Olmesartan

Olmesartan medoxomil Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation and renal reabsorption of sodium.

• Olmesartan medoxomil and hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide is not indicated for the initial therapy of hypertension [see Dosage and Administration (2) ] .ICD-10: I10

• Olmesartan medoxomil and hydrochlorothiazide is contraindicated: In patients with hypersensitivity to any component of olmesartan medoxomil and hydrochlorothiazide [see Adverse Reactions ( 6.1 , 6.2 )] In patients with anuria [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ] For coadministration with aliskiren in patients with diabetes [ s ee Drug Interactions (7.4) ]. Hypersensitivity to any component of olmesartan medoxomil and hydrochlorothiazide ( 4 ) Anuria ( 4 ) Do not co-administer aliskiren with olmesartan medoxomil and hydrochlorothiazide in patients with diabetes.contraindicated

The recommended starting dose of olmesartan medoxomil and hydrochlorothiazide is 40/12.5 mg once daily in patients whose blood pressure is not adequately controlled with olmesartan monotherapy. Dose can be titrated up to 40 /25 mg if necessary. The recommended starting dose of olmesartan medoxomil and hydrochlorothiazide is 20/12.5 mg once daily in patients whose blood pressure is not adequately controlled with HCT monotherapy or who experience dose-limiting adverse reactions with hydrochlorothiazide. Dose can be titrated up to 40 /25 mg if necessary. Patients titrated to the individual components (olmesartan and hydrochlorothiazide) may instead receive the corresponding dose of olmesartan medoxomil and hydrochlorothiazide. Recommended starting dose in patients not adequately controlled with olmesartan monotherapy, 40/12.5 mg ( 2 ) Recommended starting dose in patients not adequately controlled with hydrochlorothiazide monotherapy, 20/12.5 mg ( 2 ) Adjust dose after 2 to 4 weeks, as needed, to a maximum of 40 mg / 25 mg olmesartan / hydrochlorothiazide ( 2 )

Hypotension: Correct volume-depletion prior to administration. ( 5.2 ) Monitor renal function and potassium in susceptible patients ( 5.3 ) Observe for signs of fluid or electrolyte imbalance. ( 5.4 ) Acute angle-closure glaucoma ( 5.5 ) Sprue-like enteropathy has been reported. Consider discontinuation of olmesartan medoxomil and hydrochlorothiazide in cases where no other etiology is found ( 5.7 ) 5.1 Fetal Toxicity Pregnancy Category D 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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide as soon as possible [ see Use in Specific Populations (8.1) ]. Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia [ s ee Use in Specific Populations (8.1) ] . 5.2 Hypotension in Volume or Salt-Depleted Patients In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients ( e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with olmesartan medoxomil and hydrochlorothiazide.

The following adverse reactions with olmesartan medoxomil and hydrochlorothiazide are described elsewhere: Hypotension in Volume- or Salt-Depleted Patients [see Warnings and Precautions (5.2) ] Impaired Renal Function [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Electrolyte and Metabolic Imbalances [see Warnings and Precautions (5.5) ] Acute Myopia and Secondary Angle-Closure Glaucoma [see Warnings and Precautions (5.6) ] Systemic Lupus Erythematosus [see Warnings and Precautions (5.7) ] Sprue-Like Enteropathy [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence ≥2%) are nausea, hyperuricemia, dizziness, and upper respiratory infection ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-332-1088 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. Olmesartan medoxomil and hydrochlorothiazide The concomitant use of olmesartan medoxomil and hydrochlorothiazide was evaluated for safety in 1243 hypertensive patients. Treatment with olmesartan medoxomil and hydrochlorothiazide was well tolerated, with an incidence of adverse events similar to that of placebo. Adverse reactions were generally mild, transient and not dependent on the dose of olmesartan medoxomil and hydrochlorothiazide.

Nursing mothers: Avoid use while nursing; discontinue either nursing or the drug ( 8.3 ). 8.1 Pregnancy Pregnancy Category D 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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. 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. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intraamniotic environment.

Metabolism

Absorption Olmesartan: Olmesartan medoxomil is completely bioactivated by ester hydrolysis to olmesartan during absorption from the gastrointestinal tract. The absolute bioavailability of olmesartan is approximately 26%.

Olmesartan medoxomil Limited data are available related to overdosage of olmesartan medoxomil 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 should occur, supportive treatment should be initiated. The dialyzability of olmesartan is unknown. No lethality was observed in acute toxicity studies in mice and rats given single oral doses up to 2000 mg/kg olmesartan medoxomil. The minimum lethal oral dose of olmesartan medoxomil in dogs was greater than 1500 mg/kg. Hydrochlorothiazide The most common signs and symptoms of hydrochlorothiazide overdose observed in humans are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD 50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.

• Apr 25, 2002NDANDA021286Cosette
• Jun 5, 2003NDANDA021532Cosette
• Sep 26, 2007NDANDA022100Cosette
• Jul 23, 2010NDANDA200175Cosette
• Oct 26, 2016ANDAANDA206884Macleods Pharms Ltd
• Oct 26, 2016ANDAANDA206137Ph Health
• Oct 28, 2016ANDAANDA207216Ajanta Pharma Ltd
• Nov 3, 2016ANDAANDA202491Teva Pharms Usa

1. 1Sprue-like Enteropathy4,2019.7%
2. 2Diarrhoea3,0167.0%
3. 3Weight Decreased2,7056.3%
4. 4Dizziness2,5786.0%
5. 5Gastrooesophageal Reflux Disease2,5445.9%
6. 6Nausea2,4845.8%
7. 7Drug Ineffective2,4165.6%
8. 8Acute Kidney Injury2,3715.5%
9. 9Fatigue2,0524.8%
10. 10Headache1,7384.0%
11. 11Haemorrhoids1,6223.8%
12. 12Constipation1,5853.7%
13. 13Hypotension1,5723.6%
14. 14Dyspnoea1,5703.6%
15. 15Vomiting1,4643.4%

The 10 most recently updated of 162 ClinicalTrials.gov registrations naming Olmesartan as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Compare the Pharmacokinetics and Safety of the ATB-U101 and ATB-U1011+ATB-U1012 and ATB-1011+ATB-1012 in Healthy Caucasian Participants
  Not yet recruiting · Phase 1 · Interventional · 36 enrolled · Autotelicbio
  NCT07590466updated 2026-05-15
• Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
  Not yet recruiting · Phase 4 · Interventional · 64 enrolled · Baylor Research Institute
  NCT07547878updated 2026-05-08
• Efficacy and Safety of Olmesartan Associated With Chlorthalidone Versus Benicar HCT® in Essential Hypertension Control
  Withdrawn · Phase 3 · Interventional · 0 enrolled · EMS
  NCT02483936updated 2025-12-08
• Efficacy and Safety of Olmesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control
  Withdrawn · Phase 3 · Interventional · 0 enrolled · EMS
  NCT02493322updated 2025-12-08
• Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
  Not yet recruiting · Observational · 13,656 enrolled · First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  NCT07262710updated 2025-12-04
• Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)
  Completed · Phase 2 · Interventional · 663 enrolled · Alnylam Pharmaceuticals
  NCT05103332updated 2025-11-03
• Study to Evaluate the Effect of Improving Systolic BP and LDL-C Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab
  Active not recruiting · Observational · 2,845 enrolled · Daewoong Pharmaceutical Co. LTD.
  NCT05411887updated 2025-08-24
• Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia
  Active not recruiting · Observational · 4,000 enrolled · Daewoong Pharmaceutical Co. LTD.
  NCT05660135updated 2025-08-24
• Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World Study
  Recruiting · Observational · 180 enrolled · Beijing Friendship Hospital
  NCT05498675updated 2025-02-13
• Fixed-dose Combination of an Angiotensin Receptor Blocker and Thiazide Diuretic for Essential Hypertension
  Not yet recruiting · Phase 3 · Interventional · 292 enrolled · Eurofarma Laboratorios S.A.
  NCT06608472updated 2024-11-27

Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

• LosartanAngiotensin 2 Receptor Blocker78%

Frequently asked questions

How does Olmesartan work?

Olmesartan medoxomil Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation and renal reabsorption of sodium.

What is Olmesartan used for?

According to FDA labeling, Olmesartan carries indications including: Olmesartan medoxomil and hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide is not indicated for the initial therapy of hypertension [see Dosage and Administration (2) ] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Olmesartan?

Olmesartan is classified as Angiotensin 2 Receptor Blocker, Angiotensin 2 Receptor Antagonists, Decreased Blood Pressure, Decreased Intravascular Volume, Decreased Mineralocorticoid Secretion, Decreased Renal K+ Excretion, Increased Renal Na+ Excretion, Renal Arterial Vasoconstriction, Renal Arterial Vasodilation.

What are the brand names for Olmesartan?

Olmesartan is marketed under brand names including Azor, Benicar, Benicar HCT, Tribenzor.

What are the contraindications for Olmesartan?

Olmesartan labeling lists contraindications including: Olmesartan medoxomil and hydrochlorothiazide is contraindicated: In patients with hypersensitivity to any component of olmesartan medoxomil and hydrochlorothiazide [see Adverse Reactions ( 6.1 , 6.2 )] In patients with anuria [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ] For coadministration with aliskiren in patients with diabetes [ s ee Drug Interactions (7.4) ]. Hypersensitivity to any component of olmesartan medoxomil and hydrochlorothiazide ( 4 ) Anuria ( 4 ) Do not co-administer aliskiren with olmesartan medoxomil and hydrochlorothiazide in patients with diabetes.. Always consult the full prescribing information and a clinician.