Olmesartan medoxomil

What Olmesartan medoxomil is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Benicar is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. …

— FDA label: Benicar, Cosette Pharmaceuticals, Inc., effective September 23, 2025. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, film coated, oral), Benicar, Cosette Pharmaceuticals, Inc.; it covers 3 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 70 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Its heading: WARNING: FETAL TOXICITY. Read it on the full label →

70 of 70 FDA labels for this medicine have a boxed warning.

Olmesartan medoxomil boxed warning: what the label says

Quoted from the boxed warning of the FDA-approved label.

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Benicar as soon as possible (5.1, 8.1). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1, 8.1). WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Benicar as soon as possible (5.1, 8.1).

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Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1, 8.1).

— FDA label: Benicar, Cosette Pharmaceuticals, Inc., effective September 23, 2025. Read the full label on DailyMed →

Olmesartan medoxomil side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The most common adverse reaction in adults was dizziness (3%) (6.1).

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To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adult Hypertension Benicar has been evaluated for safety in more than 3825 patients/subjects, including more than 3275 patients treated for hypertension in controlled trials. This experience included about 900 patients treated for at least 6 months and more than 525 for at least 1 year. Events generally were mild, transient and had no relationship to the dose of Benicar. Analysis of gender, age and race groups demonstrated no differences between Benicar and placebo-treated patients. The rate of withdrawals due to adverse reactions in all trials of hypertensive patients was 2.4% (i.e., 79/3278) of patients treated with Benicar and 2.7% (i.e., 32/1179) of control patients. In placebo-controlled trials, the only adverse reaction that occurred in more than 1% of patients treated with Benicar and at a higher incidence versus placebo was dizziness (3% vs. 1%). Facial edema was reported in five patients receiving Benicar. Angioedema has been reported with angiotensin II antagonists. Pediatric Hypertension No relevant differences were identified between the adverse experience profile for pediatric patients aged 1 to 16 years and that previously reported for adult patients. 6.2 Post-Marketing Experience The following adverse reactions have been reported in post-marketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Body as a Whole: Asthenia, angioedema, anaphylactic reactions Gastrointestinal: Vomiting, sprue-like enteropathy [see Warnings and Precautions (5.5)] Metabolic and Nutritional Disorders: Hyperkalemia Musculoskeletal: Rhabdomyolysis Urogenital System: Acute renal failure, increased blood creatinine levels Skin and Appendages: Alopecia, pruritus, urticaria Data from one controlled trial and an epidemiologic study have suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive.

— FDA label: Benicar, Cosette Pharmaceuticals, Inc., effective September 23, 2025. This is part of the section. Read the full label on DailyMed →

Olmesartan medoxomil drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

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).

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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. 7.3 Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on Benicar and other agents that affect the RAS. Do not co-administer aliskiren with Benicar in patients with diabetes [see Contraindications (4)]. Avoid use of aliskiren with Benicar in patients with renal impairment (GFR <60 ml/min). 7.4 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including BENICAR. Monitor serum lithium levels during concomitant use. 7.5 Colesevelam Hydrochloride Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect.

— FDA label: Benicar, Cosette Pharmaceuticals, Inc., effective September 23, 2025. This is part of the section. Read the full label on DailyMed →

Olmesartan medoxomil dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

Indication Starting Dose Dose Range Adult Hypertension (2.1) 20 mg once daily 20 - 40 mg once daily Pediatric Hypertension (6 years of age and older) (2.2) 20 to <35 kg 20 to <35 kg 10 mg once daily 10 - 20 mg once daily ≥ 35 kg ≥ 35 kg 20 mg once daily 20 - 40 mg once daily 2.1 Adult Hypertension Dosage must be individualized. The usual recommended starting dose of Benicar is 20 mg once daily when used as monotherapy in patients who are not volume-contracted.

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For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Benicar 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 Benicar 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 Benicar 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 Benicar 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 Benicar in children <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 Benicar 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 Benicar 20 mg tablets and allow to stand for a minimum of 5 minutes. Shake the container for at least 1 minute and allow the suspension to stand for at least 1 minute. Repeat 1-minute shaking and 1-minute standing for four additional times. Add 100 mL of ORA-Sweet ® and 50 mL of ORA-Plus ®* to the suspension and shake well for at least 1 minute. The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 4 weeks. Shake the suspension well before each use and return promptly to the refrigerator. * ORA-Sweet ® and ORA-Plus ® are registered trademarks of Paddock Laboratories, Inc.

— FDA label: Benicar, Cosette Pharmaceuticals, Inc., effective September 23, 2025. Read the full label on DailyMed →

Olmesartan medoxomil in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary Benicar 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.

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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. In animal reproduction studies, Benicar treatment during organogenesis resulted in increased embryofetal toxicity in rats at doses lower than maternally toxic doses. When pregnancy is detected, discontinue Benicar as soon as possible. Consider alternative antihypertensive therapy during pregnancy. 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). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death. In patients taking Benicar during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to Benicar for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to Benicar, if oliguria or hypotension occurs, utilize measures to maintain adequate blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and supporting renal function.

— FDA label: Benicar, Cosette Pharmaceuticals, Inc., effective September 23, 2025. This is part of the section. Read the full label on DailyMed →

When Olmesartan medoxomil should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Do not co-administer aliskiren with Benicar in patients with diabetes [see Drug Interactions (7.3)]. Do not co-administer aliskiren with Benicar in patients with diabetes (4).

— FDA label: Benicar, Cosette Pharmaceuticals, Inc., effective September 23, 2025. Read the full label on DailyMed →

Olmesartan medoxomil overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurs. If symptomatic hypotension occurs, initiate supportive treatment. The dialyzability of olmesartan is unknown.

— FDA label: Benicar, Cosette Pharmaceuticals, Inc., effective September 23, 2025. Read the full label on DailyMed →

Forms and how it is given

Same medicine, other forms and combinations

Prescription medicine pages on this site that share an active ingredient with this one, from the FDA NDC Directory. A combination is a different medicine: ask your pharmacist before you switch.

Other medicines that contain Olmesartan medoxomil

• Olmesartan medoxomil and hydrochlorothiazideBenicar Hct · 81 products
• Amlodipine and olmesartan medoxomilAzor · 54 products
• Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideTribenzor · 43 products

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Bryant Ranch Prepack19 products
• A-S Medication Solutions16 products
• Direct_Rx7 products
• Cosette Pharmaceuticals, Inc.6 products
• Remedyrepack Inc.5 products
• Proficient Rx LP4 products
• Cadila Pharmaceuticals Limited3 products
• Modavar Pharmaceuticals LLC3 products
• Lannett Company, Inc.3 products
• Macleods Pharmaceuticals Limited3 products
• ScieGen Pharmaceuticals, Inc.3 products
• Jubilant Cadista Pharmacuticals Inc.3 products
• Alembic Pharmaceuticals Inc.3 products
• Aurobindo Pharma Limited3 products
• Glenmark Pharmaceuticals Inc., USA3 products
• Lifestar Pharma LLC3 products
• Golden State Medical Supply, Inc.3 products
• Rising Pharma Holdings, Inc.3 products
• Novadoz Pharmaceuticals LLC3 products
• HEC Pharm USA Inc.3 products
• Solco Healthcare US, LLC3 products
• Inventia Healthcare Limited.3 products
• Umedica Laboratories USA Inc.3 products
• Ascend Laboratories, LLC3 products
• Chartwell RX, LLC3 products
• Alembic Pharmaceuticals Limited3 products
• Accord Healthcare Inc.3 products
• Camber Pharmaceuticals, Inc.3 products
• Quallent Pharmaceuticals Health LLC3 products
• NorthStar RxLLC3 products

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (15)

• ANDA203012Alembic · April 24, 2017
• ANDA204798Aurobindo Pharma · April 24, 2017
• ANDA204814Macleods Pharms · April 24, 2017
• ANDA205482Jubilant Generics · April 24, 2017
• ANDA206763Alkem Labs Ltd · April 24, 2017
• ANDA207662Accord Hlthcare · April 24, 2017
• ANDA203281Glenmark Pharms Ltd · May 25, 2017
• ANDA208130Sciegen Pharms · June 29, 2018
• ANDA211049Sunshine · February 22, 2019
• ANDA207135Pharmazone · July 18, 2019
• ANDA208659Adaptis · May 18, 2020
• ANDA206720Prinston Inc · December 2, 2022
• ANDA217399Msn · January 18, 2023
• ANDA205499Hetero Labs Ltd V · October 31, 2024
• ANDA210682Cadila Pharms Ltd · November 8, 2024

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

1. April 29, 2021 · Class III · Terminated · D-0392-2021

   Presence of Foreign Tablet/Capsule

   Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30. — Ascend Laboratories LLC

2. January 24, 2020 · Class II · Terminated · D-0828-2020

   cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.

   Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90. — Ascend Laboratories LLC

Official identifiers

Next steps

• Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
• Latest FDA drug recallsAll medicines, newest first
• BenicarBrand page: products, maker and price
• Heart failureCondition named on the label: hospitals that treat it
• High blood pressureCondition named on the label: hospitals that treat it
• StrokeCondition named on the label: hospitals that treat it
• Bryant Ranch PrepackMaker or distributor
• A-S Medication SolutionsMaker or distributor
• Direct_RxMaker or distributor
• All prescription drugs A to ZSearch by generic, brand or Spanish name

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Benicar, Cosette Pharmaceuticals, Inc., effective September 23, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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