Medicine guide

Irbesartan and Hydrochlorothiazide

300 mg + 12.5 mg · Tablet, Film Coated

Prescription only
Angiotensin 2 Receptor Blocker

Active substance: Irbesartan and Hydrochlorothiazide
Used in: Heart, blood pressure and circulation
Made by: Teva Pharmaceuticals USA, Inc.
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 · 2026-01-28

What it is

Angiotensin 2 Receptor Blocker

Used for

Irbesartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension.

The label’s usual adult dose

Not recommended for patients with severe renal impairment (creatinine clearance <30 mL/min).

The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 300/25 mg once daily as needed to control blood pressure [see Clinical Studies ( 14.2 )] .

Full directions ↓

Serious warning

FETAL TOXICITY When pregnancy is detected, discontinue irbesartan and hydrochlorothiazide tablets as soon as possible [see Warnings and Precautions ( 5.1 ) and 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

25other products contain Irbesartan 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

Figure 1a:

Irbesartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension.
Irbesartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy.
Irbesartan and hydrochlorothiazide tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
The choice of irbesartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks.
Patients with stage 2 (moderate or severe) hypertension are at 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 may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.
Data from Studies V and VI [see Clinical Studies ( 14.2 )] provide estimates of the probability of reaching a blood pressure goal with irbesartan and hydrochlorothiazide tablets compared to irbesartan or hydrochlorothiazide (HCTZ) monotherapy.
The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with irbesartan and hydrochlorothiazide tablets compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b.
Probability of Achieving SBP <140 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7) * Figure 1b:
Probability of Achieving SBP <130 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7) * Figure 2a:
Probability of Achieving DBP <90 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7) * Figure 2b:
Probability of Achieving DBP <80 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7) * * For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to-treat analysis).
The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure ≤140 mmHg) for the treatment groups.
The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group.
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 blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone).
The likelihood of achieving these goals on irbesartan and hydrochlorothiazide tablets rises to about 40% (systolic) or 70% (diastolic).
Irbesartan and hydrochlorothiazide tablets are a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension:
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 ) Figure 1a Figure 1b Figure 2a Figure 2b

From the official label · 2026-01-28 · DailyMed

How it works

From this product’s own US prescribing label.

Irbesartan Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II).
Angiotensin II is the principal pressor agent of the RAS and also stimulates aldosterone synthesis and secretion by adrenal cortex, cardiac contraction, renal resorption of sodium, activity of the sympathetic nervous system, and smooth muscle cell growth.

Peak level after1.5–2 h

Half-life11–15 h

Mostly cleared after≈ 3 daysfive 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

Metabolism and Elimination Irbesartan Irbesartan is metabolized via glucuronide conjugation and oxidation.

How it leaves the body

Irbesartan and its metabolites are excreted by both biliary and renal routes.

With food

Food does not affect the bioavailability of irbesartan.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-01-28

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

Irbesartan 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 irbesartan and hydrochlorothiazide tablets in patients with diabetes [see Drug Interactions ( 7 )].
Hypersensitivity to any component of this product.
( 4 ) Anuria.
( 4 ) Hypersensitivity to sulfonamide-derived drugs.
( 4 ) Do not coadminister aliskiren with irbesartan 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.

General Considerations Maximum effects within 2 to 4 weeks after dose change.
( 2.1 ) Renal impairment:
Not recommended for patients with severe renal impairment (creatinine clearance <30 mL/min).
( 2.1 , 5.8 ) Hypertension Initiate with 150/12.5 mg.
Titrate to 300/12.5 mg then 300/25 mg if needed.
( 2.2 ) Replacement therapy: May be substituted for titrated components.
( 2.3 )
2.1 General Considerations The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter [see Adverse Reactions ( 6 )] .
Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
Irbesartan and hydrochlorothiazide tablets may be administered with or without food.
Irbesartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.
Renal Impairment The usual regimens of therapy with irbesartan and hydrochlorothiazide tablets may be followed as long as the patient’s creatinine clearance is >30 mL/min.
In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so irbesartan and hydrochlorothiazide tablets are not recommended.
Hepatic Impairment No dosage adjustment is necessary in patients with hepatic impairment.
2.2 Add-On Therapy In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of irbesartan and hydrochlorothiazide tablets, in order of increasing mean effect, are (irbesartan and hydrochlorothiazide) 150/12.5 mg, 300/12.5 mg, and 300/25 mg.
The largest incremental effect will likely be in the transition from monotherapy to 150/12.5 mg [see Clinical Studies ( 14.2 )] .
2.3 Replacement Therapy Irbesartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy The usual starting dose is irbesartan and hydrochlorothiazide tablets 150/12.5 mg once daily.
The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 300/25 mg once daily as needed to control blood pressure [see Clinical Studies ( 14.2 )] .
Irbesartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions ( 5.2 )] .

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

Other warnings

Hypotension: Correct volume depletion prior to administration.
( 5.2 ) Impaired renal function.
( 5.7 ) Thiazide diuretics may cause an exacerbation or activation of systemic lupus erythematosus.
( 5.4 ) Acute angle-closure glaucoma, acute myopia, and choroidal effusion.
( 5.8 )
5.1 Fetal Toxicity Irbesartan and hydrochlorothiazide can cause fetal harm when administered to a pregnant woman.
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 irbesartan and hydrochlorothiazide as soon as possible [see Use in Specific Populations ( 8.1 )].
adults.
5.2 Hypotension in Volume or Salt-Depleted Patients Excessive reduction of blood pressure was rarely seen in patients with uncomplicated hypertension treated with irbesartan alone (<0.1%) or with irbesartan and hydrochlorothiazide (approximately 1%).
Initiation of antihypertensive therapy may cause symptomatic hypotension in patients with intravascular volume or sodium depletion, e.g., in patients treated vigorously with diuretics or in patients on dialysis.
Such volume depletion should be corrected prior to administration of antihypertensive therapy.
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 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.
5.4 Systemic Lupus Erythematosus Hydrochlorothiazide Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.
5.5 Electrolyte and Metabolic Imbalances Irbesartan and Hydrochlorothiazide In double-blind clinical trials of various doses of irbesartan and hydrochlorothiazide, the incidence of hypertensive patients who developed hypokalemia (serum potassium <3.5 mEq/L) was 7.5% versus 6.0% for placebo; the incidence of hyperkalemia (serum potassium >5.7 mEq/L) was <1.0% versus 1.7% for placebo.
No patient discontinued due to increases or decreases in serum potassium.
On average, the combination of irbesartan and hydrochlorothiazide had no effect on serum potassium.
Higher doses of irbesartan ameliorated the hypokalemic response to hydrochlorothiazide.
Coadministration of irbesartan and hydrochlorothiazide tablets with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes or other drugs that raise serum potassium levels may result in hyperkalemia, sometimes severe.
Hydrochlorothiazide 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.
Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.
The antihypertensive effects of the drug may be enhanced in the post-sympathectomy patient.
Thiazides may decrease urinary calcium excretion.
Thiazides may cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Marked hypercalcemia may be evidence of hidden hyperparathyroidism.
Thiazides should be discontinued before carrying out tests for parathyroid function.
5.6 Hepatic Impairment Hydrochlorothiazide Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
5.7 Impaired Renal Function As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals [see Drug Interactions ( 7 )].
In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with ACE inhibitors has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death.
Irbesartan would be expected to behave similarly.
In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or BUN have been reported.
There has been no known use of irbesartan in patients with unilateral or bilateral renal artery stenosis, but a similar effect should be anticipated.
Thiazides should be used with caution in severe renal disease.
In patients with renal disease, thiazides may precipitate azotemia.
Cumulative effects of the drug may develop in patients with impaired renal function.
5.8 Acute Angle-Closure Glaucoma, Acute Myopia, and Choroidal Effusion Hydrochlorothiazide Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction resulting in acute angle-closure glaucoma and elevated intraocular pressure with or without a noticeable acute myopic shift and/or choroidal effusions.
Cases of acute angle-closure glaucoma have been reported with hydrochlorothiazide.
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 may result in permanent vision loss.The primary treatment is to discontinue drug intake 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.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary Irbesartan and hydrochlorothiazide 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 [ see Clinical Considerations ] .
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 irbesartan and hydrochlorothiazide as soon as possible.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes regardless of drug exposure.
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 preeclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and postpartum 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 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 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 irbesartan and hydrochlorothiazide for hypotension, oliguria, and hyperkalemia and other symptoms of renal impairment.
In neonates with a history of in utero exposure to irbesartan and hydrochlorothiazide, if oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion.
Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function.
Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in
adults [see Warnings and Precautions ( 5.1 )].
Data Animal data Irbesartan crosses the placenta in rats and rabbits.
In female rats given irbesartan prior to mating through gestation and lactation at oral doses of 50, 180, or 650 mg/kg/day (1.6 to 21.1 times the maximum recommended human dose (MRHD) based on body surface area), fetuses examined on Gestation Day 20 showed increased incidences of hydroureter and renal pelvic cavitation and/or absence of renal papilla in all irbesartan-treated groups.
Subcutaneous edema also occurred in fetuses at maternal doses ≥180 mg/kg/day (5.8 times the MRHD).
These anomalies occurred when female rats received irbesartan from prior to mating through Day 20 of gestation but were not observed in pups postnatally in the same study, or when irbesartan was given to pregnant rats only during organogenesis (Gestation Day 6 through Gestation Day 15) at oral doses from 50 to 450 mg/kg/day (up to 14.6 times the MRHD).
In addition, no adverse effects on kidney development were observed in pups from dams given irbesartan from Gestation Day 15 through Lactation Day 24 at doses of 50, 180, or 650 mg/kg/day (up to 21.1 times the MRHD).
The observed effects are believed to be late gestational effects of the drug.
Pregnant rabbits given oral doses of irbesartan of 30 mg/kg/day (1.9 times the MRHD based on body surface area) experienced a high rate of maternal mortality and abortion.
Surviving females had a slight increase in early resorptions and a corresponding decrease in live fetuses.
Radioactivity was present in the rat and rabbit fetuses during late gestation following oral doses of radiolabeled irbesartan.
When pregnant mice and rats were given hydrochlorothiazide at doses up to 3000 and 1000 mg/kg/day, respectively (about 600 and 400 times the MRHD) during their respective periods of major organogenesis, there was no evidence of fetal harm.
A development toxicity study was performed in rats with doses of 50/50 mg/kg/day and 150/150 mg/kg/day irbesartan and hydrochlorothiazide.
Although the high dose combination appeared to be more toxic to the dams than either drug alone, there did not appear to be an increase in toxicity to the developing embryos.
There are no available data on the presence of irbesartan in human milk, effects on milk production, or the breastfed infant.
Irbesartan or some metabolite of irbesartan is secreted in the milk of lactating rats.
Thiazides appear in human milk [see Clinical Pharmacology ( 12.3 )].
Because of the potential for adverse effects on the nursing infant, the use of irbesartan and hydrochlorothiazide in breastfeeding women is not recommended.
IN SPECIFIC POPULATIONS Lactation: Potential for adverse effects in infant.
( 8.2 )
8.1 Pregnancy Risk Summary Irbesartan and hydrochlorothiazide 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 [ see Clinical Considerations ] .
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 irbesartan and hydrochlorothiazide as soon as possible.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes regardless of drug exposure.
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 preeclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and postpartum 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 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 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 irbesartan and hydrochlorothiazide for hypotension, oliguria, and hyperkalemia and other symptoms of renal impairment.
In neonates with a history of in utero exposure to irbesartan and hydrochlorothiazide, if oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion.
Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function.
Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in
adults [see Warnings and Precautions ( 5.1 )].
Data Animal data Irbesartan crosses the placenta in rats and rabbits.
In female rats given irbesartan prior to mating through gestation and lactation at oral doses of 50, 180, or 650 mg/kg/day (1.6 to 21.1 times the maximum recommended human dose (MRHD) based on body surface area), fetuses examined on Gestation Day 20 showed increased incidences of hydroureter and renal pelvic cavitation and/or absence of renal papilla in all irbesartan-treated groups.
Subcutaneous edema also occurred in fetuses at maternal doses ≥180 mg/kg/day (5.8 times the MRHD).
These anomalies occurred when female rats received irbesartan from prior to mating through Day 20 of gestation but were not observed in pups postnatally in the same study, or when irbesartan was given to pregnant rats only during organogenesis (Gestation Day 6 through Gestation Day 15) at oral doses from 50 to 450 mg/kg/day (up to 14.6 times the MRHD).
In addition, no adverse effects on kidney development were observed in pups from dams given irbesartan from Gestation Day 15 through Lactation Day 24 at doses of 50, 180, or 650 mg/kg/day (up to 21.1 times the MRHD).
The observed effects are believed to be late gestational effects of the drug.
Pregnant rabbits given oral doses of irbesartan of 30 mg/kg/day (1.9 times the MRHD based on body surface area) experienced a high rate of maternal mortality and abortion.
Surviving females had a slight increase in early resorptions and a corresponding decrease in live fetuses.
Radioactivity was present in the rat and rabbit fetuses during late gestation following oral doses of radiolabeled irbesartan.
When pregnant mice and rats were given hydrochlorothiazide at doses up to 3000 and 1000 mg/kg/day, respectively (about 600 and 400 times the MRHD) during their respective periods of major organogenesis, there was no evidence of fetal harm.
A development toxicity study was performed in rats with doses of 50/50 mg/kg/day and 150/150 mg/kg/day irbesartan and hydrochlorothiazide.
Although the high dose combination appeared to be more toxic to the dams than either drug alone, there did not appear to be an increase in toxicity to the developing embryos.
8.2 Lactation There are no available data on the presence of irbesartan in human milk, effects on milk production, or the breastfed infant.
Irbesartan or some metabolite of irbesartan is secreted in the milk of lactating rats.
Thiazides appear in human milk [see Clinical Pharmacology ( 12.3 )].
Because of the potential for adverse effects on the nursing infant, the use of irbesartan and hydrochlorothiazide in breastfeeding women is not recommended.
8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use Of 1694 patients receiving irbesartan and hydrochlorothiazide in controlled clinical studies of hypertension, 264 (15.6%) were 65 years and over, while 45 (2.7%) were 75 years and over.
No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14 )].

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

Other medicines

NSAIDs and selective COX-2 inhibitors:
Can reduce diuretic, natriuretic of diuretic, may lead to increased risk of renal impairment and reduced antihypertensive effect.
Monitor renal function periodically.
( 7 ) Dual blockade of the renin-angiotensin system:
Increased risk of renal impairment, hypotension, and hyperkalemia.
( 7 ) Antidiabetic drugs: Dosage adjustment of antidiabetic may be required.
( 7 ) Cholestyramine and colestipol: Reduced absorption of thiazides.
( 7 ) Lithium: Increases in serum lithium concentrations and lithium toxicity.
( 7 ) Carbamazepine: Increased risk of hyponatremia.
( 7 )
7.1 Nonsteroidal Anti-inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) Irbesartan 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 irbesartan, may result in deterioration of renal function, including possible acute renal failure.
These effects are usually reversible.
Therefore, monitor renal function and blood pressure periodically in patients receiving irbesartan and NSAID therapy.
Hydrochlorothiazide Administration of a nonsteroidal anti-inflammatory agent, including a selective COX-2 inhibitor can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing, and thiazide diuretics.
Therefore, when irbesartan and hydrochlorothiazide tablets 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.
7.2 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.
Closely monitor blood pressure, renal function, and electrolytes in patients on irbesartan and hydrochlorothiazide and other agents that affect the RAS.
In most patients no benefit has been associated with using two RAS inhibitors concomitantly.
In general, avoid combined use of RAS inhibitors.
Do not coadminister aliskiren with irbesartan and hydrochlorothiazide tablets in patients with diabetes.
Avoid use of aliskiren with irbesartan and hydrochlorothiazide tablets in patients with renal impairment (GFR <60 mL/min).
7.3 Agents Increasing Serum Potassium Coadministration of irbesartan and hydrochlorothiazide tablets with other drugs that raise serum potassium levels may result in hyperkalemia, sometimes severe.
Monitor serum potassium in such patients.
7.4 Antidiabetic Drugs (oral agents and insulin) Dosage adjustment of the antidiabetic drug may be required when coadministered with hydrochlorothiazide.
7.5 Cholestyramine and Colestipol Resins Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Stagger the dosage of hydrochlorothiazide and the resin such that irbesartan and hydrochlorothiazide tablets are administered at least 4 hours before or 4 to 6 hours after the administration of the resin.
7.6 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of irbesartan or thiazide diuretics.
Monitor lithium levels in patients receiving irbesartan and hydrochlorothiazide tablets and lithium.
7.7 Carbamazepine Concomitant use of carbamazepine and hydrochlorothiazide has been associated with the risk of symptomatic hyponatremia.
Monitor electrolytes during concomitant use.

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.

Irbesartan No data are available in regard to overdosage in humans.
However, daily doses of 900 mg for 8 weeks were well tolerated.
The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.
Irbesartan is not removed by hemodialysis.
To obtain up-to-date information about the treatment of overdosage, a good resource is a certified regional Poison Control Center.
Telephone numbers of certified Poison Control Centers are listed in the Physicians’ Desk Reference (PDR).
In managing overdose, consider the possibilities of multiple-drug interactions, drug-drug interactions, and unusual drug kinetics in the patient.
Laboratory determinations of serum levels of irbesartan are not widely available, and such determinations have, in any event, no established role in the management of irbesartan overdose.
Acute oral toxicity studies with irbesartan in mice and rats indicated acute lethal doses were in excess of 2000 mg/kg, about 25-fold and 50-fold the MRHD (300 mg) based on body surface area.
Hydrochlorothiazide The most common signs and symptoms of 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 in pediatric patients have not been established.

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

Use in older people

Of 1694 patients receiving irbesartan and hydrochlorothiazide in controlled clinical studies of hypertension, 264 (15.6%) were 65 years and over, while 45 (2.7%) were 75 years and over.
No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14 )].

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

Side effects

Most common adverse events (≥5% on irbesartan and hydrochlorothiazide tablets and more often than on placebo) are dizziness, fatigue, and musculoskeletal pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials 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.
Irbesartan and Hydrochlorothiazide Irbesartan and hydrochlorothiazide tablets have been evaluated for safety in 1694 patients treated for essential hypertension in 6 clinical trials.
In Studies I through IV with irbesartan and hydrochlorothiazide, no adverse events peculiar to this combination drug product have been observed.
Adverse events have been limited to those that were reported previously with irbesartan or hydrochlorothiazide (HCTZ).
The overall incidence of adverse events was similar with the combination and placebo.
In general, treatment with irbesartan and hydrochlorothiazide was well tolerated.
For the most part, adverse events have been mild and transient in nature and have not required discontinuation of therapy.
In controlled clinical trials, discontinuation of irbesartan and hydrochlorothiazide therapy due to clinical adverse events was required in only 3.6%.
This incidence was significantly less (p=0.023) than the 6.8% of patients treated with placebo who discontinued therapy.
In these double-blind controlled clinical trials, the following adverse events reported with irbesartan and hydrochlorothiazide occurred in ≥1% of patients, and more often on the irbesartan and hydrochlorothiazide combination than on placebo, regardless of drug relationship:
Irbesartan/HCTZ Placebo Irbesartan HCTZ (n=898) (n=236) (n=400) (n=380) (%) (%) (%) (%) Body as a Whole Chest Pain 2 1 2 2 Fatigue 6 3 4 3 Influenza 3 1 2 2 Cardiovascular Edema 3 3 2 2 Tachycardia 1 0 1 1 Gastrointestinal Abdominal Pain 2 1 2 2 Dyspepsia/heartburn 2 1 0 2 Nausea/vomiting 3 0 2 2 Immunology Allergy 1 0 1 1 Musculoskeletal Musculoskeletal Pain 6 5 6 10 Nervous System Dizziness 8 4 6 5 Dizziness Orthostatic 1 0 1 1 Renal/Genitourinary Abnormality Urination 2 1 1 2 The following adverse events were also reported at a rate of 1% or greater, but were as, or more, common in the placebo group:
headache, sinus abnormality, cough, URI, pharyngitis, diarrhea, rhinitis, urinary tract infection, rash, anxiety/nervousness, and muscle cramp.
Adverse events occurred at about the same rates in men and women, older and younger patients, and black and non-black patients.
Adverse events in Studies V and VI were similar to those described above in Studies I through IV.
Irbesartan Other adverse events that have been reported with irbesartan, without regard to causality, are listed below:
Body as a Whole:
fever, chills, orthostatic effects, facial edema, upper extremity edema Cardiovascular:
flushing, hypertension, cardiac murmur, myocardial infarction, angina pectoris, hypotension, syncope, arrhythmic/conduction disorder, cardiorespiratory arrest, heart failure, hypertensive crisis Dermatologic:
pruritus, dermatitis, ecchymosis, erythema face, urticaria Endocrine/Metabolic/Electrolyte Imbalances:
sexual dysfunction, libido change, gout Gastrointestinal:
diarrhea, constipation, gastroenteritis, flatulence, abdominal distention Musculoskeletal/Connective Tissue:
musculoskeletal trauma, extremity swelling, muscle cramp, arthritis, muscle ache, musculoskeletal chest pain, joint stiffness, bursitis, muscle weakness Nervous System:
anxiety/nervousness, sleep disturbance, numbness, somnolence, vertigo, emotional disturbance, depression, paresthesia, tremor, transient ischemic attack, cerebrovascular accident Renal/Genitourinary:
prostate disorder Respiratory:
cough, upper respiratory infection, epistaxis, tracheobronchitis, congestion, pulmonary congestion, dyspnea, wheezing Special Senses:
vision disturbance, hearing abnormality, ear infection, ear pain, conjunctivitis Hydrochlorothiazide Other adverse events 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 Initial Therapy In the moderate hypertension Study V (mean SeDBP between 90 and 110 mmHg), the types and incidences of adverse events reported for patients treated with irbesartan and hydrochlorothiazide were similar to the adverse event profile in patients on initial irbesartan or HCTZ monotherapy.
There were no reported events of syncope in the irbesartan and hydrochlorothiazide treatment group and there was one reported event in the HCTZ treatment group.
The incidences of prespecified adverse events on irbesartan and hydrochlorothiazide, irbesartan, and HCTZ, respectively, were:
0.9%, 0%, and 0% for hypotension; 3.0%, 3.8%, and 1.0% for dizziness; 5.5%, 3.8%, and 4.8% for headache; 1.2%, 0%, and 1.0% for hyperkalemia; and 0.9%, 0%, and 0% for hypokalemia.
The rates of discontinuation due to adverse events on irbesartan and hydrochlorothiazide, irbesartan alone, and HCTZ alone were 6.7%, 3.8%, and 4.8%.
In the severe hypertension (SeDBP ≥110 mmHg) Study VI, the overall pattern of adverse events reported through 7 weeks of follow-up was similar in patients treated with irbesartan and hydrochlorothiazide as initial therapy and in patients treated with irbesartan as initial therapy.
The incidences of the prespecified adverse events on irbesartan and hydrochlorothiazide and irbesartan, respectively, were:
0% and 0% for syncope; 0.6% and 0% for hypotension; 3.6% and 4.0% for dizziness; 4.3% and 6.6% for headache; 0.2% and 0% for hyperkalemia; and 0.6% and 0.4% for hypokalemia.
The rates of discontinuation due to adverse events were 2.1% and 2.2% [see Clinical Studies ( 14.2 )].
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of irbesartan and hydrochlorothiazide.
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.
Decisions to include these reactions in labeling are typically based on one or more of the following factors:
(1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to irbesartan and hydrochlorothiazide.
Irbesartan and hydrochlorothiazide Blood and lymphatic system :
Thrombocytopenia Hepatobiliary :
Hepatitis, Jaundice Renal and urinary :
Impaired renal function including renal failure Skin and subcutaneous tissue :
Urticaria Irbesartan Blood and lymphatic system :
Anemia Ear and labyrinth :
Tinnitus Gastrointestinal :
Intestinal angioedema Skin and subcutaneous tissue :
Angioedema (involving swelling of the face, lips, pharynx, and/or tongue) Immune system :
Anaphylactic reaction including anaphylactic shock Investigations :
Increased CPK (Creatine Phosphokinase) Metabolism and nutrition :
Hyperkalemia, Hypoglycemia in diabetic patients Hydrochlorothiazide Eye :
acute angle-closure glaucoma, acute myopia, and choroidal effusion 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 ≥50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.
6.3 Laboratory Abnormalities In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of irbesartan and hydrochlorothiazide.
Creatinine, Blood Urea Nitrogen:
Minor increases in blood urea nitrogen (BUN) or serum creatinine were observed in 2.3% and 1.1%, respectively, of patients with essential hypertension treated with irbesartan and hydrochlorothiazide alone.
No patient discontinued taking irbesartan and hydrochlorothiazide due to increased BUN.
One patient discontinued taking irbesartan and hydrochlorothiazide due to a minor increase in serum creatinine.
Liver Function Tests:
Occasional elevations of liver enzymes and/or serum bilirubin have occurred.
In patients with essential hypertension treated with irbesartan and hydrochlorothiazide alone, one patient was discontinued due to elevated liver enzymes.
Serum Electrolytes: [see Warnings and Precautions ( 5.2 , 5.6 )].

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

What to discuss with your doctor

Pregnancy Tell female patients of childbearing age about the consequences of exposure to irbesartan and hydrochlorothiazide tablets during pregnancy.
Discuss treatment options with women planning to become pregnant.
Ask patients to report pregnancies to their physician as soon as possible.
Symptomatic Hypotension Tell patients using irbesartan and hydrochlorothiazide tablets that they may feel lightheaded, especially during the first days of use.
Tell patients to inform their physician if they feel lightheaded or faint.
Tell the patient, if fainting occurs, stop using irbesartan and hydrochlorothiazide tablets and contact the prescribing doctor.
Tell patients using irbesartan and hydrochlorothiazide tablets that getting dehydrated can lower their blood pressure too much and lead to lightheadedness and possible fainting.
Dehydration may occur with excessive sweating, diarrhea, or vomiting and with not drinking enough liquids.
Potassium Supplements Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see Drug Interactions ( 7.3 )] .
Acute Angle-Closure Glaucoma, Acute Myopia, and Choroidal Effusion Advise patients to discontinue irbesartan and hydrochlorothiazide tablets and seek immediate medical attention if they experience symptoms of acute angle-closure glaucoma, acute myopia, and choroidal effusion [see Warnings and Precautions ( 5.8 )] .
Non-melanoma Skin Cancer Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.
Manufactured In Croatia By: Pliva Hrvatska d.o.o.
Zagreb, Croatia Manufactured For: Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454 Rev.
Q 12/2025

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

Strengths and forms

FORMS AND STRENGTHS Irbesartan and hydrochlorothiazide tablets USP, 150/12.5 mg are light pink to pink film-coated, capsule-shaped tablets, debossed with “TEVA” on one side of the tablet and “7238” on the other side.
Irbesartan and hydrochlorothiazide tablets USP, 300/12.5 mg are light pink to pink film-coated, capsule-shaped tablets, debossed with “TEVA” on one side of the tablet and “7239” on the other side. 150 mg irbesartan/12.5 mg hydrochlorothiazide tablets ( 3 ) 300 mg irbesartan/12.5 mg hydrochlorothiazide tablets ( 3 )

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

What it looks like and how it is packed

16.1 How Supplied Irbesartan and hydrochlorothiazide tablets, USP are available as follows:
150 mg/12.5 mg:
Light pink to pink, film-coated, capsule-shaped tablets, debossed with “TEVA” on one side of the tablet and “7238” on the other side and are available in bottles of 30 (NDC 0093-8238-56) and 90 (NDC 0093-8238-98). 300 mg/12.5 mg:
Light pink to pink, film-coated, capsule-shaped tablets, debossed with “TEVA” on one side of the tablet and “7239” on the other side and are available in bottles of 30 (NDC 0093-8232-56) and 90 (NDC 0093-8232-98).
16.2 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

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

How to store it

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Quoted from the official label, section “Storage and Handling”.

What is in it

Irbesartan and Hydrochlorothiazide Tablets USP are a combination of an angiotensin II receptor antagonist (AT 1 subtype), irbesartan, USP and a thiazide diuretic, hydrochlorothiazide (HCTZ), USP.
Irbesartan, USP is a non-peptide compound, chemically described as a 2-Butyl-3-[ p -( o -1 H -tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one.
Its structural formula is: C 25 H 28 N 6 O M.W.
428.5 Irbesartan, USP is a white to off-white crystalline powder.
It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4.
Irbesartan, USP is slightly soluble in alcohol and methylene chloride and practically insoluble in water.
Hydrochlorothiazide, USP is 6-Chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.
Its structural formula is: C 7 H 8 ClN 3 O 4 S 2 M.W.
297.7 Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder.
Hydrochlorothiazide, USP is very slightly soluble in water and freely soluble in sodium hydroxide solution.
Irbesartan and Hydrochlorothiazide Tablets USP are available for oral administration in film-coated tablets containing either 150 mg or 300 mg of irbesartan, USP combined with 12.5 mg of hydrochlorothiazide, USP.
Inactive ingredients include:
colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, povidone, pregelatinized corn starch and titanium dioxide. image 1 image 2

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.

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 (10)

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

Showing 10 of 10

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.

Medicine passport: one printable page to show a pharmacist abroad

European UnionNo exact match for this strength and form

Every strength and form (6)

Canada12 matching products

Every strength and form (33)

Details

Made by	Teva Pharmaceuticals USA, Inc.
Active substance	Irbesartan and Hydrochlorothiazide
Used in	Heart, blood pressure and circulation
Strength	300 mg + 12.5 mg
Form	Tablet, Film Coated
Route	Oral
Packs	30 TABLET, FILM COATED in 1 BOTTLE · 90 TABLET, FILM COATED in 1 BOTTLE
NDC	0093-8232

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).

Report wrong or outdated information on this page

Other strengths and forms

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

Tablet, Film Coated12 products
- 150 mg + 12.5 mg6
  150 mg + 12.5 mg · 6 companies
- 300 mg + 12.5 mg4
  300 mg + 12.5 mg · 4 companies
  - Aurobindo Pharma Limited
  - Macleods Pharmaceuticals Limited
  - Teva Pharmaceuticals USA, Inc. · this page
  - Unichem Pharmaceuticals (USA), Inc.
- 300 mg + 25 mg2
  300 mg + 25 mg · 2 companies
  - Alembic Pharmaceuticals Inc.
  - Aurobindo Pharma Limited
Tablet12 products
- 150 mg + 12.5 mg6
  150 mg + 12.5 mg · 6 companies
- 300 mg + 12.5 mg5
  300 mg + 12.5 mg · 5 companies
- 300 mg + 25 mg

Same active substance

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

See every product with Irbesartan and Hydrochlorothiazide