🇺🇸 Hydrea in United States

FDA authorised Hydrea on 7 December 1967 · 3,290 US adverse-event reports

Marketing authorisations

FDA — authorised 7 December 1967

  • Application: NDA016295
  • Marketing authorisation holder: WAYLIS THERAP
  • 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 — 453 reports (13.77%)
  2. Fatigue — 403 reports (12.25%)
  3. Anaemia — 394 reports (11.98%)
  4. Pyrexia — 343 reports (10.43%)
  5. Nausea — 312 reports (9.48%)
  6. Diarrhoea — 304 reports (9.24%)
  7. Platelet Count Decreased — 283 reports (8.6%)
  8. Haemoglobin Decreased — 276 reports (8.39%)
  9. Death — 271 reports (8.24%)
  10. Dyspnoea — 251 reports (7.63%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Hydrea approved in United States?

Yes. FDA authorised it on 7 December 1967; FDA has authorised it.

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

WAYLIS THERAP holds the US marketing authorisation.