Azilsartan

The active ingredients of Edarbyclor target two separate mechanisms involved in blood pressure regulation. Azilsartan medoxomil Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzymes (ACE, kinase II).

• Edarbyclor is indicated for the treatment of hypertension, to lower blood pressure. Edarbyclor may be used in patients whose blood pressure is not adequately controlled on monotherapy.ICD-10: I10

• Edarbyclor is contraindicated in patients with anuria [see Warnings and Precautions (5.3) ]. Do not coadminister aliskiren-containing products with Edarbyclor in patients with diabetes [see Drug Interactions (7) ] .contraindicated

Starting dose is 40/12.5 mg once daily ( 2.1 ) Edarbyclor may be used to provide additional blood pressure lowering for patients not adequately controlled on azilsartan medoxomil 80 mg or chlorthalidone 25 mg ( 2.1 ) Dose may be increased to 40/25 mg after 2 to 4 weeks as needed to achieve blood pressure goals ( 2.1 ) Maximal dose is 40/25 mg ( 2.1 ) May be administered with other antihypertensive agents ( 2.1 ) Edarbyclor may be administered with or without food ( 2.1 ) Replace volume in volume-depleted patients prior to use ( 2.2 ) 2.1 Dosing Information The recommended starting dose of Edarbyclor is 40/12.5 mg taken orally once daily. Most of the antihypertensive effect is apparent within 1 to 2 weeks. The dosage may be increased to 40/25 mg after 2 to 4 weeks as needed to achieve blood pressure goals. Edarbyclor doses above 40/25 mg are probably not useful. Patients titrated to the individual components (azilsartan medoxomil and chlorthalidone) may instead receive the corresponding dose of Edarbyclor. Edarbyclor may be administered with other antihypertensive agents as needed. 2.2 Prior to Dosing Correct any volume depletion prior to administration of Edarbyclor, particularly in patients with impaired renal function or those treated with high doses of diuretics [see Warnings and Precautions (5.2) ]. Patients who experience dose-limiting adverse reactions on chlorthalidone may be switched to Edarbyclor, initially with a lower dose of chlorthalidone [see Warnings and Precautions (5.4) ]. 2.3 Handling Instructions Do not repackage Edarbyclor.

In patients with an activated renin-angiotensin-aldosterone system (RAAS), such as volume- and/or salt-depleted patients, Edarbyclor can cause excessive hypotension. Correct volume or salt depletion prior to administration of Edarbyclor ( 5.2 ) In patients with renal artery stenosis, Edarbyclor may cause renal failure ( 5.3 ) Monitor renal function in patients with renal impairment. Consider discontinuing Edarbyclor with progressive renal impairment ( 5.3 ) Monitor serum electrolytes periodically ( 5.4 ) 5.1 Fetal Toxicity Azilsartan medoxomil Edarbyclor can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Edarbyclor as soon as possible [see Use in Specific Populations (8.1) ]. Chlorthalidone Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia. 5.2 Hypotension in Volume- or Salt-Depleted Patients In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with Edarbyclor.

The following potential adverse reactions with Edarbyclor, azilsartan medoxomil, or chlorthalidone and similar agents are included in more detail in the Warnings and Precautions section of the label: Fetal toxicity [see Warnings and Precautions (5.1) ] Hypotension in Volume- or Salt-Depleted Patients [see Warnings and Precautions (5.2) ] Impaired Renal Function [see Warnings and Precautions (5.3) ] Hypokalemia [see Warnings and Precautions (5.4) ] Hyperuricemia [see Warnings and Precautions (5.5) ] Most common adverse reactions (incidence ≥2%) are dizziness and fatigue ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. Edarbyclor has been evaluated for safety in more than 3900 patients with hypertension; more than 700 patients were treated for at least 6 months and more than 280 for at least 1 year. Adverse reactions have generally been mild and transient in nature. Common adverse reactions that occurred in the 8-week factorial design trial in at least 2% of Edarbyclor-treated patients and greater than azilsartan medoxomil or chlorthalidone are presented in Table 1. Table 1.

Lactation: Breastfeeding is not recommended. ( 8.2 ) 8.1 Pregnancy Risk Summary Edarbyclor can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death ( see Clinical Considerations ). Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. When pregnancy is detected, discontinue Edarbyclor as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage).

Metabolism

Edarbyclor Following oral administration of Edarbyclor, peak plasma concentrations of azilsartan and chlorthalidone are reached at 3 and 1 hours, respectively. The rate (C max and T max ) and extent (AUC) of absorption of azilsartan are similar when it is administered alone or with chlorthalidone.

Limited data are available related to overdosage in humans. Azilsartan medoxomil Limited data are available related to overdosage in humans. During controlled clinical trials in healthy subjects, once daily doses up to 320 mg of azilsartan medoxomil were administered for 7 days and were well tolerated. In the event of an overdose, supportive therapy should be instituted as dictated by the patient's clinical status. Azilsartan is not dialyzable. Chlorthalidone Symptoms of acute overdosage include nausea, weakness, dizziness, and disturbances of electrolyte balance. The oral LD50 of the drug in the mouse and the rat is more than 25,000 mg/kg body weight. The minimum lethal dose (MLD) in humans has not been established. There is no specific antidote, but gastric lavage is recommended, followed by supportive treatment. Where necessary, this may include intravenous dextrose-saline with potassium, administered with caution.

• Feb 25, 2011NDANDA200796Azurity
• Dec 20, 2011NDANDA202331Azurity
• Jul 20, 2022ANDAANDA214489Lupin

1. 1Dizziness2295.6%
2. 2Diarrhoea2195.3%
3. 3Hypertension2125.2%
4. 4Drug Ineffective1894.6%
5. 5Nausea1864.5%
6. 6Fatigue1784.3%
7. 7Blood Pressure Increased1603.9%
8. 8Headache1543.7%
9. 9Hypotension1373.3%
10. 10Malaise1313.2%
11. 11Off Label Use1283.1%
12. 12Wrong Technique In Product Usage Process1062.6%
13. 13Decreased Appetite1052.6%
14. 14Dyspnoea1042.5%
15. 15Renal Impairment1012.5%

The 10 most recently updated of 70 ClinicalTrials.gov registrations naming Azilsartan as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
  Not yet recruiting · Phase 4 · Interventional · 64 enrolled · Baylor Research Institute
  NCT07547878updated 2026-05-08
• Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
  Not yet recruiting · Observational · 13,656 enrolled · First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  NCT07262710updated 2025-12-04
• A Study of Azilsartan in Children From 6 to Less Than 16 Years Old With High Blood Pressure
  Completed · Observational · 5 enrolled · Takeda
  NCT05107960updated 2025-09-10
• Bioequivalence Study of Azilsartan Medoxomil 80 mg Tablets (Gedeon Richter Plc., Hungary) and Edarbi® 80 mg Tablets (JSC Nizhpharm, Russia)
  Not yet recruiting · Phase 1 · Interventional · 56 enrolled · Gedeon Richter Plc.
  NCT06990204updated 2025-05-25
• An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension
  Completed · Phase 3 · Interventional · 377 enrolled · Arbor Pharmaceuticals, Inc.
  NCT02235909updated 2025-02-25
• Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World Study
  Recruiting · Observational · 180 enrolled · Beijing Friendship Hospital
  NCT05498675updated 2025-02-13
• A Study of TAK-536 in Children From 2 to Less Than 6 Years Old With High Blood Pressure
  Completed · Phase 3 · Interventional · 10 enrolled · Takeda
  NCT04668157updated 2024-12-09
• Drug-Drug Interaction Study Between HUC2-565-A and HUC2-565-B
  Active not recruiting · Phase 1 · Interventional · 46 enrolled · Huons Co., Ltd.
  NCT06618079updated 2024-10-01
• Efficacy and Safety of Mexartan Potassium Tablets (AZL-M) and Calcium Channel Blockers (CCB) in the Treatment of Adults With Essential Hypertension in Chinese Population: a National Multicenter, Prospective, Observational Study
  Unknown · Observational · 1,215 enrolled · Hasten Biopharmaceutical Co., Ltd.
  NCT05947448updated 2024-04-01
• A Study for PMS of AZL-M/CLD FDC in the Treatment of Participants With Essential HTN in South Korea
  Completed · Observational · 718 enrolled · Celltrion Pharm, Inc.
  NCT04470830updated 2023-10-26

Frequently asked questions

How does Azilsartan work?

The active ingredients of Edarbyclor target two separate mechanisms involved in blood pressure regulation. Azilsartan medoxomil Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzymes (ACE, kinase II).

What is Azilsartan used for?

According to FDA labeling, Azilsartan carries indications including: Edarbyclor is indicated for the treatment of hypertension, to lower blood pressure. Edarbyclor may be used in patients whose blood pressure is not adequately controlled on monotherapy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Azilsartan?

Azilsartan is classified as Angiotensin 2 Receptor Blocker, Angiotensin 2 Receptor Antagonists, Angiotensin 2 Type 1 Receptor Antagonists, Arterial Vasodilation, Decreased Blood Pressure.

What are the brand names for Azilsartan?

Azilsartan is marketed under brand names including Edarbi, Edarbyclor.

What are the contraindications for Azilsartan?

Azilsartan labeling lists contraindications including: Edarbyclor is contraindicated in patients with anuria [see Warnings and Precautions (5.3) ]. Do not coadminister aliskiren-containing products with Edarbyclor in patients with diabetes [see Drug Interactions (7) ] .. Always consult the full prescribing information and a clinician.