Edarbi (Azilsartan) - Oral

Warning:

The United States Food and Drug Administration (FDA) has issued a boxed warning for Edarbi. Boxed warnings are the agency’s strongest warnings for serious and potentially life-threatening risks. Review these warnings and discuss your concerns with your healthcare provider before starting treatment.

The boxed warning:

  • When pregnancy is detected, discontinue Edarbi as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.



What Is Edarbi?

Edarbi (azilsartan) is a prescription medication administered orally that is used alone or in combination therapy to treat hypertension (high blood pressure). Edarbi belongs to the class of drugs called angiotensin II receptor antagonists (ARBs), a group of medications prescribed to treat hypertension. Within the body, angiotensin II (a naturally occurring hormone) causes the blood vessels to tighten and become narrow.

To combat this, Edarbi selectively inhibits angiotensin II from binding to specific receptors allowing the blood vessels to relax and widen. As a result, the medication causes the blood to flow more easily through blood vessels to reduce blood pressure.

Edarbi is available as an oral tablet.

Drug Facts

Generic Name: Azilsartan

Brand Name(s): Edarbi

Drug Availability: Prescription

Administration Route: Oral

Therapeutic Classification: Antihypertensive

Available Generically: Yes

Controlled Substance: N/A

Active Ingredient: Azilsartan medoxomil

Dosage Form(s): Tablet

What Is Edarbi Used For?

The Food and Drug Administration (FDA) has approved Edarbi to treat hypertension in adults 18 years or older. It can be used alone or in combination with other antihypertensive drugs.

How to Take Edarbi

Read the prescription label carefully before taking any medicine, and ask your healthcare provider about anything you don't understand.

Take an Edarbi tablet by mouth once daily, with or without food, or as directed by your healthcare provider. Don’t take less or more often than prescribed. The dose is based on your medical condition and response to treatment.

Edarbi controls blood pressure, but it does not cure it. Take your medicine regularly to get the maximum benefit from it. It may take two weeks before you notice the full benefit of Edarbi. To help you remember, take medicine at the same time each day. Keep taking Edarbi even if you feel well. Consult your healthcare provider if your condition does not improve or worsen.

Storage

Store tablets in the original container at room temperature, away from light and moisture. Do not put the tablets in a different container. Do not store it in the bathroom or other areas prone to high levels of moisture. Keep all drugs locked away from the reach and sight of children and pets.

Do not keep unwanted or expired medication with you. Don't throw medicines in a waste bin, flush medications down the toilet, or pour them into a drain unless instructed to do so. Discard unwanted or expired medication by consulting your pharmacist or local waste disposal company.

Off-Label Uses

There are currently no FDA-approved off-label uses for Edarbi. However, some research has shown that Edarbi may be effective in treating diabetes and atrial fibrillation (congestive heart failure).

How Long does Edarbi Take to Work?

Edarbi causes a reduction in blood pressure within two weeks of initiation of treatment; however, it will take four weeks to notice the full effects.

What Are the Side Effects of Edarbi?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

As with all medications, Edarbi can cause side effects. Tell your healthcare provider about any side effects you experience while taking this medication.

Common Side Effects

The most common side effects of Edarbi are:

If any of these symptoms become worse, immediately contact your healthcare provider.

Severe Side Effects

The FDA has issued a boxed warning for Edarbi. Boxed warnings are the agency’s strongest warnings for serious and potentially life-threatening risks. Review these warnings and discuss your concerns with your healthcare provider before starting treatment.

The boxed warning:

  • When pregnancy is detected, discontinue Edarbi as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • Hypotension or severe dizziness.
  • Symptoms of high potassium levels in the blood.
  • Angiodema (swelling underneath the skin as a reaction to a trigger, such as a medicine or something you're allergic to)

Report Side Effects

Edarbi may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Edarbi Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For high blood pressure:
      • Adults—80 milligrams (mg) once a day. Certain patients may need to start with 40 mg once daily.
      • Children—Use and dose must be determined by your doctor.

Modifications

Users should be aware of the following before taking Edarbi:

Severe allergic reaction: Avoid using Edarbi if you have a known allergy to it or any of its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.

Pregnancy: ​​Do not take Edarbi if you plan on becoming pregnant. If you discover you are pregnant while taking Edarbi, contact your healthcare provider and discontinue your prescription immediately.

Breastfeeding: Due to the potential for consequential side effects, breastfeeding is not recommended while taking Edarbi. Talk with your healthcare provider if you plan to breastfeed.

Adults over 65: There is no dose adjustment necessary in Edarbi for older adults. However, while there are no differences in the safety or effectiveness of Edarbi between older people and younger people, greater sensitivity in some older individuals cannot be ruled out.

Pediatrics: The safety and effectiveness of Edarbi in young people have not been sufficiently studied. As a result, Edarbi has been approved by the FDA only for people 18 years or older.

People who smoke: Smoking can lower the effectiveness of Edarbi. Try to stop smoking before starting Edarbi, and avoid smoking while taking the medication. Your healthcare provider can help you with this goal.

Missed Dose

If you have missed a dose of Edarbi, take it as soon as you remember. If you forget to take it until the following day, skip the missed dose. Don't take two doses simultaneously to make up for a missed dose.

Overdose: What Happens If I Take Too Much Edarbi?

Limited data are available regarding overdosing on Edarbi. Do not take more Edarbi than directed on the package label.

In case of any presenting signs or symptoms indicative of an overdose (e.g., nausea or vomiting, appetite loss, or excessive sweating) call the Poison Control Center immediately. If the victim has collapsed, has tremors, or has difficulty breathing, call 911 right away. 

What Happens If I Overdose on Edarbi?

If you think you or someone else may have overdosed on Edarbi, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Edarbi, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position or if you have been taking a diuretic (water pill). Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning. If you faint, call your doctor right away.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water and may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

What Are Reasons I Shouldn't Take Edarbi?

Edarbi is not appropriate for everyone. You should not take this medication if you are allergic to azilsartan or any of the inactive ingredients in Edarbi.

Edarbi may be discouraged in some people only if the healthcare provider determines it is unsafe. This includes:

  • Pregnant people should not consume ARBs. Edarbi (azilsartan) is a teratogenic drug (a drug that is toxic to a fetus or embryo). If taken during early pregnancy, the risk of congenital abnormalities (e.g., heart defects, neural tube defects, and Down syndrome) increases greatly.
  • ARB drugs are also fetotoxic (a substance or agent that can poison or cause degenerative effects in a developing fetus or embryo) during the second and third trimesters. Therefore, if a pregnant person has previously been on any ARB such as Edarbi and becomes pregnant immediately (within two days of pregnancy confirmation), discontinue Edarbi.

What Other Medications May Interact With Edarbi?

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter (OTC) medicines, and vitamins or supplements. 

The following medications can increase the risk of toxicity when taken with Edarbi:

Edarbi is metabolized by the CYP2C9 enzyme — a gene that provides instructions for making an enzyme that is found in a cell structure called the endoplasmic reticulum (the primary transportation system of the eukaryotic cell). Therefore, users should be aware that caution is recommended when taking Edarbi along with strong activators of this enzyme, such as Jantoven (warfarin).

What Medications Are Similar?

Other drugs belonging to the class of ARBs include:

Edarbi is relatively a new addition to the ARB class of antihypertensive agents. It received FDA approval in 2011.

Various clinical studies have shown that Edarbi works better than many of the other drugs in its class. Edarbi, at its maximal dose, has superior efficacy to other ARBs, such as olmesartan and valsartan, at their maximal, approved doses without increasing adverse effects. It could provide higher rates of hypertension management within the ARB class.

Frequently Asked Questions

  • What is Edarbi used for?

    Edarbi (azilsartan) is a prescription medicine used to treat the symptoms of hypertension (high blood pressure). Edarbi may be used alone or in a combination of other medications.

  • How does Edarbi work?

    Edarbi works by blocking the action of angiotensin II in the arteries. It can help relax your blood vessels to lower blood pressure and improve blood flow.

  • How long does it take for Edarbi to work?

    Edarbi shows an improved effect within two weeks of starting the treatment; however, the full effect will be seen in four weeks.

How Can I Stay Healthy While Taking Edarbi?

High blood pressure can be a leading cause of many other life-threatening diseases, such as diabetes, heart disease, and stroke. Managing blood pressure with medicine and lifestyle changes can help avoid these problems.

Edarbi is a relatively new addition to antihypertensive drugs and proved highly effective with minor side effects. Take your medicine regularly and keep appointments with your healthcare provider and the laboratory. Monitor your blood pressure regularly to determine your response to Edarbi. Consult a healthcare provider if you have any concerns about your medication.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

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Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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