🇺🇸 Bactrim in United States

FDA authorised Bactrim on 30 July 1973 · 30,636 US adverse-event reports

Marketing authorisations

FDA — authorised 30 July 1973

  • Application: NDA017377
  • Marketing authorisation holder: SUN PHARM INDUSTRIES
  • Status: supplemented

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. Pyrexia — 4,137 reports (13.5%)
  2. Nausea — 3,642 reports (11.89%)
  3. Diarrhoea — 3,525 reports (11.51%)
  4. Off Label Use — 3,387 reports (11.06%)
  5. Fatigue — 3,339 reports (10.9%)
  6. Vomiting — 2,574 reports (8.4%)
  7. Rash — 2,568 reports (8.38%)
  8. Drug Hypersensitivity — 2,563 reports (8.37%)
  9. Pneumonia — 2,468 reports (8.06%)
  10. Dyspnoea — 2,433 reports (7.94%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Bactrim approved in United States?

Yes. FDA authorised it on 30 July 1973; FDA has authorised it.

Who is the marketing authorisation holder for Bactrim in United States?

SUN PHARM INDUSTRIES holds the US marketing authorisation.