Is Regadenoson approved by the US FDA?

Drugs@FDA lists 14 application product lines for Regadenoson, including LEXISCAN (Prescription); REGADENOSON (Prescription); REGADENOSON (Prescription); REGADENOSON (Prescription); REGADENOSON (Prescription).

Is Regadenoson authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Regadenoson: Rapiscan.

Are there safety signals or safety updates for Regadenoson?

US FDA: 1 entry (latest 2018-05-31).

Active substance

Regadenoson

US FDA 14
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
LEXISCAN	0.4MG/5ML (0.08MG/ML)	solution · intravenous	ASTELLAS	Prescription	10 Apr 2008
REGADENOSON	0.4MG/5ML (0.08MG/ML)	solution · intravenous	APOTEX	Prescription	11 Apr 2022
REGADENOSON	0.4MG/5ML (0.08MG/ML)	solution · intravenous	MEITHEAL	Prescription	11 Apr 2022
REGADENOSON	0.4MG/5ML (0.08MG/ML)	solution · intravenous	DR REDDYS	Prescription	11 Apr 2022
REGADENOSON	0.4MG/5ML (0.08MG/ML)	solution · intravenous	ACCORD HLTHCARE	Prescription	11 Apr 2022
REGADENOSON	0.4MG/5ML (0.08MG/ML)	solution · intravenous	IMS LTD	Prescription	23 May 2022
REGADENOSON	0.4MG/5ML (0.08MG/ML)	solution · intravenous	GLAND	Prescription	12 Jul 2022
REGADENOSON	0.4MG/5ML (0.08MG/ML)	solution · intravenous	HOSPIRA	Prescription	31 Aug 2022
REGADENOSON	0.4MG/5ML (0.08MG/ML)	solution · intravenous	EUGIA PHARMA	Prescription	26 Oct 2022
REGADENOSON	0.4MG/5ML (0.08MG/ML)	solution · intravenous	HIKMA	Prescription	2 Feb 2023
REGADENOSON	0.4MG/5ML (0.08MG/ML)	solution · intravenous	BAXTER HLTHCARE CORP	Prescription	23 May 2023
REGADENOSON	0.4MG/5ML (0.08MG/ML)	solution · intravenous	INDIES PHARMA	Prescription	22 Aug 2024
REGADENOSON	0.4MG/5ML (0.08MG/ML)	solution · intravenous	MYLAN	Discontinued	4 Apr 2023
REGADENOSON	0.4MG/5ML (0.08MG/ML)	solution · intravenous	GE HEALTHCARE	Discontinued	5 Aug 2024

EMA European Union — centrally authorised medicines

Rapiscan GE Healthcare AS · Authorised · authorised 6 Sep 2010 · ATC C01EB21

Therapeutic indication (EMA)

This medicinal product is for diagnostic use only. Rapiscan is a selective coronary vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging (MPI) in adult patients unable to undergo adequate exercise stress.

Safety signals and safety-related labeling changes

US FDA 31 May 2018 LEXISCAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for regadenoson →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.