What the label lists and what reports show
Bacillus calmette-guerin substrain tice live antigen side effects
Bacillus calmette-guerin substrain tice live antigen's FDA label: “The most common complaints were malaise, fatigue and lethargy, fever, and abdominal pain.” FAERS holds 1,767 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is product availability issue (236 reports).
- No generic listed
- Boxed warning
Check it at the source: the bacillus calmette-guerin substrain tice live antigen FDA label on DailyMed (effective February 20, 2026); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common complaints were malaise, fatigue and lethargy, fever, and abdominal pain.
Table 6: Most Common Adverse Reactions in SWOG Study 8795 The adverse reaction profile of TICE BCG was similar in the Nijmegen study. 8
| Adverse event | All Grades | Grade ≥3 | All Grades | Grade ≥3 |
|---|---|---|---|---|
| Dysuria | 115 (52%) | 6 (3%) | 77 (35%) | 5 (2%) |
| Urgency/frequency | 112 (50%) | 5 (2%) | 63 (29%) | 7 (3%) |
| Hematuria | 85 (38%) | 6 (3%) | 56 (25%) | 5 (2%) |
| Flu-like symptoms | 54 (24%) | 1 (<1%) | 29 (13%) | 0 |
| Fever | 37 (17%) | 1 (<1%) | 7 (3%) | 0 |
| Pain (not specified) | 37 (17%) | 4 (2%) | 22 (10%) | 1 (<1%) |
| Hemorrhagic cystitis | 19 (9%) | 3 (1%) | 10 (5%) | 0 |
| Chills | 19 (9%) | 0 | 2 (1%) | 0 |
| Bladder cramps | 18 (8%) | 0 | 9 (4%) | 0 |
| Nausea | 16 (7%) | 0 | 12 (5%) | 0 |
| Incontinence | 8 (4%) | 0 | 3 (1%) | 0 |
| Myalgia/arthralgia | 7 (3%) | 0 | 0 | 0 |
| Diaphoresis | 7 (3%) | 0 | 1 (<1%) | 0 |
| Rash | 6 (3%) | 1 (<1%) | 16 (7%) | 2 (1%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedSymptoms of bladder irritability, related to the inflammatory response induced, are reported in approximately 60% of patients receiving TICE ® BCG. The symptoms typically begin 4 to 6 hours after instillation and last 24 to 72 hours. The irritative side effects are usually seen following the third instillation, and tend to increase in severity after each administration. The irritative bladder adverse effects can usually be managed symptomatically with products such as pyridium, propantheline bromide, oxybutynin chloride, and acetaminophen. The mechanism of action of the irritative side effects has not been firmly established, but is most consistent with an immunological mechanism. 3 There is no evidence that dose reduction or antituberculous drug therapy can prevent or lessen the irritative toxicity of TICE BCG. "Flu-like" symptoms (malaise, fever, and chills) which may accompany the localized, irritative toxicities often reflect hypersensitivity reactions which can be treated symptomatically. Antihistamines have also been used. 5 Adverse reactions to TICE BCG tend to be progressive in frequency and severity with subsequent instillation. Delay or postponement of subsequent treatment may or may not reduce the severity of a reaction during subsequent instillation. Although uncommon, serious infectious complications of intravesical BCG have been reported. …
Source: FDA drug label, Merck Sharp & Dohme LLC, effective February 20, 2026 (SPL set c9b74876-e665-442b-87ad-b7333bc9a67a), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,767 reports list bacillus calmette-guerin substrain tice live antigen among the medicines taken, each a report of something that happened, not proof the medicine caused it; 70 are coded as a death and 262 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 16 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Bacillus calmette-guerin substrain tice live antigen: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions