🇺🇸 BCG vaccine (Freeze-dried) in United States
11 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: 11
Most-reported reactions
- Hyperkalaemia — 2 reports (18.18%)
- Aspartate Aminotransferase Increased — 1 report (9.09%)
- Bladder Cancer — 1 report (9.09%)
- Blood Alkaline Phosphatase Increased — 1 report (9.09%)
- C-Reactive Protein Increased — 1 report (9.09%)
- Catheter Site Infection — 1 report (9.09%)
- Catheter Site Swelling — 1 report (9.09%)
- Cerebral Ventricle Dilatation — 1 report (9.09%)
- Clonic Convulsion — 1 report (9.09%)
- Device Breakage — 1 report (9.09%)
Other Immunology / Infectious Disease approved in United States
Frequently asked questions
Is BCG vaccine (Freeze-dried) approved in United States?
BCG vaccine (Freeze-dried) does not currently have US marketing authorisation in our dataset.
Who is the marketing authorisation holder for BCG vaccine (Freeze-dried) in United States?
Tuberculosis Research Centre, India is the originator. The local marketing authorisation holder may differ — check the official source linked above.