Medicine guide

Valsartan and Hydrochlorothiazide

320 mg + 25 mg · Tablet, Film Coated

Prescription only
Angiotensin 2 Receptor Blocker

Active substance: Valsartan and Hydrochlorothiazide
Used in: Heart, blood pressure and circulation
Made by: Proficient Rx LP
Source: Official label

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 · 2019-11-01

What it is

Angiotensin 2 Receptor Blocker

Used for

In patients not adequately controlled with monotherapy. (1)
Probability of Achieving Diastolic Blood Pressure <80 mmHg at Week 8

The label’s usual adult dose

Dose once daily. Titrate as needed to a maximum dose of 320 mg/25 mg. (2)

May be substituted for titrated components. (2.3) 2.1 General Considerations The usual starting dose is valsartan and hydrochlorothiazide tablets 160 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320 mg/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2) ]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose. 2.2 Add-On Therapy A patient whose blood pressure is not adequately controlled with valsartan (or another ARB) alone or hydrochlorothiazide alone may be switched to combination therapy with valsartan and hydrochlorothiazide tablets. A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of 320 mg/25 mg. 2.3 Replacement Therapy Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components. 2.4 Initial Therapy Valsartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2) ] . 2.5 Use with Other Antihypertensive Drugs Valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

Full directions ↓

Serious warning

When pregnancy is detected, discontinue valsartan and hydrochlorothiazide as soon as possible [see Warnings and Precautions (5.1) ].

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

84other products contain Valsartan 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

Valsartan and hydrochlorothiazide tablets, USP are 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets, USP. 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 1 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 have also 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 (e.g., 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. Add-On Therapy Valsartan and hydrochlorothiazide tablets, USP may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy Valsartan and hydrochlorothiazide tablets, USP may be substituted for the titrated components. Initial Therapy Valsartan and hydrochlorothiazide tablets, USP may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of valsartan and hydrochlorothiazide tablets, USP as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient's risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1) ] provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets, USP compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets, USP 320 mg/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of <140 mmHg (systolic) and 60% likelihood of achieving <90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on hydrochlorothiazide alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets, USP rise to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic). Valsartan and hydrochlorothiazide is the combination tablet of valsartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic. Valsartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension, to lower blood pressure:

In patients not adequately controlled with monotherapy. (1)
As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. (1) Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Figure 1:
Probability of Achieving Systolic Blood Pressure <140 mmHg at Week 8 Figure 2:
Probability of Achieving Diastolic Blood Pressure <90 mmHg at Week 8 Figure 3:
Probability of Achieving Systolic Blood Pressure <130 mmHg at Week 8 Figure 4:
Probability of Achieving Diastolic Blood Pressure <80 mmHg at Week 8

From the official label · 2019-11-01 · DailyMed

How it works

From this product’s own US prescribing label.

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 after2–4 h

Half-life6 h

Mostly cleared after≈ 30 hfive half-lives — our arithmetic

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

In vitro metabolism studies involving recombinant CYP 450 enzymes indicated that the CYP 2C9 isoenzyme is responsible for the formation of valeryl-4-hydroxy valsartan.

How it leaves the body

Hydrochlorothiazide: About 70% of an orally administered dose of hydrochlorothiazide is eliminated in the urine as unchanged drug.

With food

Food decreases the exposure (as measured by AUC) to valsartan by about 40% and peak plasma concentration (C max ) by about 50%.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2019-11-01

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 valsartan 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) ].
When pregnancy is detected, discontinue valsartan 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)

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

Do not take it if

Valsartan and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product.
Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
Do not coadminister aliskiren with valsartan and hydrochlorothiazide tablets in patients with diabetes [see Drug Interactions (7) ] .
Anuria;
Hypersensitivity to any sulfonamide-derived drugs or any component;
Do not coadminister aliskiren with valsartan 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.

Dose once daily. Titrate as needed to a maximum dose of 320 mg/25 mg. (2)
May be used as add-on/switch therapy for patients not adequately controlled on any of the components (valsartan or hydrochlorothiazide). (2)
May be substituted for titrated components. (2.3) 2.1 General Considerations The usual starting dose is valsartan and hydrochlorothiazide tablets 160 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320 mg/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2) ]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose. 2.2 Add-On Therapy A patient whose blood pressure is not adequately controlled with valsartan (or another ARB) alone or hydrochlorothiazide alone may be switched to combination therapy with valsartan and hydrochlorothiazide tablets. A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of 320 mg/25 mg. 2.3 Replacement Therapy Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components. 2.4 Initial Therapy Valsartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2) ] . 2.5 Use with Other Antihypertensive Drugs Valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

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

Other warnings

Hypotension: Correct volume depletion prior to initiation. (5.2)
Observe for signs of fluid or electrolyte imbalance. (5.9)
Monitor renal function and potassium in susceptible patients. (5.3, 5.7)
Exacerbation or activation of systemic lupus erythematosus. (5.5)
Acute angle-closure glaucoma. (5.8) 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 valsartan and hydrochlorothiazide as soon as possible [see Use in Specific Populations (8.1) ] . Intrauterine exposure to thiazide diuretics is associated with fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in
adults. 5.2 Hypotension in Volume- and/or Salt-Depleted Patients Excessive reduction of blood pressure was rarely seen (0.7%) in patients with uncomplicated hypertension treated with valsartan and hydrochlorothiazide in controlled trials. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of valsartan and hydrochlorothiazide, or the treatment should start under close medical supervision. If hypotension occurs, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized. 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 valsartan and hydrochlorothiazide. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on valsartan and hydrochlorothiazide [see Drug Interactions (7) ] . 5.4 Hypersensitivity Reaction Hydrochlorothiazide:
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 Systemic Lupus Erythematosus Hydrochlorothiazide:
Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus. 5.6 Lithium Interaction Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of valsartan or thiazide diuretics. Monitor lithium levels in patients receiving valsartan and hydrochlorothiazide and lithium [see Drug Interactions (7) ] . 5.7 Potassium Abnormalities Valsartan and Hydrochlorothiazide:
In the controlled trials of various doses of valsartan and hydrochlorothiazide the incidence of hypertensive patients who developed hypokalemia (serum potassium <3.5 mEq/L) was 3%; the incidence of hyperkalemia (serum potassium >5.7 mEq/L) was 0.4%. Hydrochlorothiazide can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Monitor serum electrolytes periodically. If hypokalemia is accompanied by clinical signs (e.g., muscular weakness, paresis, or ECG alterations), valsartan and hydrochlorothiazide should be discontinued. Correction of hypokalemia and any coexisting hypomagnesemia is recommended prior to the initiation of thiazides. Some patients with heart failure have developed increases in potassium with valsartan therapy. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of the diuretic and/or valsartan may be required [see Adverse Reactions (6.1) ] . 5.8 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. 5.9 Metabolic Disturbances Hydrochlorothiazide Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients. Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels in patients with hypercalcemia receiving valsartan and hydrochlorothiazide.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Teratogenic Effects 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 valsartan 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 intra-amniotic environment.
If oligohydramnios is observed, discontinue valsartan and hydrochlorothiazide, unless it is considered lifesaving for the mother.
Fetal testing may be appropriate, based on the week of pregnancy.
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 valsartan and hydrochlorothiazide for hypotension, oliguria, and hyperkalemia [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 higher than 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 EPH (Edema, Proteinuria, Hypertension) gestosis (pre-eclampsia), these drugs should not be used to treat hypertension in pregnant women.
The use of hydrochlorothiazide for other indications (e.g., heart disease) in pregnancy should be avoided.
It is not known whether valsartan is excreted in human milk.
Valsartan was excreted into the milk of lactating rats; however, animal breast milk drug levels may not accurately reflect human breast milk levels.
Hydrochlorothiazide is excreted in human breast milk.
Because many drugs are excreted into human milk and because of the potential for adverse reactions in nursing infants from valsartan and hydrochlorothiazide, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
IN SPECIFIC POPULATIONS Nursing Mothers: Nursing or drug should be discontinued.
(8.3)
8.1 Pregnancy Teratogenic Effects 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 valsartan 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 intra-amniotic environment.
If oligohydramnios is observed, discontinue valsartan and hydrochlorothiazide, unless it is considered lifesaving for the mother.
Fetal testing may be appropriate, based on the week of pregnancy.
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 valsartan and hydrochlorothiazide for hypotension, oliguria, and hyperkalemia [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 higher than 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 EPH (Edema, Proteinuria, Hypertension) gestosis (pre-eclampsia), these drugs should not be used to treat hypertension in pregnant women.
The use of hydrochlorothiazide for other indications (e.g., heart disease) in pregnancy should be avoided.
8.3 Nursing Mothers It is not known whether valsartan is excreted in human milk.
Valsartan was excreted into the milk of lactating rats; however, animal breast milk drug levels may not accurately reflect human breast milk levels.
Hydrochlorothiazide is excreted in human breast milk.
Because many drugs are excreted into human milk and because of the potential for adverse reactions in nursing infants from valsartan and hydrochlorothiazide, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
8.4 Pediatric Use Safety and effectiveness of valsartan and hydrochlorothiazide in pediatric patients have not been established.
Neonates with a history of in utero exposure to valsartan and hydrochlorothiazide:
If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion.
Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.
8.5 Geriatric Use In the controlled clinical trials of valsartan and hydrochlorothiazide, 764 (17.5%) patients treated with valsartan and hydrochlorothiazide were ≥65 years and 118 (2.7%) were ≥75 years.
No overall difference in the efficacy or safety of valsartan and hydrochlorothiazide was observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
8.6 Renal Impairment Safety and effectiveness of valsartan and hydrochlorothiazide 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 mL/min) renal impairment.
8.7 Hepatic Impairment Valsartan No dose adjustment is necessary for patients with mild-to-moderate liver disease.
No dosing recommendations can be provided for patients with 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

Valsartan and Hydrochlorothiazide:
Lithium:
Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists or thiazides. Monitor lithium levels in patients taking valsartan and hydrochlorothiazide. Valsartan:
No clinically significant pharmacokinetic interactions were observed when valsartan was coadministered with amlodipine, atenolol, cimetidine, digoxin, furosemide, glyburide, hydrochlorothiazide, or indomethacin. The valsartan-atenolol combination was more antihypertensive than either component, but it did not lower the heart rate more than atenolol alone. Coadministration of valsartan and warfarin did not change the pharmacokinetics of valsartan or the time-course of the anticoagulant properties of warfarin. CYP 450 Interactions:
In vitro metabolism studies indicate that CYP 450 mediated drug interactions between valsartan and coadministered drugs are unlikely because of the low extent of metabolism [see Clinical Pharmacology (12.3) ] . Transporters:
The results from an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and the hepatic efflux transporter MRP2. Coadministration of inhibitors of the uptake transporter (rifampin, cyclosporine) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan. Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors):
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including valsartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving valsartan and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including valsartan may be attenuated by NSAIDs including selective COX-2 inhibitors. Potassium:
Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. If comedication is considered necessary, monitoring of serum potassium is advisable. Dual Blockade of the Renin-Angiotensin System (RAS):
Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general,
avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function, and electrolytes in patients on valsartan and hydrochlorothiazide and other agents that affect the RAS. Do not coadminister aliskiren with valsartan and hydrochlorothiazide in patients with diabetes.
Avoid use of aliskiren with valsartan and hydrochlorothiazide in patients with renal impairment (GFR <60 mL/min). Hydrochlorothiazide:
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. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs and COX-2 selective inhibitors) - When valsartan and hydrochlorothiazide and nonsteroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained. Carbamazepine – May lead to symptomatic hyponatremia. 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 to 6 hours after the administration of resins would potentially minimize the interaction [see Clinical Pharmacology (12.3) ] . Cyclosporine :
Concomitant treatment with cyclosporine may increase the risk of hyperuricemia and gout-type complications.
Antidiabetic Drugs: Dosage adjustment of antidiabetic may be required. (7)
Cholestyramine and Colestipol: Reduced absorption of thiazides. (12.3)
Lithium:
Increased risk of lithium toxicity. Monitor serum lithium concentrations during concurrent use. (7)
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):
May increase risk of renal impairment. Can reduce diuretic, natriuretic and antihypertensive effects of diuretics. (7)
Dual Inhibition of the Renin-angiotensin System:
Increased risk of renal impairment, hypotension, and hyperkalemia. (7)

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.

Valsartan and Hydrochlorothiazide:
Limited data are available related to overdosage in humans.
The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation.
Depressed level of consciousness, circulatory collapse and shock have been reported.
If symptomatic hypotension should occur, supportive treatment should be instituted.
Valsartan is not removed from the plasma by dialysis.
The degree to which hydrochlorothiazide is removed by hemodialysis has not been established.
The most common signs and symptoms observed in patients 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.
In rats and marmosets, single oral doses of valsartan up to 1524 and 762 mg/kg in combination with hydrochlorothiazide at doses up to 476 and 238 mg/kg, respectively, were very well tolerated without any treatment-related effects.
These no adverse effect doses in rats and marmosets, respectively, represent 46.5 and 23 times the maximum recommended human dose (MRHD) of valsartan and 188 and 113 times the MRHD of hydrochlorothiazide on a mg/m 2 basis.
(Calculations assume an oral dose of 320 mg/day valsartan in combination with 25 mg/day hydrochlorothiazide and a 60 kg patient.) Valsartan:
Valsartan was without grossly observable adverse effects at single oral doses up to 2000 mg/kg in rats and up to 1000 mg/kg in marmosets, except for salivation and diarrhea in the rat and vomiting in the marmoset at the highest dose (60 and 31 times, respectively, the MRHD on a mg/m 2 basis).
(Calculations assume an oral dose of 320 mg/day and a 60 kg patient.) Hydrochlorothiazide:
The oral LD 50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats, which represents 2027 and 4054 times, respectively, the MRHD on a mg/m 2 basis.
(Calculations assume an oral dose of 25 mg/day and a 60 kg patient.)

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness of valsartan and hydrochlorothiazide in pediatric patients have not been established.
Neonates with a history of in utero exposure to valsartan and hydrochlorothiazide:
If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion.
Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.

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

Use in older people

In the controlled clinical trials of valsartan and hydrochlorothiazide, 764 (17.5%) patients treated with valsartan and hydrochlorothiazide were ≥65 years and 118 (2.7%) were ≥75 years.
No overall difference in the efficacy or safety of valsartan and hydrochlorothiazide was observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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

Side effects

The most common reasons for discontinuation of therapy with valsartan and hydrochlorothiazide were headache and dizziness.
The only adverse experience that occurred in ≥2% of patients treated with valsartan and hydrochlorothiazide and at a higher incidence than placebo was nasopharyngitis (2.4% vs. 1.9%).
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 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 reactions 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.
The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Hypertension Valsartan and hydrochlorothiazide has been evaluated for safety in more than 5700 patients, including over 990 treated for over 6 months, and over 370 for over 1 year.
Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.
The overall incidence of adverse reactions with valsartan and hydrochlorothiazide was comparable to placebo.
The overall frequency of adverse reactions was neither dose-related nor related to gender, age, or race.
In controlled clinical trials, discontinuation of therapy due to side effects was required in 2.3% of valsartan and hydrochlorothiazide patients and 3.1% of placebo patients.
The most common reasons for discontinuation of therapy with valsartan and hydrochlorothiazide were headache and dizziness.
The only adverse reaction that occurred in controlled clinical trials in at least 2% of patients treated with valsartan and hydrochlorothiazide and at a higher incidence in valsartan and hydrochlorothiazide (n=4372) than placebo (n=262) patients was nasopharyngitis (2.4% vs. 1.9%).
Dose-related orthostatic effects were seen in fewer than 1% of patients.
In individual trials, a dose-related increase in the incidence of dizziness was observed in patients treated with valsartan and hydrochlorothiazide.
Other adverse reactions that have been reported with valsartan and hydrochlorothiazide (>0.2% of valsartan and hydrochlorothiazide patients in controlled clinical trials) without regard to causality, are listed below:
Cardiovascular:
Palpitations and tachycardia.
Ear and Labyrinth: Tinnitus and vertigo.
Gastrointestinal:
Dyspepsia, diarrhea, flatulence, dry mouth, nausea, abdominal pain, abdominal pain upper, and vomiting.
General and Administration Site Conditions:
Asthenia, chest pain, fatigue, peripheral edema and pyrexia.
Infections and Infestations:
Bronchitis, bronchitis acute, influenza, gastroenteritis, sinusitis, upper respiratory tract infection, and urinary tract infection.
Investigations: Blood urea increased.
Musculoskeletal: Arthralgia, back pain, muscle cramps, myalgia, and pain in extremity.
Nervous System: Dizziness postural, paresthesia, and somnolence.
Psychiatric: Anxiety and insomnia.
Renal and Urinary: Pollakiuria.
Reproductive System: Erectile dysfunction.
Respiratory, Thoracic and Mediastinal:
Dyspnea, cough, nasal congestion, pharyngolaryngeal pain, and sinus congestion.
Skin and Subcutaneous Tissue: Hyperhidrosis and rash.
Vascular: Hypotension.
Other reported reactions seen less frequently in clinical trials included abnormal vision, anaphylaxis, bronchospasm, constipation, depression, dehydration, decreased libido, dysuria, epistaxis, flushing, gout, increased appetite, muscle weakness, pharyngitis, pruritus, sunburn, syncope, and viral infection.
Initial Therapy - Hypertension In a clinical study in patients with severe hypertension (diastolic blood pressure ≥110 mmHg and systolic blood pressure ≥140 mmHg), the overall pattern of adverse reactions reported through 6 weeks of follow-up was similar in patients treated with valsartan and hydrochlorothiazide as initial therapy and in patients treated with valsartan as initial therapy.
Comparing the groups treated with valsartan and hydrochlorothiazide (force-titrated to 320 mg/25 mg) and valsartan (force-titrated to 320 mg), dizziness was observed in 6% and 2% of patients, respectively.
Hypotension was observed in 1% of those patients receiving valsartan and hydrochlorothiazide and 0% of patients receiving valsartan.
There were no reported cases of syncope in either treatment group.
Laboratory changes with valsartan and hydrochlorothiazide as initial therapy in patients with severe hypertension were similar to those reported with valsartan and hydrochlorothiazide in patients with less severe hypertension [see Clinical Studies (14.2) and Drug Interactions (7) ] .
Valsartan:
In trials in which valsartan was compared to an ACE inhibitor with or without placebo, the incidence of dry cough was significantly greater in the ACE inhibitor group (7.9%) than in the groups who received valsartan (2.6%) or placebo (1.5%).
In a 129-patient trial limited to patients who had dry cough when they had previously received ACE inhibitors, the incidences of cough in patients who received valsartan, hydrochlorothiazide, or lisinopril were 20%, 19%, 69% respectively (p <0.001).
Other reported reactions seen less frequently in clinical trials included chest pain, syncope, anorexia, vomiting, and angioedema.
Hydrochlorothiazide:
Other adverse reactions not listed above that have been reported with hydrochlorothiazide, without regard to causality, 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:
hyperglycemia, glycosuria, hyperuricemia Musculoskeletal:
muscle spasm Nervous System/Psychiatric:
restlessness Renal:
renal failure, 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 In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of valsartan and hydrochlorothiazide.
Creatinine/Blood Urea Nitrogen (BUN):
Minor elevations in creatinine and BUN occurred in 2% and 15% respectively, of patients taking valsartan and hydrochlorothiazide and 0.4% and 6% respectively, given placebo in controlled clinical trials Hemoglobin and Hematocrit:
Greater than 20% decreases in hemoglobin and hematocrit were observed in less than 0.1% of valsartan and hydrochlorothiazide patients, compared with 0% in placebo-treated patients Liver Function Tests:
Occasional elevations (greater than 150%) of liver chemistries occurred in valsartan and hydrochlorothiazide-treated patients Neutropenia:
Neutropenia was observed in 0.1% of patients treated with valsartan and hydrochlorothiazide and 0.4% of patients treated with placebo
6.2 Postmarketing Experience The following additional adverse reactions have been reported in valsartan or valsartan and hydrochlorothiazide postmarketing experience.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hypersensitivity: There are rare reports of angioedema.
Some of these patients previously experienced angioedema with other drugs including ACE inhibitors.
Valsartan and hydrochlorothiazide should not be re-administered to patients who have had angioedema.
Digestive:
Elevated liver enzymes and very rare reports of hepatitis Renal:
Impaired renal function Clinical Laboratory Tests:
Hyperkalemia Dermatologic:
Alopecia, bullous dermatitis Vascular:
Vasculitis Nervous System:
Syncope Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.
Hydrochlorothiazide:
The following additional adverse reactions have been reported in postmarketing experience with hydrochlorothiazide:
Acute renal failure, renal disorder, aplastic anemia, erythema multiforme, pyrexia, muscle spasm, asthenia, acute angle-closure glaucoma, bone marrow failure, worsening of diabetes control, hypokalemia, blood lipids increased, hyponatremia, hypomagnesemia, hypercalcemia, hypochloremic alkalosis, impotence, and visual impairment.
Pathological changes in the parathyroid gland of patients with hypercalcemia and hypophosphatemia have been observed in a few patients on prolonged thiazide therapy.
If hypercalcemia occurs, further diagnostic evaluation is necessary.

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

What to discuss with your doctor

Information for Patients Advise the patient to read the FDA-approved patient labeling (Patient Information) Pregnancy:
Female patients of childbearing age should be told about the consequences of exposure to valsartan and hydrochlorothiazide during pregnancy.
Discuss treatment options with women planning to become pregnant.
Patients should be asked to report pregnancies to their physicians as soon as possible.
Symptomatic Hypotension:
A patient receiving valsartan and hydrochlorothiazide should be cautioned that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to the prescribing physician.
The patients should be told that if syncope occurs, valsartan and hydrochlorothiazide should be discontinued until the physician has been consulted.
All patients should be cautioned that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.
Potassium Supplements:
A patient receiving valsartan and hydrochlorothiazide should be told not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician.

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

Strengths and forms

FORMS AND STRENGTHS
80 mg/12.5 mg tablets are light orange colored, ovaloid, beveled edge, biconvex film-coated tablets debossed with ‘I’ on one side and ‘61’ on other side.
160 mg/12.5 mg tablets are dark red colored, ovaloid, beveled edge, biconvex film-coated tablets debossed with ‘I’ on one side and ‘62’ on other side.
160 mg/25 mg tablets are brown-orange colored, ovaloid, beveled edge, biconvex film-coated tablets debossed with ‘I’ on one side and ‘63’ on other side.
320 mg/12.5 mg tablets are pink colored, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘I’ on one side and ‘64’ on other side.
320 mg/25 mg tablets are yellow colored, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘I’ on one side and ‘65’ on other side. Tablets (valsartan and hydrochlorothiazide):
80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg. (3)

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

What it looks like and how it is packed

Valsartan and hydrochlorothiazide tablets, USP are available as non-scored tablets containing valsartan and hydrochlorothiazide 320 mg/12.5 mg are available as follows.
Valsartan and Hydrochlorothiazide Tablets USP, 320 mg/25 mg are yellow colored, oval shaped, beveled edge, biconvex film-coated tablets debossed with 'I' on one side and '65' on other side.
Bottles of 30 NDC 63187-694-30 Bottles of 60 NDC 63187-694-60 Bottles of 90 NDC 63187-694-90
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
Protect from moisture and heat.
Dispense in tight container (USP).

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

What is in it

Valsartan and hydrochlorothiazide is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT 1 receptor subtype, and hydrochlorothiazide, a diuretic.
Valsartan, a nonpeptide molecule, is chemically described as N -(1-oxopentyl)- N -[[2′-(1 H -tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine.
Its molecular formula is C 24 H 29 N 5 O 3 , its molecular weight is 435.5, and its structural formula is:
Valsartan USP is a white, fine hygroscopic powder.
It is soluble in ethanol and methanol and practically insoluble in water.
Hydrochlorothiazide USP is a white or practically white, practically odorless, crystalline powder.
It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n -butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids.
Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.
Hydrochlorothiazide is a thiazide diuretic.
Its molecular formula is C 7 H 8 ClN 3 O 4 S 2 , its molecular weight is 297.73, and its structural formula is:
Valsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg.
The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, talc, and titanium dioxide.
In addition, the 80 mg/12.5 mg and 160 mg/12.5 mg contains iron oxide red and iron oxide yellow, the 160 mg/25 mg contains iron oxide black, iron oxide red, and iron oxide yellow, 320 mg/12.5 mg contains iron oxide black and iron oxide red, and the 320 mg/25 mg contains iron oxide yellow.
Valsartan Chemical Structure Hydrochlorothiazide Chemical Structure

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.

Every version of this medicine (16)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

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Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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FranceNo exact match for this strength and form

Every strength and form (38)

Canada6 matching products

Every strength and form (34)

Details

Made by	Proficient Rx LP
Active substance	Valsartan and Hydrochlorothiazide
Used in	Heart, blood pressure and circulation
Strength	320 mg + 25 mg
Form	Tablet, Film Coated
Route	Oral
Packs	30 TABLET, FILM COATED in 1 BOTTLE · 60 TABLET, FILM COATED in 1 BOTTLE
NDC	63187-694
NDC	71205-015

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

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

Tablet, Film Coated77 products
- 12.5 mg + 320 mg
- 12.5 mg + 80 mg2
  12.5 mg + 80 mg · 2 companies
  - Lupin Pharmaceuticals, Inc.
  - Proficient Rx LP
- 12.5 mg + 160 mg
- 25 mg + 320 mg
- 25 mg + 160 mg
- 80 mg + 12.5 mg14
  80 mg + 12.5 mg · 14 companies
  +6 more
- 160 mg + 12.5 mg16
  160 mg + 12.5 mg · 16 companies
  +8 more
- 160 mg + 25 mg12
  160 mg + 25 mg · 12 companies
  +4 more
- 320 mg + 25 mg15
  320 mg + 25 mg · 15 companies
  +7 more
- 320 mg + 12.5 mg14
  320 mg + 12.5 mg · 14 companies
  +6 more
Tablet3 products
- 160 mg + 25 mg3
  160 mg + 25 mg · 3 companies

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Diovan Hct80 mg + 12.5 mgPrescription onlyTablet, Film Coated Novartis Pharmaceuticals Corporation · Valsartan and Hydrochlorothiazide Diovan Hct160 mg + 12.5 mgPrescription onlyTablet, Film Coated Novartis Pharmaceuticals Corporation · Valsartan and Hydrochlorothiazide Diovan Hct160 mg + 25 mgPrescription onlyTablet, Film Coated Novartis Pharmaceuticals Corporation · Valsartan and Hydrochlorothiazide Diovan Hct320 mg + 12.5 mgPrescription onlyTablet, Film Coated Novartis Pharmaceuticals Corporation · Valsartan and Hydrochlorothiazide Diovan Hct320 mg + 25 mgPrescription onlyTablet, Film Coated Novartis Pharmaceuticals Corporation · Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide80 mg + 12.5 mgPrescription onlyTablet, Film Coated Mylan Pharmaceuticals Inc. · Valsartan and Hydrochlorothiazide

See every product with Valsartan and Hydrochlorothiazide