azilsartan medoxomil
Edarbi · ATC code C09CA09
Also known as: Azilsartanmedoxomil, Azilsartan medoksomil
- Key facts
- Active substance
- azilsartan medoxomil
- ATC code
- C09CA09
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Edarbi 20 mg tablets / Edarbi 40 mg tablets / Edarbi 80 mg tablets
- Marketing authorisation holder
- Takeda Pharma A/S
- Information as of
- 2026-10-29
Key facts
Azilsartan medoxomil is an angiotensin II receptor antagonist (sartan). It is used to treat essential hypertension in adults.
What it is used for
- Treatment of essential hypertension in adults.
Dosing
- Edarbi (tablets): recommended starting dose 40 mg once daily; may be increased to a maximum of 80 mg once daily if blood pressure is not adequately controlled. Near-maximal effect at 2 weeks, maximal effect by 4 weeks.
- Can be combined with other antihypertensives, including diuretics (e.g. chlortalidone, hydrochlorothiazide) and calcium channel blockers.
- Elderly: no adjustment needed; in the very elderly (≥ 75 years) at risk of hypotension, 20 mg can be considered as a starting dose.
- Mild to moderate hepatic impairment: close monitoring, consider 20 mg as starting dose; not recommended in severe hepatic impairment.
- Mild or moderate renal impairment: no adjustment; caution in severe renal impairment and end-stage renal disease.
- Volume or salt depletion: start under close medical supervision and consider 20 mg as starting dose. May be taken with or without food.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Second and third trimester of pregnancy.
- Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73 m2).
Important warnings
- In patients whose renal function depends predominantly on the RAAS (e.g. heart failure, renal artery stenosis), hypotension, azotaemia, oliguria or rarely acute renal failure may occur.
- Dual RAAS blockade (ACE inhibitors, sartans, aliskiren) is not recommended because of hypotension, hyperkalaemia and decreased renal function.
- Hyperkalaemia, especially in the elderly, renal insufficiency, diabetes or with potassium-sparing diuretics and potassium supplements; monitor potassium.
- Symptomatic hypotension in volume depletion; special caution in aortic or mitral valve stenosis and hypertrophic obstructive cardiomyopathy.
- Not recommended in primary hyperaldosteronism; intestinal angioedema has been reported.
Side effects
- Common: dizziness, diarrhoea.
- Uncommon: hypotension, nausea, rash, pruritus. Rare: angioedema.
- Adverse reactions were mostly mild or moderate, with an overall incidence similar to placebo.
Interactions
- Lithium: combination not recommended; if necessary, monitor serum lithium levels carefully.
- NSAIDs (including COX-2 inhibitors and acetylsalicylic acid > 3 g/day): attenuated antihypertensive effect and risk of worsening renal function.
- Potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, heparin: serum potassium may increase.
Pregnancy and breastfeeding
- Not recommended in the first trimester and contraindicated in the second and third trimesters; stop immediately when pregnancy is diagnosed.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- EdarbiTakeda Pharma A/S · EMEA/H/C/002293
Source: European Medicines Agency (EMA), product information
Turkey
- AzedokSABA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Edarbi
- Liechtenstein
- Edarbi
- Norway
- Edarbi
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Sources
- European Medicines Agency. Edarbi – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/edarbi-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.