Plain-language summary, compiled from the cited regulatory records
Irbesartan is an angiotensin II receptor blocker (ARB) [1]. It is approved for the treatment of hypertension, which is high blood pressure [1]. Lowering blood pressure can help reduce the risk of cardiovascular events, such as strokes and heart attacks [1].
Additionally, irbesartan is indicated for patients with type 2 diabetes who have high blood pressure, elevated serum creatinine, and proteinuria, to treat diabetic nephropathy [1]. Irbesartan is available under various brand names, including Avalide [1].
In the past 12 months, there have been 2,144 adverse event reports associated with irbesartan [2]. The most frequently reported adverse events include acute kidney injury, nausea, fatigue, vomiting, and falls [2].
This is not medical advice. Consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 29, 2026[1]
Irbesartan Zentiva is indicated in adults for the treatment of essential hypertension. 1).
How to take
GBOfficial regulatory label
CACanada· Health Canada
75 products
Uses
CAOfficial regulatory label· revised May 6, 2026[2]
and 14 CLINICAL TRIALS). The dosage may be increased after 2 - 4 weeks of therapy to a maximum of 300 mg / 25 mg once daily. IRBESARTAN AND HYDROCHLOROTHIAZIDE is not recommended as initial therapy in patients with intravascular volume depletion (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
DOSE ADJUSTMENT IN SPECIAL POPULATION Diuretic Treated Patients In patients receiving diuretics, irbesartan therapy should be initiated with caution, since these patients may be volume-depleted and thus more likely to experience hypotension following initiation of additional antihypertensive therapy.
Whenever possible, all diuretics should be discontinued 2 – 3 days prior to the administration of irbesartan to reduce the likelihood of hypotension (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, and 9 DRUG INTERACTIONS). If this is not possible because of the patient’s condition, irbesartan should be administered with caution and the blood pressure monitored When used in pregnancy, angiotensin receptor (AT1) blockers (ARB) can cause injury and even death of the developing fetus.
USUnited States· FDA
12 products
Uses
USOfficial regulatory label· revised May 13, 2026[3]
1 INDICATIONS AND USAGE Irbesartan tablet is an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
1 ) • Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. 1 Hypertension Irbesartan tablets are indicated for the treatment of hypertension, to lower blood pressure.
Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug.
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.
EUEuropean Union· EMA
10 products
Uses
EUOfficial regulatory label· revised May 6, 2026[4]
Ifirmasta is indicated in adults for the treatment of essential hypertension. 1).
How to take
EUOfficial regulatory label
Drug interactions
Known interactions involving Irbesartan. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 484. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PLGB177801083 · revised May 29, 2026
[2]Health Canada (DPD) · 02404001 · revised May 6, 2026
[3]FDA DailyMed · 197871da-e0c5-49… · revised May 13, 2026 [PDF]
[4]European Medicines Agency · EMEA/H/C/000962 · revised May 6, 2026
[5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Posology The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Irbesartan Zentiva at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years.
1). 5). In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease. 1). Special Populations Renal impairment No dosage adjustment is necessary in patients with impaired renal function.
4). Hepatic impairment No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment. Older people Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for older people.
Paediatric population The safety and efficacy of Irbesartan Zentiva in children aged 0 to 18 has not been established. 2 but no recommendation on a posology can be made. Method of Administration For oral use.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 29, 2026[1]
5%). 5%). The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment. , uncommon) but in excess of placebo. The following table presents the adverse drug reactions that were reported in placebo- controlled trials in which 1,965 hypertensive patients received irbesartan.
Terms marked with a star (*) refer to the adverse reactions that were additionally reported in > 2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo. The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Adverse reactions additionally reported from post–marketing experience are also listed. These adverse reactions are derived from spontaneous reports.
4) Reproductive system and breast disorders Uncommon: sexual dysfunction General disorders and administration site conditions Common: fatigue Uncommon: chest pain Investigations Very common: Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group. 3% of the patients in the placebo group. 7%) in irbesartan treated subjects. None of these increases were associated with identifiable clinical musculoskeletal events.
7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed. 9%). 5%) and elevated CK values in 2% of child recipients.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised May 29, 2026[1]
Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Irbesartan Zentiva.
Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin- angiotensin-aldosterone system.
While this is not documented with Irbesartan Zentiva, a similar effect should be anticipated with angiotensin-II receptor antagonists. Renal impairment and kidney transplantation: when Irbesartan Zentiva is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
There is no experience regarding the administration of Irbesartan Zentiva in patients with a recent kidney transplantation. Hypertensive patients with type 2 diabetes and renal disease: the effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease.
1). Dual blockade of the renin-angiotensin-aldosterone system (RAAS): there is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
8). These patients presented with abdominal pain, nausea, vomiting and diarrhoea. Symptoms resolved after discontinuation of angiotensin II receptor antagonists. If intestinal angioedema is diagnosed, irbesartan should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 29, 2026[1]
1. 6). 1).
This is not medical advice. Consult a qualified healthcare professional.
1 WARNINGS AND PRECAUTIONS, Special Populations). IRBESARTAN AND HYDROCHLOROTHIAZIDE (Irbesartan and hydrochlorothiazide tablets) Page 6 of 51 Protected B / Protégé B closely. The recommended starting dose of irbesartan is 75 mg once daily in hypovolemic patients (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
Thereafter, the dosage should be adjusted according to the individual response of the patient. Geriatric No initial dosage adjustment in irbesartan is necessary for most elderly patients. Appropriate caution should nevertheless be used when prescribing to the elderly, as increased vulnerability to drug effect is possible in this patient population (see 7 WARNINGS AND PRECAUTIONS, Special Populations).
Renal Insufficiency No initial dosage adjustment in irbesartan is generally necessary in patients with renal impairment, although due to the apparent greater sensitivity of hemodialysis patients, an initial dose of 75 mg is recommended in this group of patients.
The usual regimens of therapy with IRBESARTAN AND HYDROCHLOROTHIAZIDE 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 is not recommended.
Hepatic Insufficiency No initial dosage adjustment in irbesartan is generally necessary in patients with mild to moderate hepatic impairment. Since thiazide diuretics may precipitate hepatic coma, the use of a fixed combination product such as IRBESARTAN AND HYDROCHLOROTHIAZIDE is not advisable.
4. Administration IRBESARTAN AND HYDROCHLOROTHIAZIDE may be administered with or without food, however it should be taken consistently with respect to food intake. 5. Missed Dose Patients should be instructed to take IRBESARTAN AND HYDROCHLOROTHIAZIDE at the next scheduled dose and not take two doses at the same time if they miss a dose.
5. Overdose No specific information is available on the treatment of overdosage with irbesartan and hydrochlorothiazide tablets. The patient should be closely monitored, and the treatment should be symptomatic and supportive, including fluid and electrolyte replacement.
Irbesartan No data or very little data available in regard to overdosage in humans. The most likely manifestations of overdosage would be hypotension and / or tachycardia; bradycardia might also occur in this setting. Irbesartan is not removed by hemodialysis.
Hydrochlorothiazide The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If IRBESARTAN AND HYDROCHLOROTHIAZIDE (Irbesartan and hydrochlorothiazide tablets) Page 7 of 51 Protected B / Protégé B digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. 6. 5 mg tablets: lactose monohydrate, microcrystalline cellulose, starch pregelatinized, croscarmellose sodium, povidone, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red and iron oxide yellow.
Irbesartan and hydrochlorothiazide 300 mg / 25 mg tablets also contain: lactose monohydrate, microcrystalline cellulose, starch pregelatinized, croscarmellose sodium, povidone, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red and iron oxide black.
5 mg tablets are peach coloured, biconvex, oval shaped, film coated tablets, debossed with ‘450’ on one side and plain on the other. 5 mg tablets are peach coloured, biconvex, oval shaped, film coated tablets, debossed with ‘451’ on one side and plain on the other.
Irbesartan And Hydrochlorothiazide 300 mg / 25 mg tablets are dark pink coloured, biconvex, oval shaped, film coated tablets, debossed with ‘452’ on one side and plain on the other. 5 mg and 300 mg / 25 mg tablets are available in 2 types of blister packs - cold formable and thermo formable blister pack.
5 mg and 300 mg / 25 mg are packed in blisters of 14 tablets, 2 such blisters are in a carton and in bottles of 30, 100 and 500 tablets. For the most recent information in the management of a suspected […]
How to take
CAOfficial regulatory label· revised May 6, 2026[2]
). • as initial therapy in patients with severe essential hypertension (Sitting DBP ≥ 110 mmHg) for whom the benefit of a prompt blood pressure reduction exceeds the risk of initiating combination therapy in these patients (see 14 CLINICAL TRIALS and 4 DOSAGE AND ADMINISTRATION).
IRBESARTAN AND HYDROCHLOROTHIAZIDE is not indicated as initial therapy in patients with mild to moderate essential hypertension. 1.
Pediatrics Pediatrics (< 18 years of age):
The safety and efficacy of irbesartan and hydrochlorothiazide tablets in patients < 18 years of age have not been established. Therefore, Health Canada has not authorized an indication for pediatric use (see 7 WARNINGS AND PRECAUTIONS, Special Populations).
2.
Geriatrics Geriatrics (> 65 years of age):
In clinical studies, no overall differences in safety or efficacy were observed between patients > 65 years of age and younger patients (see 7. WARNINGS AND PRECAUTIONS, Special Populations). 2. Contraindications IRBESARTAN AND HYDROCHLOROTHIAZIDE is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised May 6, 2026[2]
, Post Market Adverse Drug Reactions). The photosensitizing action of hydrochlorothiazide may be a possible mechanism for NMSC (see 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity). Patients taking hydrochlorothiazide should be informed of the potential risk of NMSC.
They should be advised to regularly check their skin for new lesions as well as changes to existing ones, and to promptly report any suspicious skin lesions. g. a broad spectrum sunscreen with a SPF of 30 or higher, clothing, and a hat) when exposed to sunlight or UV light to minimize the risk of skin cancer.
) (see 8 ADVERSE REACTIONS, Post-Market Adverse Drug Reactions). Cardiovascular Hypotension Occasionally, symptomatic hypotension has occurred after administration of irbesartan, in some cases after the first dose. It is more likely to occur in patients who are volume depleted by diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting.
In these patients, because of the potential fall in blood pressure, therapy should be started under close medical supervision (see 4 DOSAGE AND ADMINISTRATION). Similar considerations apply to patients with ischemic heart or cerebrovascular disease, in whom an excessive fall in blood pressure could result in myocardial infarction or cerebrovascular accident.
Valvular Stenosis There is concern on theoretical grounds that patients with aortic stenosis might be at particular risk of decreased coronary perfusion when treated with vasodilators because they do not develop as much afterload reduction.
73m2). Therefore, the use of IRBESARTAN AND HYDROCHLOROTHIAZIDE in combination with aliskiren-containing drugs is contraindicated in these patients (see 2 CONTRAINDICATIONS). The use of IRBESARTAN AND HYDROCHLOROTHIAZIDE in combination with an ACE inhibitor is contraindicated in patients with diabetic nephropathy (see 2 CONTRAINDICATIONS).
Further, co-administration of ARBs, including the irbesartan component of IRBESARTAN AND HYDROCHLOROTHIAZIDE, with other agents blocking the RAS, such as ACE inhibitors or aliskiren- IRBESARTAN AND HYDROCHLOROTHIAZIDE (Irbesartan and hydrochlorothiazide tablets) Page 9 of 51 Protected B / Protégé B containing drugs, is generally not recommended in other patients, since such treatment has been associated with an increased incidence of severe hypotension, renal failure, and hyperkalemia.
Driving and Operating Machinery The effect of irbesartan on the ability to drive and use machinery has not been studied, but based on its pharmacodynamic properties, irbesartan is unlikely to affect this ability. When driving vehicles or operating machinery, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension.
Endocrine and Metabolism Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypokalemia, hyponatremia and hypochloremic alkalosis). Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.
Calcium excretion is decreased by thiazides which may cause intermittent and slight elevation of serum calcium. , vitamin D therapy) is prescribed, serum calcium levels should be monitored, and calcium dosage adjusted accordingly. Marked hypercalcemia suggests the possibility of hyperparathyroidism.
Thiazides should be discontinued before carrying out tests for parathyroid function. Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesemia. Hyperuricemia may occur, and an acute attack of gout may be precipitated in certain patients receiving thiazide therapy.
Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy. Thiazides may decrease serum PBI levels without signs of thyroid disturbance. IRBESARTAN AND HYDROCHLOROTHIAZIDE may induce hypoglycemia, particularly in patients treated for diabetes.
Therefore, dose adjustment of antidiabetic treatment such as repaglinide or insulin may be required (see 8 ADVERSE REACTIONS). Insulin requirements in diabetic patients may be altered and latent diabetes mellitus may become manifest during thiazide diuretic therapy.
Gastrointestinal Intestinal angioedema has been reported in patients treated with angiotensin II receptor antagonists, including irbesartan and hydrochlorothiazide tablets. These patients presented with abdominal pain, (with or without nausea, vomiting and diarrhoea).
Symptoms resolved after discontinuation of angiotensin II receptor antagonists. Intestinal angioedema should be included in the differential diagnosis of patients treated with angiotensin II receptor antagonists presenting with abdominal pain.
If intestinal angioedema is diagnosed, IRBESARTAN AND HYDROCHLOROTHIAZIDE should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred. Hepatic / Biliary / Pancreatic Thiazides should be used with caution in patients with impaired hepatic function or progressive liver […]
CAOfficial regulatory label· Warnings and precautions· revised May 6, 2026[2]
, Special Populations). 2.
Geriatrics Geriatrics (> 65 years of age):
In clinical studies, no overall differences in safety or efficacy were observed between patients > 65 years of age and younger patients (see 7. WARNINGS AND PRECAUTIONS, Special Populations). 2. Contraindications IRBESARTAN AND HYDROCHLOROTHIAZIDE is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Patients who are hypersensitive to other sulphonamide-derived drugs, because of the hydrochlorothiazide component. • Patients with anuria. • Pregnant women (see 7.
WARNINGS AND PRECAUTIONS, Special Populations). • Nursing women (see 7. WARNINGS AND PRECAUTIONS, Special Populations). 73m2) (see 7. WARNINGS AND PRECAUTIONS, Renal, and 9. DRUG INTERACTIONS). • Combination with angiotensin converting enzyme (ACE) inhibitors in patients with diabetic nephropathy (see 7.
WARNINGS AND PRECAUTIONS, Renal, and 9. DRUG INTERACTIONS). • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (due to lactose component of the IRBESARTAN AND HYDROCHLOROTHIAZIDE).
IRBESARTAN AND HYDROCHLOROTHIAZIDE (Irbesartan and hydrochlorothiazide tablets) Page 5 of 51 Protected B / Protégé B 3. Serious Warnings and Precautions Box 4. 1. Dosing Considerations • Dosage must be individualized. • The fixed combination is not for initial therapy except for severe hypertension.
• The dose of IRBESARTAN AND HYDROCHLOROTHIAZIDE should be determined by the titration of the individual components. • Use of IRBESARTAN AND HYDROCHLOROTHIAZIDE in patients with liver impairment is not advisable. 2 Recommended Dose and Dosage Adjustment).
2. 5 mg or 300 mg / 25 mg once daily may be substituted if the doses on which the patient was stabilized are the same as those in the fixed combination. Irbesartan Monotherapy The recommended dose of irbesartan is 150 mg once daily. In patients whose blood pressure is not adequately controlled, the daily dose may be increased to 300 mg.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised May 6, 2026[2]
). The use of IRBESARTAN AND HYDROCHLOROTHIAZIDE in combination with an ACE inhibitor is contraindicated in patients with diabetic nephropathy (see 2 CONTRAINDICATIONS). Further, co-administration of ARBs, including the irbesartan component of IRBESARTAN AND HYDROCHLOROTHIAZIDE, with other agents blocking the RAS, such as ACE inhibitors or aliskiren- IRBESARTAN AND HYDROCHLOROTHIAZIDE (Irbesartan and hydrochlorothiazide tablets) Page 9 of 51 Protected B / Protégé B containing drugs, is generally not recommended in other patients, since such treatment has been associated with an increased incidence of severe hypotension, renal failure, and hyperkalemia.
Driving and Operating Machinery The effect of irbesartan on the ability to drive and use machinery has not been studied, but based on its pharmacodynamic properties, irbesartan is unlikely to affect this ability. When driving vehicles or operating machinery, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension.
Endocrine and Metabolism Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypokalemia, hyponatremia and hypochloremic alkalosis). Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.
Calcium excretion is decreased by thiazides which may cause intermittent and slight elevation of serum calcium. , vitamin D therapy) is prescribed, serum calcium levels should be monitored, and calcium dosage adjusted accordingly. Marked hypercalcemia suggests the possibility of hyperparathyroidism.
Thiazides should be discontinued before carrying out tests for parathyroid function. Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesemia. Hyperuricemia may occur, and an acute attack of gout may be precipitated in certain patients receiving thiazide therapy.
Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy. Thiazides may decrease serum PBI levels without signs of thyroid disturbance. IRBESARTAN AND HYDROCHLOROTHIAZIDE may induce hypoglycemia, particularly in patients treated for diabetes.
Therefore, dose adjustment of antidiabetic treatment such as repaglinide or insulin may be required (see 8 ADVERSE REACTIONS). Insulin requirements in diabetic patients may be altered and latent diabetes mellitus may become manifest during thiazide diuretic therapy.
Gastrointestinal Intestinal angioedema has been reported in patients treated with angiotensin II receptor antagonists, including irbesartan and hydrochlorothiazide tablets. These patients presented with abdominal pain, (with or without nausea, vomiting and diarrhoea).
Symptoms resolved after discontinuation of angiotensin II receptor antagonists. Intestinal angioedema should be included in the differential diagnosis of patients treated with angiotensin II receptor antagonists presenting with abdominal pain.
If intestinal angioedema is diagnosed, IRBESARTAN AND HYDROCHLOROTHIAZIDE should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred. Hepatic / Biliary / Pancreatic Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations in fluid and electrolyte balance may precipitate hepatic coma.
IRBESARTAN AND HYDROCHLOROTHIAZIDE (Irbesartan and hydrochlorothiazide tablets) Page 10 of 51 Protected B / Protégé B Immune Hypersensitivity Reaction Sensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma.
Systemic Lupus Erythematosus Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus. Ophthalmologic Choroidal effusion, Secondary Acute Angle-Closure Glaucoma and / or Acute Myopia Hydrochlorothiazide is a sulfonamide.
Sulfonamide or sulfonamide derivative drugs can cause an idiosyncratic reaction, which may result in choroidal effusion, secondary acute angle-closure glaucoma and / or acute transient myopia (see 8 ADVERSE REACTIONS, Post-Market Adverse Drug Reactions).
Symptoms include acute onset of decreased visual acuity, blurred vision 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. Renal Azotemia Azotemia may be precipitated or increased by hydrochlorothiazide.
Cumulative effects of the drug may develop in patients with impaired renal function. If increasing azotemia and oliguria occur during treatment of severe progressive renal impairment the diuretic should be discontinued. Renal Impairment As a consequence of inhibiting the renin-angiotensin-aldosterone system (RAAS), changes in renal function have been seen in susceptible individuals.
In patients whose renal function may depend on the activity of the RAAS, such as patients with bilateral renal artery stenosis, unilateral renal artery stenosis to a solitary kidney, or severe congestive heart failure, treatment with agents that inhibit this system has been associated with oliguria, progressive azotemia, and rarely, acute renal failure and/or death.
In susceptible patients, concomitant diuretic use may further increase risk. 73m2) (see 2 […]
This is not medical advice. Consult a qualified healthcare professional.
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 also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit.
Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Irbesartan tablets may be used alone or in combination with other antihypertensive agents. 2 Nephropathy in Type 2 Diabetic Patients Irbesartan tablets are indicated for the treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension, an elevated serum creatinine, and proteinuria (>300 mg/day).
2 )].
How to take
USOfficial regulatory label· revised May 13, 2026[3]
1 General Considerations Irbesartan tablets may be administered with other antihypertensive agents and with or without food. 2 Hypertension The recommended initial dose of irbesartan tablets is 150 mg once daily. 1 )]. 2 )]. 2 )].
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 2,144 reports total. [5]
Acute Kidney Injury 155
Nausea 136
Fatigue 134
Vomiting 124
Fall 123
Headache 122
Malaise 122
Off Label Use 122
Diarrhoea 116
Asthenia 109
Cough 97
Pain 94
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised May 13, 2026[3]
3 )] Nephropathy in type 2 diabetic patients: The most common adverse reactions which were more frequent than placebo were hyperkalemia dizziness, orthostatic dizziness, and orthostatic hypotension. gov/medwatch. 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. Hypertension Irbesartan has been evaluated for safety in more than 4300 patients with hypertension and about 5000 subjects overall.
This experience includes 1303 patients treated for over 6 months and 407 patients for 1 year or more. In placebo-controlled clinical trials, the following adverse reactions were reported in at least 1% of patients treated with irbesartan (n=1965) and at a higher incidence versus placebo (n=641), excluding those too general to be informative and those not reasonably associated with the use of drug because they were associated with the condition being treated or are very common in the treated population, include: diarrhea (3% vs 2%), dyspepsia/heartburn (2% vs 1%), and fatigue (4% vs 3%).
Irbesartan use was not associated with an increased incidence of dry cough, as is typically associated with ACE inhibitor use. 7% in patients receiving placebo. 0% in the placebo group. 4% in the placebo group. 2%). 2 Post-Marketing Experience The following adverse reactions have been identified during post-approval use of irbesartan.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure. Urticaria; angioedema (involving swelling of the face, lips, pharynx, and/or tongue); anaphylactic reaction including anaphylactic shock; increased liver function tests; jaundice; hepatitis; hyperkalemia; anemia; thrombocytopenia; increased cpk; tinnitus ; and hypoglycemia in diabetic patients.
USOfficial regulatory label· Warnings and precautions· revised May 13, 2026[3]
5 WARNINGS AND PRECAUTIONS • Hypotension: Correct volume or salt depletion prior to administration. 2 ) • Monitor renal function and serum potassium. 1 Fetal Toxicity Irbesartan 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. 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. 1 )]. , those being treated with high doses of diuretics), symptomatic hypotension may occur after initialization of treatment with irbesartan.
4 )]. 3 Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system. , patients with renal artery stenosis, chronic kidney disease, severe heart failure, or volume depletion) may be at particular risk of developing acute renal failure or death on irbesartan.
Monitor renal function periodically in these patients. 3 )].
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised May 13, 2026[3]
4 CONTRAINDICATIONS Irbesartan tablets are contraindicated in patients who are hypersensitive to any component of this product. Do not co-administrate aliskiren with irbesartan tablets in patients with diabetes. • Hypersensitivity to any component of this product.
( ) • Co-administration with aliskiren in patients with diabetes. ( )
This is not medical advice. Consult a qualified healthcare professional.
Posology The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Ifirmasta at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years.
1). 5). In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease. 1). Special Populations Renal impairment No dose adjustment is necessary in patients with impaired renal function.
4). Hepatic impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment. Elderly Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dose adjustment is not usually necessary for older people.
Paediatric population The safety and efficacy of Ifirmasta in children aged 0 to 18 has not been established. 2 but no recommendation on a posology can be made. Method of Administration For oral use.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised May 6, 2026[4]
5%). 5%). The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment. , uncommon) but in excess of placebo. The following table presents the adverse medicinal product reactions that were reported in placebo- controlled trials in which 1,965 hypertensive patients received irbesartan.
Terms marked with a star (*) refer to the adverse reactions that were additionally reported in > 2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo. The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Adverse reactions additionally reported from post–marketing experience are also listed. These adverse reactions are derived from spontaneous reports.
4) Reproductive system and breast disorders: Uncommon: sexual dysfunction General disorders and administration site conditions: Common: fatigue Uncommon: chest pain Investigations: Very common: Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group. 3% of the patients in the placebo group. 7%) in irbesartan treated subjects. None of these increases were associated with identifiable clinical musculoskeletal events.
7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed. 9%). 5%) and elevated CK values in 2% of child recipients.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised May 6, 2026[4]
Intravascular volume depletion Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Ifirmasta.
Renovascular hypertension There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal 4 products that affect the renin-angiotensin-aldosterone system.
While this is not documented with Ifirmasta, a similar effect should be anticipated with angiotensin-II receptor antagonists. Renal impairment and kidney transplantation When Ifirmasta is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
There is no experience regarding the administration of Ifirmasta in patients with a recent kidney transplantation. Hypertensive patients with type 2 diabetes and renal disease The effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease.
1). Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Hyperkalemia As with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalemia may occur during the treatment with Ifirmasta, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.
5). Hypoglycaemia Irbesartan may induce hypoglycaemia, particularly in diabetic patients. 5). 8). These patients presented with abdominal pain, nausea, vomiting and diarrhoea. Symptoms resolved after discontinuation of angiotensin II receptor antagonists.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised May 6, 2026[4]
1. 6). 1).
This is not medical advice. Consult a qualified healthcare professional.
Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan Zentiva, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.
5).
Hypoglycaemia:
Irbesartan Zentiva may induce hypoglycaemia, particularly in diabetic patients. 5). 5). Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Primary aldosteronism: patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system. Therefore, the use of Irbesartan Zentiva is not recommended.
g. 5). As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke. 1). Pregnancy: angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. 6). 2).
Excipients:
Lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Sodium:
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
5 mg once daily (see 1 INDICATIONS and 14 CLINICAL TRIALS). The dosage may be increased after 2 - 4 weeks of therapy to a maximum of 300 mg / 25 mg once daily. IRBESARTAN AND HYDROCHLOROTHIAZIDE is not recommended as initial therapy in patients with intravascular volume depletion (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
DOSE ADJUSTMENT IN SPECIAL POPULATION Diuretic Treated Patients In patients receiving diuretics, irbesartan therapy should be initiated with caution, since these patients may be volume-depleted and thus more likely to experience hypotension following initiation of additional antihypertensive therapy.
Whenever possible, all diuretics should be discontinued 2 – 3 days prior to the administration of irbesartan to reduce the likelihood of hypotension (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, and 9 DRUG INTERACTIONS). If this is not possible because of the patient’s condition, irbesartan should be administered with caution and the blood pressure monitored When used in pregnancy, angiotensin receptor (AT1) blockers (ARB) can cause injury and even death of the developing fetus.
1 WARNINGS AND PRECAUTIONS, Special Populations). IRBESARTAN AND HYDROCHLOROTHIAZIDE (Irbesartan and hydrochlorothiazide tablets) Page 6 of 51 Protected B / Protégé B closely. The recommended starting dose of irbesartan is 75 mg once daily in hypovolemic patients (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
Thereafter, the dosage should be adjusted according to the individual response of the patient. Geriatric No initial dosage adjustment in irbesartan is necessary for most elderly patients. Appropriate caution should nevertheless be used when prescribing to the elderly, as increased vulnerability to drug effect is possible in this patient population (see 7 WARNINGS AND PRECAUTIONS, Special Populations).
Renal Insufficiency No initial dosage adjustment in irbesartan is generally necessary in patients with renal impairment, although due to the apparent greater sensitivity of hemodialysis patients, an initial dose of 75 mg is recommended in this group of patients.
The usual regimens of therapy with IRBESARTAN AND HYDROCHLOROTHIAZIDE 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 is not recommended.
Hepatic Insufficiency No initial dosage adjustment in irbesartan is generally necessary in patients with mild to moderate hepatic impairment. Since thiazide diuretics may precipitate hepatic coma, the use of a fixed combination product such as IRBESARTAN AND HYDROCHLOROTHIAZIDE is not advisable.
4. Administration IRBESARTAN AND HYDROCHLOROTHIAZIDE may be administered with or without food, however it should be taken consistently with respect to food intake. 5. Missed Dose Patients should be instructed to take IRBESARTAN AND HYDROCHLOROTHIAZIDE at the next scheduled dose and not take two […]
If intestinal angioedema is diagnosed, irbesartan should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred. 5). Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Primary aldosteronism Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system. Therefore, the use of Ifirmasta is not recommended.
g. 5). As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke. 1). Pregnancy Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. 6). 2).