FDA — authorised 20 December 2011
- Application: NDA202331
- Marketing authorisation holder: AZURITY
- Local brand name: EDARBYCLOR
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Azilsartan medoxomil - chlorthalidone in United States
FDA authorised Azilsartan medoxomil - chlorthalidone on 20 December 2011 · 21 US adverse-event reports
Marketing authorisation
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: 22 April 2025 – 22 April 2026
- Total reports: 21
Most-reported reactions
- Brash Syndrome — 3 reports (14.29%)
- Aortic Valve Incompetence — 2 reports (9.52%)
- Blood Pressure Increased — 2 reports (9.52%)
- Cardiac Failure Chronic — 2 reports (9.52%)
- Drug-Induced Liver Injury — 2 reports (9.52%)
- Dyspnoea — 2 reports (9.52%)
- Left Ventricular Hypertrophy — 2 reports (9.52%)
- Mitral Valve Incompetence — 2 reports (9.52%)
- Nausea — 2 reports (9.52%)
- Supraventricular Extrasystoles — 2 reports (9.52%)
Other Cardiovascular approved in United States
Frequently asked questions
Is Azilsartan medoxomil - chlorthalidone approved in United States?
Yes. FDA authorised it on 20 December 2011.
Who is the marketing authorisation holder for Azilsartan medoxomil - chlorthalidone in United States?
AZURITY holds the US marketing authorisation.