🇺🇸 Urea cream in United States

FDA authorised Urea cream on 22 December 1976 · 56 US adverse-event reports

Marketing authorisations

FDA — authorised 22 December 1976

  • Application: NDA017698
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: STERILE UREA
  • Indication: INJECTABLE — INJECTION
  • 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. Pain In Extremity — 7 reports (12.5%)
  2. Diarrhoea — 6 reports (10.71%)
  3. Dyspnoea — 6 reports (10.71%)
  4. Fatigue — 6 reports (10.71%)
  5. Rash — 6 reports (10.71%)
  6. Vomiting — 6 reports (10.71%)
  7. Dizziness — 5 reports (8.93%)
  8. Nausea — 5 reports (8.93%)
  9. Urticaria — 5 reports (8.93%)
  10. Dehydration — 4 reports (7.14%)

Source database →

Urea cream 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 Urea cream approved in United States?

Yes. FDA authorised it on 22 December 1976; FDA has authorised it.

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

HOSPIRA holds the US marketing authorisation.