Irbesartan 150 mg Tablet, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Angiotensin 2 Receptor Blocker class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Irbesartan is used alone or in combination with other medications to treat high blood pressure. It is also used to treat kidney disease caused by diabetes in patients with type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) and high blood pressure. Irbesartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently. High b...
Read the full MedlinePlus article ↗- Irbesartan is used for two main things. First, it lowers high blood pressure, which helps protect you from serious events like stroke and heart attack. Second, if you have type 2 d...
- Food doesn't affect how well irbesartan works, so you can take it with or without a meal — whatever fits your routine best. The most important thing is to take it around the same t...
- Does it matter if I take it with food or at a certain time of day?
- Most people do fine on irbesartan. The most common things you might notice are mild diarrhea, heartburn, fatigue, or occasional dizziness — especially when you stand up quickly. Th...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Irbesartan — tap one for details:
Irbesartan may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII UTY7PDF93L
A plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII R75537T0T4
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
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Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII SA1B764746
A synthetic polymer commonly used as a solvent and binder in medicines. It helps dissolve active ingredients, improve texture, and ensure consistent tablet or capsule formation.
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UNII 390RMW2PEQ
Povidone K29/32 is a synthetic polymer made from vinyl pyrrolidone. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break down in the stomach for drug release.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
10 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.111 | $3.33 / 30 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2998 | $8.99 / 30 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.2325 | $6.98 / 30 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Irbesartan 150 mg 31722-0730-05 | Camber | 500 tablets | $0.111 | AB | Availability likely | — |
| Irbesartan 150 mgthis 33342-0048-07 | Macleods | 30 tablets | $0.111 | AB | Availability likely | — |
| Irbesartan 150 mg 43547-0375-03 | Solco | 30 tablets | $0.111 | AB | Availability likely | — |
| Irbesartan 150 mg 50268-0441-15 | AvPAK | 50 tablets | $0.111 | AB | Discontinued | — |
| Irbesartan 150 mg 62332-0042-30 | Alembic | 30 tablets | $0.111 | AB | Availability likely | — |
| Irbesartan 150 mg 72603-0671-01 | NorthStar | 90 tablets | $0.111 | AB | Availability likely | — |
| Avapro 150 mg 00024-5851-30 | Sanofi-Aventis | 30 tablets | $7.345 | AB | Availability likely | +6521% |
| Irbesartan 150 mg 29300-0213-05 | Unichem | 500 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 31722-0161-10 | Camber | 1000 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 42291-0941-90 | AvKARE | 90 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 42658-0122-01 | Hisun | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 46708-0440-30 | Alembic | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 50090-1284-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 50228-0161-10 | ScieGen | 1000 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 59746-0448-05 | Jubilant | 500 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 62135-0977-30 | Chartwell | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 63187-0737-10 | Proficient | 100 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 65162-0285-03 | Amneal | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 65862-0638-05 | Aurobindo | 500 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 68788-8670-09 | Preferred | 90 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 70518-1690-01 | REMEDYREPACK | 90 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 70518-2245-00 | REMEDYREPACK | 90 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 71205-0082-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 71205-0452-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 71335-1244-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 71335-1263-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 71335-2168-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 72162-2354-03 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 72162-2355-03 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 72189-0205-90 | direct | 90 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 72205-0328-05 | Novadoz | 500 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 83008-0084-30 | Quality | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 150 mg 68180-0411-02 | Lupin | 500 tablets | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 33342-0048-07 You're viewing this | 30 TABLET in 1 BOTTLE (33342-048-07) | $0.1109 / ea | $3.33 | 2012-09-27 | Active |
| 33342-0048-10 | 90 TABLET in 1 BOTTLE (33342-048-10) | $0.1109 / ea | $9.98 | 2013-03-11 | Active |
| 33342-0048-12 | 10 BLISTER PACK in 1 CARTON (33342-048-12) / 10 TABLET in 1 BLISTER PACK | — | — | 2012-09-27 | Active |
| 33342-0048-15 | 500 TABLET in 1 BOTTLE (33342-048-15) | — | — | 2012-09-27 | Active |
| 33342-0048-65 | 6800 TABLET in 1 POUCH (33342-048-65) | — | — | 2019-02-26 | Active |
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1109 NADAC).
This pack accounts for about 2.1% of this product's recent Medicaid fills; most go to the 90 tablets pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 33342-0048-07?
What is the difference between NDC 33342-0048-07 and NDC 33342-0048-10?
What NDC number is used to bill for this package of Irbesartan 150 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue irbesartan 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 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 )
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Irbesartan 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. ( 1.1 ) Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. ( 1.2 )
1.1Hypertension 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. 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.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Irbesartan tablets may be used alone or in combination with other antihypertensive agents.
1.2Nephropathy 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). In this population, irbesartan tablets reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies ( 14.2 )].
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION Indication Dose Hypertension ( 2.2 ) 150 to 300 mg once daily Diabetic Nephropathy ( 2.3 ) 300 mg once daily
2.1General Considerations Irbesartan tablets may be administered with other antihypertensive agents and with or without food.
2.2Hypertension The recommended initial dose of irbesartan tablets are 150 mg once daily. The dosage can be increased to a maximum dose of 300 mg once daily as needed to control blood pressure [see Clinical Studies ( 14.1 )].
2.3Nephropathy in Type 2 Diabetic Patients The recommended dose is 300 mg once daily [see Clinical Studies ( 14.2 )].
2.4Dose Adjustment in Volume and Salt-Depleted Patients The recommended initial dose is 75 mg once daily in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis) [see Warnings and Precautions ( 5.2 )].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS Irbesartan tablets 75 mg are a white to off-white, oval shaped, film-coated tablets debossed with “ML 94” on one side and plain on the other side. Irbesartan tablets 150 mg are a white to off-white, oval shaped, film-coated tablets debossed with “ML 95” on one side and plain on the other side. Irbesartan tablets 300 mg are a white to off-white, oval shaped, film-coated tablets debossed with “ML 96” on one side and plain on the other side. • Tablets: 75 mg, 150 mg, 300 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Irbesartan tablets are contraindicated in patients who are hypersensitive to any component of this product. Do not coadminister aliskiren with irbesartan tablets in patients with diabetes. • Hypersensitivity to any component of this product. ( 4 ) • Coadministration with aliskiren in patients with diabetes. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Hypotension: Correct volume or salt depletion prior to administration. ( 5.2 ) • Monitor renal function and serum potassium. ( 5.3 )
5.1Fetal Toxicity Irbesartan tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. 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 tablets as soon as possible [see Use in Specific Populations ( 8.1 )].
5.2Hypotension in Volume or Salt-Depleted Patients In patients with an activated renin-angiotensin system, such as volume or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initialization of treatment with irbesartan tablets. Correct volume or salt depletion prior to administration of irbesartan tablets or use a lower starting dose [see Dosage and Administration ( 2.4 )].
5.3Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe heart failure, or volume depletion) may be at particular risk of developing acute renal failure or death on irbesartan tablets. Monitor renal function periodically in these patients.
Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on irbesartan tablets [see Drug Interactions ( 7.3 )].
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in the labeling: • Hypotension in Volume or Salt-Depleted Patients [see Warnings and Precautions ( 5.2 )] • Impaired Renal Function [see Warnings and Precautions ( 5.3 )] • 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical 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 tablets 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 tablets (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. In placebo-controlled studies, the incidence of cough in irbesartan-treated patients was 2.8% versus 2.7% in patients receiving placebo. Nephropathy in Type 2 Diabetic Patients Hyperkalemia: In the Irbesartan Diabetic Nephropathy Trial (IDNT) (proteinuria ≥900 mg/day, and serum creatinine ranging from 1.0-3.0 mg/dL), the percent of patients with potassium >6 mEq/L was 18.6% in the irbesartan tablets group versus 6.0% in the placebo group.
Discontinuations due to hyperkalemia in the irbesartan tablets group were 2.1% versus 0.4% in the placebo group. In IDNT, the adverse reactions were similar to those seen in patients with hypertension with the exception of an increased incidence of orthostatic symptoms which occurred more frequently in the irbesartan tablets versus placebo group: dizziness (10.2% vs 6.0%), orthostatic dizziness (5.4% vs 2.7%) and orthostatic hypotension (5.4% vs 3.2%).
6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of irbesartan tablets. 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. Blood and lymphatic system : Anemia, Thrombocytopenia Ear and labyrinth : Tinnitus Gastrointestinal : Intestinal angioedema Hepatobiliary : Hepatitis, Jaundice Immune system : Anaphylactic reaction including anaphylactic shock Investigations : Increased liver function tests, Increased CPK (Creatine Phosphokinase) Metabolism and nutrition : Hyperkalemia, Hypoglycemia in diabetic patients Skin and subcutaneous tissue : Urticaria, Angioedema (involving swelling of the face, lips, pharynx, and/or tongue)
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Lithium: Risk of lithium toxicity. ( 7 ) • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and COX-2 inhibitors: Increased risk of renal impairment. Reduced antihypertensive effects. ( 7 ) • Dual blockade of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. ( 7 )
7.1Agents Increasing Serum Potassium Coadministration of irbesartan tablets with other drugs that raise serum potassium levels may result in hyperkalemia, sometimes severe. Monitor serum potassium in such patients.
7.2Lithium Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of irbesartan and lithium. Monitor lithium levels in patients receiving irbesartan and lithium.
7.3Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including irbesartan) may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving irbesartan and NSAID therapy.
The antihypertensive effect of angiotensin II receptor antagonists, including irbesartan, may be attenuated by NSAIDs including selective COX-2 inhibitors.
7.4Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors.
Closely monitor blood pressure, renal function and electrolytes in patients on irbesartan tablets and other agents that affect the RAS. Do not coadminister aliskiren with irbesartan tablets in patients with diabetes. Avoid use of aliskiren with irbesartan tablets in patients with renal impairment (GFR <60 mL/min).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Lactation: Potential for adverse effects in infants. ( 8.2 )
8.1Pregnancy Risk Summary Irbesartan tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death [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 tablets 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. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus.
Perform serial ultrasound examinations to assess the intra-amniotic environment. 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.
If oligohydramnios is observed, consider alternative treatment. Closely observe infants with histories of in utero exposure to irbesartan tablets for hypotension, oliguria, and hyperkalemia and other symptoms of renal impairment. In neonates with a history of in utero exposure to irbesartan tablets, 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. 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 M…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Irbesartan tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death [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 tablets 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. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus.
Perform serial ultrasound examinations to assess the intra-amniotic environment. 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.
If oligohydramnios is observed, consider alternative treatment. Closely observe infants with histories of in utero exposure to irbesartan tablets for hypotension, oliguria, and hyperkalemia and other symptoms of renal impairment. In neonates with a history of in utero exposure to irbesartan tablets, 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. 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…
🧒 Pediatric Use ▾
8.4Pediatric Use Irbesartan, in a study at a dose of up to 4.5 mg/kg/day, once daily, did not appear to lower blood pressure effectively in pediatric patients ages 6 to 16 years. Irbesartan tablets has not been studied in pediatric patients less than 6 years old.
🧓 Geriatric Use ▾
8.5Geriatric Use Of 4925 subjects receiving irbesartan tablets in controlled clinical studies of hypertension, 911 (18.5%) were 65 years and over, while 150 (3.0%) were 75 years and over. No overall differences in effectiveness or safety were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. [See Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14.1 ).]
🆘 Overdosage ▾
10 OVERDOSAGE 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. 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, respectively.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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 primary vasoactive hormone of the renin-angiotensin system, and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT 1 angiotensin II receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland). There is also an AT 2 receptor in many tissues, but it is not involved in cardiovascular homeostasis. Irbesartan is a specific competitive antagonist of AT 1 receptors with a much greater affinity (more than 8500-fold) for the AT 1 receptor than for the AT 2 receptor and no agonist activity.
Blockade of the AT 1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effects of irbesartan on blood pressure. Irbesartan does not inhibit ACE or renin or affect other hormone receptors or ion channels known to be involved in the cardiovascular regulation of blood pressure and sodium homeostasis.
12.2Pharmacodynamics In healthy subjects, single oral irbesartan doses of up to 300 mg produced dose-dependent inhibition of the pressor effect of angiotensin II infusions. Inhibition was complete (100%) 4 hours following oral doses of 150 mg or 300 mg and partial inhibition was sustained for 24 hours (60% and 40% at 300 mg and 150 mg, respectively). In hypertensive patients, angiotensin II receptor inhibition following chronic administration of irbesartan causes a 1.5-fold to 2-fold rise in angiotensin II plasma concentration and a 2-fold to 3-fold increase in plasma renin levels.
Aldosterone plasma concentrations generally decline following irbesartan administration, but serum potassium levels are not significantly affected at recommended doses. In hypertensive patients, chronic oral doses of irbesartan (up to 300 mg) had no effect on glomerular filtration rate, renal plasma flow, or filtration fraction. In multiple dose studies in hypertensive patients, there were no clinically important effects on fasting triglycerides, total cholesterol or HDL-cholesterol concentrations.
There was no effect on serum uric acid during chronic oral administration, and no uricosuric effect.
12.3Pharmacokinetics Absorption The oral absorption of irbesartan is rapid and complete with an average absolute bioavailability of 60% to 80%. Following oral administration of irbesartan tablets, peak plasma concentrations of irbesartan are attained at 1.5 to 2 hours after dosing. Food does not affect the bioavailability of irbesartan.
Irbesartan exhibits linear pharmacokinetics over the therapeutic dose range. Distribution Irbesartan is 90% bound to serum proteins (primarily albumin and α1-acid glycoprotein) with negligible binding to cellular components of blood. The average volume of distribution is 53 to 93 liters.
Studies in animals indicate that radiolabeled irbesartan weakly crosses the blood-brain barrier and placenta. Irbesartan is excreted in the milk of lactating rats. Elimination Total plasma and renal clearances are in the range of 157 to 176 mL/min and 3.0 to 3.5 mL/min, respectively.
The terminal elimination half-life of irbesartan averages 11 to 15 hours. Steady-state concentrations are achieved within 3 days. Limited accumulation of irbesartan (<20%) is observed in plasma upon repeated once-daily dosing and is not clinically relevant.
Metabolism Irbesartan is an orally active agent that does not require biotransformation into an active form. Irbesartan is metabolized via glucuronide conjugation and oxidation. Following oral or intravenous administration of 14 C-labeled irbesartan, more than 80% of the circulating pl…
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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 primary vasoactive hormone of the renin-angiotensin system, and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT 1 angiotensin II receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland). There is also an AT 2 receptor in many tissues, but it is not involved in cardiovascular homeostasis. Irbesartan is a specific competitive antagonist of AT 1 receptors with a much greater affinity (more than 8500-fold) for the AT 1 receptor than for the AT 2 receptor and no agonist activity.
Blockade of the AT 1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effects of irbesartan on blood pressure. Irbesartan does not inhibit ACE or renin or affect other hormone receptors or ion channels known to be involved in the cardiovascular regulation of blood pressure and sodium homeostasis.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Irbesartan USP is available as white to off-white, oval shaped, film-coated tablets, debossed on one side with “ML 94”, “ML 95” and “ML 96” respectively for 75 mg, 150 mg and 300 mg tablets and plain on the other side. (see Table below). Unit-of-use bottles contain 30, 90 or 500 tablets and blister packs contain 100 tablets or 90 tablets, as follows: 75 mg 150 mg 300 mg Debossing “ ML 94” “ML 95” “ML 96” Bottle of 30 33342-047-07 33342-048-07 33342-049-07 Bottle of 90 33342-047-10 33342-048-10 33342-049-10 Bottle of 500 33342-047-15 33342-048-15 33342-049-15 Blister of 100 33342-047-12 33342-048-12 --- Blister of 90 --- --- 33342-049-39 Store at 20° to 25°C (68° to 77° F); excursions permitted to 15° to 30°C (59° to 86° F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Irbesartan USP is an angiotensin II receptor (AT 1 subtype) antagonist. 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 molecular formula is C 25 H 28 N 6 O, and the structural formula: Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.5.
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. Irbesartan is available for oral administration in unscored film-coated tablets containing 75 mg, 150 mg, or 300 mg of irbesartan USP.
Inactive ingredients include: carboxymethylcellulose calcium, povidone, colloidal silicon dioxide, sodium starch glycolate, talc and magnesium stearate. The film coating comprises of hypromellose, lactose monohydrate, titanium dioxide and polyethylene glycol. irbesartan
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Pregnancy Advise female patients of childbearing age about the consequences of exposure to irbesartan tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
Potassium Supplements Advise patients receiving irbesartan tablets not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see Drug Interactions ( 7.1 )]. Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufactured by: Macleods Pharmaceuticals Limited, INDIA Revision: September 2025