FDA-filed SPL labeling · retrieved through openFDA

Amlodipine / Olmesartan Medoxomil

Amlodipine / olmesartan medoxomil is a two-medicine combination tablet, sold generically and as Azor, that lowers high blood pressure (hypertension).

Brand name Azor
Drug classes ⓘ Angiotensin 2 Receptor Blocker
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 17 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 →

At a glance
Linked label effectiveApr 28, 2026
Clinical labels in scope ⓘ17
AvailabilityRx
Earliest approval/marketing year ⓘ2007
FDA-listed product records ⓘ122
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Oct 1, 2026
⭐ Amlodipine / Olmesartan Medoxomil at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Amlodipine / olmesartan medoxomil is a combination tablet that treats high blood pressure. It must not be used in pregnancy. Take it as prescribed, report swelling, dizziness or severe diarrhea, and check with your pharmacist before adding NSAIDs or other blood pressure drugs.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Do not take this medicine during pregnancy. Drugs like olmesartan, which act on the renin-angiotensin system, can injure or even cause the death of a developing baby, especially in the second and third trimesters. If you find out you are pregnant, contact your doctor right away so the medicine can be stopped and a safer option chosen. Do not stop on your own before talking with your doctor unless told to.

Read the full warning on DailyMed →

📖 Amlodipine / Olmesartan Medoxomil: Patient Information Guide

A plain-language walkthrough of Amlodipine / Olmesartan Medoxomil — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

What Amlodipine / Olmesartan Medoxomil is used for

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This combination is used for one condition across the supported products.

  • High blood pressure (hypertension), alone or with other blood pressure medicines (generic amlodipine and olmesartan medoxomil tablets and Azor).
  • Initial treatment for people likely to need more than one medicine to reach their blood pressure goal.

How Amlodipine / Olmesartan Medoxomil works

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Amlodipine is a calcium channel blocker. It limits calcium entering muscle cells in blood vessel walls, so the vessels relax and widen. Olmesartan is an angiotensin II receptor blocker. It blocks angiotensin II, a natural substance that narrows blood vessels, from attaching to its receptor.

Because the two work differently, together they lower blood pressure more than either alone.

How Amlodipine / Olmesartan Medoxomil is taken (dosage)

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The tablet is taken by mouth, usually once a day, with or without food. Your prescriber typically starts at the lowest strength and may increase it after 1 to 2 weeks as needed. Follow your prescriber's directions and your label.

Amlodipine / Olmesartan Medoxomil side effects in detail

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Most side effects are mild. Common ones include:

  • Swelling (edema), especially in the legs
  • Dizziness
  • Headache
  • Flushing
  • Palpitations
  • Lightheadedness on standing

Call your doctor for fainting, worse chest pain, severe lasting diarrhea with weight loss, facial swelling, yellow skin or eyes, or very little urine.

Amlodipine / Olmesartan Medoxomil warnings and precautions

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  • Pregnancy: can cause fetal injury and death; stop and call your doctor if pregnant.
  • Low blood pressure, especially if dehydrated or on high-dose diuretics.
  • Possible increase in angina or heart attack when starting or raising the dose, particularly with severe coronary artery disease.
  • Kidney function changes and high potassium; periodic blood tests may be needed.
  • Severe diarrhea with weight loss (sprue-like enteropathy) can appear months to years in.

Amlodipine / Olmesartan Medoxomil interactions: what it interacts with

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Several medicines can change how this combination works or raise risks.

  • Aliskiren: contraindicated in diabetes because of kidney, potassium and blood pressure risks.
  • ACE inhibitors or other ARBs: higher risk of low blood pressure, high potassium and kidney problems.
  • NSAIDs: can reduce the blood pressure effect and harm kidneys.
  • Simvastatin: limit to 20 mg daily with amlodipine.
  • Cyclosporine and tacrolimus: levels may rise.
  • CYP3A inhibitors: can raise amlodipine levels.
  • Lithium: levels may rise and cause toxicity.
  • Colesevelam: take olmesartan at least 4 hours before.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

Before taking Amlodipine / Olmesartan Medoxomil

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  • Do not use during pregnancy; breastfeeding is not recommended.
  • Do not combine with aliskiren if you have diabetes.
  • Tell your doctor about dehydration, kidney disease, liver disease, severe aortic stenosis or severe coronary artery disease.
  • Not recommended as initial therapy with liver impairment or at age 75 and older.
  • Not established as safe and effective in children.

Amlodipine / Olmesartan Medoxomil overdose: if you take too much

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Overdose information in humans is limited. Too much would most likely cause very low blood pressure and a fast heartbeat, and possibly a slow heartbeat. Seek emergency care right away; treatment is supportive, such as monitoring and blood pressure support.

Pharmacodynamics: what Amlodipine / Olmesartan Medoxomil does in the body

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Amlodipine widens blood vessels, lowering standing and lying blood pressure without a significant change in heart rate, and its effect lasts at least 24 hours. Olmesartan blocks the blood pressure-raising effects of angiotensin II, and had minimal influence on aldosterone and no effect on potassium in the label's studies.

Pharmacokinetics: how your body processes Amlodipine / Olmesartan Medoxomil

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The combination tablet is absorbed like the two medicines taken separately, and food does not affect either one. Olmesartan peaks in about 1 to 2 hours, while amlodipine peaks in 6 to 12 hours. Amlodipine is mostly broken down by the liver and has a long half-life of about 45 hours, so it builds up gradually. Olmesartan is cleared by the kidneys and through bile in stool, with a half-life of around 13 hours.

How to store Amlodipine / Olmesartan Medoxomil

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Store at 25° C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .

📄 Written from Amlodipine / Olmesartan Medoxomil’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 →

🩺 Amlodipine / Olmesartan Medoxomil: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Amlodipine / Olmesartan Medoxomil — the kind of thing our pharmacy team would talk through with you at the counter.

What is this medicine for?

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It treats high blood pressure. It combines two medicines that work differently, so it can lower pressure more than either alone. Lowering blood pressure helps reduce the risk of strokes and heart attacks.

How should I take it?

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Take it by mouth once a day, with or without food. Your doctor may raise the strength after a week or two. Follow your label and ask me if you miss a dose.

What side effects should I expect?

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The most common is swelling in the ankles or legs. Some people feel dizzy, flushed, or get headaches or a pounding heartbeat. Call your doctor if you faint, have worse chest pain, or have severe diarrhea with weight loss.

Can I take it if I am pregnant or planning a pregnancy?

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No. It can seriously harm or even kill an unborn baby. If you become pregnant, call your doctor right away so you can switch to a safer medicine. Breastfeeding is also not recommended.

Can I take pain relievers with it?

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Check with me first. NSAIDs like ibuprofen or naproxen can weaken the blood pressure effect and may strain your kidneys, especially if you are older or dehydrated.

Are there other medicines I should avoid?

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Do not take aliskiren with this if you have diabetes. Tell me about other blood pressure medicines, simvastatin, lithium, cyclosporine or tacrolimus, since they can interact.

Is Amlodipine / Olmesartan Medoxomil available over the counter?

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Amlodipine / Olmesartan Medoxomil is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.

When was Amlodipine / Olmesartan Medoxomil first available?

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Amlodipine / Olmesartan Medoxomil has been available in the United States since at least 2007, based on FDA approval history (Drugs@FDA) and product marketing records.

Who makes Amlodipine / Olmesartan Medoxomil?

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Amlodipine / Olmesartan Medoxomil is supplied by 20 manufacturers listed in the FDA NDC Directory, including Ajanta Pharma USA Inc., Macleods Pharmaceuticals Limited, Aurobindo Pharma Limited.

💬 Answers drafted from Amlodipine / Olmesartan Medoxomil’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 →

🧰 More about Amlodipine / Olmesartan Medoxomil on HelloPharmacist

💊 Amlodipine / Olmesartan Medoxomil forms and strengths (how it comes)

Amlodipine / Olmesartan Medoxomil 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

By mouth
Brands Azor
How this form is used
What it may be used for
  • Azor tablets are used to treat high blood pressure, alone or with other blood pressure medicines.
  • Amlodipine and olmesartan medoxomil tablets are used to treat high blood pressure and may be used as initial therapy in people likely to need more than one medicine.
Important instructions
  • Azor is taken by mouth once daily, and the dose may be raised after 1 to 2 weeks.
  • Amlodipine and olmesartan medoxomil tablets are taken by mouth once daily, and your prescriber adjusts the dose as needed.
Available strengths 4 strengths
122 FDA-listed product records ⓘ

📊 Amlodipine / Olmesartan Medoxomil on the U.S. market: products, makers and brands

How Amlodipine / Olmesartan Medoxomil 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.

1
Dose forms ⓘ
20
Manufacturers
3
Brand names
122
FDA-listed product records ⓘ
2007
First marketed ⓘ
Ajanta Pharma USA Inc.10%
Macleods Pharmaceuticals Limited10%
Aurobindo Pharma Limited10%
Ascend Laboratories, LLC10%
Cosette Pharmaceuticals, Inc.7%
Micro Labs Limited7%
Other makers48%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Amlodipine / Olmesartan Medoxomil is used (Medicaid data)

A general measure of how commonly Amlodipine / Olmesartan Medoxomil is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1 2025 – Q1 2026, summed across every form and brand of the drug.

Think of this as a proxy for how widely Amlodipine / Olmesartan Medoxomil 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.

58,586
Medicaid prescriptions filled (Q1 2025 – Q1 2026)
$1.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Amlodipine / Olmesartan Medoxomil prescribed? Of the 1,599 medications we measure, Amlodipine / Olmesartan Medoxomil ranks #606 by Medicaid prescriptions — more than 62% of them.

Where Amlodipine / Olmesartan Medoxomil ranks among the drugs we measure · Q1 2025 – Q1 2026 · neighbors ±5

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Amlodipine / Olmesartan Medoxomil, 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 33 of 188 listed Amlodipine / Olmesartan Medoxomil NDCs with Medicaid activity.

🔍 Compare Amlodipine / Olmesartan Medoxomil products

A representative set of FDA-listed product records for Amlodipine / Olmesartan Medoxomil — 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.)

Showing 122 of 122 products — FDA National Drug Code Directory. See every product, package size and price: browse all 122 Amlodipine / Olmesartan Medoxomil NDCs →

🏷️ Amlodipine / Olmesartan Medoxomil brand names

Azor

🏭 Who makes Amlodipine / Olmesartan Medoxomil: manufacturers and labelers

Ajanta Pharma USA Inc. 12 Macleods Pharmaceuticals Limited 12 Aurobindo Pharma Limited 12 Ascend Laboratories, LLC 12 Cosette Pharmaceuticals, Inc. 8 Micro Labs Limited 8 ScieGen Pharmaceuticals, Inc 8 Glenmark Pharmaceuticals Inc., USA 8 Amneal Pharmaceuticals NY LLC 4 AvKARE 4 Golden State Medical Supply, Inc. 4 Zydus Lifesciences Limited 4 Zydus Pharmaceuticals USA Inc. 4 Daiichi Sankyo Inc. 4 Jubilant Cadista Pharmaceuticals Inc. 4 medsource pharmaceuticals 4 Torrent Pharmaceuticals Limited 4 Camber Pharmaceuticals, Inc. 3 Bryant Ranch Prepack 2 A-S Medication Solutions 1

🔬 Sources for this Amlodipine / Olmesartan Medoxomil page

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 28, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Amlodipine / Olmesartan Medoxomil.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Amlodipine / Olmesartan Medoxomil after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
17
NDC products indexed
122
Distinct labelers/manufacturers represented
20
Linked representative label ⓘ
Golden State Medical Supply, Inc.
Linked label effective
Apr 28, 2026
Composite sections available
23
Linked SPL Set ID
132cca8f-48a2-2516-e063-6394a90a5f32
Linked SPL Document ID
508d4d92-abe0-6182-e063-6394a90a7bcc
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 17 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. Golden State Medical Supply, Inc. 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.