🇺🇸 Olumiant in United States

FDA authorised Olumiant on 31 May 2018 · 2,214 US adverse-event reports

Marketing authorisations

FDA — authorised 31 May 2018

  • Application: NDA207924
  • Marketing authorisation holder: ELI LILLY AND CO
  • Local brand name: OLUMIANT
  • 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. Drug Ineffective — 431 reports (19.47%)
  2. Covid-19 — 283 reports (12.78%)
  3. Off Label Use — 280 reports (12.65%)
  4. Rheumatoid Arthritis — 233 reports (10.52%)
  5. Headache — 190 reports (8.58%)
  6. Therapy Interrupted — 173 reports (7.81%)
  7. Herpes Zoster — 171 reports (7.72%)
  8. Nausea — 162 reports (7.32%)
  9. Pneumonia — 153 reports (6.91%)
  10. Death — 138 reports (6.23%)

Source database →

Olumiant 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 Olumiant approved in United States?

Yes. FDA authorised it on 31 May 2018; FDA has authorised it.

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

ELI LILLY AND CO holds the US marketing authorisation.