pharmacopeia
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/api/v1/drug/irbesartan

Boxed 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 )

2D structure
2-butyl-3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one
SMILES CCCCC1=NC2(CCCC2)C(=O)N1CC3=CC=C(C=C3)C4=CC=CC=C4C5=NNN=N5
InChIKey YOSHYTLCDANDAN-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Angiotensin 2 Receptor Antagonists.

Angiotensin 2 Receptor

Indications

Sourced from openFDA
  • Irbesartan tablets are 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.ICD-10: I10

Contraindications

Sourced from openFDA
  • Irbesartan tablets are contraindicated in patients who are hypersensitive to any component of this product. Do not coadministrate aliskiren with irbesartan tablets in patients with diabetes.contraindicated

Dosage & administration

Sourced from openFDA

Indication Dose Hypertension ( 2.2 ) 150 to 300 mg once daily Diabetic Nephropathy ( 2.3 ) 300 mg once daily 2.1 General Considerations Irbesartan tablets may be administered with other antihypertensive agents and with or without food. 2.2 Hypertension The recommended initial dose of irbesartan tablets is 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) ]. 2.3 Nephropathy in Type 2 Diabetic Patients The recommended dose is 300 mg once daily [see Clinical Studies (14.2) ]. 2.4 Dose 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) ].

Warnings & precautions

Sourced from openFDA

Hypotension: Correct volume or salt depletion prior to administration. ( 5.2 ) Monitor renal function and serum potassium. ( 5.3 ) 5.1 Fetal 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) ]. 5.2 Hypotension 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) ]. 5.3 Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system.

Adverse reactions

Sourced from openFDA

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 Solco Healthecare US LLC. at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Hypertension Irbesartan tablets have 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.

Use in specific populations

Sourced from openFDA

Lactation: Potential for adverse effects in infants. ( 8.2 ) 8.1 Pregnancy 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.

Overdosage

Sourced from openFDA

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) base on body surface area, respectively.

Approval history

Sourced from openFDA
  • Sep 30, 1997NDANDA020757Sanofi Aventis Us
  • Sep 30, 1997NDANDA020758Sanofi Aventis Us
  • Mar 30, 2012ANDAANDA077369Teva
  • Sep 27, 2012ANDAANDA203071Prinston Inc
  • Sep 27, 2012ANDAANDA203081Aurobindo Pharma Ltd
  • Sep 27, 2012ANDAANDA202414Macleods Pharms Ltd
  • Sep 27, 2012ANDAANDA202910Hetero Labs Ltd V
  • Oct 3, 2012ANDAANDA202254Macleods Pharms Ltd

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
48,659 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea2,7805.7%
  2. 2Fatigue2,7725.7%
  3. 3Diarrhoea2,4855.1%
  4. 4Drug Ineffective2,4235.0%
  5. 5Dizziness2,3224.8%
  6. 6Dyspnoea2,2314.6%
  7. 7Acute Kidney Injury2,1664.5%
  8. 8Headache2,1314.4%
  9. 9Fall2,1244.4%
  10. 10Asthenia1,8843.9%
  11. 11Off Label Use1,7953.7%
  12. 12Malaise1,7903.7%
  13. 13Vomiting1,7163.5%
  14. 14Pain1,7113.5%
  15. 15Blood Pressure Increased1,7083.5%

Literature

View JSON

Recent PubMed references pinned to Irbesartan as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 140 ClinicalTrials.gov registrations naming Irbesartan as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Irbesartan work?
Mechanism-of-action class: Angiotensin 2 Receptor Antagonists.
What is Irbesartan used for?
According to FDA labeling, Irbesartan carries indications including: Irbesartan tablets are 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Irbesartan?
Irbesartan is classified as Angiotensin II receptor blockers (ARBs), plain, Angiotensin 2 Receptor Blocker, Angiotensin 2 Receptor Antagonists, Decreased Blood Pressure, Decreased Intravascular Volume, Decreased Mineralocorticoid Secretion, Decreased Renal K+ Excretion, Increased Renal Na+ Excretion, Renal Arterial Vasodilation.
What are the brand names for Irbesartan?
Irbesartan is marketed under brand names including Avalide, Avapro.
What are the contraindications for Irbesartan?
Irbesartan labeling lists contraindications including: Irbesartan tablets are contraindicated in patients who are hypersensitive to any component of this product. Do not coadministrate aliskiren with irbesartan tablets in patients with diabetes.. Always consult the full prescribing information and a clinician.
Note. Data for irbesartan is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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