🇺🇸 Mometasone Furoate Cream in United States

FDA authorised Mometasone Furoate Cream on 30 April 1987 · 131 US adverse-event reports

Marketing authorisations

FDA — authorised 30 April 1987

  • Application: NDA019543
  • Marketing authorisation holder: ORGANON
  • Local brand name: ELOCON
  • Indication: OINTMENT — TOPICAL
  • 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. No Adverse Event — 26 reports (19.85%)
  2. Drug Ineffective — 19 reports (14.5%)
  3. Product Administered At Inappropriate Site — 17 reports (12.98%)
  4. Product Use In Unapproved Indication — 13 reports (9.92%)
  5. Application Site Pain — 10 reports (7.63%)
  6. Off Label Use — 10 reports (7.63%)
  7. Product Physical Consistency Issue — 10 reports (7.63%)
  8. Product Physical Issue — 9 reports (6.87%)
  9. Product Use Issue — 9 reports (6.87%)
  10. Accidental Exposure To Product — 8 reports (6.11%)

Source database →

Mometasone Furoate 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 Mometasone Furoate Cream approved in United States?

Yes. FDA authorised it on 30 April 1987; FDA has authorised it.

Who is the marketing authorisation holder for Mometasone Furoate Cream in United States?

ORGANON holds the US marketing authorisation.