🇺🇸 Hydroxy Urea in United States

10 US adverse-event reports

Marketing authorisation

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. Acute Kidney Injury — 1 report (10%)
  2. Aortic Stenosis — 1 report (10%)
  3. Arthropathy — 1 report (10%)
  4. Cardiogenic Shock — 1 report (10%)
  5. Chronic Kidney Disease — 1 report (10%)
  6. Clostridium Difficile Infection — 1 report (10%)
  7. Coagulopathy — 1 report (10%)
  8. Death — 1 report (10%)
  9. Dehydration — 1 report (10%)
  10. Diarrhoea — 1 report (10%)

Source database →

Hydroxy Urea in other countries

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

Other Oncology approved in United States

Frequently asked questions

Is Hydroxy Urea approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Hydroxy Urea in United States?

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh is the originator. The local marketing authorisation holder may differ — check the official source linked above.