FDA — authorised 11 April 2022
- Application: ANDA207604
- Marketing authorisation holder: APOTEX
- Status: approved
🇺🇸 Regadenoson in United States
FDA authorised Regadenoson on 11 April 2022 · 378 US adverse-event reports
Marketing authorisations
FDA — authorised 23 May 2022
- Application: ANDA214252
- Marketing authorisation holder: IMS LTD
- Status: approved
FDA — authorised 12 July 2022
- Application: ANDA207320
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 2 February 2023
- Application: ANDA215827
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 22 August 2024
- Application: ANDA218054
- Marketing authorisation holder: INDIES PHARMA
- 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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 378
Most-reported reactions
- Nausea — 61 reports (16.14%)
- Hypotension — 58 reports (15.34%)
- Dyspnoea — 53 reports (14.02%)
- Chest Pain — 35 reports (9.26%)
- Dizziness — 35 reports (9.26%)
- Headache — 32 reports (8.47%)
- Cardiac Arrest — 27 reports (7.14%)
- Bradycardia — 26 reports (6.88%)
- Vomiting — 26 reports (6.88%)
- Unresponsive To Stimuli — 25 reports (6.61%)
Regadenoson in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Regadenoson approved in United States?
Yes. FDA authorised it on 11 April 2022; FDA authorised it on 23 May 2022; FDA authorised it on 12 July 2022.
Who is the marketing authorisation holder for Regadenoson in United States?
APOTEX holds the US marketing authorisation.