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Edarbi

Last reviewed on RxList: 6/16/2017
Edarbi Side Effects Center

Last reviewed on RxList 06/16/2017

Edarbi (azilsartan medoxomil) is an antihypertensive drug indicated for the treatment of hypertension. If blood pressure is not controlled with Edarbi alone, additional blood pressure reduction can be achieved by taking Edarbi with other antihypertensive agents. Common side effects of Edarbi include:

  • nausea,
  • diarrhea,
  • fatigue,
  • cough,
  • dizziness on standing,
  • weakness/lack of energy, and
  • tired feeling.

Tell your doctor if you have serious side effects of Edarbi including:

  • muscle spasms,
  • unusual changes in the amount of urine,
  • symptoms of a high potassium blood level (such as muscle weakness, slow or irregular heartbeat),
  • feeling like you might pass out,
  • confusion,
  • loss of appetite,
  • vomiting,
  • pain in your side or lower back,
  • swelling, or
  • rapid weight gain.

The recommended dose of Edarbi in adults is 80 mg taken orally once daily. A starting dose of 40 mg is considered for patients who are treated with high doses of diuretics. Edarbi may interact with other heart or blood pressure medications, diuretics (water pills), or nonsteroidal anti-inflammatory drugs (NSAIDs). Tell your doctor all medications and supplements you use. Do not use Edarbi if you are pregnant, and stop using if you become pregnant. Edarbi can cause injury or death to the fetus if taken during the second or third trimester. Use effective birth control. It is unknown if Edarbi passes into breast milk or if it could harm a nursing baby. Breastfeeding while taking Edarbi is not recommended.

Our Edarbi (azilsartan medoxomil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Edarbi Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • feeling like you might pass out;
  • urinating less or not at all;
  • confusion, loss of appetite, vomiting, pain in your side or lower back; or
  • swelling, rapid weight gain.

Other common side effects may include:

  • diarrhea, nausea;
  • cough;
  • muscle spasm;
  • mild dizziness; or
  • weakness, tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Edarbi (azilsartan medoxomil)

Edarbi Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 4814 patients were evaluated for safety when treated with Edarbi at doses of 20, 40, or 80 mg in clinical trials. This includes 1704 patients treated for at least six months; of these, 588 were treated for at least one year.

Treatment with Edarbi was well-tolerated with an overall incidence of adverse reactions similar to placebo. The rate of withdrawals due to adverse events in placebo-controlled monotherapy and combination therapy trials was 2.4% (19/801) for placebo, 2.2% (24/1072) for Edarbi 40 mg, and 2.7% (29/1074) for Edarbi 80 mg. The most common adverse event leading to discontinuation, hypotension/orthostatic hypotension, was reported by 0.4% (8/2146) patients randomized to Edarbi 40 mg or 80 mg compared to 0% (0/801) patients randomized to placebo. Generally, adverse reactions were mild, not dose related, and similar regardless of age, gender, and race.

In placebo-controlled monotherapy trials, diarrhea was reported up to 2% in patients treated with Edarbi 80 mg daily compared with 0.5% of patients on placebo.

Other adverse reactions with a plausible relationship to treatment that have been reported with an incidence of > 0.3% and greater than placebo in more than 3300 patients treated with Edarbi in controlled trials are listed below:

Gastrointestinal Disorders: nausea

General Disorders and Administration Site Conditions: asthenia, fatigue

Musculoskeletal and Connective Tissue Disorders: muscle spasm

Nervous System Disorders: dizziness, dizziness postural

Respiratory, Thoracic, and Mediastinal Disorders: cough

Clinical Laboratory Findings

In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommon with administration of Edarbi.

Serum Creatinine

Small reversible increases in serum creatinine are seen in patients receiving 80 mg of Edarbi. The increase may be larger when coadministered with chlorthalidone or hydrochlorothiazide.

In addition, patients taking Edarbi who had moderate to severe renal impairment at baseline or who were > 75 years of age were more likely to report serum creatinine increases.

Hemoglobin/Hematocrit

Low hemoglobin, hematocrit, and RBC counts were observed in 0.2%, 0.4%, and 0.3% of Edarbi-treated subjects, respectively. None of these abnormalities were reported in the placebo group. Low and high markedly abnormal platelet and WBC counts were observed in < 0.1% of subjects.

Postmarketing Experience

The following adverse reactions have been identified during the postmarketing use of EDARBI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Edarbi (azilsartan medoxomil)

Related Resources for Edarbi

Read the Edarbi User Reviews »

© Edarbi Patient Information is supplied by Cerner Multum, Inc. and Edarbi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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