Mediclarum
Medicine guide

Olmesartan Medoxomil and Hydrochlorothiazide

40 mg + 25 mg · Tablet, Film Coated

  • Prescription only
  • Angiotensin 2 Receptor Blocker
Made by
Golden State Medical Supply, Inc.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-07-23

What it is

Angiotensin 2 Receptor Blocker

Used for
  • Olmesartan medoxomil and hydrochlorothiazide tablets is indicated for the treatment of hypertension, to lower blood pressure [see Dosage and Administration ( 2 )]. Lowering blood pressure reduces the risk of…
The label’s usual adult dose

Recommended starting dose in patients not adequately controlled with olmesartan monotherapy, 40/12.5 mg ( 2 )

Full directions ↓
Serious warning

FETAL TOXICITY When pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide tablets as soon as possible [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 )].

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
53other products contain Olmesartan Medoxomil and Hydrochlorothiazide — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • Olmesartan medoxomil and hydrochlorothiazide tablets is indicated for the treatment of hypertension, to lower blood pressure [see Dosage and Administration ( 2 )]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Olmesartan medoxomil and hydrochlorothiazide tablets may be used alone or in combination with other antihypertensive drugs. Limitations of Use Olmesartan medoxomil and hydrochlorothiazide tablets is not indicated for the initial therapy of hypertension.
  • Olmesartan medoxomil and hydrochlorothiazide tablets is a combination of olmesartan, an angiotensin II receptor blocker and hydrochlorothiazide, a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1 ) Limitations of Use Olmesartan medoxomil and hydrochlorothiazide tablets is not indicated for initial therapy. ( 1 )

From the official label · 2026-07-23 · DailyMed

How it works

From this product’s own US prescribing label.

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.

Peak level after1–2 h
Half-life2 h
Mostly cleared after≈ 10 hfive half-lives — our arithmetic
PeakHalf gone10 h0
The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.
How the body breaks it down

Hydrochlorothiazide: Hydrochlorothiazide is not metabolized.

How it leaves the body

Approximately 35% to 50% of the absorbed dose is recovered in urine while the remainder is eliminated in feces via the bile.

With food

Food does not affect the bioavailability of olmesartan.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-07-23

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

  • FETAL TOXICITY When pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide tablets as soon as possible [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 )].
  • Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 )].
  • WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.
  • When pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide tablets 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 ).

Quoted from the official label, section “Boxed Warning”.

Do not take it if

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

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • The recommended starting dose of Olmesartan medoxomil and hydrochlorothiazide tablets 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 tablets 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 tablets.
  • 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 )

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • 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. ( 5.5 )
  • Acute angle-closure glaucoma ( 5.6 )
  • Sprue-like enteropathy has been reported. Consider discontinuation of olmesartan medoxomil and hydrochlorothiazide tablets in cases where no other etiology is found ( 5.8 ) 5.1 Fetal Toxicity Olmesartan medoxomil and hydrochlorothiazide tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system (RAS) 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 tablets 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 [see 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 tablets. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. When electrolyte and fluid imbalances have been corrected, olmesartan medoxomil and hydrochlorothiazide tablets usually can be continued without difficulty. A transient hypotensive response is not a contraindication to further treatment. 5.3 Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system ( e.g. , patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on olmesartan medoxomil and hydrochlorothiazide tablets. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on olmesartan medoxomil and hydrochlorothiazide tablets [see Drug Interactions ( 7 )]. 5.4 Hypersensitivity Reactions Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history. 5.5 Electrolyte and Metabolic Imbalances Olmesartan medoxomil and hydrochlorothiazide tablets contains hydrochlorothiazide which can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion. Olmesartan medoxomil and hydrochlorothiazide tablets also contains olmesartan, a drug that inhibits the RAS. Drugs that inhibit the RAS can cause hyperkalemia. Monitor serum electrolytes periodically. Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. Hyperuricemia may occur or frank gout may be precipitated in patients receiving thiazide therapy. Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels. 5.6 Acute Myopia and Secondary Angle-Closure Glaucoma Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. 5.7 Systemic Lupus Erythematosus Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus. 5.8 Sprue-Like Enteropathy Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider discontinuation of olmesartan medoxomil and hydrochlorothiazide tablets in cases where no other etiology is identified.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Risk Summary Olmesartan medoxomil and hydrochlorothiazide tablets 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.
  • 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.
  • When pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide tablets as soon as possible.
  • Use 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% to 4% and 15% to 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 Olmesartan 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.
  • 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 olmesartan medoxomil and hydrochlorothiazide tablets for hypotension, oliguria, and hyperkalemia.
  • If oliguria or hypotension occur, 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 [see Use in Specific Populations ( 8.4 )].
  • Hydrochlorothiazide Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma.
  • Hydrochlorothiazide, like other diuretics, can cause placental hypoperfusion.
  • It accumulates in the amniotic fluid, with reported concentrations up to 19 times that in umbilical vein plasma.
  • Use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia.
  • Since they do not prevent or alter the course of preeclampsia, these drugs should not be used to treat hypertension in pregnant women.
  • The use of HCTZ for other indications (e.g., heart disease) in pregnancy should be avoided.
  • Data Animal Data Olmesartan No teratogenic effects were observed when olmesartan medoxomil was administered to pregnant rats at oral doses up to 1000 mg/kg/day (240 times the maximum recommended human dose [MRHD] on a mg/m 2 basis) or pregnant rabbits at oral doses up to 1 mg/kg/day (half the MRHD on a mg/m 2 basis; higher doses could not be evaluated for effects on fetal development as they were lethal to the does).
  • In rats, significant decreases in pup birth weight and weight gain were observed at doses ≥1.6 mg/kg/day, and delays in developmental milestones (delayed separation of ear auricula, eruption of lower incisors, appearance of abdominal hair, descent of testes, and separation of eyelids) and dose-dependent increases in the incidence of dilation of the renal pelvis were observed at doses ≥ 8 mg/kg/day.
  • The no observed effect dose for developmental toxicity in rats is 0.3 mg/kg/day, about one-tenth the MRHD of 40 mg/day.
  • Olmesartan medoxomil and Hydrochlorothiazide.
  • No teratogenic effects were observed when 1.6:1 combinations of olmesartan medoxomil and hydrochlorothiazide were administered to pregnant mice at oral doses up to 1625 mg/kg/day (122 times the maximum recommended human dose MRHD on a mg/m 2 basis) or pregnant rats at oral doses up to 1625 mg/kg/day (243 times the MRHD on a mg/m2 basis).
  • In rats, however, fetal body weights at 1625 mg/kg/day (a toxic, sometimes lethal dose in the dams) were significantly lower than control.
  • The no observed effect dose for developmental toxicity in rats, 162.5 mg/kg/day, is about 24 times, on a mg/m2 basis, the MRHD of 40 mg olmesartan medoxomil /25 mg hydrochlorothiazide/day (calculations based on a 60 kg patient).
  • Hydrochlorothiazide No teratogenic effects were observed when hydrochlorothiazide was administered to mice and rats via gavage at doses up to 3000 and 1000 mg/kg/day, respectively (about 600 and 400 times the MRHD), on gestation days 6 through 15.
  • IN SPECIFIC POPULATIONS
  • Lactation:
  • Breastfeeding is not recommended ( 8.2 ). 8.1 Pregnancy Risk Summary Olmesartan medoxomil and hydrochlorothiazide tablets 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. 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. When pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide tablets as soon as possible. Use 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% to 4% and 15% to 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 Olmesartan 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. 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 olmesartan medoxomil and hydrochlorothiazide tablets for hypotension, oliguria, and hyperkalemia. If oliguria or hypotension occur, 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 [see Use in Specific Populations ( 8.4 )]. Hydrochlorothiazide Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma. Hydrochlorothiazide, like other diuretics, can cause placental hypoperfusion. It accumulates in the amniotic fluid, with reported concentrations up to 19 times that in umbilical vein plasma. Use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia. Since they do not prevent or alter the course of preeclampsia, these drugs should not be used to treat hypertension in pregnant women. The use of HCTZ for other indications (e.g., heart disease) in pregnancy should be avoided. Data Animal Data Olmesartan No teratogenic effects were observed when olmesartan medoxomil was administered to pregnant rats at oral doses up to 1000 mg/kg/day (240 times the maximum recommended human dose [MRHD] on a mg/m 2 basis) or pregnant rabbits at oral doses up to 1 mg/kg/day (half the MRHD on a mg/m 2 basis; higher doses could not be evaluated for effects on fetal development as they were lethal to the does). In rats, significant decreases in pup birth weight and weight gain were observed at doses ≥1.6 mg/kg/day, and delays in developmental milestones (delayed separation of ear auricula, eruption of lower incisors, appearance of abdominal hair, descent of testes, and separation of eyelids) and dose-dependent increases in the incidence of dilation of the renal pelvis were observed at doses ≥ 8 mg/kg/day. The no observed effect dose for developmental toxicity in rats is 0.3 mg/kg/day, about one-tenth the MRHD of 40 mg/day. Olmesartan medoxomil and Hydrochlorothiazide. No teratogenic effects were observed when 1.6:1 combinations of olmesartan medoxomil and hydrochlorothiazide were administered to pregnant mice at oral doses up to 1625 mg/kg/day (122 times the maximum recommended human dose MRHD on a mg/m 2 basis) or pregnant rats at oral doses up to 1625 mg/kg/day (243 times the MRHD on a mg/m2 basis). In rats, however, fetal body weights at 1625 mg/kg/day (a toxic, sometimes lethal dose in the dams) were significantly lower than control. The no observed effect dose for developmental toxicity in rats, 162.5 mg/kg/day, is about 24 times, on a mg/m2 basis, the MRHD of 40 mg olmesartan medoxomil /25 mg hydrochlorothiazide/day (calculations based on a 60 kg patient). Hydrochlorothiazide No teratogenic effects were observed when hydrochlorothiazide was administered to mice and rats via gavage at doses up to 3000 and 1000 mg/kg/day, respectively (about 600 and 400 times the MRHD), on gestation days 6 through 15. 8.2 Lactation Risk Summary There is limited information regarding the presence of olmesartan medoxomil and hydrochlorothiazide tablets in human milk, the effects on the breastfed infant, or the effects on milk production. Olmesartan is present in rat milk ( see Data ). Hydrochlorothiazide is present in human milk. Because of the potential for adverse effects on the nursing infant, advise a nursing woman that breastfeeding is not recommended during treatment with olmesartan medoxomil and hydrochlorothiazide tablets. Data Presence of olmesartan in milk was observed after a single oral administration of 5 mg/kg [14C] olmesartan medoxomil to lactating rats. 8.4 Pediatric Use Safety and effectiveness of olmesartan medoxomil and hydrochlorothiazide tablets in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of olmesartan medoxomil and hydrochlorothiazide tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy. Olmesartan and hydrochlorothiazide are substantially excreted by the kidney, and the risk of toxic reactions to olmesartan medoxomil and hydrochlorothiazide tablets may be greater in patients with impaired renal function. 8.6 Renal Impairment Safety and effectiveness of olmesartan medoxomil and hydrochlorothiazide tablets in patients with severe renal impairment (CrCl ≤ 30 mL/min) have not been established. No dose adjustment is required in patients with mild (CrCl 60 to 90 mL/min) or moderate (CrCl 30 to 60) renal impairment. 8.7 Hepatic Impairment Olmesartan medoxomil No dose adjustment is necessary for patients with mild to severe liver disease. Hydrochlorothiazide Minor alterations of fluid and electrolyte balance may precipitate hepatic coma in patients with impaired hepatic function or progressive liver disease.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • Agents increasing potassium levels may lead to increase in serum potassium ( 7.1 ).
  • Lithium: Risk of lithium toxicity ( 7.2 )
  • Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):
  • Reduced diuretic, natriuretic and antihypertensive effects; increased risk of renal toxicity ( 7.3 )
  • Dual inhibition of the renin-angiotensin system:
  • Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.4 )
  • Colesevelam hydrochloride:
  • Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose ( 7.5 )
  • Antidiabetic drugs: Dosage adjustment may be required ( 7.6 )
  • Cholestyramine and colestipol:
  • Reduced absorption of thiazides ( 7.6 ) 7.1 Agents Increasing Serum Potassium Coadministration of olmesartan medoxomil and hydrochlorothiazide with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists or hydrochlorothiazide. Monitor serum lithium levels during concomitant use. 7.3 Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) Olmesartan medoxomil 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. Hydrochlorothiazide In some patients the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effects of thiazide diuretics. Therefore, monitor blood pressure closely. 7.4 Dual Blockade of the Renin Angiotensin System 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 olmesartan medoxomil and hydrochlorothiazide tablets and other agents that affect the RAS. Do not co-administer aliskiren with olmesartan medoxomil and hydrochlorothiazide tablets in patients with diabetes [see Contraindications ( 4 )].
  • Avoid use of aliskiren with olmesartan medoxomil and hydrochlorothiazide tablets in patients with renal impairment (GFR <60 ml/min). 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. Consider administering olmesartan at least 4 hours before the colesevelam hydrochloride dose [see Clinical Pharmacology ( 12.3 )]. 7.6 Use of Hydrochlorothiazide with Other Drugs When administered concurrently the following drugs may interact with thiazide diuretics:
  • Antidiabetic drugs (oral agents and insulin):
  • Dosage adjustment of the antidiabetic drug may be required. Ion exchange resins:
  • Staggering the dosage of hydrochlorothiazide and ion exchange resins (e.g., cholestyramine, colestipol) such that hydrochlorothiazide is administered at least 4 hours before or 4 - 6 hours after the administration of resins would potentially minimize the interaction [see Clinical Pharmacology ( 12.3 )]. Corticosteroids, ACTH:
  • Intensified electrolyte depletion, particularly hypokalemia.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • 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.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness of olmesartan medoxomil and hydrochlorothiazide tablets in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • Clinical studies of olmesartan medoxomil and hydrochlorothiazide tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
  • Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
  • In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy.
  • Olmesartan and hydrochlorothiazide are substantially excreted by the kidney, and the risk of toxic reactions to olmesartan medoxomil and hydrochlorothiazide tablets may be greater in patients with impaired renal function.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • The following adverse reactions with olmesartan medoxomil and hydrochlorothiazide tablets 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 ScieGen Pharmaceuticals, Inc. at 1-855-724-3436 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. 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. The rate of withdrawals for adverse events in all trials of hypertensive patients was 2.0% (25/1243) on olmesartan medoxomil plus hydrochlorothiazide and 2.0% (7/342) on placebo. In a placebo-controlled, factorial clinical trial of olmesartan medoxomil (2.5 mg to 40 mg) and hydrochlorothiazide (12.5 mg to 25 mg), the following adverse reactions reported in Table 1 occurred in >2% of patients, and more often on the olmesartan medoxomil and hydrochlorothiazide combination than on placebo. Table 1:
  • Adverse Reactions in a Factorial Trial of Patients with Hypertension Olmesartan/HCTZ (N=247) (%) Olmesartan (N=125) (%) HCTZ (N=88) (%) Placebo (N=42) (%) Nausea 3 2 1 0 Hyperuricemia 4 0 2 2 Dizziness 9 1 8 2 Upper Respiratory Infection 7 6 7 0 Other adverse reactions that have been reported with an incidence of greater than 1.0%, whether or not attributed to treatment, in the more than 1200 hypertensive patients treated with olmesartan medoxomil and hydrochlorothiazide in controlled or open-label trials are listed below. Body as a Whole :
  • chest pain, back pain, peripheral edema Central and Peripheral Nervous System :
  • vertigo Gastrointestinal :
  • abdominal pain, dyspepsia, gastroenteritis, diarrhea Liver and Biliary System :
  • SGOT increased, GGT increased, ALT increased Metabolic and Nutritional :
  • creatine phosphokinase increased Musculoskeletal :
  • arthritis, arthralgia, myalgia Respiratory System :
  • coughing Skin and Appendages Disorders :
  • rash Urinary System :
  • hematuria Facial edema was reported in 2/1243 patients receiving olmesartan medoxomil and hydrochlorothiazide. Angioedema has been reported with angiotensin II receptor antagonists, including olmesartan medoxomil and hydrochlorothiazide. Hydrochlorothiazide Other adverse reactions that have been reported with hydrochlorothiazide are listed below:
  • Body as a Whole:
  • weakness Digestive :
  • pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation Hematologic :
  • aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia Hypersensitivity :
  • purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions Metabolic :
  • glycosuria, hyperuricemia Musculoskeletal :
  • muscle spasm Nervous System/Psychiatric :
  • restlessness Renal:
  • renal dysfunction, interstitial nephritis Skin :
  • erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis Special Senses :
  • transient blurred vision, xanthopsia Clinical Laboratory Test Findings Creatinine/blood urea nitrogen (BUN):
  • Minor elevations in creatinine and BUN occurred in 1.7% and 2.5% respectively, of patients taking olmesartan medoxomil and hydrochlorothiazide tablets and 0% and 0% respectively, given placebo in controlled clinical trials. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of olmesartan medoxomil and hydrochlorothiazide tablets. 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 Gastrointestinal :
  • Vomiting Metabolic :
  • Hyperkalemia Musculoskeletal :
  • Rhabdomyolysis Skin and Appendages :
  • Alopecia, pruritus 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. The randomized, placebo-controlled, double-blind ROADMAP trial (Randomized Olmesartan And Diabetes MicroAlbuminuria Prevention trial, n=4447) examined the use of olmesartan, 40 mg daily, vs. placebo in patients with type 2 diabetes mellitus, normoalbuminuria, and at least one additional risk factor for CV disease. The trial met its primary endpoint, delayed onset of microalbuminuria, but olmesartan had no beneficial effect on decline in glomerular filtration rate (GFR). There was a finding of increased CV mortality (adjudicated sudden cardiac death, fatal myocardial infarction, fatal stroke, revascularization death) in the olmesartan group compared to the placebo group (15 olmesartan vs. 3 placebo, HR 4.9, 95% confidence interval [CI], 1.4, 17), but the risk of non-fatal myocardial infarction was lower with olmesartan (HR 0.64, 95% CI 0.35, 1.18). The epidemiologic study included patients 65 years and older with overall exposure of > 300,000 patient-years. In the sub-group of diabetic patients receiving high-dose olmesartan (40 mg/d) for > 6 months, there appeared to be an increased risk of death (HR 2.0, 95% CI 1.1, 3.8) compared to similar patients taking other angiotensin receptor blockers. In contrast, high-dose olmesartan use in non-diabetic patients appeared to be associated with a decreased risk of death (HR 0.46, 95% CI 0.24, 0.86) compared to similar patients taking other angiotensin receptor blockers. No differences were observed between the groups receiving lower doses of olmesartan compared to other angiotensin blockers or those receiving therapy for < 6 months. Overall, these data raise a concern of a possible increased CV risk associated with the use of high-dose olmesartan in diabetic patients. There are, however, concerns with the credibility of the finding of increased CV risk, notably the observation in the large epidemiologic study for a survival benefit in non-diabetics of a magnitude similar to the adverse finding in diabetics. Non-melanoma Skin Cancer Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥50,000mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • Pregnancy:
  • Advise female patients of childbearing age about the consequences of exposure to olmesartan medoxomil and hydrochlorothiazide tablets during pregnancy.
  • Discuss treatment options with women planning to become pregnant.
  • Tell patients to report pregnancies to their physicians as soon as possible [ See Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )].
  • Lactation:
  • Advise nursing women not to breastfeed during treatment with olmesartan medoxomil and hydrochlorothiazide tablets [see Use in Specific Populations ( 8.2 )].
  • Symptomatic hypotension and syncope:
  • Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report this symptom to a healthcare provider.
  • Inform patients that dehydration from inadequate fluid intake, excessive perspiration, vomiting, or diarrhea may lead to an excessive fall in blood pressure.
  • If syncope occurs advise patients, to contact their healthcare provider.
  • Potassium Supplements:
  • Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider.
  • Acute myopia and secondary angle-closure glaucoma:
  • Advise patients to discontinue olmesartan medoxomil and hydrochlorothiazide tablets and seek immediate medical attention if they experience symptoms of acute myopia or secondary angle-closure glaucoma [see Warnings and Precautions ( 5.6 )].
  • Non-melanoma Skin Cancer:
  • Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.
  • Manufactured by: ScieGen Pharmaceuticals, Inc.
  • Hauppauge, NY 11788 USA RX only Revised: 5/2026 Marketed by: GSMS, Inc.
  • Camarillo, CA 93012 USA

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • FORMS AND STRENGTHS Olmesartan modoxomil and hydrochlorothiazide tablets are supplied as:
  • 20 mg/12.5 mg:
  • light orange, round, film coated tablets debossed with ‘SG’ on one side and ‘342’ on other side.
  • Each tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. 40 mg/12.5 mg:
  • light orange, oval, film coated tablets debossed with ‘SG’ on one side and ‘343’ on other side.
  • Each tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. 40 mg/25 mg:
  • brownish red, oval, film coated tablets debossed with ‘SG’ on one side and ‘344’ on other side.
  • Each tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
  • Tablets:
  • (olmesartan medoxomil and hydrochlorothiazide) 20/12.5 mg; 40/12.5 mg; 40/25 mg ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • Olmesartan medoxomil and hydrochlorothiazide tablets are supplied as follows:
  • 20 mg/12.5 mg - light orange, round, film coated tablets debossed with ‘SG’ on one side and ‘342’ on other side.
  • Each tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. 40 mg/12.5 mg - light orange, oval, film coated tablets debossed with ‘SG’ on one side and ‘343’ on other side.
  • Each tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. 40 mg/25 mg - brownish red, oval, film coated tablets debossed with ‘SG’ on one side and ‘344’ on other side.
  • Each tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
  • Tablets are supplied as follows:
  • 20 mg/12.5 mg Bottle of 90 tablets:
  • NDC 84677-056-90 Bottle of 1000 tablets:
  • NDC 84677-056-10 40 mg/12.5 mg Bottle of 90 tablets:
  • NDC 84677-057-90 Bottle of 1000 tablets:
  • NDC 84677-057-10 40 mg/25 mg Bottle of 90 tablets:
  • NDC 84677-058-90 Bottle of 1000 tablets:
  • NDC 84677-058-10 Storage
  • Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Quoted from the official label, section “How Supplied”.

What is in it

  • Olmesartan medoxomil and hydrochlorothiazide tablet is a combination of an angiotensin II receptor antagonist (AT 1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ).
  • Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p ( o -1 H -tetrazol-5-ylphenyl) benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate.
  • Its empirical formula is C 29 H 30 N 6 O 6 and its structural formula is:
  • Olmesartan medoxomil is a white to off-white crystalline powder with a molecular weight of 558.59.
  • It is practically insoluble in water and sparingly soluble in methanol.
  • Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H -1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide.
  • Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 and its structural formula is:
  • Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74.
  • Hydrochlorothiazide is very slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butyl amine, and in dimethyl formamide; sparingly soluble in methanol; insoluble in ether, in chloroform and in dilute mineral acids.
  • Olmesartan medoxomil and hydrochlorothiazide is available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide.
  • Inactive ingredients include:
  • croscarmellose sodium, lactose monohydrate, magnesium stearate, pregelatinized starch, silicifed microcrystalline cellulose, polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, polyethylene glycol 8000, yellow iron oxide, red iron oxide and additionally, 40mg/25mg tablets contain black Iron Oxide. 505 505

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.
  • Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

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Details

Made byGolden State Medical Supply, Inc.
Active substanceOlmesartan Medoxomil and Hydrochlorothiazide
Used inHeart, blood pressure and circulation
Strength40 mg + 25 mg
FormTablet, Film Coated
RouteOral
Packs1000 TABLET, FILM COATED in 1 BOTTLE · 90 TABLET, FILM COATED in 1 BOTTLE
NDC84677-058

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

54 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

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Olmesartan Medoxomil and Hydrochlorothiazide20 mg + 12.5 mgPrescription onlyTablet, Film Coated Accord Healthcare Inc. · Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and Hydrochlorothiazide40 mg + 12.5 mgPrescription onlyTablet, Film Coated Accord Healthcare Inc. · Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and Hydrochlorothiazide40 mg + 25 mgPrescription onlyTablet, Film Coated Accord Healthcare Inc. · Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and Hydrochlorothiazide20 mg + 12.5 mgPrescription onlyTablet, Film Coated Camber Pharmaceuticals, Inc. · Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and Hydrochlorothiazide40 mg + 12.5 mgPrescription onlyTablet, Film Coated Camber Pharmaceuticals, Inc. · Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and Hydrochlorothiazide40 mg + 25 mgPrescription onlyTablet, Film Coated Camber Pharmaceuticals, Inc. · Olmesartan Medoxomil and Hydrochlorothiazide

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