Azilsartan and chlorthalidone Brand names: Edarbyclor

What is azilsartan and chlorthalidone used for?

From the label: indications and usage

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. Edarbyclor may be used as initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including thiazide-like diuretics such as chlorthalidone and ARBs such as azilsartan medoxomil. […]

Conditions named in the indications of azilsartan and chlorthalidone's FDA labels, with every medicine labeled for each:

• High blood pressure

FDA pharmacologic class: Angiotensin 2 Receptor Blocker and Thiazide-like Diuretic.

What does the patient leaflet for azilsartan and chlorthalidone say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about Edarbyclor?

Edarbyclor can cause harm or death to your unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you become pregnant while taking Edarbyclor, tell your doctor right away. Your doctor may switch you to a different medicine to treat your high blood pressure. What Is Edarbyclor? Edarbyclor is a prescription medicine that contains azilsartan medoxomil, an angiotensin receptor blocker (ARB) and chlorthalidone, a water pill (diuretic). Edarbyclor is used to treat high blood pressure (hypertension): when one medicine to lower your high blood pressure is not enough as the first medicine to lower your high blood pressure if your doctor decides you are likely to need more than one medicine. It is not known if Edarbyclor is safe and effective in children under 18 years of age. Who should not take Edarbyclor? Do not take Edarbyclor if you: make less urine because of kidney problems

From the patient leaflet: How should I store Edarbyclor?

Store Edarbyclor at room temperature between 68°F to 77°F (20°C to 25°C). Store Edarbyclor in the original container that you received from your pharmacist or doctor. Do not put Edarbyclor into a different container. Keep the container closed tightly, and keep Edarbyclor out of the light. Keep Edarbyclor and all medicines out of the reach of children.

Is there a generic for azilsartan and chlorthalidone (Edarbyclor)?

The FDA approved the first generic azilsartan and chlorthalidone on January 21, 2025. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

The Orange Book lists 3 patents for Edarbyclor tablets, the last expiring on July 1, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

What do pharmacies pay for azilsartan and chlorthalidone (Edarbyclor)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $8.49 per Edarbyclor 40-12.5 mg tablet, about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Has azilsartan and chlorthalidone been recalled?

The FDA's Enforcement Report lists 2 recalls naming azilsartan and chlorthalidone since 2021: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

What does the azilsartan and chlorthalidone label say about other medicines?

The azilsartan and chlorthalidone label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Check azilsartan and chlorthalidone against other medicines

What do FAERS reports show for azilsartan and chlorthalidone?

The FDA Adverse Event Reporting System holds 1,253 reports that list azilsartan and chlorthalidone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 39 are coded as a death and 219 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

• 189
• 144
• 131
• 133
• 119
• 76
• 53
• 80
• 62
• 60
• 28

• 2016
• 2017
• 2018
• 2019
• 2020
• 2021
• 2022
• 2023
• 2024
• 2025
• 2026

The most reported reactions

• Dizziness (named in the label)107
• Fatigue (named in the label)78
• Blood Pressure Increased72
• Drug Ineffective (a use or a product term, not a reaction)67
• Diarrhoea (named in the label)62
• Nausea (named in the label)62
• Hypotension (named in the label)58
• Headache (named in the label)55

Side effects: the label's list and every FAERS reaction

What else is labeled for the same conditions as azilsartan and chlorthalidone?

69 other medicines are given the same way (oral) and in the same FDA class as azilsartan and chlorthalidone or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Every medicine labeled for the same conditions as azilsartan and chlorthalidone

What next?

Alternatives to azilsartan and chlorthalidone

69 medicines for the same use

Other ARBs

the pharmacologic class, with prices and generics

Azilsartan and chlorthalidone side effects

the label's list beside FAERS reports

Check an interaction

what two or more labels say about each other