Olmesartan medoxomil is a nonpeptide, benzimidazole derivative angiotensin II type 1 (AT1) receptor antagonist (also referred to as an angiotensin II receptor blocker [ARB]).1
Olmesartan medoxomil is used alone or in combination with other classes of antihypertensive agents in the management of hypertension.1, 31, 139, 144
Efficacy of olmesartan medoxomil in the treatment of hypertension in adults has been established in 7 placebo-controlled studies of 6—12 weeks' duration in patients with essential hypertension.1 In these studies, olmesartan dosages ranging from 2.5-80 mg once daily were associated with dose-related reductions in both systolic and diastolic blood pressure.1 A 20-mg daily dose produced mean trough blood pressure reductions over placebo of approximately 10 mm Hg systolic and 6 mm Hg diastolic, while a 40-mg dose produced reductions of approximately 12 mm Hg systolic and 7 mm Hg diastolic.1 Doses above 40 mg provided little additional benefit.1 The antihypertensive effect was sustained over a 24-hour dosing interval, with trough-to-peak ratios for both systolic and diastolic blood pressure ranging from 60-80%.1 There was no evidence of tachyphylaxis during long-term olmesartan therapy, and rebound hypertension following abrupt withdrawal of the drug after 1 year of treatment has not been reported.1 The antihypertensive response to olmesartan medoxomil was comparable between male and female patients, as well as between patients above and below 65 years of age.1 The blood pressure-lowering effect was less pronounced in Black patients, a pattern also observed with other agents that act on the renin-angiotensin system, including angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, and angiotensin receptor blockers.1
Efficacy of olmesartan medoxomil for the treatment of hypertension in pediatric patients 6-16 years of age was established in a randomized, double-blind study involving 302 patients with hypertension.1, 136 Patients in the study were enrolled into 1 of 2 cohorts (an all-Black cohort or a mixed racial cohort, 18.4% of whom were Black).1, 136 Weight-based dosages of olmesartan (2.5 or 20 mg once daily for patients weighing 20 to <35 kg and 5 or 40 mg once daily for those weighing ≥35 kg) were administered for 3 weeks, followed by a 2-week randomized withdrawal phase, where patients were re-randomized to continue taking olmesartan or to switch to placebo.1, 136 During the dose-response phase, olmesartan produced dose-dependent reductions in systolic blood pressure, with mean reductions from baseline of 6.6 mm Hg (low dose) and 11.9 mm Hg (high dose).1 In the withdrawal phase, patients who continued olmesartan maintained lower trough systolic and diastolic blood pressures (by 3.2 and 2.8 mm Hg, respectively) compared to those switched to placebo.1
In the same study, an open-label phase enrolled 59 pediatric patients aged 1-5 years weighing at least 5 kg; these patients received olmesartan medoxomil at a dosage of 0.3 mg/kg once daily for 3 weeks.1 Patients were then randomized to continue olmesartan or switch to placebo in a double-blind withdrawal phase.1 At the end of the 2-week withdrawal period, mean trough systolic and diastolic blood pressures were each 3 mm Hg lower in the olmesartan group compared to placebo, but the differences were not statistically significant.1
The principal goal of preventing and treating hypertension is to reduce the risk of cardiovascular and renal morbidity and mortality, including target organ damage.1200, 1300 The relationship between blood pressure and cardiovascular disease is continuous, consistent, and independent of other risk factors.1200, 1300 The higher the blood pressure, the more likely the development of coronary artery disease, heart failure, stroke, and chronic kidney disease across all ages and ethnic groups.1200, 1300 Each 20-mm Hg increment in systolic blood pressure or 10-mm Hg increment in diastolic blood pressure has been shown to double the risk of death from stroke, heart disease, or other vascular disease.171, 1200, 1300
Accurate blood pressure measurement in the office or clinic is essential for proper diagnosis and management of hypertension.1200, 1300, 1302 Out-of-office blood pressure measurements are recommended to confirm the diagnosis.1200, 1300, 1642 Blood pressure categories range from normal to different grades/stages of hypertension and are intended to align therapeutic approaches with blood pressure levels.1300, 1302 Guidelines published in 2025, written and developed by the American College of Cardiology (ACC), the American Heart Association (AHA), and several other US professional organizations, define stage 1 hypertension as a systolic blood pressure of 130-139 mm Hg or a diastolic blood pressure of 80-89 mm Hg.1200 Treatment recommendations generally include nonpharmacologic therapy with consideration of pharmacologic therapy based on cardiovascular risk.1200, 1300, 1302, 1642
Comprehensive guidelines for the management of hypertension have been published by various authoritative groups.501, 1200, 1300, 1301, 1302, 1642 The first such guideline was published by the National Heart Lung and Blood Institute (NHLBI) in 1977, followed by a series of Joint National Committee (JNC) guidelines with JNC8 being the last iteration of these guidelines in 2014.501, 1200 The ACC, AHA, and other experts, including the International Society of Hypertension (ISH), have published more recent clinical practice guidelines for the treatment of hypertension.1200, 1300, 1302, 1642 These guidelines all state that lifestyle/behavioral modifications (e.g., weight reduction in patients who are overweight or obese, dietary changes, sodium reduction, potassium supplementation, increased physical activity, moderation of alcohol intake, smoking cessation, stress reduction) are essential in the management of hypertension and should be implemented to lower blood pressure and reduce total cardiovascular risk.1300, 1302, 1642 The decision whether to initiate antihypertensive drug therapy should be based on blood pressure levels while also considering cardiovascular risk factors.1200, 1300, 1302, 1642 The 2025 ACC/AHA guidelines recommend initiation of drug therapy in all patients with confirmed blood pressure ≥140/90 mm Hg.1200 These guidelines also recommend initiation of drug therapy in patients with blood pressure ≥130/80 mm Hg who have clinical cardiovascular disease, diabetes, or chronic kidney disease (CKD), or who are at increased short-term cardiovascular disease risk.1200 In patients with hypertension and low cardiovascular risk, the 2025 ACC/AHA guidelines recommend initiation of drug therapy if blood pressure remains ≥130/80 mm Hg after a 3- to 6-month trial of lifestyle interventions.1200
Current evidence-based practice guidelines for the management of hypertension in adults generally recommend the use of drugs from 4 classes of antihypertensive agents (angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor antagonists, long-acting dihydropyridine calcium-channel blockers, and thiazide or thiazide-like diuretics); data from clinical outcome trials indicate that lowering blood pressure with any of these drug classes can reduce the complications of hypertension and provide similar cardiovascular risk reduction benefits.501, 503, 1200, 1300, 1302, 1642 However, recommendations for initial drug selection and use in specific patient populations may vary across these guidelines.501, 503, 1200 Ultimately, choice of antihypertensive therapy should be individualized, considering the clinical characteristics of the patient (e.g., age, ethnicity/race, comorbid conditions, cardiovascular risk factors) as well as drug-related factors (e.g., ease of administration, availability, adverse effects, costs).501, 503, 1200, 1300, 1302 Angiotensin II receptor antagonists or ACE inhibitors may be particularly useful in the management of hypertension in patients with certain coexisting conditions such as diabetes mellitus, chronic coronary artery disease, heart failure, peripheral artery disease, or CKD.1200 Other antihypertensive drugs such as nondihydropyridine calcium-channel blockers, beta-adrenergic blockers, direct vasodilators, alpha-1 blockers, loop diuretics, and aldosterone antagonists are available, but generally recommended as second-line agents or only in specific clinical situations.1200
Experts state that initiation of drug therapy with a single first-line antihypertensive drug is reasonable in adults with stage 1 hypertension (systolic BP 130-139 and diastolic BP 80-89 mm Hg), older adults (e.g., frail), or in those with a history of hypotension or multiple drug-related adverse events; this should be followed by dosage titration and sequential addition of other antihypertensive drugs as need to achieve the target blood pressure.1200 Because most patients with hypertension will require at least 2 antihypertensive drugs to achieve adequate blood pressure control, use of single-pill combinations is generally recommended to improve adherence and blood pressure control when available.1200, 1302 Drug regimens with complementary activity, where a second antihypertensive agent is used to block compensatory responses to the first agent or affect a different pressor mechanism, can result in additive blood pressure lowering and are preferred.1200 Drug combinations that have similar mechanisms of action or clinical effects (e.g., the combination of an ACE inhibitor and an angiotensin II receptor antagonist) generally should be avoided.1200 Antihypertensive drug dosages should be adjusted and/or other agents substituted or added until goal blood pressure is achieved.1200 After initiation of antihypertensive drug therapy, a blood pressure goal of <130/80 mm Hg within 3 months is generally recommended if tolerated, but should be individualized.1200, 1301, 1302 While there is evidence from a randomized controlled study (SPRINT) demonstrating that intensive systolic blood pressure lowering (to <120 mm Hg) may be beneficial in patients with increased risk of cardiovascular disease, the study excluded patients with diabetes mellitus or prior stroke, and those younger than 50 years of age, which may decrease the generalizability of these findings.1210, 1219
The 2025 ACC/AHA hypertension guidelines make specific recommendations for patients with hypertension and certain comorbidities.1200 In patients with hypertension and CKD (i.e., estimated glomerular filtration rate [eGFR] <60 mL/minute per 1.73 m2) and albuminuria of ≥30 mg/g, with or without diabetes, use of either an angiotensin II receptor antagonist or an ACE inhibitor, but not both, is recommended.1200 Use of either an ACE inhibitor or an angiotensin II receptor antagonist should be considered in patients with hypertension and diabetes with mild albuminuria (<30 mg/g).1200 Thiazide-type diuretics, ACE inhibitors, or angiotensin II receptor antagonists are the recommended drug classes in patients with hypertension who have had an ischemic stroke, transient ischemic attack, or intracerebral hemorrhage.1200
The 2025 ACC/AHA guidelines also provide recommendations for the management of patients with resistant hypertension (defined as blood pressure above goal despite treatment with 3 antihypertensive medications with complementary mechanisms of action, including a diuretic at maximally tolerated doses, or blood pressure at goal but requiring 4 or more medications).1200 Risk factors for resistant hypertension include older age, obesity, chronic kidney disease, and diabetes; such patients have a ≥50% higher risk of MI, stroke, end-stage kidney disease, and cardiovascular death than adults with hypertension without resistance to treatment.1200 In adults with uncontrolled resistant hypertension despite optimal treatment with first-line antihypertensive therapies, additional agents such as a mineralocorticoid receptor antagonist (e.g., spironolactone, eplerenone), beta-adrenergic blocker, alpha-adrenergic blocker, amiloride, central sympatholytic drugs (e.g., clonidine), dual endothelin receptor antagonists (e.g., aprocitentan), or direct vasodilators (e.g., hydralazine) may be considered for further blood pressure reduction.1200
Specific guidelines and recommendations for the management of hypertension in pregnancy have been published by experts such as ACC/AHA and the American College of Obstetricians and Gynecologists (ACOG).1200, 1300, 1305, 1306 First-line oral antihypertensive drugs generally recommended in pregnant patients include labetalol, nifedipine (extended-release), or methyldopa.1200, 1302, 1305 Renin-angiotensin system (RAS) blockers (e.g., ACE inhibitors, angiotensin II receptor antagonists, direct renin inhibitors) are contraindicated during pregnancy due to adverse fetal and neonatal outcomes.1200, 1300, 1302, 1305
The American Academy of Pediatrics (AAP) has published a clinical practice guideline for the management of high blood pressure in children and adolescents.1150 The guideline recommends calcium-channel blockers (e.g., nifedipine, amlodipine), ACE inhibitors, angiotensin II receptor antagonists, and thiazide diuretics for the initial management of hypertension in children requiring drug therapy.1150
Both angiotensin II receptor antagonists and ACE inhibitors have been shown to slow the rate of progression of renal disease in patients with diabetes mellitus and persistent albuminuria†.1600, 1630, 1631
Guidelines from Kidney Disease: Improving Global Outcomes (KDIGO) recommend initiation of an ACE inhibitor or angiotensin II receptor antagonist in patients who have diabetes, hypertension, and moderately to severely elevated albuminuria (i.e., urine to creatinine ratio >30 mg/g).1600, 1630 Once initiated, these medications should be titrated to the maximum dose that is tolerated.1600, 1630 In patients who have diabetes and albuminuria, but are normotensive†, ACE inhibitors or angiotensin II receptor antagonists may be considered.1600 Treatment with ACE inhibitors or angiotensin II receptor antagonists should be continued unless the serum creatinine rises by >30% within the first month after initiation, or following an increase in dosage.1600
Current standards of care from the American Diabetes Association (ADA) and KDIGO provide similar management recommendations for patients with diabetes and CKD.1631 Treatment recommendations include optimization of glucose management and blood pressure control (<130/80 mmHg) to slow the progression of CKD.1631 For patients with diabetes and hypertension with moderate proteinuria (<300 mg/day), use of either an ACE inhibitor or an angiotensin II receptor antagonist is recommended.1631 For patients with severely increased proteinuria (≥300 mg/day) or renal impairment (eGFR <60 mL/min/1.73 m2), an ACE inhibitor or an angiotensin II receptor antagonist, given at maximally tolerated doses, is strongly recommended to prevent progression of CKD and reduce the risk of cardiovascular events.1631 These agents are generally not recommended for primary prevention of CKD in patients with diabetes who are normotensive and have no evidence of CKD.1631
Angiotensin II receptor antagonists have also been used for the management of patients with nondiabetic CKD with moderate or severely increased albuminuria† (i.e., urinary albumin to creatinine ratio >30 mg/g) to prevent progression of CKD.1601, 1630 Once initiated, these medications should be titrated to the maximum dose that is tolerated.1630 Angiotensin II receptor antagonists can also be considered in patients with CKD and normal to mildly increased albuminuria† (i.e., urinary albumin to creatinine ratio <30 mg/g) when other compelling indications (e.g., hypertension, heart failure, or low ejection fraction) are present.1601, 1630
Angiotensin II receptor antagonists have been evaluated for the treatment of acute coronary syndrome (ACS)†, including non-ST-elevation ACS and ST-elevation myocardial infarction (STEMI).1633
Current guidelines on the management of patients with ACS (including unstable angina, non-ST-segment elevation myocardial infarction [non-STEMI], and STEMI) discuss treatment strategies for ACS, including the use of analgesics, antiplatelets/anticoagulants, and lipid reduction agents.1633 In high-risk patients with ACS (left ventricular ejection fraction [LVEF] ≤40%, hypertension, diabetes mellitus, or STEMI with an anterior location), an ACE inhibitor or an angiotensin receptor antagonist is recommended to reduce all-cause death and major cardiovascular events.1633 In patients with ACS who are not considered high risk, an oral ACE inhibitor or angiotensin receptor antagonist is reasonable to reduce major adverse cardiovascular events (MACE).1633
Dispensing and Administration Precautions
Olmesartan medoxomil is administered orally without regard to meals.1 Twice-daily dosing offers no therapeutic advantage over the same total dose given once daily.1
Olmesartan medoxomil is commercially available as a film-coated tablet.1 It is also commercially available in fixed-combination tablets containing olmesartan medoxomil with hydrochlorothiazide, olmesartan medoxomil with amlodipine and hydrochlorothiazide, and olmesartan medoxomil with amlodipine; see the full prescribing information of these products for administration information.31, 139, 144
Store olmesartan tablets at 20-25°C.1
For pediatric patients unable to swallow tablets, olmesartan may be administered orally as an extemporaneously prepared suspension.1 An extemporaneous suspension containing olmesartan medoxomil 2 mg/mL can be prepared in the following manner.1 First, 50 mL of purified water is added to an amber polyethylene terephthalate (PET) bottle containing twenty 20-mg tablets of olmesartan medoxomil, and the contents allowed to stand for a minimum of 5 minutes.1 The container should then be shaken for at least 1 minute and allowed to stand for at least 1 minute; this step of alternating shaking and standing should be repeated 4 additional times.1 The concentrated suspension should then be diluted with 100 mL of syrup (Ora-Sweet®) and 50 mL of a suspending vehicle (Ora-Plus®) and the container shaken well for at least 1 minute to disperse the ingredients.1 The suspension should be shaken well before dispensing each dose.1 The extemporaneous suspension is stable for up to 4 weeks when stored at 2-8°C.1 Olmesartan medoxomil tablets and the extemporaneously prepared oral suspension of the drug are bioequivalent.1
Olmesartan is available as olmesartan medoxomil; dosages are expressed in terms of the salt.1 Dosage of olmesartan medoxomil must be individualized.1
The usual initial dosage of olmesartan medoxomil as monotherapy is 20 mg once daily in adults without depletion of intravascular volume.1 If blood pressure response is inadequate with the initial dosage, the dosage may be increased as tolerated to 40 mg daily.1 Olmesartan medoxomil dosages exceeding 40 mg daily do not appear to provide additional therapeutic benefit.1 The antihypertensive effect of olmesartan medoxomil generally is evident within 1 week, with a maximum reduction observed after 2 weeks.1
The manufacturer recommends that patients with depletion of intravascular volume (e.g., those receiving diuretics, particularly with reduced renal function) be monitored closely for symptomatic hypotension; in such patients, consideration should be given to administering a lower initial dosage of the drug.1
The dosage of olmesartan medoxomil in pediatric patients is based on weight.1 For pediatric patients 6-16 years of age weighing 20 to <35 kg, the usual initial dosage of olmesartan medoxomil is 10 mg once daily; the dosage may be increased to a maximum of 20 mg once daily after 2 weeks if further reduction in blood pressure is needed.1 For pediatric patients 6-16 years of age weighing ≥35 kg, the recommended initial dosage of olmesartan medoxomil is 20 mg once daily; if necessary, the dosage may be increased to a maximum of 40 mg once daily after 2 weeks.1
For children who cannot swallow tablets, the same recommended dosage can be administered using the extemporaneous oral suspension.1
The manufacturer states that no initial dosage adjustment is warranted in patients with moderate to severe hepatic impairment.1
The manufacturer states that no initial dosage adjustment is warranted in patients with moderate to severe renal impairment (creatinine clearance <40 mL/minute).1
The manufacturer states that no adjustment in initial olmesartan medoxomil dosage is necessary in geriatric patients.1
Fetal/Neonatal Morbidity and Mortality
A boxed warning is included in the prescribing information for olmesartan about the risk of fetal harm when the drug is administered during pregnancy.1 Drugs that act on the renin-angiotensin system (e.g., angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor antagonists, aliskiren) can reduce fetal renal function and increase fetal and neonatal morbidity and mortality when used in pregnancy during the second and third trimesters.1 Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.1 Potential neonatal effects include skull hypoplasia, anuria, hypotension, renal failure, and death.1 Olmesartan should be discontinued as soon as possible when pregnancy is detected.1
Olmesartan must not be used for the treatment of hypertension in infants younger than 1 year of age because drugs that act on the renin-angiotensin-aldosterone (RAA) system can affect the development of immature kidneys.1
Because symptomatic hypotension may occur in patients with an activated RAA system (e.g., patients with volume or salt depletion secondary to salt restriction or prolonged diuretic therapy), olmesartan should be initiated in such patients under close medical supervision and consideration should be given to administering a lower initial dose of the drug.1
If hypotension occurs in patients receiving olmesartan, the patient should be placed in the supine position and administered an IV infusion of 0.9% sodium chloride injection if needed.1 Transient hypotension is not a contraindication to additional doses of olmesartan, and therapy with the drug can be cautiously reinstated after blood pressure has been stabilized (e.g., with volume expansion).1
Because the RAA system appears to contribute substantially to maintenance of glomerular filtration in patients with heart failure in whom renal perfusion is severely compromised, renal function may deteriorate markedly (e.g., oliguria, progressive azotemia, renal failure, death) in these patients during therapy with an ACE inhibitor or an angiotensin II receptor antagonist (e.g., olmesartan).1 Renal artery stenosis also is a risk factor for renal impairment during therapy with drugs that inhibit the RAA system; increases in BUN or serum creatinine are possible in patients with unilateral or bilateral renal artery stenosis.1 Although reports received to date have involved patients treated with ACE inhibitors, this adverse effect also would be expected to occur when drugs with similar pharmacologic activity (e.g., angiotensin II receptor antagonists) are used in a similar manner.1
Sprue-like enteropathy, an intestinal condition characterized by severe chronic diarrhea with substantial weight loss, has been reported during postmarketing experience in patients receiving olmesartan; in some cases, intestinal biopsy revealed villous atrophy.1 This adverse event can occur months to years after initiating olmesartan.1
If symptoms of sprue-like enteropathy develop during olmesartan therapy, the possibility of other etiologies (e.g., celiac disease) should be excluded; if no other causative factor can be identified, alternative antihypertensive therapy should be considered.1
Drugs that inhibit the RAA system may cause hyperkalemia, particularly in individuals with risk factors that include renal insufficiency, diabetes mellitus, and concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salt substitutes.1
Serum potassium must be monitored in patients receiving olmesartan therapy.1
When preparations containing olmesartan in fixed combination with other drugs (e.g., amlodipine, hydrochlorothiazide) are used, the cautions, precautions, contraindications, and drug interactions associated with each drug in the fixed combination must be considered.31, 139, 144
Olmesartan may cause fetal and neonatal morbidity and mortality when administered to a pregnant woman.1 Olmesartan should be discontinued as soon as possible when pregnancy is detected.1 Alternative antihypertensive agents should be considered during pregnancy.1
Untreated hypertension during pregnancy is associated with an increased risk of maternal preeclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and risk of post-partum hemorrhage).1 Hypertension also increases the risk of fetal growth restriction in utero, and intrauterine death.1
In pregnant women who receive olmesartan during pregnancy, serial ultrasound examinations should be performed along with fetal testing, based on gestational age.1 Oligohydramnios may not appear, however, until the fetus has sustained irreversible injury.1
In infants with exposure to olmesartan in utero, carefully observe for hypotension, oliguria, and hyperkalemia, and use appropriate measures to maintain adequate blood pressure and renal perfusion.1 Exchange transfusions or dialysis may be required.1
Olmesartan is distributed into milk in rats; it is not known whether the drug is distributed into milk in humans.1 The effects of olmesartan on the breast-fed child or on milk production are not known.1 Because of the potential for serious adverse reactions to olmesartan in breast-feeding infants, a decision should be made whether to discontinue breast-feeding or the drug, taking into account the importance of the drug to the woman.1
Safety and efficacy of olmesartan have been established in a randomized, double-blind, placebo-controlled trial in pediatric patients 6-16 years of age with hypertension.1 Similar to adults, smaller blood pressure reductions have been observed in Black pediatric patients compared with non-Black pediatric patients.1 Adverse effects generally were similar to those observed in adults.1
Olmesartan has also been studied in 59 patients who were 1-5 years of a treatment with olmesartan medoxomil (0.3 mg/kg once daily) in this age group did not result in a statistically significant reduction in blood pressure compared with placebo.1 The manufacturer states that olmesartan has not been shown to be effective for hypertension in patients <6 years of age.1 Olmesartan has not been evaluated in infants <1 year of a because of the possibility of abnormal kidney development, the drug must not be used in this age group.1
Pharmacokinetics of olmesartan have been evaluated in pediatric patients 1-16 years of a clearance of the drug (adjusted for body weight) in these pediatric patients was similar to that observed in adults.1
No overall differences in safety and efficacy of olmesartan have been observed in geriatric patients ≥65 years of age relative to younger adults, but increased sensitivity to the drug cannot be ruled out.1
Modest accumulation of olmesartan has been observed in geriatric patients following repeated doses.1
In patients with hepatic impairment, total exposure of olmesartan is increased by about 60%.1 However, no initial dosage adjustment is required in patients with moderate or severe hepatic impairment.1
Following repeated dosing, the total exposure of olmesartan was approximately tripled in patients with severe renal impairment (creatinine clearance <20 mL/minute).1 Although serum concentrations of olmesartan may be increased in patients with renal impairment, the manufacturer states that no initial dosage adjustment is required.1 The pharmacokinetics of olmesartan in patients undergoing hemodialysis have not been studied.1
Deterioration of renal function may occur during therapy.1
Blood pressure reduction with olmesartan may be diminished in Black patients as compared to patients of other races.1
In placebo-controlled studies, the only adverse effect that occurred in more than 3% of adults receiving olmesartan, and at an incidence greater than with placebo, was dizziness.1 The incidence of adverse effects was not affected by age, gender, or race.1
Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes
Olmesartan is not metabolized by the cytochrome P-450 (CYP) isoenzyme system and does not alter activity of CYP isoenzymes; pharmacokinetic interactions are unlikely with inhibitors or inducers of CYP isoenzymes or with drugs that are metabolized by these isoenzymes.1
Drugs that Block the Renin-Angiotensin System
Increased risk of renal impairment, hyperkalemia, and hypotension with concomitant use of other drugs that block the renin-angiotensin system (e.g., angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor antagonists, aliskiren); when olmesartan is used concomitantly with such drugs, blood pressure, renal function, and serum concentrations of electrolytes should be monitored closely.1 The manufacturer states that most patients do not derive additional benefit from combination therapy with 2 renin-angiotensin system inhibitors compared with monotherapy.1 Concomitant use of olmesartan and aliskiren is contraindicated in patients with diabetes mellitus; in addition, such concomitant use should be avoided in patients with renal impairment (glomerular filtration rate [GFR] <60 mL/minute).1
Drugs that Increase Serum Potassium Concentrations
Increased serum potassium levels may result when olmesartan is used concomitantly with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes that contain potassium, or other drugs that increase potassium levels (e.g., heparin).1 If these agents are used concomitantly with olmesartan, monitoring of serum potassium is recommended.1
Pharmacokinetic interactions between antacids and olmesartan are unlikely.1
Concomitant administration of colesevelam and olmesartan may lead to decreased systemic exposure and peak plasma concentrations of olmesartan.1 Administration of olmesartan at least 4 hours prior to colesevelam decreases the extent of this interaction and should be considered.1
Pharmacokinetic interaction between digoxin and olmesartan is unlikely.1
Increased serum lithium concentrations resulting in lithium toxicity have been reported when angiotensin II receptor antagonists are used concomitantly with lithium.1 Serum lithium concentrations should be carefully monitored.1
Nonsteroidal Anti-inflammatory Agents
Hypotensive effects may be attenuated when angiotensin II receptor antagonists are used concomitantly with nonsteroidal anti-inflammatory agents (NSAIAs), including selective cyclooxygenase-2 (COX-2) inhibitors.1 Deterioration of renal function, including possible acute renal failure, may occur in geriatric, volume-depleted (including those receiving concomitant diuretic therapy), or renally impaired patients; renal function should be monitored periodically in patients receiving concomitant therapy with olmesartan and an NSAIA, including selective COX-2 inhibitors.1
Pharmacokinetic interaction between warfarin and olmesartan is unlikely.1
Olmesartan medoxomil is a nonpeptide, benzimidazole-derivative angiotensin II type 1 (AT1) receptor antagonist.1 Olmesartan selectively blocks the binding of angiotensin II to the AT1 receptor in vascular smooth muscle, leading to decreased vasoconstriction and aldosterone-secreting effects.1 Olmesartan does not interfere with response to bradykinin.1
Olmesartan medoxomil is a prodrug that is hydrolyzed during absorption in the GI tract to olmesartan.1 Following rapid and complete ester hydrolysis of olmesartan medoxomil to olmesartan, there is virtually no further metabolism of olmesartan.1 The oral bioavailability of olmesartan is 26%.1 Following oral administration, peak plasma concentrations of olmesartan are achieved in 1-2 hours.1 With once daily administration, steady state levels of olmesartan are attained in 3-5 days with no accumulation.1 Olmesartan is highly bound to plasma proteins (99%).1 Olmesartan is not metabolized by the cytochrome P-450 (CYP) microsomal enzyme system.1 Approximately 35-50% of an absorbed dose is recovered in urine while the remainder is excreted in feces via the bile.1 Olmesartan is eliminated in a biphasic manner with an elimination half-life of approximately 13 hours.1 Minor differences in pharmacokinetics have been observed in women compared to men; peak plasma concentrations and total exposure to olmesartan are 10-15% higher in women than men.1
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, film-coated | 5 mg* | Olmesartan Medoxomil Tablets | |
Cosette Pharmaceuticals | ||||
20 mg* | Olmesartan Medoxomil Tablets | |||
Benicar® | Cosette Pharmaceuticals | |||
40 mg* | Olmesartan Medoxomil Tablets | |||
Benicar® | Cosette Pharmaceuticals |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 20 mg with amlodipine 5 mg* | Amlodipine and Olmesartan Medoxomil Tablets | |
Azor® | Cosette Pharmaceuticals | |||
20 mg with 10 mg* | Amlodipine and Olmesartan Medoxomil Tablets | |||
Azor® | Cosette Pharmaceuticals | |||
40 mg with amlodipine 5 mg* | Amlodipine and Olmesartan Medoxomil Tablets | |||
Azor® | Cosette Pharmaceuticals | |||
40 mg with 10 mg* | Amlodipine and Olmesartan Medoxomil Tablets | |||
Azor® | Cosette Pharmaceuticals | |||
Tablets, film-coated | 20 mg with amlodipine 5 mg and hydrochlorothiazide 12.5 mg* | Olmesartan Medoxomil, Amlodipine, Hydrochlorothiazide Tablets | ||
Cosette Pharmaceuticals | ||||
20 mg with hydrochlorothiazide 12.5 mg* | Olmesartan Medoxomil and Hydrochlorothiazide Tablets | |||
Benicar® HCT | Cosette Pharmaceuticals | |||
40 mg with amlodipine 5 mg and hydrochlorothiazide 12.5 mg* | Olmesartan Medoxomil, Amlodipine, Hydrochlorothiazide Tablets | |||
Tribenzor® | Cosette Pharmaceuticals | |||
40 mg with amlodipine 5 mg and hydrochlorothiazide 25 mg* | Olmesartan Medoxomil, Amlodipine, Hydrochlorothiazide Tablets | |||
Tribenzor® | Cosette Pharmaceuticals | |||
40 mg with amlodipine 10 mg and hydrochlorothiazide 12.5 mg* | Olmesartan Medoxomil, Amlodipine, Hydrochlorothiazide Tablets | |||
Tribenzor® | Cosette Pharmaceuticals | |||
40 mg with amlodipine 10 mg and hydrochlorothiazide 25 mg* | Olmesartan Medoxomil, Amlodipine, Hydrochlorothiazide Tablets | |||
Tribenzor® | Cosette Pharmaceuticals | |||
40 mg with hydrochlorothiazide 12.5 mg* | Olmesartan Medoxomil and Hydrochlorothiazide Tablets | |||
Benicar® HCT | Cosette Pharmaceuticals | |||
40 mg with hydrochlorothiazide 25 mg* | Olmesartan Medoxomil and Hydrochlorothiazide Tablets | |||
Benicar® HCT | Cosette Pharmaceuticals |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
1. Cosette Pharmaceuticals, Inc. Benicar® (olmesartan medoxomil) tablets prescribing information. South Plainfield, NJ; 2022 Feb.
31. Cosette Pharmaceuticals, Inc. Benicar HCT® (olmesartan medoxomil and hydrochlorothiazide) tablets prescribing information. South Plainfield, NJ; 2022 Feb.
136. Hazan L, Hernández Rodriguez OA, Bhorat AE et al. A double-blind, dose-response study of the efficacy and safety of olmesartan medoxomil in children and adolescents with hypertension. Hypertension . 2010; 55:1323-30. [PubMed 20385971]
139. Cosette Pharmaceuticals, Inc. Tribenzor® (olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets prescribing information. South Plainfield, NJ; 2022 Feb.
144. Cosette Pharmaceuticals, Inc. Azor® (amlodipine and olmesartan medoxomil) tablets prescribing information. South Plainfield, NJ; 2022 Feb.
171. Lewington S, Clarke R, Qizilbash N, Peto R, Collins R. Age-specific relevance of usual blood pressure to vascular mortality. Lancet. 2002;360:1903-13
501. James PA, Oparil S, Carter BL et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA . 2014; 311:507-20. [PubMed 24352797]
503. Go AS, Bauman MA, Coleman King SM et al. An effective approach to high blood pressure control: a science advisory from the American Heart Association, the American College of Cardiology, and the Centers for Disease Control and Prevention. Hypertension . 2014; 63:878-85. [PubMed 24243703]
510. Staessen JA, Fagard R, Thijs L et al. Randomised double-blind comparison of placebo and active treatment for older patients with isolated systolic hypertension. The Systolic Hypertension in Europe (Syst-Eur) Trial Investigators. Lancet . 1997; 350:757-64. [PubMed 9297994]
999. By the 2023 American Geriatrics Society Beers Criteria® Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria® for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023 Jul;71(7):2052-2081.
1150. Flynn J, Kaelber D, Baker-Smith C, et al. Clinical practice guidelines for screening and management of high blood pressure in children and adolescents. Pediatrics. 2017;140(3):e20171904.
1200. Jones DW, Ferdinand KC, Taler SJ, et al. 2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. Published online August 14, 2025.
1210. SPRINT Research Group, Wright JT, Williamson JD et al. A randomized trial of intensive versus standard blood-pressure control. N Engl J Med . 2015; 373:2103-16. [PubMed 26551272]
1218. Messerli FH, Bangalore S, Bavishi C et al. Angiotensin-converting enzyme inhibitors in hypertension: to use or not to use?. J Am Coll Cardiol . 2018; 71:1474-1482. [PubMed 29598869]
1219. Karmali KN, Lloyd-Jones DM. Global risk assessment to guide blood pressure management in cardiovascular disease prevention. Hypertension . 2017; 69:e2-e9. [PubMed 28115516]
1300. Mancia G, Kreutz R, Brunström M, et al. 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA). J Hypertens. 2023 Dec 1;41(12):1874-2071. doi: 10.1097/HJH.0000000000003480. Epub 2023 Sep 26. Erratum in: J Hypertens. 2024 Jan 1;42(1):194. doi: 10.1097/HJH.0000000000003621. PMID: 37345492.
1301. American Diabetes Association Professional Practice Committee. 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(Supplement_1):S207-S238. doi: 10.2337/dc25-S010. PMID: 39651970; PMCID: PMC11635050
1302. Unger T, Borghi C, Charchar F, et al. 2020 International Society of Hypertension Global Hypertension Practice Guidelines. Hypertension. 2020 Jun;75(6):1334-1357. doi: 10.1161/HYPERTENSIONAHA.120.15026. Epub 2020 May 6. PMID: 32370572.
1304. Tita AT, Szychowski JM, Boggess K et al; Chronic Hypertension and Pregnancy (CHAP) Trial Consortium. Treatment for Mild Chronic Hypertension during Pregnancy. N Engl J Med. 2022 May 12;386(19):1781-1792. doi: 10.1056/NEJMoa2201295. Epub 2022 Apr 2. PMID: 35363951; PMCID: PMC9575330.
1305. Garovic VD, Dechend R, Easterling T et al; American Heart Association Council on Hypertension; Council on the Kidney in Cardiovascular Disease, Kidney in Heart Disease Science Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Lifestyle and Cardiometabolic Health; Council on Peripheral Vascular Disease; and Stroke Council. Hypertension in Pregnancy: Diagnosis, Blood Pressure Goals, and Pharmacotherapy: A Scientific Statement From the American Heart Association. Hypertension. 2022 Feb;79(2):e21-e41. doi: 10.1161/HYP.0000000000000208. Epub 2021 Dec 15. Erratum in: Hypertension. 2022 Mar;79(3):e70. doi: 10.1161/HYP.0000000000000212. PMID: 34905954; PMCID: PMC9031058.
1306. American College of Obstetricians and Gynecologists Practice Advisory. Clinical Guidance for the Integration of the Findings of the Chronic Hypertension and Pregnancy (CHAP) Study. Accessed 2024 Jul 10. http://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2022/04/clinical-guidance-for-the-integration-of-the-findings-of-the-chronic-hypertension-and-pregnancy-chap-study
1600. Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2022 clinical practice guideline for diabetes management in chronic kidney disease. Kidney Int. 2022;102(5S):S1-S127.
1601. Kidney Disease: Improving Global Outcomes (KDIGO) Blood Pressure Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney Disease. Kidney Int. 2021;99(3S):S1-S87.
1630. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024;105(4S):S117-S314.
1631. American Diabetes Association Professional Practice Committee. 11. Chronic kidney disease and risk management: Standards of Care in Diabetes-2025. Diabetes Care. 2025;48(Suppl 1): S239-S251.
1633. Rao S, Odonoghue M, Ruel M, et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the management of patients with acute coronary syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025;151:e771-e862.
1642. McEvoy JW, McCarthy CP, Bruno RM, et al. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. 2024;45(38):3912-4018.