Irbesartan Generic

Last updated on RxList: 8/14/2019
Irbesartan Generic Side Effects Center

Last reviewed on RxList 8/14/2019

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. Irbesartan is also indicated for treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. Irbesartan is available in generic form. Common side effects of irbesartan include:

The dose of irbesartan to treat hypertension is 150 mg to 300 mg once daily. The dose of irbesartan to treat diabetic nephropathy is 300 mg once daily. Irbesartan may interact with lithium, nonsteroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors, other drugs that raise blood potassium levels, other angiotensin receptor blockers, ACE inhibitors, and aliskiren. Tell your doctor all medications and supplements you use. Irbesartan is not recommended for use during pregnancy. If used during the second and third trimesters, irbesartan can cause birth defects and fetal death. It is unknown if irbesartan passes into breast milk. Because of the potential for unwanted effects in a nursing infant, breastfeeding while using irbesartan is not recommended.

Our Irbesartan Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Irbesartan Generic Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • little or no urination;
  • high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common side effects may include:

  • dizziness;
  • feeling light-headed; or
  • high potassium.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Irbesartan Generic (irbesartan)

SLIDESHOW

How to Lower Blood Pressure: Exercise Tips See Slideshow
Irbesartan Generic Professional Information

SIDE EFFECTS

The following important adverse reactions are described elsewhere in the labeling:

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 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%).

Post Marketing Experience

The following adverse reactions have been identified during post-approval 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.

Urticaria; angioedema (involving swelling of the face, lips, pharynx, and/or tongue); increased liver function tests; jaundice; hepatitis; hyperkalemia; thrombocytopenia; increased CPK; tinitus.

Read the entire FDA prescribing information for Irbesartan Generic (irbesartan)

© Irbesartan Generic Patient Information is supplied by Cerner Multum, Inc. and Irbesartan Generic Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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