Last reviewed 2026-04-20 · How we verify

Benicar (OLMESARTAN MEDOXOMIL)

Benicar works by blocking the action of angiotensin II, a hormone that constricts blood vessels, to lower blood pressure.

Benicar (Olmesartan medoxomil) is an angiotensin 2 receptor blocker (ARB) developed by Daiichi Sankyo and currently owned by Cosette. It targets the type-1 angiotensin II receptor to treat hypertension. Approved by the FDA in 2002, Benicar is now off-patent with 25 generic manufacturers. The drug has a half-life of 13 hours and bioavailability of 26%. It is used to treat hypertensive disorders.

At a glance

Mechanism of action

Angiotensin II is formed from angiotensin in 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 blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle. Its action is, therefore, independent of the pathways for angiotensin II synthesis.An AT2 receptor is found also in many tissues, but this receptor is not known to be associated with cardiovascular homeostasis. Olmesartan has more than 12,500-fold greater affinity for the AT1 receptor than for the AT2 receptor.Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is mechanism of man

Approved indications

• Hypertensive disorder

Boxed warnings

• WARNING: FETAL TOXICITY When pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide as soon as possible [see Warnings and Precautions (5.1) ] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) ] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide as soon as possible ( 5.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 ).

Common side effects

• Diarrhea
• Headache
• Hematuria
• Hyperglycemia
• Hypertriglyceridemia
• Influenza-like symptoms
• Pharyngitis
• Rhinitis
• Sinusitis
• Cough
• Bronchitis
• Creatine phosphokinase increased

Key clinical trials

• Efficacy and Safety of Olmesartan Associated With Chlorthalidone Versus Benicar HCT® in Essential Hypertension Control (PHASE3)
• Efficacy and Safety of Olmesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control (PHASE3)
• Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
• Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2) (PHASE2)
• 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
• Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia
• Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World Study
• Impact of Antihypertensive Therapy on Recurrence Risk of Ovarian Cancer for Bevacizumab-associated Hypertension

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Benicar CI brief — competitive landscape report
• Benicar updates RSS · CI watch RSS
• Cosette portfolio CI