🇺🇸 Astagraf XL in United States

FDA authorised Astagraf XL on 19 July 2013 · 147 US adverse-event reports

Marketing authorisations

FDA — authorised 19 July 2013

  • Application: NDA204096
  • Marketing authorisation holder: ASTELLAS
  • Local brand name: ASTAGRAF XL
  • Indication: CAPSULE, EXTENDED RELEASE — ORAL
  • Status: approved

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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. Death — 27 reports (18.37%)
  2. Inappropriate Schedule Of Drug Administration — 20 reports (13.61%)
  3. Diarrhoea — 15 reports (10.2%)
  4. Off Label Use — 15 reports (10.2%)
  5. Hospitalisation — 14 reports (9.52%)
  6. Pneumonia — 13 reports (8.84%)
  7. Malaise — 12 reports (8.16%)
  8. Treatment Noncompliance — 11 reports (7.48%)
  9. Kidney Transplant Rejection — 10 reports (6.8%)
  10. Nausea — 10 reports (6.8%)

Source database →

Astagraf XL 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 Astagraf XL approved in United States?

Yes. FDA authorised it on 19 July 2013; FDA has authorised it.

Who is the marketing authorisation holder for Astagraf XL in United States?

ASTELLAS holds the US marketing authorisation.