🇺🇸 Otezla in United States

FDA authorised Otezla on 21 March 2014 · 128,423 US adverse-event reports

Marketing authorisations

FDA — authorised 21 March 2014

  • Application: NDA205437
  • Marketing authorisation holder: AMGEN INC
  • Status: supplemented

FDA — authorised 29 August 2025

  • Application: NDA210745
  • Marketing authorisation holder: AMGEN INC
  • Local brand name: OTEZLA
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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. Diarrhoea — 23,636 reports (18.4%)
  2. Nausea — 21,230 reports (16.53%)
  3. Psoriasis — 19,912 reports (15.51%)
  4. Headache — 16,974 reports (13.22%)
  5. Drug Ineffective — 14,307 reports (11.14%)
  6. Abdominal Discomfort — 7,521 reports (5.86%)
  7. Psoriatic Arthropathy — 7,122 reports (5.55%)
  8. Pain — 5,974 reports (4.65%)
  9. Vomiting — 5,874 reports (4.57%)
  10. Rash — 5,873 reports (4.57%)

Source database →

Otezla in other countries

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

Other Immunology approved in United States

Frequently asked questions

Is Otezla approved in United States?

Yes. FDA authorised it on 21 March 2014; FDA authorised it on 29 August 2025; FDA has authorised it.

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

AMGEN INC holds the US marketing authorisation.