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Edarbi

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Edarbi

Edarbi Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

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. Edarbi may be taken with or without food. Side effects of Edarbi can include nausea, fatigue, muscle spasm, and dizziness.

Edarbi is to be taken once daily. No clinically significant drug interactions have been observed in studies of Edarbi. Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Edarbi passes into your breast milk. You and your doctor should decide if you will take Edarbi or breastfeed. You should not do both. Talk with your doctor about the best way to feed your baby if you take Edarbi.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Edarbi in Detail - Patient Information: Side Effects

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 a serious side effect such as:

  • feeling like you might pass out;
  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, vomiting; or
  • swelling, weight gain, feeling short of breath.

Less serious side effects may include:

  • diarrhea, mild 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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Edarbi Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, diarrhea, or fatigue, may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: muscle spasms, unusual change in the amount of urine, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Edarbi (azilsartan medoxomil)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Edarbi FDA Prescribing Information: Side Effects
(Adverse Reactions)

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) »

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Edarbi - User Reviews

Edarbi User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Edarbi sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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