🇺🇸 Kenalog 10 in United States

FDA authorised Kenalog 10 on 4 January 1960 · 164 US adverse-event reports

Marketing authorisation

FDA — authorised 4 January 1960

  • Application: NDA012041
  • Marketing authorisation holder: APOTHECON
  • Status: supplemented

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. Product Storage Error — 42 reports (25.61%)
  2. Headache — 18 reports (10.98%)
  3. Injection Site Atrophy — 16 reports (9.76%)
  4. Drug Ineffective — 15 reports (9.15%)
  5. Insomnia — 14 reports (8.54%)
  6. Intentional Product Use Issue — 13 reports (7.93%)
  7. Anxiety — 12 reports (7.32%)
  8. Off Label Use — 12 reports (7.32%)
  9. Pain — 11 reports (6.71%)
  10. Urticaria — 11 reports (6.71%)

Source database →

Frequently asked questions

Is Kenalog 10 approved in United States?

Yes. FDA authorised it on 4 January 1960.

Who is the marketing authorisation holder for Kenalog 10 in United States?

APOTHECON holds the US marketing authorisation.