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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Irbesartan
Generic Name
Irbesartan
Active Ingredient
IrbesartanCategory
Angiotensin 2 Receptor Blocker [EPC]
Variants
80
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 150 mg/1 | TABLET | ORAL | 70518-1690 |
| 150 mg/1 | TABLET, FILM COATED | ORAL | 72205-328 |
| 300 mg/1 | TABLET | ORAL | 31722-162 |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Irbesartan, you must consult a qualified healthcare professional.
| 75 mg/1 | TABLET | ORAL | 31722-729 |
| 150 mg/1 | TABLET | ORAL | 46708-440 |
| 300 mg/1 | TABLET | ORAL | 50090-7622 |
| 150 mg/1 | TABLET | ORAL | 50268-441 |
| 75 mg/1 | TABLET | ORAL | 59746-447 |
| 75 mg/1 | TABLET | ORAL | 62135-976 |
| 75 mg/1 | TABLET | ORAL | 63629-8259 |
| 150 mg/1 | TABLET | ORAL | 68788-8670 |
| 75 mg/1 | TABLET | ORAL | 71205-379 |
+ 38 more variants
Detailed information about Irbesartan
Irbesartan is a potent, long-acting angiotensin II receptor blocker (ARB) used to treat hypertension and diabetic nephropathy. It works by blocking the vasoconstrictive effects of angiotensin II to lower blood pressure and protect renal function.
The dosage of Irbesartan must be individualized based on the patient's clinical response and the specific condition being treated. For the treatment of hypertension, the recommended starting dose is typically 150 mg once daily. For patients who require further blood pressure reduction, the dose may be increased to 300 mg once daily. In clinical trials, doses above 300 mg did not show significantly greater blood pressure lowering effects but did increase the risk of side effects. For the treatment of nephropathy in type 2 diabetic patients, the target maintenance dose is 300 mg once daily. Patients who are volume-depleted (e.g., those treated vigorously with diuretics) should start at a lower dose of 75 mg to minimize the risk of excessive hypotension (low blood pressure).
Irbesartan is FDA-approved for the treatment of hypertension in children aged 6 to 12 years. The recommended starting dose for pediatric patients in this age range is 75 mg once daily. If the blood pressure response is inadequate, the dose may be increased to 150 mg once daily. For children older than 13, the adult starting dose of 150 mg may be considered. Irbesartan has not been studied or approved for use in children under the age of 6 or for the treatment of diabetic nephropathy in any pediatric population. Pediatric dosing should always be closely monitored by a specialist.
In most cases of renal impairment, no initial dosage adjustment is necessary for Irbesartan. However, in patients with severe renal impairment or those on hemodialysis, healthcare providers may opt for a lower starting dose of 75 mg. Irbesartan is not removed by hemodialysis. Close monitoring of serum potassium and creatinine levels is essential in this population.
For patients with mild to moderate hepatic impairment (liver disease), no dosage adjustment is generally required. The pharmacokinetics of Irbesartan are not significantly altered in these patients. There is limited data regarding the use of Irbesartan in patients with severe hepatic impairment, and caution is advised in this group.
No overall differences in efficacy or safety have been observed between elderly patients (65 years and older) and younger patients. While the pharmacokinetics may show slightly higher plasma concentrations in the elderly, these changes are not clinically significant enough to warrant a routine dose adjustment. However, clinicians often start at the lower end of the dosing range due to the higher prevalence of co-morbidities and other medications in this age group.
Irbesartan should be taken exactly as prescribed by your healthcare provider. It is usually taken once daily, at the same time each day, to maintain consistent blood levels. The tablets can be taken with or without food. They should be swallowed whole with a glass of water. If you have difficulty swallowing tablets, talk to your pharmacist; however, crushing or splitting the tablets is generally not recommended as it may affect the rate of absorption. Store the medication at room temperature, away from excessive moisture and heat. Keeping a consistent routine helps ensure you do not miss a dose.
If you miss a dose of Irbesartan, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at once to make up for a missed one, as this can lead to a sudden and dangerous drop in blood pressure. If you miss multiple doses, contact your healthcare provider for guidance.
Symptoms of an Irbesartan overdose may include extreme hypotension (very low blood pressure), dizziness, and tachycardia (abnormally fast heartbeat). In some cases, bradycardia (slow heartbeat) may occur due to parasympathetic stimulation. If an overdose is suspected, seek emergency medical attention immediately or contact a poison control center. Treatment is generally supportive, focusing on maintaining blood pressure through fluid replacement and monitoring cardiac function.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
Irbesartan is generally well-tolerated, but like all medications, it can cause side effects. The most common side effect reported in clinical trials, particularly in patients being treated for diabetic nephropathy, is dizziness. This sensation of lightheadedness often occurs when moving from a sitting or lying position to standing (orthostatic hypotension). Fatigue and a general feeling of tiredness are also frequently reported. In patients with diabetic kidney disease, hyperkalemia (high potassium levels in the blood) occurred in more than 10% of patients. Hyperkalemia may not cause noticeable symptoms initially but can lead to dangerous heart rhythm issues if left untreated. Most common side effects are mild and transient, often resolving as the body adjusts to the medication.
Between 1% and 10% of patients may experience gastrointestinal issues such as diarrhea, heartburn, or dyspepsia (indigestion). Musculoskeletal pain, including back pain and muscle aches, has been reported. Some patients may experience a minor cough, though this is significantly less common than with ACE inhibitors. Rash and urticaria (hives) may occur in a small percentage of users. In clinical trials for hypertension, headache was reported at a rate similar to placebo, but it remains a noted side effect for some individuals.
Irbesartan is a potent cardiovascular medication that requires careful oversight. Patients must be aware that the full blood-pressure-lowering effect may not be apparent for 2 to 6 weeks after starting therapy. It is vital not to stop taking the medication abruptly, even if you feel well, as hypertension often has no outward symptoms. Patients should be cautioned against using salt substitutes that contain potassium without consulting their doctor, as this significantly increases the risk of hyperkalemia. Dehydration from excessive sweating, vomiting, or diarrhea can lead to a dangerous drop in blood pressure while taking this medication.
Irbesartan is classified as Pregnancy Category D. This means there is clear evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans. Use of Irbesartan during the second and third trimesters can cause fetal injury including skull hypoplasia, limb contractures, and underdeveloped lungs. If a patient is planning a pregnancy, they should be switched to an alternative antihypertensive (such as methyldopa or labetalol) before conception. If pregnancy occurs during therapy, the drug must be stopped immediately.
It is not known whether Irbesartan is excreted in human breast milk. However, it is known to be present in the milk of lactating rats. Because of the potential for serious adverse reactions in nursing infants (including effects on kidney development), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Most clinicians recommend alternative medications for breastfeeding mothers.
Irbesartan is approved for the treatment of hypertension in children aged 6 years and older. Clinical studies have shown it to be effective and generally well-tolerated in this age group. It has not been studied in children under 6 years of age, and there are concerns regarding the effect of RAAS-acting drugs on the developing kidneys of very young children. Irbesartan is not approved for the treatment of diabetic nephropathy in pediatric patients, as this condition is rare in this population.
Irbesartan is a highly selective, competitive antagonist of the Angiotensin II Type 1 (AT1) receptor. Angiotensin II is the primary vasoactive hormone of the renin-angiotensin system and plays a fundamental role in the pathophysiology of hypertension, heart failure, and renal disease. By binding to the AT1 receptor with high affinity (more than 10,000 times greater than its affinity for the AT2 receptor), Irbesartan prevents Angiotensin II from causing vasoconstriction and stimulating the release of aldosterone. Unlike ACE inhibitors, Irbesartan does not inhibit Angiotensin-Converting Enzyme (ACE), meaning it does not interfere with the breakdown of bradykinin or substance P. This specificity accounts for the lower incidence of dry cough and angioedema compared to ACE inhibitors.
The blood-pressure-lowering effect of Irbesartan is dose-related between 75 mg and 300 mg. Once-daily administration produces a trough (24-hour) reduction in blood pressure that is approximately 60-70% of the peak response. The onset of the antihypertensive effect is usually seen within 1 to 2 weeks, with the full effect achieved by 4 to 6 weeks. There is no evidence of 'first-dose' phenomenon (an exaggerated drop in BP after the very first dose) in uncomplicated hypertensive patients, nor is there evidence of rebound hypertension after abrupt withdrawal.
Common questions about Irbesartan
Irbesartan is primarily used to treat high blood pressure (hypertension) in adults and children at least 6 years old. It is also used to treat kidney disease caused by type 2 diabetes (diabetic nephropathy) in people with high blood pressure. By lowering blood pressure, it helps prevent strokes, heart attacks, and kidney failure. Some doctors may also use it off-label for heart failure management. It belongs to a class of drugs called angiotensin II receptor blockers (ARBs). Always use this medication exactly as prescribed by your healthcare provider.
The most common side effects include dizziness, lightheadedness, and a feeling of tiredness or fatigue. Some patients may experience heartburn, diarrhea, or stomach upset. In patients with diabetes and kidney disease, high potassium levels (hyperkalemia) are frequently observed. Dizziness is most common when standing up quickly from a sitting or lying position. Most of these side effects are mild and tend to go away as your body gets used to the medicine. If side effects persist or become severe, contact your doctor immediately.
It is generally recommended to limit or avoid alcohol while taking Irbesartan. Alcohol can increase the blood-pressure-lowering effect of the medication, which may lead to severe dizziness or fainting. This is especially likely when you first start the medication or when your dose is increased. Drinking alcohol while on blood pressure medication can also lead to dehydration, which further stresses the kidneys. If you choose to drink, do so in moderation and only after discussing it with your doctor. Always monitor how you feel when combining the two.
No, Irbesartan is not safe to use during pregnancy and carries an FDA Black Box Warning for fetal toxicity. Taking this medication during the second or third trimester can cause severe injury or death to the developing fetus. It can lead to kidney failure in the baby and problems with the development of the baby's skull and lungs. If you are pregnant or planning to become pregnant, you should not take Irbesartan. If you discover you are pregnant while taking this drug, stop taking it immediately and contact your healthcare provider for an alternative medication.
While Irbesartan begins to work within a few hours of the first dose, it takes time for the full effect on blood pressure to be realized. Most patients will see a significant reduction in blood pressure within 1 to 2 weeks. However, the maximum benefit is typically reached after 4 to 6 weeks of consistent daily use. It is important to keep taking the medication even if you do not feel a difference immediately. Hypertension often has no symptoms, so the drug is working even if you feel 'normal.' Your doctor will likely check your blood pressure after a month to see if the dose needs adjustment.
You should not stop taking Irbesartan suddenly without consulting your doctor. Stopping the medication abruptly can cause your blood pressure to rise quickly, increasing your risk of heart attack or stroke. If you need to stop the medication due to side effects, your doctor will provide a plan to transition you to another treatment safely. Most blood pressure medications are intended for long-term use. Even if your blood pressure improves, you may need to continue taking the medication to keep it under control. Always ensure you have enough refills so you do not run out of the drug.
If you miss a dose, take it as soon as you remember on the same day. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Never take two doses at the same time to make up for a missed one, as this can cause your blood pressure to drop dangerously low. Setting an alarm or using a pillbox can help you remember to take your medication at the same time every day. If you miss several doses in a row, contact your healthcare provider for advice on how to restart. Consistency is key to managing hypertension effectively.
Weight gain is not a common side effect of Irbesartan. In clinical trials, there was no significant difference in weight changes between patients taking Irbesartan and those taking a placebo. If you notice rapid weight gain or swelling in your hands, ankles, or feet, it may be a sign of fluid retention or a change in kidney function rather than fat gain. This should be reported to your doctor immediately. Maintaining a healthy diet and exercise routine is important while managing high blood pressure. If you are concerned about your weight, discuss it with your healthcare provider.
Irbesartan can interact with several other medications, so it is vital to inform your doctor of everything you take. It should not be taken with Aliskiren if you have diabetes, and it is generally not used with ACE inhibitors. Serious interactions can occur with lithium, potassium supplements, and certain diuretics (water pills). Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen can reduce the effectiveness of Irbesartan and harm the kidneys. Even herbal supplements like St. John's Wort can affect how the drug works. Always check with a pharmacist before starting any new over-the-counter medication.
Yes, Irbesartan is available as a generic medication and is significantly less expensive than the brand-name version, Avapro. Generic versions are required by the FDA to have the same active ingredient, strength, dosage form, and route of administration as the brand-name drug. They must also prove bioequivalence, meaning they work in the body the same way. Most insurance plans prefer the generic version. You may notice that the tablets look different (color or shape) depending on the manufacturer, but the therapeutic effect remains the same. Ask your pharmacist if you have questions about the generic version you receive.
Other drugs with the same active ingredient (Irbesartan)
Rare but documented side effects include sexual dysfunction (decreased libido or impotence), jaundice (yellowing of the skin or eyes indicating liver issues), and thrombocytopenia (a low platelet count which can lead to easy bruising or bleeding). Some patients have reported tinnitus (ringing in the ears) or taste disturbances. While rare, these symptoms should be discussed with a healthcare provider to determine if the medication should be continued.
> Warning: Stop taking Irbesartan and call your doctor immediately if you experience any of these.
With prolonged use, the primary concern with Irbesartan is its effect on renal function and electrolyte balance. Over years of therapy, some patients may develop chronic elevations in serum creatinine, which requires careful monitoring to distinguish between the drug's protective effects and potential toxicity. Long-term use in patients with renal artery stenosis (narrowing of the arteries to the kidneys) can lead to progressive renal impairment. There is no evidence that Irbesartan causes cumulative toxicity in other organ systems, such as the liver or brain, over many years of use.
Irbesartan carries a significant FDA Black Box Warning regarding Fetal Toxicity. When pregnancy is detected, Irbesartan should be discontinued as soon as possible. Drugs that act directly on the renin-angiotensin system (like Irbesartan) can cause injury and even death to the developing fetus, particularly during the second and third trimesters. Potential risks include oligohydramnios (insufficient amniotic fluid), which can lead to fetal lung hypoplasia (underdeveloped lungs) and skeletal deformations. Neonatal risks include skull hypoplasia, anuria (failure of the kidneys to produce urine), hypotension, renal failure, and death. Women of childbearing age should be counseled on these risks and use effective contraception while taking Irbesartan.
Report any unusual symptoms to your healthcare provider.
While rare, hypersensitivity reactions, including anaphylaxis and angioedema, have been reported. Patients with a history of angioedema while taking other medications (especially ACE inhibitors) should be monitored closely, although they can often safely take Irbesartan.
There are currently no known associations between Irbesartan and an increased risk of suicidality or QT interval prolongation. It is considered safe from a cardiac conduction and psychiatric standpoint.
Patients taking Irbesartan require periodic laboratory monitoring to ensure safety. The most critical tests include:
Irbesartan may cause dizziness or fatigue, especially during the first few days of treatment or when the dose is increased. Patients should observe how they react to the medication before driving a car, operating heavy machinery, or performing tasks that require alertness. If you feel dizzy or lightheaded, avoid these activities and sit or lie down until the feeling passes.
Alcohol can enhance the blood-pressure-lowering effect of Irbesartan, which may lead to increased dizziness, lightheadedness, or fainting. It is generally advised to limit alcohol consumption while taking this medication. Discuss your alcohol intake with your healthcare provider to determine what is safe for you.
Stopping Irbesartan suddenly can cause your blood pressure to rise rapidly (rebound hypertension). While it does not typically cause a 'withdrawal syndrome' like beta-blockers, it is important to taper the medication only under the guidance of a physician. If you must stop the medication due to a side effect, your doctor will likely start you on an alternative antihypertensive immediately.
> Important: Discuss all your medical conditions with your healthcare provider before starting Irbesartan.
Irbesartan does not typically interfere with common laboratory tests. However, it will affect the results of tests related to the renin-angiotensin system. For instance, it may increase plasma renin activity and decrease serum aldosterone levels. It is important to inform your lab technician and doctor that you are taking an ARB if you are undergoing specialized endocrine testing.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
There is no documented cross-sensitivity between Irbesartan and other classes of antihypertensives like beta-blockers or calcium channel blockers. While some patients who experience angioedema with ACE inhibitors may also experience it with ARBs, the incidence is very low (less than 1%). However, healthcare providers will exercise caution when prescribing Irbesartan to someone with a history of ACE inhibitor-induced angioedema.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Irbesartan.
In clinical trials, no overall differences in safety or effectiveness were observed between patients over 65 and younger patients. However, elderly patients are more likely to have decreased renal function and may be taking other medications that interact with Irbesartan. There is a higher risk of falls in the elderly if the medication causes significant dizziness or orthostatic hypotension. Therefore, blood pressure should be monitored closely during the initiation of therapy.
For patients with mild to moderate renal impairment, no dose adjustment is typically needed. In patients with severe renal impairment (Creatinine Clearance < 30 mL/min), the risk of hyperkalemia and further renal decline is increased. In these patients, a lower starting dose of 75 mg is often used. Regular monitoring of serum potassium and creatinine is mandatory. Irbesartan is not removed from the body by hemodialysis.
Patients with mild to moderate hepatic impairment (Child-Pugh Class A or B) do not require dosage adjustments as the liver's ability to metabolize Irbesartan remains sufficient. There is no clinical experience with Irbesartan in patients with severe hepatic impairment (Child-Pugh Class C), so it should be used with extreme caution or avoided in this specific population.
> Important: Special populations require individualized medical assessment.
| Parameter | Value |
|---|---|
| Bioavailability | 60% - 80% |
| Protein Binding | ~99% (Albumin) |
| Half-life | 11 - 15 hours |
| Tmax | 1.5 - 2 hours |
| Metabolism | Hepatic (CYP2C9) |
| Excretion | Renal 20%, Fecal 80% |
Irbesartan is a white to off-white crystalline powder with the molecular formula C25H28N6O and a molecular weight of 428.5 g/mol. It is a non-peptide, tetrazole-derivative. It is slightly soluble in alcohol and methylene chloride and practically insoluble in water. The structure includes a biphenyl ring system and a substituted imidazole ring, which are characteristic of the 'sartan' class of drugs.
Irbesartan is classified as an Angiotensin II Receptor Blocker (ARB). It belongs to the same therapeutic family as losartan, valsartan, and candesartan. Within the broader category of antihypertensives, it is considered a first-line agent for patients with hypertension and diabetes, or those who cannot tolerate ACE inhibitors.