🇺🇸 BCG VACCINE in United States

465 US adverse-event reports

Marketing authorisation

FDA

  • Status: approved

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.

Most-reported reactions

  1. Drug Ineffective — 89 reports (19.14%)
  2. Disseminated Bacillus Calmette-Guerin Infection — 80 reports (17.2%)
  3. Immune Reconstitution Inflammatory Syndrome — 68 reports (14.62%)
  4. Off Label Use — 49 reports (10.54%)
  5. Drug Intolerance — 39 reports (8.39%)
  6. Non-Hodgkin^S Lymphoma — 35 reports (7.53%)
  7. Pyrexia — 32 reports (6.88%)
  8. Arthralgia — 27 reports (5.81%)
  9. Rheumatoid Arthritis — 25 reports (5.38%)
  10. No Adverse Event — 21 reports (4.52%)

Source database →

BCG VACCINE in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is BCG VACCINE approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for BCG VACCINE in United States?

Marketing authorisation holder not available in our data.