Edarbyclor (Azilsartan and Chlorthalidone) - Oral

Warning:

The United States Food and Drug Administration (FDA) has issued a boxed warning for Edarbyclor. 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, stop Edarbyclor as soon as possible.
  • Drugs that operate directly on the renin-angiotensin system (RAAS) can cause serious harm to a developing fetus.

What Is Edarbyclor?

Edarbyclor (azilsartan and chlorthalidone) is a combination prescription option for the treatment of hypertension (high blood pressure). It can be used as initial therapy for someone who recently developed high blood pressure. This medication can also be used for people whose blood pressure hasn’t been well-controlled with just one medication.

Edarbyclor contains azilsartan—an angiotensin II receptor blocker (ARB)—that lowers blood pressure by blocking a type of hormone called angiotensin II.

Angiotensin II raises blood pressure by pinching blood vessels and encouraging the release of aldosterone, another hormone.

Aldosterone also raises blood pressure by influencing the kidneys to hold on to salt and water. With higher amounts of salt and water in the body, blood pressure also rises. Angiotensin II and aldosterone are some of the hormones in the renin-angiotensin system (RAS).

Edarbyclor also contains chlorthalidone, which is a thiazide-like diuretic (water pill). Chlorthalidone is thought to lower blood pressure by encouraging the kidneys to get rid of salt and water.

Edarbyclor is available in tablet form.

Drug Facts

Generic Name: Azilsartan and chlorthalidone

Brand Name(s): Edarbyclor

Drug Availability: Prescription

Administration Route: Oral

Therapeutic Classification: Antihypertensive

Available Generically: Yes

Controlled Substance: N/A

Active Ingredient: Azilsartan kamedoxomil; chlorthalidone

Dosage Form(s): Tablet

What Is Edarbyclor Used For?

Edarbyclor is a treatment option for high blood pressure. Your blood pressure measurement is high when the top number is more than 130 millimeters, of mercury or the bottom number is greater than 80 millimeters of mercury.

In the United States (U.S.), nearly half of adults have high blood pressure or take medication for this medical condition. However, 75% of these adults have uncontrolled high blood pressure. This uncontrolled medical condition raises the risk of heart attack and stroke, the leading causes of death in the U.S.

How to Take Edarbyclor

Take Edarbyclor once daily with or without food. Do not take more or less than prescribed by your healthcare provider.

Storage

Edarbyclor is a non-controlled prescription. Therefore, your healthcare provider can give you refills for up to a year from the originally written date on the prescription.

If Edarbyclor is new for you or your dose has recently changed, your healthcare provider might only give you a few refills to initially keep a closer eye on your blood pressure and side effects.

Store the medication at room temperature when you bring Edarbyclor home from the pharmacy. Edarbyclor has a safe storage range of 59 degrees F to 86 degrees F for a short period. Keep the medication in its original container, and keep it tightly closed to protect Edarbyclor from moisture and light.

If you plan to travel with Edarbyclor, become familiar with the regulations of your final destination. In general, however, consider having a copy of your Edarbyclor prescription. Again, remember to keep the medication in its original container.

How Long Does Edarbyclor Take to Work?

Azilsartan might take up to two weeks for full effectiveness. As for chlorthalidone, you might start noticing frequent urination starting about two and a half hours after one dose.

What Are the Side Effects of Edarbyclor?

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 800-FDA-1088.

As with all medications, Edarbyclor 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 Edarbyclor include:

Severe Side Effects

The FDA has issued a boxed warning for Edarbyclor. 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, stop Edarbyclor as soon as possible.
  • Drugs that operate directly on the RAAS can cause serious harm to a developing fetus.

In people with low water and salt in their bodies, Edarbyclor can lead to extremely low blood pressure. Get medical help right away if you experience the following symptoms of low blood pressure:

Edarbyclor might also worsen kidney function in people with some kidney impairment. Seek medical attention if you have the following symptoms of worsening kidney function:

  • Ammonia on breath
  • Appetite changes
  • Foam in urine
  • Lethargy
  • Trouble urinating
  • Upper back pain

Edarbyclor can also cause abnormal amounts of different salts in your body. Therefore, your healthcare provider will closely monitor your labs.

If you suspect you’re pregnant, inform your healthcare provider—who may advise you to stop Edarbyclor. Taking this medication during pregnancy can have negative effects on the unborn baby.

Long-Term Side Effects

Long-term treatment with Edarbyclor for one year is linked to mild side effects. Some people, however, did experience abnormal kidney-related labs.

Report Side Effects

Edarbyclor 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 Edarbyclor 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—One tablet once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 milligrams (mg) of azilsartan and 25 mg of chlorthalidone.
      • Children—Use and dose must be determined by your doctor.

Modifications

Users should be aware of the following before beginning Edarbyclor:

Pregnancy: Taking Edarbyclor during pregnancy can cause harm to the unborn baby. If you suspect you are pregnant, discuss the next steps with your healthcare provider to help you stop taking Edarbyclor as soon as possible.

Breastfeeding: There is limited effectiveness and safety data on nursing babies. Due to the potential for negative effects on nursing babies, the manufacturer recommends against taking Edarbyclor when nursing.

Older adults: No dose adjustments with Edarbyclor are necessary for older adults. Of the total people in clinical studies with Edarbyclor, 24% were older (65 or older), while 5.7% were 75 and older. As a result, no overall differences in safety or effectiveness were observed between older and younger individuals.

However, the greater sensitivity of some older individuals cannot be ruled out as it relates to dosing.

Pediatrics: The safety and effectiveness of Edarbyclor in pediatric individuals under 18 years of age have not been established. Therefore, speak with your healthcare provider regarding other treatment options for high blood pressure therapies available for your child.

Missed Dose

If you accidentally miss a dose, take it as soon as you remember. However, if it’s close to your next scheduled dose, then take the following dose at this scheduled time.

Don’t try to double up and take more than one dose at the same time.

Overdose: What Happens If I Take Too Much Edarbyclor?

There is little overdose-related data for azilsartan. However, a high dose of azilsartan 320 milligrams for up to a week is well-tolerated.

As for chlorthalidone, overdose symptoms may include:

  • Abnormal amount of salts in the body
  • Dizziness
  • Nausea
  • Weakness

What Happens If I Overdose on Edarbyclor?

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

If someone collapses or isn't breathing after taking Edarbyclor, 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 and urine 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 the medicine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position or after the first dose of this medicine. 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 which may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

Hypokalemia (low potassium in the blood) may occur after using this medicine. Check with your doctor right away if you have any of the following symptoms: dry mouth, increased thirst, muscle cramps, nausea, or vomiting.

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 Edarbyclor?

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

The manufacturer recommends against taking Edarbyclor if the following applies to you:

  • Anuria: Anuria is the inability of your kidneys to make any urine.
  • Pregnancy: Taking Edarbyclor can have negative effects on the unborn baby.
  • Tekturna (aliskiren) use: If you take Tekturna and have diabetes, don’t take Edarbyclor.

What Other Medications May Interact With Edarbyclor?

Take the following medications with caution:

  • Dual blockage of RAS: In addition to Tekturna and other ARBs, other medications that also block RAS include angiotensin-converting enzyme inhibitors (ACE inhibitors)—like lisinopril. Taking Edarbyclor with medicines that block RAS raises the risk of high potassium in your body, worsening kidney function, and seriously low blood pressure.
  • Lithium: Lithium is a mood stabilizer. Taking lithium with Edarbyclor can lead to high amounts of lithium in your body, raising the risk of lithium toxicity.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs): NSAIDs—like Advil (ibuprofen) and Naprosyn (naproxen)—are commonly used to relieve fever and pain. However, combining NSAIDs and Edarbyclor can lower Edarbyclor’s effectiveness and raise the risk of worsening kidney function.

What Medications Are Similar?

There are multiple medication classes used to treat blood pressure, and Edarbyclor is a combination of a thiazide-like water pill and an ARB.

Other than chlorthalidone, indapamide is the only other thiazide-like water pill used to treat high blood pressure. However, there are no combination products with indapamide in the U.S.

As for ARBs, there are numerous ARBs other than azilsartan. The following are ARBs that are available with a water pill as combination products:

However, the water pill in all of these combination products is hydrochlorothiazide (HCTZ). HCTZ is a thiazide water pill, which is not in the same medication class as chlorthalidone.

Some experts actually prefer chlorthalidone because it is linked to a lower risk of heart disease. Additionally, azilsartan has very few foods and drug interactions. Of all the combination blood pressure medications, Edarbyclor is the only product that contains an ARB and a thiazide-like water pill.

Compared to other ARBs, however, the FDA hasn’t approved azilsartan for medical conditions other than high blood pressure.

Although all of these medications are similar, taking multiple ARBS—that all block RAS—is not usually recommended. If you have any questions, discuss them with your healthcare provider.

Frequently Asked Questions

  • Will Edarbyclor’s side effects ever go away?

    Edarbyclor’s side effects are usually mild and temporary.

  • Will Edarbyclor make me go to the restroom all the time?

    Since Edarbyclor contains a water pill, it will make you go to the restroom. For most water pills, this symptom usually only lasts a few hours after a dose. So, try to take this medication in the morning—instead of at night—to prevent waking up multiple times at night to use the restroom.

    For chlorthalidone, in particular, frequent urination will usually go away after a few more weeks of treatment.

  • Will I need other blood pressure medications in addition to Edarbyclor?

    The necessary number of medications is different for every individual. Some people might take multiple medications to achieve blood pressure goals. If needed, Edarbyclor can be taken with other blood pressure medications.

  • Will I need to take Edarbyclor for life?

    The duration of Edarbyclor treatment will also vary for each individual. To prevent a heart attack or stroke, Edarbyclor is usually a life-long medication. With healthy dietary and physical activity changes, some people may achieve their blood pressure goals. Before you stop or lower the dose of your blood pressure medication, however, talk with your healthcare provider.

How Can I Stay Healthy While Taking Edarbyclor?

In addition to taking Edarbyclor, lifestyle changes are important to achieve blood pressure goals. To stay healthy while taking Edarbyclor, consider the following:

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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By Ross Phan, PharmD, BCACP, BCGP, BCPS
Ross is a writer for Verywell with years of experience practicing pharmacy in various settings. She is also a board-certified clinical pharmacist and the founder of Off Script Consults.