🇺🇸 Lialda in United States

FDA authorised Lialda on 16 January 2007 · 5,735 US adverse-event reports

Marketing authorisations

FDA — authorised 16 January 2007

  • Application: NDA022000
  • Marketing authorisation holder: TAKEDA PHARMS USA
  • Status: supplemented

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 — 993 reports (17.31%)
  2. Colitis Ulcerative — 792 reports (13.81%)
  3. Diarrhoea — 786 reports (13.71%)
  4. Fatigue — 526 reports (9.17%)
  5. Haematochezia — 496 reports (8.65%)
  6. Injection Site Pain — 492 reports (8.58%)
  7. Nausea — 433 reports (7.55%)
  8. Abdominal Pain — 426 reports (7.43%)
  9. Arthralgia — 397 reports (6.92%)
  10. Headache — 394 reports (6.87%)

Source database →

Lialda in other countries

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

Other Other approved in United States

Frequently asked questions

Is Lialda approved in United States?

Yes. FDA authorised it on 16 January 2007; FDA has authorised it.

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

TAKEDA PHARMS USA holds the US marketing authorisation.