🇺🇸 Prograf in United States

FDA authorised Prograf on 8 April 1994 · 12,213 US adverse-event reports

Marketing authorisations

FDA — authorised 8 April 1994

  • Application: NDA050709
  • Marketing authorisation holder: ASTELLAS
  • Status: supplemented

FDA — authorised 8 April 1994

  • Application: NDA050708
  • Marketing authorisation holder: ASTELLAS
  • Status: supplemented

FDA — authorised 24 May 2018

  • Application: NDA210115
  • Marketing authorisation holder: ASTELLAS
  • 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. Off Label Use — 2,194 reports (17.96%)
  2. Drug Ineffective — 1,634 reports (13.38%)
  3. Death — 1,460 reports (11.95%)
  4. Diarrhoea — 1,382 reports (11.32%)
  5. Pneumonia — 1,069 reports (8.75%)
  6. Pyrexia — 1,061 reports (8.69%)
  7. Transplant Rejection — 920 reports (7.53%)
  8. Renal Failure — 874 reports (7.16%)
  9. Vomiting — 821 reports (6.72%)
  10. Nausea — 798 reports (6.53%)

Source database →

Prograf in other countries

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

Other Other approved in United States

Frequently asked questions

Is Prograf approved in United States?

Yes. FDA authorised it on 8 April 1994; FDA authorised it on 8 April 1994; FDA authorised it on 24 May 2018.

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

ASTELLAS holds the US marketing authorisation.