🇺🇸 Bacillus Calmette-Guerin (BCG) in United States

59 US adverse-event reports

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

• Window: 22 April 2025 – 22 April 2026
• Total reports: 59

Most-reported reactions

1. Drug Ineffective — 12 reports (20.34%)
2. Drug Intolerance — 12 reports (20.34%)
3. Non-Hodgkin^S Lymphoma — 12 reports (20.34%)
4. Arthralgia — 5 reports (8.47%)
5. Rheumatoid Arthritis — 5 reports (8.47%)
6. Joint Swelling — 4 reports (6.78%)
7. Drug Hypersensitivity — 3 reports (5.08%)
8. Off Label Use — 2 reports (3.39%)
9. Product Use Issue — 2 reports (3.39%)
10. Tuberculin Test Positive — 2 reports (3.39%)

Source database →

Frequently asked questions

Is Bacillus Calmette-Guerin (BCG) approved in United States?

Bacillus Calmette-Guerin (BCG) does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Bacillus Calmette-Guerin (BCG) in United States?

Massachusetts General Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.