Azilsartan Kamedoxomil / Chlorthalidone
Azilsartan medoxomil and chlorthalidone is a combination prescription medicine used to treat high blood pressure (hypertension) in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
WARNING: This medicine can cause serious harm or death to an unborn baby. Edarbyclor acts on a hormone system that controls blood pressure, and when taken during pregnancy — especially after the first trimester — it can damage the developing baby's kidneys, cause very low amniotic fluid, and lead to birth defects or death. If you discover you are pregnant while taking Edarbyclor, stop it as soon as possible and call your doctor immediately.
📖 Azilsartan Kamedoxomil / Chlorthalidone: Patient Information Guide
A plain-language walkthrough of Azilsartan Kamedoxomil / Chlorthalidone — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Azilsartan medoxomil and chlorthalidone (sold as Edarbyclor) is approved to treat high blood pressure in adults.
- Edarbyclor tablets are used to lower high blood pressure (hypertension) in adults
- Edarbyclor tablets may be used when one blood-pressure medicine alone hasn't been enough
- Edarbyclor tablets may be used as a first-line treatment when a prescriber expects that more than one drug will be needed to reach blood pressure goals
⚙️How it works▾
Edarbyclor contains two active ingredients that work on different pathways. Azilsartan blocks angiotensin II — a hormone that tightens blood vessels and raises blood pressure — from attaching to its receptor (the AT1 receptor). This allows blood vessels to relax. Chlorthalidone is a thiazide-like diuretic that acts in the kidney's early distal tubule, reducing how much sodium and water the body holds. Less fluid in circulation means lower pressure. Because these two mechanisms complement each other, the combination is more effective than either drug alone.
Chlorthalidone's diuretic effect begins in about 2–3 hours and can last up to 72 hours. Azilsartan starts working quickly after absorption, with most of its blood-pressure effect visible within 1 to 2 weeks of starting treatment.
💊How it's taken▾
Edarbyclor is taken once daily by mouth as a tablet, with or without food. Your prescriber will typically start you on a lower-strength tablet; if your blood pressure hasn't reached goal after 2 to 4 weeks, the dose may be increased. Do not exceed the maximum dose your prescriber prescribes.
- Can be taken at any time of day — with or without a meal
- Store in the original container (protects from light and moisture); do not repackage
- If you are dehydrated or low on body fluid, your doctor should address that before you start this medicine
- Follow your prescriber's and pharmacist's instructions exactly — do not adjust your dose on your own
🤒Side effects — in detail▾
Most side effects with Edarbyclor are mild, but there are a few to know about:
- Dizziness — the most common; reported in about 1 in 11 patients
- Fatigue (tiredness)
- Low blood pressure (hypotension) and fainting (syncope)
- Increased creatinine (a sign of kidney stress) — more common with Edarbyclor than with either drug alone
- Diarrhea, nausea, muscle spasm, and cough (seen with azilsartan alone in studies)
- Rash, headache, and elevated uric acid or cholesterol (seen with chlorthalidone)
- Postmarketing reports: loss of consciousness, itching (pruritus), and angioedema (severe facial/throat swelling)
Call your doctor right away for signs of serious reactions — especially swelling of the face or throat, very low blood pressure, markedly reduced urination, or loss of consciousness.
⚠️Warnings & precautions▾
- Fetal toxicity (most critical): Edarbyclor can cause serious injury or death to a developing baby. Stop it immediately if pregnancy is detected and call your doctor.
- Low blood pressure: Risk is highest in people who are dehydrated, salt-depleted, or on high-dose diuretics. Correct fluid deficits before starting.
- Kidney problems: Edarbyclor can worsen kidney function, especially in people with existing kidney disease, renal artery narrowing, or severe heart failure. Kidney labs should be monitored regularly.
- Electrolyte imbalances: Chlorthalidone can lower potassium (hypokalemia); azilsartan can raise it (hyperkalemia). Periodic blood tests are important.
- Gout/high uric acid (hyperuricemia): Chlorthalidone can raise uric acid levels and trigger gout attacks in susceptible people.
- Anuria (no urine output): Edarbyclor must not be used in patients who are not producing urine at all.
🔀What it interacts with▾
Several medicines and conditions can interact with Edarbyclor in important ways:
- NSAIDs (ibuprofen, naproxen, COX-2 inhibitors): can blunt the blood-pressure benefit of Edarbyclor and raise the risk of kidney damage — especially in older adults or people with kidney disease
- Lithium: chlorthalidone reduces lithium clearance by the kidneys, which can push lithium levels to toxic heights
- Aliskiren (Tekturna): must not be combined with Edarbyclor in people with diabetes; should be avoided in people with kidney impairment
- Other RAS-blocking drugs (ACE inhibitors, other ARBs): combining them increases the risk of low blood pressure, high potassium, and acute kidney injury
- Digoxin: low potassium from chlorthalidone can make digoxin more likely to cause heart rhythm problems
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Do not use Edarbyclor if you are pregnant. Stop it immediately and call your doctor if you become pregnant while taking it.
- Breastfeeding: Breastfeeding is not recommended while taking Edarbyclor — both ingredients can pass into breast milk.
- Children: Safety and effectiveness in patients under 18 have not been established.
- Kidney disease: Use with caution; kidney function should be monitored closely. Not recommended in severe renal impairment.
- Renal artery stenosis (narrowed arteries to the kidneys): increased risk of kidney failure.
- Dehydration or low sodium: Correct before starting — risk of a dangerous blood pressure drop.
- Diabetes with aliskiren use: Combining aliskiren and Edarbyclor is contraindicated.
- Anuria (no urine output): Edarbyclor is contraindicated — must not be taken.
- Older adults: No dose adjustment needed, but some older individuals may be more sensitive to blood pressure drops and kidney effects.
🚑If you take too much▾
A large overdose of the chlorthalidone component can cause nausea, weakness, dizziness, and dangerous shifts in electrolyte (salt) levels. There is no specific antidote. If an overdose is suspected, seek emergency medical care right away — treatment is supportive. Note that azilsartan cannot be removed from the body by dialysis.
📡Pharmacodynamics — effects in the body▾
Edarbyclor lowers blood pressure through two complementary actions. Azilsartan blocks the blood-vessel-tightening effects of angiotensin II, relaxing peripheral blood vessels and reducing resistance. Chlorthalidone promotes sodium and fluid excretion through the kidneys, reducing overall fluid volume in the body — its diuretic effect begins within about 2–3 hours and can last up to 72 hours. Together, these effects produce sustained blood-pressure lowering across the full 24-hour dosing interval.
🔬Pharmacokinetics — how your body processes it▾
After you take an Edarbyclor tablet, azilsartan reaches peak blood levels in about 1.5 to 3 hours, and chlorthalidone peaks in about 1 hour. Food does not meaningfully affect how much of either drug your body absorbs. Azilsartan is processed mainly by the liver (CYP2C9 enzyme) and eliminated roughly half in feces and half in urine, with a half-life of about 11 hours — meaning stable levels build up within 5 days of once-daily dosing. Chlorthalidone has a much longer half-life of about 42–45 hours and is eliminated primarily unchanged in the urine and feces.
📦How to store it▾
Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F) . Protect from moisture and light. store in original container.
📄 Written from Azilsartan Kamedoxomil / Chlorthalidone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Azilsartan Kamedoxomil / Chlorthalidone — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Edarbyclor and why did my doctor prescribe two medicines in one pill? ▾
Can I take Edarbyclor with food, and does it matter what time of day I take it? ▾
I felt dizzy after my first dose — is that normal, and when should I worry? ▾
Is it safe to take ibuprofen or other over-the-counter pain relievers with Edarbyclor? ▾
What should I do if I find out I'm pregnant while taking Edarbyclor? ▾
What signs should make me call my doctor right away while on this medicine? ▾
Is Azilsartan Kamedoxomil / Chlorthalidone available over the counter? ▾
When was Azilsartan Kamedoxomil / Chlorthalidone first available? ▾
Who makes Azilsartan Kamedoxomil / Chlorthalidone? ▾
💬 Answers drafted from Azilsartan Kamedoxomil / Chlorthalidone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Azilsartan Kamedoxomil / Chlorthalidone comes
Azilsartan Kamedoxomil / Chlorthalidone is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Edarbyclor tablets are used to treat high blood pressure (hypertension) in adults
- Edarbyclor tablets may be used when a single blood-pressure medicine has not reached blood pressure goals
- Edarbyclor tablets may be used as initial therapy when a prescriber expects multiple medicines will be needed
- Edarbyclor tablets are taken by mouth once daily, with or without food
- Edarbyclor tablets should be stored and dispensed in the original container to protect from light and moisture — do not repackage
- If you are dehydrated or volume-depleted, your doctor should correct that before you start Edarbyclor tablets
- Your prescriber may increase your Edarbyclor tablet dose after 2 to 4 weeks if blood pressure goals have not been met
📊 Azilsartan Kamedoxomil / Chlorthalidone across the U.S. market
How Azilsartan Kamedoxomil / Chlorthalidone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Azilsartan Kamedoxomil / Chlorthalidone is used
A general measure of how commonly Azilsartan Kamedoxomil / Chlorthalidone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Azilsartan Kamedoxomil / Chlorthalidone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Azilsartan Kamedoxomil / Chlorthalidone prescribed? Of the 1,597 medications we measure, Azilsartan Kamedoxomil / Chlorthalidone ranks #1,099 by Medicaid prescriptions — more than 31% of them.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Azilsartan Kamedoxomil / Chlorthalidone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 3 listed Azilsartan Kamedoxomil / Chlorthalidone NDCs with Medicaid activity.
🔍 Compare Azilsartan Kamedoxomil / Chlorthalidone products
A representative set of FDA-listed product records for Azilsartan Kamedoxomil / Chlorthalidone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 40; 12.5 mg/1; mg | Oral | Arbor Pharmaceuticals | NDA | View NDC → |
| 40; 25 mg/1; mg | Oral | Arbor Pharmaceuticals | NDA | View NDC → |
| AZILSARTAN KAMEDOXOMIL 40 mg/1; CHLORTHALIDONE 12.5 mg | Oral | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | NDA | View NDC → |
| AZILSARTAN KAMEDOXOMIL 40 mg/1; CHLORTHALIDONE 25 mg | Oral | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | NDA | View NDC → |
| 40; 12.5 mg/1; mg | Oral | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | NDA | View NDC → |
| 40; 25 mg/1; mg | Oral | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | NDA | View NDC → |
| AZILSARTAN KAMEDOXOMIL 40 mg/1; CHLORTHALIDONE 25 mg | Oral | Pharma Packaging Solutions, LLC dba Tjoapack LLC | NDA | View NDC → |
Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Azilsartan Kamedoxomil / Chlorthalidone NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Azilsartan Kamedoxomil / Chlorthalidone — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Azilsartan Kamedoxomil / Chlorthalidone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Azilsartan Kamedoxomil / Chlorthalidone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Azilsartan Kamedoxomil / Chlorthalidone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
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🏭 Manufacturers & labelers
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Arbor Pharmaceuticals is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.