Edarbi Side Effects

Generic name: azilsartan medoxomil

Note: This document contains side effect information about azilsartan medoxomil. Some of the dosage forms listed on this page may not apply to the brand name Edarbi.

Some side effects of Edarbi may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to azilsartan medoxomil: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking azilsartan medoxomil (the active ingredient contained in Edarbi) 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.

For Healthcare Professionals

Applies to azilsartan medoxomil: oral tablet

Cardiovascular

Cardiovascular side effects have included hypotension/orthostatic hypotension (0.4%).

Gastrointestinal

Gastrointestinal side effects have included diarrhea (up to 2%) and nausea.

Hematologic

Hematologic side effects have included low hemoglobin, hematocrit, and RBC counts in less than 0.5% of patients. Low and high markedly abnormal platelet and WBC counts were observed in less than 0.1% of patients.

Musculoskeletal

Musculoskeletal side effects have included muscle spasm.

Nervous system

Nervous system side effects have included dizziness, postural dizziness, asthenia, and fatigue.

Renal

Renal side effects have included small reversible increases in serum creatinine in patients receiving 80 mg of azilsartan and may be larger when coadministered with chlorthalidone or hydrochlorothiazide.

Respiratory

Respiratory side effects have included cough.

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