Edarbi
Angiotensin II Receptor Blocker (ARB) for High Blood Pressure
Quick Facts About Edarbi
Key Takeaways About Edarbi
- Superior blood pressure lowering: Clinical trials show Edarbi provides greater blood pressure reduction than several other ARBs, including valsartan and olmesartan, at their maximum recommended doses
- Once-daily dosing: Take one tablet daily at the same time, with or without food, for consistent 24-hour blood pressure control
- Not for use in pregnancy: Edarbi must NOT be taken during the last 6 months of pregnancy as it can cause serious harm to the unborn baby
- Watch for low blood pressure: Patients who are dehydrated or taking diuretics may experience dizziness or fainting when starting Edarbi
- Full effect takes 4 weeks: While blood pressure begins to drop within 2 weeks, the maximum benefit of any dose is reached at approximately 4 weeks
What Is Edarbi and What Is It Used For?
Edarbi (azilsartan medoxomil) is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a hormone that causes blood vessels to constrict. It is prescribed to treat essential hypertension (high blood pressure) in adults aged 18 years and older.
Edarbi contains the active ingredient azilsartan medoxomil, which belongs to a class of medications known as angiotensin II receptor blockers, or ARBs. Angiotensin II is a naturally occurring substance in the body that binds to AT1 receptors on blood vessel walls and in the adrenal glands. When angiotensin II binds to these receptors, it triggers vasoconstriction (narrowing of blood vessels), stimulates the release of aldosterone (a hormone that causes sodium and water retention), and activates the sympathetic nervous system. All of these actions contribute to raising blood pressure.
Azilsartan medoxomil is a prodrug, meaning it is converted into its active form (azilsartan) during absorption in the gastrointestinal tract. Once active, azilsartan selectively and competitively blocks angiotensin II from binding to the AT1 receptor. By preventing this binding, Edarbi causes blood vessels to relax and dilate, reduces aldosterone secretion, and decreases sympathetic nervous system activity. The net result is a significant reduction in blood pressure.
Edarbi is specifically indicated for the treatment of essential hypertension in adults. Essential (or primary) hypertension is the most common type of high blood pressure and accounts for approximately 90–95% of all hypertension cases. Unlike secondary hypertension, which is caused by an identifiable underlying condition, essential hypertension develops gradually over many years and is influenced by genetic, dietary, and lifestyle factors. The European Society of Cardiology (ESC) and the European Society of Hypertension (ESH) recommend ARBs as one of the five first-line antihypertensive drug classes.
A measurable reduction in blood pressure is typically observed within 2 weeks of starting treatment with Edarbi, and the full blood pressure-lowering effect of any given dose is achieved within approximately 4 weeks. This gradual onset allows the body to adjust to the lower blood pressure and minimises the risk of symptomatic hypotension. Lowering blood pressure is critically important because sustained hypertension significantly increases the risk of stroke, myocardial infarction (heart attack), heart failure, chronic kidney disease, and premature cardiovascular death.
In head-to-head clinical trials, azilsartan medoxomil at 80 mg demonstrated significantly greater blood pressure reductions compared to valsartan 320 mg and olmesartan 40 mg (their maximum recommended doses). This has positioned Edarbi as one of the most potent ARBs available. However, individual responses to blood pressure medications vary, and your doctor will choose the medication best suited to your specific clinical situation.
What Should You Know Before Taking Edarbi?
Before starting Edarbi, inform your doctor about all your medical conditions, especially kidney disease, liver disease, heart problems, and any other medications you are taking. Edarbi is contraindicated in pregnancy (particularly the last 6 months) and must not be combined with aliskiren in patients with diabetes or renal impairment.
Contraindications
You should not take Edarbi if any of the following apply to you:
- Allergy to azilsartan medoxomil or any of the other ingredients in the tablet (listed in the contents section below)
- Last 6 months of pregnancy – Edarbi can cause serious harm to the developing baby, including birth defects and foetal death. It is also best to avoid Edarbi during the first trimester
- Concurrent use of aliskiren in patients with diabetes mellitus or moderate-to-severe renal impairment – this combination significantly increases the risk of dangerously low blood pressure (hypotension), acute kidney injury, and hyperkalaemia (high potassium levels)
Warnings and Precautions
Talk to your doctor before taking Edarbi if you have or have had any of the following conditions:
- Kidney problems – including chronic kidney disease, previous kidney transplant, or if you are undergoing dialysis. Edarbi is primarily eliminated through the kidneys and may require dose adjustment or additional monitoring
- Severe liver disease – limited clinical experience exists in patients with severe hepatic impairment. Your doctor may recommend a lower starting dose
- Heart problems – including heart failure, recent myocardial infarction (heart attack), or a history of stroke
- Low blood pressure (hypotension) or if you feel dizzy or faint – particularly relevant for patients who are volume-depleted due to diuretic therapy, salt-restricted diet, diarrhoea, or vomiting
- Elevated potassium levels (hyperkalaemia) – ARBs can increase serum potassium. This risk is heightened if you are also taking potassium supplements, potassium-sparing diuretics, or salt substitutes containing potassium
- Primary hyperaldosteronism – a disorder of the adrenal glands in which ARBs are generally not effective
- Aortic or mitral valve stenosis (narrowing of heart valves) or obstructive hypertrophic cardiomyopathy (abnormally thick heart muscle) – vasodilating agents must be used with extreme caution in these conditions
- Concurrent use of an ACE inhibitor (such as enalapril, lisinopril, or ramipril) – especially if you have diabetes-related kidney problems, as dual renin-angiotensin system blockade increases the risk of adverse events
Your doctor will regularly monitor your kidney function, blood pressure, and electrolyte levels (particularly potassium) while you are taking Edarbi. If you experience abdominal pain, nausea, vomiting, or diarrhoea after starting Edarbi, inform your doctor promptly. Do not stop taking Edarbi on your own without medical advice.
As with other ARBs, Edarbi may be less effective at lowering blood pressure in Black patients compared to patients of other ethnic backgrounds. This is a well-recognised class effect of renin-angiotensin system inhibitors and does not reflect an individual response. Your doctor may consider combination therapy (for example, adding a thiazide diuretic or calcium channel blocker) to optimise blood pressure control.
Use in Children and Adolescents
There are limited clinical data on the use of Edarbi in children and adolescents under 18 years of age. As a result, Edarbi should not be given to children or adolescents. Your child's doctor will prescribe an alternative antihypertensive medication with an established paediatric safety and dosing profile if blood pressure treatment is needed.
Pregnancy and Breastfeeding
Pregnancy: If you are pregnant or think you might become pregnant, contact your doctor immediately. Edarbi is not recommended during the first trimester and must NOT be taken during the last 6 months of pregnancy (second and third trimesters). Angiotensin II receptor blockers taken during this period can cause serious harm to the developing foetus, including reduced amniotic fluid (oligohydramnios), foetal kidney damage, skeletal malformations, and neonatal death. Your doctor will usually recommend switching to a safer alternative such as labetalol, methyldopa, or nifedipine before you plan a pregnancy or as soon as pregnancy is confirmed.
Breastfeeding: It is not known whether azilsartan passes into human breast milk. Due to the potential for adverse effects in the nursing infant, Edarbi is not recommended during breastfeeding. Your doctor may choose an alternative treatment if you wish to breastfeed, particularly if your baby is newborn or was born prematurely.
Driving and Operating Machinery
Edarbi is unlikely to affect your ability to drive or operate machinery under normal circumstances. However, some patients may experience dizziness or fatigue, particularly at the start of treatment or after a dose increase. If you experience any of these symptoms, do not drive or use tools or machinery until the symptoms have resolved.
Sodium Content
Each Edarbi tablet contains less than 1 mmol (23 mg) of sodium, meaning it is essentially "sodium-free". This is relevant for patients following a sodium-restricted diet.
How Does Edarbi Interact with Other Drugs?
Edarbi can interact with several medications, including lithium, NSAIDs, ACE inhibitors, aliskiren, potassium-raising drugs, and diuretics. Always tell your doctor about all medications you are taking, including over-the-counter products and herbal supplements.
Edarbi may affect the way other medicines work, and other medicines may affect the way Edarbi works. The most clinically significant drug interactions are summarised in the tables below. If you are currently taking any of these medications, your doctor may need to adjust your doses or increase the frequency of monitoring.
Major Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Aliskiren | Direct renin inhibitor | Dual renin-angiotensin blockade increases risk of hypotension, hyperkalaemia, and acute kidney injury | Contraindicated in patients with diabetes or renal impairment; avoid in all other patients |
| ACE inhibitors (enalapril, lisinopril, ramipril) | Antihypertensive | Dual renin-angiotensin blockade increases risk of hypotension, renal failure, and hyperkalaemia | Avoid combination, especially in patients with diabetic nephropathy |
| Lithium | Mood stabiliser (psychiatric) | ARBs reduce lithium excretion, leading to potentially toxic lithium levels | Monitor lithium levels closely if combination is necessary; dose adjustment may be required |
| Potassium supplements / potassium-sparing diuretics | Electrolyte supplement / diuretic | Additive risk of hyperkalaemia (dangerously high potassium) | Monitor serum potassium regularly; avoid potassium supplements unless prescribed |
Moderate Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| NSAIDs (ibuprofen, diclofenac, celecoxib) | Anti-inflammatory / pain relief | May reduce the blood pressure-lowering effect of Edarbi; increase risk of kidney impairment and hyperkalaemia | Use with caution; monitor kidney function and blood pressure |
| Aspirin (high dose, >3 g/day) | Anti-inflammatory | May attenuate antihypertensive effect of Edarbi and increase risk of renal impairment | Low-dose aspirin (75–100 mg/day) is generally safe; monitor at higher doses |
| Heparin | Anticoagulant | May increase risk of hyperkalaemia when combined with ARBs | Monitor potassium levels, especially in patients with renal impairment |
| Diuretics (furosemide, hydrochlorothiazide) | Antihypertensive / diuretic | Additive blood pressure-lowering effect; risk of symptomatic hypotension in volume-depleted patients | Start Edarbi at a lower dose (20 mg) if already on diuretics; monitor blood pressure closely |
| Salt substitutes containing potassium | Dietary supplement | Additive risk of hyperkalaemia | Avoid potassium-based salt substitutes while taking Edarbi |
If you are already taking other medications for high blood pressure, Edarbi can provide additional blood pressure lowering. However, certain combinations require careful monitoring. Edarbi is commonly and safely combined with calcium channel blockers (such as amlodipine) and thiazide-like diuretics (such as chlorthalidone) as part of an optimised antihypertensive regimen. Always inform your doctor or pharmacist about all medications, including over-the-counter medicines, vitamins, and herbal products.
What Is the Correct Dosage of Edarbi?
The recommended starting dose for most adults is 40 mg once daily. Depending on blood pressure response, your doctor may increase the dose to a maximum of 80 mg once daily, or reduce it to 20 mg for specific patient populations. Take the tablet at the same time each day with a glass of water, with or without food.
Always take Edarbi exactly as your doctor has told you. Do not change your dose without consulting your doctor first. The tablet should be swallowed whole with plenty of water and can be taken at any time of day, with or without food. However, it is important to take it at the same time each day for consistent blood pressure control.
Adults
Essential Hypertension (High Blood Pressure)
Starting dose: 40 mg once daily
Maximum dose: 80 mg once daily
Your doctor may increase the dose to 80 mg after approximately 4 weeks if blood pressure is not adequately controlled. A measurable blood pressure reduction is typically observed within 2 weeks, and the full effect of each dose level is achieved within 4 weeks.
Elderly Patients (75 Years and Older)
Elderly Starting Dose
Starting dose: 20 mg once daily
Maximum dose: 80 mg once daily
A lower starting dose is recommended for very elderly patients (75 years and older) to reduce the risk of symptomatic hypotension. The dose may be increased gradually based on blood pressure response and tolerability.
Patients with Liver Impairment
Mild to Moderate Hepatic Impairment
Starting dose: 20 mg once daily
Patients with mild to moderate liver disease may start with a lower dose. Edarbi has not been studied extensively in patients with severe hepatic impairment, and your doctor will carefully evaluate whether it is appropriate for your situation.
Volume-Depleted Patients
Patients with Recent Fluid Loss
Starting dose: 20 mg once daily
If you have recently lost body fluids through vomiting, diarrhoea, or use of diuretics (water tablets), your doctor may recommend starting with a lower dose to prevent excessive blood pressure drops. Volume and salt status should ideally be corrected before initiating Edarbi.
Patients with Severe Kidney Disease or Heart Failure
If you have severe kidney disease (including patients on dialysis) or heart failure, your doctor will carefully select the most appropriate starting dose and monitor you closely. The dose will be adjusted based on your individual response, kidney function, and overall clinical condition.
Missed Dose
If you forget to take a dose, simply skip it and take your next dose at the usual time. Do not take a double dose to make up for the missed one. If you miss doses frequently, consider setting a daily reminder or linking your tablet to a regular daily activity to help you remember.
Overdose
Taking too many Edarbi tablets can cause dangerously low blood pressure (hypotension), which may lead to dizziness, lightheadedness, or fainting. In severe cases, cardiovascular collapse may occur. If you have taken more than your prescribed dose, or if someone else has taken your medication, contact your doctor or emergency services immediately. You should provide information about the number of tablets taken and the time of ingestion.
Stopping Edarbi
Do not stop taking Edarbi without first talking to your doctor. If you stop taking Edarbi abruptly, your blood pressure may rise again, increasing the risk of cardiovascular complications. Your doctor will advise you on the safest way to discontinue the medication and may recommend an alternative treatment if necessary.
What Are the Side Effects of Edarbi?
The most common side effects of Edarbi are dizziness, diarrhoea, and elevated creatine phosphokinase (CPK) levels. Serious but rare side effects include angioedema (swelling of the face, lips, tongue, or throat). Most side effects are mild and tend to resolve as your body adjusts to the medication.
Like all medicines, Edarbi can cause side effects, although not everybody gets them. Most side effects are dose-dependent and tend to be mild and transient. If you experience any side effect that becomes severe or does not improve, consult your doctor or pharmacist.
- Difficulty breathing or swallowing
- Swelling of the face, lips, tongue, or throat (angioedema)
- Itchy skin with raised bumps (urticaria)
These allergic reactions are rare (may affect up to 1 in 1,000 people) but can be life-threatening if not treated promptly.
Common
May affect up to 1 in 10 people
- Dizziness
- Diarrhoea
- Elevated creatine phosphokinase (CPK) levels in blood tests (indicates muscle effects)
Uncommon
May affect up to 1 in 100 people
- Low blood pressure (hypotension), which may cause dizziness or faintness
- Fatigue
- Swollen hands, ankles, or feet (peripheral oedema)
- Skin rash and itching (pruritus)
- Nausea
- Muscle spasms
- Elevated serum creatinine (a marker of kidney function)
- Increased uric acid levels in the blood
Rare
May affect up to 1 in 1,000 people
- Angioedema (swelling of face, lips, tongue, and/or throat)
- Changes in blood test results, including decreased haemoglobin (a protein in red blood cells)
Not Known
Frequency cannot be estimated from available data
- Joint pain (arthralgia)
- Intestinal angioedema: swelling of the intestinal wall causing abdominal pain, nausea, vomiting, and diarrhoea (reported with similar ARB medications)
Side Effects When Combined with Other Medications
When Edarbi is taken together with chlorthalidone (a thiazide-like diuretic), higher levels of certain blood markers (such as creatinine) and low blood pressure have been reported more frequently (common, affecting fewer than 1 in 10 users). When Edarbi is taken with amlodipine (a calcium channel blocker), peripheral oedema (swollen ankles and feet) occurs more frequently (common) compared to Edarbi alone (uncommon). These effects are more commonly observed when amlodipine is taken as monotherapy.
If you experience any side effects not listed here, or if any side effect becomes severe, contact your doctor or pharmacist. Reporting suspected side effects helps ensure ongoing monitoring of the medicine's benefit-risk balance.
How Should You Store Edarbi?
Store Edarbi tablets in their original packaging to protect them from light and moisture. Keep them out of the reach and sight of children. Do not use after the expiry date printed on the packaging.
Keep Edarbi in its original blister packaging at all times, as the tablets are sensitive to light and moisture. No special temperature storage conditions are required. Check the expiry date (marked "EXP" on the carton) before taking any tablet. The expiry date refers to the last day of the stated month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment from pharmaceutical contamination.
What Does Edarbi Contain?
Each Edarbi tablet contains the active ingredient azilsartan medoxomil (as potassium salt) and several inactive ingredients. The tablets are white, round, and imprinted with "ASL" on one side and the strength number on the other.
Active Ingredient
The active substance is azilsartan medoxomil (as the potassium salt). Each tablet contains either 20 mg, 40 mg, or 80 mg of azilsartan medoxomil (as potassium).
Inactive Ingredients (Excipients)
The other ingredients are: mannitol, fumaric acid, sodium hydroxide, hydroxypropylcellulose, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate. These are standard pharmaceutical excipients that ensure proper tablet formation, disintegration, and absorption.
Sodium Content
This medicine contains less than 1 mmol (23 mg) sodium per tablet, meaning it is essentially "sodium-free". This information is relevant for patients on a controlled sodium diet.
Tablet Appearance and Packaging
All strength tablets are white and round, with "ASL" imprinted on one side and "20", "40", or "80" on the other, corresponding to the milligram strength. Edarbi is available in blister packs of 14, 28, 30, 56, 90, or 98 tablets. Not all pack sizes may be marketed in your country.
How Does Edarbi Work in the Body?
Edarbi works by selectively blocking the AT1 receptor for angiotensin II, preventing this hormone from constricting blood vessels and raising blood pressure. Azilsartan medoxomil is a prodrug that is rapidly converted to its active form during absorption, with peak blood levels reached within 1.5 to 3 hours and an elimination half-life of approximately 11 hours.
The renin-angiotensin-aldosterone system (RAAS) is one of the body's primary mechanisms for regulating blood pressure and fluid balance. When blood pressure or blood volume drops, the kidneys release an enzyme called renin, which converts angiotensinogen (produced by the liver) into angiotensin I. Angiotensin-converting enzyme (ACE), predominantly found in the lungs, then converts angiotensin I into angiotensin II, a potent vasoconstrictor hormone.
Angiotensin II exerts its effects primarily through two receptor subtypes: AT1 and AT2. The AT1 receptor mediates most of the harmful cardiovascular effects of angiotensin II, including vasoconstriction, aldosterone release, sodium reabsorption, cardiac hypertrophy, and vascular remodelling. The AT2 receptor, in contrast, is thought to have vasodilatory and anti-proliferative effects. Azilsartan selectively blocks the AT1 receptor with very high affinity, which has been shown in binding studies to exceed that of several other commercially available ARBs.
By blocking the AT1 receptor, Edarbi prevents angiotensin II from causing blood vessel constriction, reduces aldosterone secretion from the adrenal glands, and decreases sympathetic nervous system activation. The result is vasodilation, reduced sodium and water retention, and an overall decrease in blood pressure. Importantly, because azilsartan blocks the receptor rather than reducing angiotensin II production (as ACE inhibitors do), the levels of angiotensin II and renin in the blood increase as a compensatory mechanism. However, this increase is unable to overcome the AT1 receptor blockade, and the blood pressure-lowering effect is maintained.
Pharmacokinetic Profile
Azilsartan medoxomil is a prodrug that is rapidly hydrolysed to its active metabolite, azilsartan, by esterases in the gastrointestinal tract and liver during absorption. Peak plasma concentrations of azilsartan are reached approximately 1.5 to 3 hours after oral administration. The oral bioavailability of azilsartan is approximately 60%, and absorption is not significantly affected by food.
Azilsartan is highly protein-bound (>99%, primarily to albumin) and has a volume of distribution of approximately 16 litres. It is metabolised primarily by CYP2C9 to form two main metabolites (M-I and M-II), neither of which has clinically significant pharmacological activity. The elimination half-life of azilsartan is approximately 11 hours, supporting once-daily dosing. Approximately 55% of the dose is excreted in the faeces and 42% in the urine, with less than 15% excreted as unchanged drug.
Frequently Asked Questions About Edarbi
Edarbi (azilsartan medoxomil) is used to treat essential hypertension (high blood pressure) in adults aged 18 and over. It belongs to the angiotensin II receptor blocker (ARB) class and works by blocking the action of angiotensin II, a hormone that causes blood vessels to constrict. By relaxing blood vessels, Edarbi lowers blood pressure and reduces the risk of cardiovascular complications such as stroke and heart attack.
The most common side effects of Edarbi include dizziness, diarrhoea, and elevated blood creatine phosphokinase (CPK) levels, which may indicate muscle effects. Less common side effects include low blood pressure, fatigue, peripheral oedema (swelling), nausea, rash, itching, and muscle spasms. Serious allergic reactions such as angioedema (swelling of the face, lips, or throat) are rare but require immediate medical attention.
No. Edarbi is not recommended during early pregnancy and must NOT be taken during the last 6 months of pregnancy, as it can cause serious harm to the developing baby, including kidney damage and skeletal abnormalities. If you become pregnant while taking Edarbi, contact your doctor immediately. Your doctor will switch you to a safer alternative blood pressure medication.
A measurable reduction in blood pressure is typically seen within 2 weeks of starting Edarbi. The full effect of any given dose is usually achieved within 4 weeks of continuous treatment. Your doctor may adjust your dose at the 4-week mark if your blood pressure is not adequately controlled. Do not stop taking Edarbi without consulting your doctor, even if you feel well.
Edarbi can be safely combined with many blood pressure medications, including calcium channel blockers (e.g. amlodipine) and thiazide diuretics. However, you should NOT combine Edarbi with ACE inhibitors (e.g. enalapril, ramipril) or aliskiren if you have diabetes or kidney problems, as this increases the risk of dangerously low blood pressure, kidney failure, and high potassium levels. Always inform your doctor about all medications you are taking.
Clinical trials have shown that azilsartan medoxomil (Edarbi) at 80 mg provides significantly greater blood pressure reduction compared to valsartan 320 mg and olmesartan 40 mg at their maximum recommended doses. This superior efficacy has been demonstrated in multiple randomised controlled trials. However, individual responses to blood pressure medications vary, and your doctor will select the medication best suited to your specific needs.
References
This article is based on the following international medical guidelines and peer-reviewed sources. All medical claims have evidence level 1A, the highest quality of evidence based on systematic reviews of randomised controlled trials.
- Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. European Heart Journal. 2018;39(33):3021–3104. doi:10.1093/eurheartj/ehy339
- Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults. Journal of the American College of Cardiology. 2018;71(19):e127–e248.
- White WB, Weber MA, Sica D, et al. Effects of the angiotensin receptor blocker azilsartan medoxomil versus olmesartan and valsartan on ambulatory and clinic blood pressure in patients with stages 1 and 2 hypertension. Hypertension. 2011;57(3):413–420. doi:10.1161/HYPERTENSIONAHA.110.163402
- Bakris GL, Sica D, Weber M, et al. The comparative effects of azilsartan medoxomil and olmesartan on ambulatory and clinic blood pressure. Journal of Clinical Hypertension. 2011;13(2):81–88.
- European Medicines Agency (EMA). Edarbi – Summary of Product Characteristics. EMA product information database. Accessed January 2026.
- National Institute for Health and Care Excellence (NICE). Hypertension in adults: diagnosis and management. NICE guideline [NG136]. Updated 2022.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd list. Geneva: WHO; 2023.
- British National Formulary (BNF). Azilsartan medoxomil. NICE BNF monograph. Accessed January 2026.
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in cardiology, clinical pharmacology, and internal medicine.
Medical Writers
Board-certified physicians specialising in cardiovascular medicine and clinical pharmacology with documented academic and clinical experience.
Medical Reviewers
Independent review board ensuring clinical accuracy, adherence to international guidelines (ESC, AHA, NICE, WHO), and evidence level 1A standards.
All content follows the GRADE evidence framework and is reviewed against current international guidelines. We have no commercial funding or pharmaceutical sponsorship. For more information, see our editorial standards and medical team pages.