Active substance
Azilsartan kamedoxomil
- US FDA 2
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| EDARBI | EQ 40MG MEDOXOMIL; EQ 80MG MEDOXOMIL | tablet · oral | AZURITY | Prescription | 25 Feb 2011 |
| AZILSARTAN MEDOXOMIL | EQ 40MG MEDOXOMIL; EQ 80MG MEDOXOMIL | tablet · oral | LUPIN | Prescription | 20 Jul 2022 |
Safety signals and safety-related labeling changes
- US FDA 16 Jan 2024 EDARBI — safety-related labeling change
Labeling sections changed: Contraindications; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 9 Mar 2020 EDARBYCLOR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations
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.