🇺🇸 Bactrim DS in United States

FDA authorised Bactrim DS on 30 July 1973 · 6,510 US adverse-event reports

Marketing authorisations

FDA — authorised 30 July 1973

  • Application: NDA017377
  • Marketing authorisation holder: SUN PHARM INDUSTRIES
  • Local brand name: BACTRIM DS
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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. Fatigue — 971 reports (14.92%)
  2. Nausea — 927 reports (14.24%)
  3. Diarrhoea — 762 reports (11.71%)
  4. Pyrexia — 626 reports (9.62%)
  5. Pneumonia — 558 reports (8.57%)
  6. Death — 551 reports (8.46%)
  7. Dyspnoea — 541 reports (8.31%)
  8. Off Label Use — 537 reports (8.25%)
  9. Vomiting — 523 reports (8.03%)
  10. Asthenia — 514 reports (7.9%)

Source database →

Bactrim DS 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 Bactrim DS approved in United States?

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

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

SUN PHARM INDUSTRIES holds the US marketing authorisation.