Micturition urgency	19	19.9 12.7–31.2ROR 20.1 · χ² 322 / p 2e-72	19.4 EB05 13.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.8	no trial data cached
Therapy non-responder	72	19.2 15.3–24.1ROR 20.0 · χ² 1,224 / p 1e-268	19.1 EB05 15.6 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 4.8 · 90% clinician	no trial data cached
Bladder disorder	14	16.7 9.9–28.2ROR 16.8 · χ² 191 / p 8e-44	15.9 EB05 9.4 · IC025 +2.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=7	no trial data cached
Incorrect product storage	17	15.2 9.4–24.3ROR 15.3 · χ² 211 / p 5e-48	14.4 EB05 9.0 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Tuberculosis	16	14.8 9.1–24.1ROR 14.9 · χ² 192 / p 6e-44	13.9 EB05 8.5 · IC025 +2.5 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 17.3	no trial data cached
Dysuria (painful urination)	43	13.9 10.3–18.6ROR 14.2 · χ² 501 / p 3e-111	13.6 EB05 10.4 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.8	no trial data cached
Cystitis	37	13.8 10.0–18.9ROR 14.0 · χ² 425 / p 1e-94	13.5 EB05 10.0 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 19.9 · 100% clinician	no trial data cached
Haematuria (blood in urine)	39	13.5 9.9–18.4ROR 13.8 · χ² 439 / p 7e-98	13.2 EB05 9.9 · IC025 +3.0 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 11.2 · 94% clinician	no trial data cached
Circumstance or information capable of leading to medication error	36	12.7 9.2–17.6ROR 13.0 · χ² 378 / p 2e-84	12.4 EB05 9.1 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious n=3	no trial data cached
Expired product administered	30	10.7 7.5–15.3ROR 10.9 · χ² 255 / p 8e-58	10.1 EB05 7.2 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Blood urine present	14	8.7 5.2–14.7ROR 8.8 · χ² 88 / p 3e-21	7.3 EB05 4.4 · IC025 +1.9 3/3 methods agree	Lab value / disease marker	serious PRR 4.4	no trial data cached
Exposure via skin contact	15	7.9 4.8–13.0ROR 7.9 · χ² 83 / p 3e-20	6.6 EB05 4.2 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Pollakiuria (frequent urination)	25	7.1 4.8–10.5ROR 7.2 · χ² 126 / p 2e-29	6.4 EB05 4.5 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 4.9	no trial data cached
Treatment failure	49	7.1 5.4–9.3ROR 7.3 · χ² 251 / p 8e-57	6.7 EB05 5.2 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 8.9	no trial data cached
Incorrect route of drug administration	19	6.2 4.0–9.7ROR 6.3 · χ² 78 / p 5e-19	5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 10.0	no trial data cached
Urinary incontinence	15	6.0 3.6–10.0ROR 6.1 · χ² 58 / p 1e-14	5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.9	no trial data cached
Injury associated with device	10	5.9 3.2–11.0ROR 5.9 · χ² 36 / p 1e-9	4.8 EB05 2.8 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Product preparation error	10	5.7 3.1–10.6ROR 5.8 · χ² 34 / p 2e-9	4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Accidental exposure to product	46	5.5 4.1–7.3ROR 5.6 · χ² 164 / p 7e-38	5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 3.3 · ♀ 88% (drug 23%)	no trial data cached
Bladder cancer	25	5.0 3.4–7.4ROR 5.0 · χ² 76 / p 2e-18	4.6 EB05 3.3 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.1	no trial data cached
Drug dose omission	66	4.7 3.7–5.9ROR 4.8 · χ² 188 / p 4e-43	4.5 EB05 3.7 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 5.2	no trial data cached
Product dose omission issue	107	4.5 3.7–5.4ROR 4.7 · χ² 288 / p 8e-65	4.4 EB05 3.7 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7	no trial data cached
Adverse event	29	3.7 2.6–5.4ROR 3.8 · χ² 56 / p 4e-14	3.5 EB05 2.6 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 6.4	no trial data cached
Inappropriate schedule of drug administration	18	3.0 1.9–4.7ROR 3.0 · χ² 22 / p 2e-6	2.8 EB05 1.9 · IC025 +0.7	Reporting / coding artifact	serious PRR 2.8	no trial data cached
Malignant neoplasm progression	24	2.8 1.9–4.2ROR 2.8 · χ² 26 / p 2e-7	2.7 EB05 1.9 · IC025 +0.7	Reporting / coding artifact	serious PRR 3.5	no trial data cached
Underdose	17	2.8 1.7–4.4ROR 2.8 · χ² 17 / p 1e-5	2.6 EB05 1.7 · IC025 +0.6	Reporting / coding artifact	serious PRR 2.3	no trial data cached
Product quality issue	27	2.4 1.6–3.5ROR 2.4 · χ² 20 / p 3e-6	2.3 EB05 1.7 · IC025 +0.6	Reporting / coding artifact	serious PRR 1.8	no trial data cached
Incorrect dose administered	44	2.3 1.7–3.1ROR 2.4 · χ² 32 / p 7e-9	2.3 EB05 1.8 · IC025 +0.7	Reporting / coding artifact	serious PRR 2.0	no trial data cached
Product storage error	16	2.2 1.3–3.6ROR 2.2 · χ² 9 / p 0.001	2.1 EB05 1.4 · IC025 +0.2	Reporting / coding artifact	–	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
No adverse event	378	25.3 23.2–27.7ROR 32.0 · χ² 8,871 / p <1e-300	25.3 EB05 23.2 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product availability issue	236	126.3 112.0–142.3ROR 145.6 · χ² 28,920 / p <1e-300	123.7 EB05 111.0 · IC025 +6.4 3/3 methods agree	Reporting / coding artifact	serious PRR 95.9	no trial data cached
Product dose omission	177	31.8 27.6–36.6ROR 35.2 · χ² 5,252 / p <1e-300	31.6 EB05 27.9 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 16.2	no trial data cached
Product dose omission issue	107	4.5 3.7–5.4ROR 4.7 · χ² 288 / p 8e-65	4.4 EB05 3.7 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7	no trial data cached
Therapy non-responder	72	19.2 15.3–24.1ROR 20.0 · χ² 1,224 / p 1e-268	19.1 EB05 15.6 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 4.8 · 90% clinician	no trial data cached
Drug dose omission	66	4.7 3.7–5.9ROR 4.8 · χ² 188 / p 4e-43	4.5 EB05 3.7 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 5.2	no trial data cached
Treatment failure	49	7.1 5.4–9.3ROR 7.3 · χ² 251 / p 8e-57	6.7 EB05 5.2 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 8.9	no trial data cached
Accidental exposure to product	46	5.5 4.1–7.3ROR 5.6 · χ² 164 / p 7e-38	5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 3.3 · ♀ 88% (drug 23%)	no trial data cached
Incorrect dose administered	44	2.3 1.7–3.1ROR 2.4 · χ² 32 / p 7e-9	2.3 EB05 1.8 · IC025 +0.7	Reporting / coding artifact	serious PRR 2.0	no trial data cached
Dysuria (painful urination)	43	13.9 10.3–18.6ROR 14.2 · χ² 501 / p 3e-111	13.6 EB05 10.4 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.8	no trial data cached
Haematuria (blood in urine)	39	13.5 9.9–18.4ROR 13.8 · χ² 439 / p 7e-98	13.2 EB05 9.9 · IC025 +3.0 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 11.2 · 94% clinician	no trial data cached
Cystitis	37	13.8 10.0–18.9ROR 14.0 · χ² 425 / p 1e-94	13.5 EB05 10.0 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 19.9 · 100% clinician	no trial data cached
Circumstance or information capable of leading to medication error	36	12.7 9.2–17.6ROR 13.0 · χ² 378 / p 2e-84	12.4 EB05 9.1 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious n=3	no trial data cached
Expired product administered	30	10.7 7.5–15.3ROR 10.9 · χ² 255 / p 8e-58	10.1 EB05 7.2 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Adverse event	29	3.7 2.6–5.4ROR 3.8 · χ² 56 / p 4e-14	3.5 EB05 2.6 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 6.4	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Pollakiuria — n=25, PRR 7.1

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Bacillus Calmette-Guerin?

In FDA FAERS, the most frequently co-reported reaction terms for Bacillus Calmette-Guerin are dysuria, haematuria, cystitis, circumstance or information capable of leading to medication error. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Bacillus Calmette-Guerin have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: TICE ® BCG contains live, attenuated mycobacteria. Because of the potential risk for transmission, prepare, handle, and dispose of TICE ® BCG as a biohazard material (see PRECAUTIONS and DOSAGE AND ADMINISTRATION sections).

Do FAERS signals prove that Bacillus Calmette-Guerin causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID c9b74876-e665-442b-87ad-b7333bc9a67a, effective 20260220; matched on openfda.generic_name.exact:"BACILLUS CALMETTE-GUERIN")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 45 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.