Skip to the answer

Olmesartan

Olmesartan is an angiotensin II receptor blocker (ARB) used to treat high blood pressure in adults and children six years and older.

Brand names BenicarOlmesartan Medoxomil
Drug class Angiotensin 2 Receptor Blocker
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 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 75 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 →

✓No current FDA shortage listed · checked Oct 7, 2026
Olmesartan at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Olmesartan (Benicar) is an angiotensin receptor blocker (ARB) for high blood pressure in adults and children six and older. It stops the hormone angiotensin II from tightening blood vessels, so they relax. It is a usual first choice, on the market since about 2004 and available as a generic. Most people tolerate it well, with less dry cough than the related ACE inhibitors, and dizziness early on is what people notice most, especially alongside a water pill. Its boxed warning is for fetal toxicity, meaning it can seriously harm or kill an unborn baby, so stop it and call your prescriber as soon as you learn you are pregnant.

Clinical pearls

  • Report severe, lasting diarrhea with weight loss, even years after starting, because olmesartan can rarely cause a sprue-like intestinal reaction.
  • Avoid potassium supplements and potassium salt substitutes unless prescribed, since olmesartan already nudges potassium upward.
  • Regular ibuprofen or naproxen can blunt olmesartan and strain the kidneys, so keep those pain relievers short and occasional.
  • If you take colesevelam for cholesterol, take olmesartan at least 4 hours before it so it absorbs properly.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

WARNING: Olmesartan can cause serious harm or death to an unborn baby. If you become pregnant while taking olmesartan, stop the medication as soon as possible and call your doctor right away. Medicines that work on the renin-angiotensin system — the body's blood pressure control pathway — can damage the developing kidneys of a fetus, especially in the second and third trimesters of pregnancy, and can lead to low amniotic fluid, birth defects, and even fetal death. Always tell your doctor if you are pregnant or planning to become pregnant before taking this medication.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record2002
Companies listing it with the FDA30
FDA label last updatedNov 1, 2024
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Olmesartan, written from its FDA label.

What Olmesartan is used for

▾

Olmesartan is approved to treat high blood pressure (hypertension) across multiple products.

  • Benicar (olmesartan medoxomil, film-coated tablet) is indicated for high blood pressure in adults and children six years of age and older, used alone or with other blood pressure medicines.
  • Olmesartan Medoxomil tablets (including coated and film-coated generics) are indicated for high blood pressure in adults and children six years of age and older, used alone or combined with other antihypertensive agents.
  • Lowering high blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily stroke and heart attack (myocardial infarction).
  • Olmesartan is not proven effective for high blood pressure in children younger than 6, and is not recommended in children under 1 year of age.

How Olmesartan works

▾

Olmesartan belongs to a class of medications called angiotensin II receptor blockers (ARBs). Angiotensin II is a hormone that narrows blood vessels and raises blood pressure. Olmesartan selectively blocks the AT1 receptor — the docking site angiotensin II uses on blood vessel walls. When that receptor is blocked, blood vessels relax and blood pressure drops. Importantly, olmesartan does not interfere with an enzyme called ACE, so it does not affect bradykinin levels the way ACE inhibitors do, making a dry cough less likely.

Over time, blocking this receptor causes angiotensin II levels in the blood to rise, but this does not reverse olmesartan's blood-pressure-lowering effect. The drug is highly selective — it binds to AT1 receptors more than 12,500 times more strongly than to AT2 receptors.

Olmesartan dosage

▾

Olmesartan tablets are taken by mouth once daily. They can be taken with or without food. Steady, consistent levels in the body are reached within 3 to 5 days of daily dosing, and the drug does not accumulate with continued once-daily use.

  • If you miss a dose, follow the instructions on your prescription label or ask your pharmacist — do not double up without guidance.
  • Your prescriber will determine the right dose for you based on your blood pressure response, kidney function, age, and other medications.
  • Olmesartan Medoxomil tablets can also be prepared as a liquid suspension for patients who have difficulty swallowing tablets — your pharmacist can provide guidance on this formulation.

Dosing details from the FDA-approved label

From the Olmesartan prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adult Hypertension
    • Starting dose 20 mg once daily
    • Dose range 20 to 40 mg once daily
Read the label’s full dosing text

2 DOSAGE & ADMINISTRATION Indication Starting Dose Dose Range Adult Hypertension (2.1) 20 mg once daily 20 to 40 mg once daily Pediatric Hypertension (6 years of age and older) ( 2.2 ) 20 to <35 kg 10 mg once daily ≥35 kg 20 mg once daily 20 to <35 kg 10 to 20 mg once daily ≥35 kg 20 to 40 mg once daily. 2.1 Adult Hypertension Dosage must be individualized. The usual recommended starting dose of olmesartan medoxomil tablets is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of olmesartan medoxomil tablets may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily. For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), initiate olmesartan medoxomil tablets under close medical supervision and give consideration to use of a lower starting dose [see Warnings and Precautions ( 5.3 )] 2.2 Pediatric Hypertension (6 Years of Age and Older) Dosage must be individualized. For children who can swallow tablets, the usual recommended starting dose of olmesartan medoxomil tablets is 10 mg once daily for patients who weigh 20 to <35 kg (44 to 77 lb), or 20 mg once daily for patients who weigh ≥35 kg. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of olmesartan medoxomil tablets may be increased to a maximum of 20 mg once daily for patients who weigh <35 kg or 40 mg once daily for patients who weigh ≥35 kg. Use of olmesartan medoxomil tablets in children less than 1 year of age is not recommended [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.4 )] . For children who cannot swallow tablets, the same dose can be given using an extemporaneous suspension as described below [see Clinical Pharmacology ( 12.3 ) ]. Follow the suspension preparation instructions below to administer olmesartan medoxomil tablets as a suspension. Preparation of Suspension (for 200 mL of a 2 mg/mL suspension) Add 50 mL of Purified Water to an amber polyethylene terephthalate (PET) bottle containing twenty olmesartan medoxomil tablets 20 mg and allow to stand for a minimum of 5 minutes.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Olmesartan side effects

▾

Most people tolerate olmesartan well. The most commonly reported side effect is dizziness, which occurred in about 3% of patients in clinical trials.

Common side effects

  • Dizziness
  • Facial swelling (facial edema)
  • Weakness or fatigue (asthenia)
  • Nausea or vomiting
  • Skin itching, hives, or hair loss
  • Elevated potassium levels (hyperkalemia)
  • Increased blood creatinine levels
  • Dizziness or lightheadedness, especially when standing up

When to get medical help

  • Get medical help right away if you are pregnant or become pregnant — this drug can seriously harm or kill an unborn baby
  • Call your doctor if you feel faint, lightheaded, or have a sudden drop in blood pressure, especially when starting treatment
  • Call your doctor if you develop severe, ongoing diarrhea and significant weight loss — this could be a rare intestinal condition called sprue-like enteropathy
  • Seek emergency care if you have signs of a severe allergic reaction: swelling of the face, lips, throat, or difficulty breathing (angioedema)
  • Call your doctor if you notice decreased urination or signs of kidney problems, such as swelling in the legs or feet
  • Tell your doctor if you develop muscle pain or weakness that is severe or unexplained — a rare reaction called rhabdomyolysis has been reported
  • Call your doctor if you feel a rapid or irregular heartbeat

Olmesartan warnings and precautions

▾
  • Fetal toxicity (most critical): Olmesartan can cause serious injury or death to a developing fetus, especially during the second and third trimesters. Stop the drug immediately if pregnancy is detected and contact your doctor.
  • Low blood pressure (hypotension): People who are dehydrated or on high-dose diuretics (water pills) may experience a sharp drop in blood pressure when starting olmesartan. Starting under close medical supervision is important for these patients.
  • Kidney function: Olmesartan can affect kidney function, especially in people with existing kidney problems or severe heart failure. Kidney function should be monitored regularly.
  • High potassium (hyperkalemia): Olmesartan can raise potassium levels. Risk is higher in people with kidney disease, diabetes, or those taking potassium supplements or potassium-sparing diuretics.
  • Sprue-like enteropathy: A rare but serious intestinal condition — severe, chronic diarrhea and significant weight loss — has been reported in some patients months to years after starting olmesartan. If this occurs and no other cause is found, switching to a different blood pressure medication may be necessary.
  • Children under 1 year: Not recommended due to potential harmful effects on developing kidneys.

Olmesartan interactions

▾

Olmesartan can interact with several medications and supplements. Always tell your doctor and pharmacist everything you take.

  • Potassium supplements, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), or potassium-containing salt substitutes: Can raise blood potassium to dangerous levels.
  • NSAIDs (e.g., ibuprofen, naproxen) and COX-2 inhibitors: Can weaken olmesartan's blood-pressure effect and increase the risk of kidney problems, especially in older adults or those with low fluid volume.
  • Aliskiren: Must not be combined with olmesartan in patients with diabetes; should be avoided in those with kidney disease (GFR below 60 mL/min).
  • ACE inhibitors or other ARBs: Combining these with olmesartan increases the risk of low blood pressure, high potassium, and kidney damage without added benefit for most patients.
  • Lithium: Olmesartan can raise lithium blood levels, increasing the risk of lithium toxicity. Lithium levels must be monitored carefully.
  • Colesevelam hydrochloride (a cholesterol medicine): Reduces how much olmesartan is absorbed. Take olmesartan at least 4 hours before colesevelam.
  • Heparin: May further raise potassium levels when used with olmesartan.

Interactions listed in the FDA-approved label

From the Olmesartan prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Agents increasing serum potassium (other renin-angiotensin system blockers, potassium-sparing diuretics e.g. spironolactone, triamterene, amiloride, potassium supplements, potassium-containing salt substitutes, other drugs that may increase potassium levels e.g. heparin): Concomitant use may lead to increases in serum potassium. If co-medication is considered necessary, monitoring of serum potassium is advisable.
  • Non-steroidal anti-inflammatory agents (NSAIDs), including selective COX-2 inhibitors: In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration may result in deterioration of renal function, including possible acute renal failure, and may attenuate the antihypertensive effect of olmesartan medoxomil. Monitor renal function periodically in patients receiving olmesartan medoxomil and NSAID therapy.
  • Dual blockade of the renin-angiotensin system (angiotensin receptor blockers, ACE inhibitors, aliskiren): Associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes. Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes. Avoid use of aliskiren with olmesartan medoxomil tablets in patients with renal impairment (GFR less than 60 ml/min).
  • Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration. Monitor serum lithium levels during concomitant use.
  • Colesevelam hydrochloride: Concurrent administration of colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Consider administering olmesartan at least 4 hours before the colesevelam hydrochloride dose.
Read the label’s full interactions text

7 DRUG INTERACTIONS • Agents increasing potassium levels may lead to increase in serum potassium ( 7.1 ). • NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect ( 7.2 ). • Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.3 ). • Lithium: Increases in serum lithium concentrations and lithium toxicity ( 7.4 ). • Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose ( 7.5 ). 7.1 Agents Increasing Serum Potassium Concomitant use of olmesartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium. If co-medication is considered necessary, monitoring of serum potassium is advisable. 7.2 Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including olmesartan medoxomil, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving olmesartan medoxomil and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including olmesartan medoxomil, may be attenuated by NSAIDs including selective COX-2 inhibitors.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿136 supplements and herbs with documented Olmesartan interactions, ranked by severity Check Olmesartan against a supplement or herb →

Before taking Olmesartan

▾
  • Pregnancy: Do not take olmesartan if you are pregnant. It can cause severe harm or death to an unborn baby. Use effective contraception while on this drug and notify your doctor immediately if you become pregnant.
  • Breastfeeding: It is unknown whether olmesartan passes into human breast milk. Because of potential risk to a nursing infant, a decision should be made whether to stop breastfeeding or stop the drug.
  • Children under 6: Olmesartan has not been shown to be effective for high blood pressure in children younger than 6.
  • Children under 1: Not recommended — the drug may harm developing kidneys.
  • Older adults (65+): Olmesartan levels may be modestly higher in older adults due to reduced kidney clearance. No routine starting dose adjustment is required, but greater sensitivity is possible.
  • Kidney disease: Olmesartan levels are significantly higher in people with severe kidney impairment. Close monitoring of kidney function is recommended.
  • Liver disease: Olmesartan exposure is about 60% higher in people with moderate liver impairment. Tell your doctor about any liver conditions.
  • Diabetes: Use caution with high-dose olmesartan — some data suggest a possible increased cardiovascular risk in diabetic patients at high doses, though the overall evidence is not conclusive. Discuss with your doctor.
  • Low fluid or salt levels: If you are on high-dose diuretics or have low sodium levels, you are at higher risk of blood pressure dropping sharply when starting olmesartan.

Olmesartan overdose

▾

There is limited information on olmesartan overdose in humans. The most likely effects of taking too much would be very low blood pressure (hypotension) and a rapid heartbeat (tachycardia); a slow heartbeat (bradycardia) could also occur. If you suspect an overdose, seek emergency medical help right away — supportive treatment should be started promptly. It is not known whether dialysis can remove olmesartan from the body.

What Olmesartan does in the body

▾

Olmesartan works by blocking the blood-vessel-tightening effects of angiotensin II. At the doses used clinically, it significantly inhibits the pressor (blood-pressure-raising) response triggered by angiotensin I, with higher doses providing more than 90% inhibition lasting a full 24 hours. While the drug raises circulating levels of angiotensin I, angiotensin II, and plasma renin activity as a compensatory response, these increases do not override its blood-pressure-lowering effect. Importantly, olmesartan has minimal impact on aldosterone levels and does not alter serum potassium at typical doses.

How your body processes Olmesartan

▾

When you swallow an olmesartan tablet, it is rapidly and completely converted to its active form (olmesartan) during absorption from the gut — no further breakdown occurs after that. Blood levels peak about 1 to 2 hours after a dose, and steady, consistent levels in the body are established within 3 to 5 days of once-daily use. The drug has a half-life (the time it takes the body to clear half of it) of roughly 13 hours, making once-daily dosing effective. About 35–50% is eliminated through the urine and the rest through the stool via bile. Food does not affect absorption. In older adults and in people with severe kidney or moderate liver impairment, olmesartan levels are higher, though no routine starting dose adjustment is required for these groups.

How to store Olmesartan

▾

Store at 20° to 25°C (68° to 77°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

136

Supplements & herbs that interact with Olmesartan

136 supplements and herbal products have documented interactions with Olmesartan in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 4
  • Moderate · 111
  • Minor · 21
ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major AMERICAN MISTLETOE Major TYRAMINE Major ADRAFINIL Moderate AGMATINE Moderate ALGAL OIL Moderate ANDROGRAPHIS Moderate +128 more
Every supplement checked against Olmesartan — ranked by severity The full interaction hub: 4 major · 111 moderate · 21 minor · every one linked to its full report. Check Olmesartan against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Olmesartan has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

COENZYME Q10 Insufficient Evidence
See the full Olmesartan nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Olmesartan: pharmacist answers to common questions

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

What exactly is olmesartan used for?

▾
Olmesartan is used to treat high blood pressure (hypertension) in adults and in kids as young as six years old. It works by relaxing your blood vessels so your heart doesn't have to work as hard. Keeping blood pressure in a healthy range lowers your risk of stroke and heart attack over time. It's available as Benicar and as generic versions, and your doctor may prescribe it alone or alongside another blood pressure medicine.

Can I take this if I'm pregnant or trying to get pregnant?

▾
No — this is one of the most important things to know about olmesartan. It can cause very serious harm to an unborn baby, including kidney failure and even death, especially after the first trimester. If you find out you're pregnant while taking it, stop the medication and call your doctor right away. If you're planning to get pregnant, talk to your doctor about switching to a safer alternative before you try to conceive.

Will olmesartan make me dizzy? What side effects should I expect?

▾
Dizziness is the most commonly reported side effect — it happens in about 3 out of 100 people in clinical trials. It's most likely when you first start the medicine, especially if you stand up quickly. Most people find this fades after a few days. Mild fatigue or nausea can also occur. However, if you feel faint, notice significant swelling (especially of your face or throat), or develop severe diarrhea with weight loss that won't go away, those need a call to your doctor.

Are there any medicines or supplements I need to avoid while taking this?

▾
Yes, a few important ones. Potassium supplements or salt substitutes containing potassium can push your potassium levels too high when combined with olmesartan — check with your doctor before using them. NSAIDs like ibuprofen or naproxen can weaken the blood-pressure-lowering effect and may stress your kidneys. If you take lithium, levels need to be monitored closely. And if you take the cholesterol medicine colesevelam, take your olmesartan at least 4 hours before it so your body can absorb the olmesartan properly.

Does it matter if I take olmesartan with food?

▾
No — food doesn't affect how well olmesartan is absorbed, so you can take it with or without a meal. The most important thing is to take it around the same time each day to keep your blood pressure steady. Once-daily dosing is all you need, and consistent levels build up in your body within about 3 to 5 days.

I've been reading about a bowel problem linked to olmesartan — should I be worried?

▾
There is a rare but real condition called sprue-like enteropathy that has been linked to olmesartan. It causes severe, chronic diarrhea and significant weight loss, and it can develop months or even years after you start the medication. It's not common, but if you ever develop persistent, unexplained diarrhea and you're losing weight without trying, tell your doctor and mention that you're on olmesartan. If no other cause is found, your doctor may need to switch you to a different blood pressure medicine — and stopping olmesartan often resolves the problem.

Is Olmesartan available over the counter?

▾
No. Olmesartan is a prescription medicine: every Olmesartan product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Olmesartan first available?

▾
The earliest FDA record we hold for Olmesartan is from 2002: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Olmesartan was first used.

Who makes Olmesartan?

▾
30 companies currently list Olmesartan products in the FDA's NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, Direct_Rx. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Olmesartan on HelloPharmacist

📊Olmesartan supplement interactions136 checked — ranked by severity 🌿Drug & Supplement CheckerOlmesartan vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Olmesartan NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Olmesartan Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Olmesartan forms and strengths (how it comes)

Olmesartan 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.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Olmesartan inactive ingredients by manufacturer.

Tablet

By mouth
Brands Benicar Olmesartan medoxomil
How this form is used
What it may be used for
  • Benicar is indicated to treat high blood pressure (hypertension) in adults and children six years of age and older
  • Olmesartan Medoxomil tablets are indicated to treat high blood pressure in adults and children six years of age and older
  • May be used alone or together with other blood pressure medicines to reach blood pressure goals
  • Lowering blood pressure with these tablets reduces the risk of stroke and heart attack
Important instructions
  • Olmesartan Medoxomil tablets and Benicar are taken by mouth once daily
  • Olmesartan Medoxomil tablets may be taken with or without food — food does not change how the medicine is absorbed
  • Benicar tablets should be taken as directed by your prescriber; do not change your dose without guidance
  • Olmesartan Medoxomil tablets can be used to prepare an oral suspension for patients who cannot swallow tablets — follow your pharmacist's instructions for that preparation
Available strengths 3 strengths
5 mg 20 mg 40 mg
210 FDA-listed product records ⓘ

Olmesartan on the U.S. market: products, makers and brands

How Olmesartan 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.

30 companies list 128 Olmesartan product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2002. Brand names on the directory include Benicar, Olmesartan Medoxomil; the rest are generics.

1
Dose forms ⓘ
30
Labelers (makers, repackagers, distributors)
2
Brand names
128
FDA-listed product records ⓘ
2002
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (24) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack14%
A-S Medication Solutions13%
Direct_Rx5%
Cosette Pharmaceuticals, Inc.5%
Remedyrepack Inc.4%
Proficient Rx LP3%
Other makers56%

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

How widely Olmesartan is used (Medicaid data)

A general measure of how commonly Olmesartan 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 Olmesartan 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.

340,022
Medicaid prescriptions filled (Q1–Q4 2025)
$5.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Olmesartan prescribed? Of the 1,601 medications we measure, Olmesartan ranks #310 by Medicaid prescriptions — more than 81% of them.

Where Olmesartan ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #310 of 1,601
#305 Brexpiprazole 344,798 Rx #306 OnabotulinumtoxinA Inj... 343,452 Rx #307 Diphenhydramine Inject... 342,553 Rx #308 Nitroglycerin Spray 340,741 Rx #309 Nitroglycerin 340,741 Rx #310 Olmesartan 340,022 Rx #311 Fluvoxamine 332,998 Rx #312 Ubrogepant 329,850 Rx #313 Midodrine 328,426 Rx #314 Dexamethasone / Neomyc... 327,807 Rx #315 Prochlorperazine 323,439 Rx

Utilization by Olmesartan product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 20 mg oral tablet is the most-dispensed Olmesartan product — about 47% of these Medicaid prescriptions.

olmesartan medoxomil 20 MG Oral Tablet Most dispensed

161,201 Medicaid prescriptions (Q1–Q4 2025) 47% of Olmesartan prescriptions shown $2.2M gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 25 of 168 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349401

olmesartan medoxomil 40 MG Oral Tablet

142,215 Medicaid prescriptions (Q1–Q4 2025) 42% of Olmesartan prescriptions shown $2.4M gross reimbursement (before rebates) ≈ $17 per prescription (gross)

Summed across the 24 of 174 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349405

olmesartan medoxomil 5 MG Oral Tablet

36,606 Medicaid prescriptions (Q1–Q4 2025) 11% of Olmesartan prescriptions shown $503,511 gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 20 of 112 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349373

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Olmesartan, 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 69 of 454 listed Olmesartan NDCs with Medicaid activity.

Compare Olmesartan products

A representative set of FDA-listed product records for Olmesartan — 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 128 of 128 products — FDA National Drug Code Directory. See every product, package size and price: browse all 128 Olmesartan NDCs →

Olmesartan side effects reported to the 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 Olmesartan — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Olmesartan are sprue-like enteropathy, diarrhoea, weight decreased; about 64% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

43,577
Reports mentioning it
64%
Reported as serious
12
Distinct effects shown
Most reported effects
Sprue-like Enteropathy
4,227
Diarrhoea
3,053
Weight Decreased
2,719
Dizziness
2,600
Gastrooesophageal Reflux Disease
2,545
Nausea
2,505
Acute Kidney Injury
2,391
Fatigue
2,077
Headache
1,763
Haemorrhoids
1,622
Age groups
Elderly · 2,548Adult · 1,794Neonate · 30Child · 8Infant · 6Adolescent · 1

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 Olmesartan 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.

Olmesartan FDA approval history

How Olmesartan went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Olmesartan was first approved by the FDA in 2002 (Brand: BENICAR · Cosette); the first generic version was approved in 2016. It remains available in U.S. pharmacies today.

2002
Brand approved
Brand: BENICAR · Cosette
2016
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Olmesartan 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.

The FDA’s enforcement reports list no Olmesartan recalls since July 2021.

✅No Olmesartan recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Olmesartan RxCUI 321064 1 dose form · 4 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 378991 In current FDA listings
    Clinical drug / strength (SCD) medoxomil 10 MG RxCUI 401971 medoxomil 20 MG RxCUI 349401 medoxomil 40 MG RxCUI 349405 medoxomil 5 MG RxCUI 349373

Look up RxCUI 321064 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Olmesartan costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 40 mg $0.111 per tablet NDC details & price history
Tablet, Film Coated · Oral 20 mg $0.080 per tablet NDC details & price history
Tablet, Film Coated · Oral 5 mg $0.057 per tablet NDC details & price history
Tablet · Oral 40 mg $0.111 per tablet NDC details & price history
Tablet · Oral 20 mg $0.080–$0.081 per tablet NDC details & price history
Tablet · Oral 5 mg $0.057 per tablet NDC details & price history
Tablet, Film Coated 5 mg $0.057 per tablet NDC details & price history
Tablet, Film Coated 20 mg $0.080 per tablet NDC details & price history
Tablet, Film Coated 40 mg $0.111 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Olmesartan brand names

Olmesartan is sold under 2 brand names in the FDA directory — Benicar, Olmesartan Medoxomil. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Benicar Olmesartan Medoxomil

Who makes Olmesartan: manufacturers and labelers

30 companies list Olmesartan products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, A-S Medication Solutions, Direct_Rx. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 18 A-S Medication Solutions 16 Direct_Rx 7 Cosette Pharmaceuticals, Inc. 6 Remedyrepack Inc. 5 Proficient Rx LP 4 Accord Healthcare Inc. 3 Alembic Pharmaceuticals Inc. 3 Alembic Pharmaceuticals Limited 3 Ascend Laboratories, LLC 3 Aurobindo Pharma Limited 3 Cadila Pharmaceuticals Limited 3 Camber Pharmaceuticals, Inc. 3 Chartwell RX, LLC 3 Glenmark Pharmaceuticals Inc., USA 3 Golden State Medical Supply, Inc. 3 HEC Pharm USA Inc. 3 Inventia Healthcare Limited 3 Jubilant Cadista Pharmacuticals Inc. 3 Lannett Company, Inc. 3 Lifestar Pharma LLC 3 Macleods Pharmaceuticals Limited 3 Modavar Pharmaceuticals LLC 3 NorthStar RxLLC 3

…and 6 more on the FDA NDC directory.

Olmesartan drug class (RxNorm)

Olmesartan belongs to the Angiotensin 2 Receptor Blocker class.

Pharmacologic class Angiotensin 2 Receptor Blocker
Drug family (ATC) Angiotensin II receptor blockers (ARBs), plain
How it works Angiotensin 2 Receptor Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Olmesartan 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 Nov 1, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Olmesartan.
📈
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 Olmesartan after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
75
Finished products in the current FDA directory
128
Companies listing them (makers, repackagers, distributors)
30
FDA labeler codes behind them ⓘ
31
Linked representative label ⓘ
Proficient Rx LP
Linked label effective
Nov 1, 2024
Composite sections available
23
Linked SPL Set ID
eff8b514-bb7f-427e-a267-7dee25fff611
Linked SPL Document ID
596ef2af-5b28-47f5-a9ef-48b2ece886c7
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Proficient Rx LP is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →