FDA — authorised 5 March 2021
- Application: NDA211801
- Marketing authorisation holder: ARDELYX INC
- Indication: Labeling
- Status: approved
🇺🇸 TENAPANOR in United States
FDA authorised TENAPANOR on 5 March 2021 · 200 US adverse-event reports
Marketing authorisations
FDA — authorised 21 March 2025
- Application: NDA213931
- Marketing authorisation holder: ARDELYX INC
- Indication: Labeling
- Status: approved
The FDA approved TENAPANOR, a drug developed by ARDELYX INC, on 2025-03-21. The approval was granted under the standard expedited pathway. The approved indication for TENAPANOR is listed in its labelling, but the specific indication is not reported in the available data.
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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 200
Most-reported reactions
- Diarrhoea — 74 reports (37%)
- Off Label Use — 30 reports (15%)
- Hospitalisation — 20 reports (10%)
- Death — 17 reports (8.5%)
- Cardiac Failure — 11 reports (5.5%)
- Peritonitis — 11 reports (5.5%)
- Cerebral Infarction — 10 reports (5%)
- Fall — 10 reports (5%)
- Shunt Occlusion — 9 reports (4.5%)
- Hyperkalaemia — 8 reports (4%)
TENAPANOR 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 approved in United States?
Yes. FDA authorised it on 5 March 2021; FDA authorised it on 21 March 2025.
Who is the marketing authorisation holder for TENAPANOR in United States?
ARDELYX INC holds the US marketing authorisation.