🇺🇸 TENAPANOR HYDROCHLORIDE in United States

FDA authorised TENAPANOR HYDROCHLORIDE on 17 October 2023 · 198 US adverse-event reports

Marketing authorisations

FDA — authorised 17 October 2023

  • Application: NDA213931
  • Marketing authorisation holder: ARDELYX INC
  • Local brand name: XPHOZAH
  • 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 — 73 reports (36.87%)
  2. Off Label Use — 30 reports (15.15%)
  3. Hospitalisation — 20 reports (10.1%)
  4. Death — 17 reports (8.59%)
  5. Cardiac Failure — 11 reports (5.56%)
  6. Peritonitis — 11 reports (5.56%)
  7. Cerebral Infarction — 10 reports (5.05%)
  8. Fall — 9 reports (4.55%)
  9. Shunt Occlusion — 9 reports (4.55%)
  10. Hyperkalaemia — 8 reports (4.04%)

Source database →

TENAPANOR HYDROCHLORIDE in other countries

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

Frequently asked questions

Is TENAPANOR HYDROCHLORIDE approved in United States?

Yes. FDA authorised it on 17 October 2023; FDA has authorised it.

Who is the marketing authorisation holder for TENAPANOR HYDROCHLORIDE in United States?

ARDELYX INC holds the US marketing authorisation.