🇺🇸 Xenical in United States

FDA authorised Xenical on 23 April 1999 · 1,185 US adverse-event reports

Marketing authorisations

FDA — authorised 23 April 1999

  • Application: NDA020766
  • Marketing authorisation holder: CHEPLAPHARM
  • Local brand name: XENICAL
  • Indication: CAPSULE — 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 — 177 reports (14.94%)
  2. Diarrhoea — 148 reports (12.49%)
  3. Weight Increased — 137 reports (11.56%)
  4. Nausea — 124 reports (10.46%)
  5. Abdominal Pain — 116 reports (9.79%)
  6. Dyspnoea — 106 reports (8.95%)
  7. Headache — 103 reports (8.69%)
  8. Fatigue — 95 reports (8.02%)
  9. Pain — 92 reports (7.76%)
  10. Abdominal Pain Upper — 87 reports (7.34%)

Source database →

Xenical in other countries

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

Other Metabolic approved in United States

Frequently asked questions

Is Xenical approved in United States?

Yes. FDA authorised it on 23 April 1999; FDA has authorised it.

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

CHEPLAPHARM holds the US marketing authorisation.