🇺🇸 Siklos in United States

FDA authorised Siklos on 21 December 2017 · 185 US adverse-event reports

Marketing authorisations

FDA — authorised 21 December 2017

  • Application: NDA208843
  • Marketing authorisation holder: THERAVIA
  • 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. Sickle Cell Anaemia With Crisis — 76 reports (41.08%)
  2. Off Label Use — 18 reports (9.73%)
  3. Pain — 17 reports (9.19%)
  4. Fatigue — 16 reports (8.65%)
  5. Hepatic Cytolysis — 12 reports (6.49%)
  6. Acute Chest Syndrome — 11 reports (5.95%)
  7. Dyspnoea — 9 reports (4.86%)
  8. Eosinophilia — 9 reports (4.86%)
  9. Plasma Cell Myeloma — 9 reports (4.86%)
  10. Abdominal Pain — 8 reports (4.32%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is Siklos approved in United States?

Yes. FDA authorised it on 21 December 2017; FDA has authorised it.

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

THERAVIA holds the US marketing authorisation.