Slideshows Images Quizzes

Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. See additional information.

Avapro

Last reviewed on RxList: 11/12/2018
Avapro Side Effects Center

Last reviewed on RxList 11/12/2018

Avapro (irbesartan) is an angiotensin II receptor antagonist used to treat high blood pressure (hypertension). Avapro is sometimes given together with other blood pressure medications. Avapro is also used to treat kidney problems caused by type 2 (non-insulin-dependent) diabetes. Avapro may be available in generic form. Common side effects of Avapro include:

  • dizziness,
  • lightheadedness, or
  • upset stomach as your body adjusts to the medication, as well as
  • diarrhea,
  • heartburn, or
  • tiredness.

To treat hypertension the recommended starting dose of Avapro is 150 mg once daily. Patients requiring further reduction in blood pressure should be adjusted to 300 mg once daily. To treat nephropathy in type 2 diabetic patients, the recommended target maintenance dose is 300 mg once daily. Avapro may interact with diuretics (water pills), digoxin, or blood thinners. Tell your doctor all medications you use. Avapro is not recommended for use during pregnancy due to the risk for harm to the fetus. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Avapro (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.

Avapro Consumer Information

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

In rare cases, irbesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • little or no urination;
  • swelling, rapid weight gain; or
  • confusion, loss of appetite, vomiting, pain in your side or lower back.

Common side effects may include:

  • diarrhea;
  • heartburn, upset stomach; or
  • tired feeling.

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 Avapro (Irbesartan)

Avapro 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

AVAPRO 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 AVAPRO (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 AVAPRO group versus 6.0% in the placebo group. Discontinuations due to hyperkalemia in the AVAPRO 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 AVAPRO 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 AVAPRO. 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; tinnitus.

Read the entire FDA prescribing information for Avapro (Irbesartan)

Related Resources for Avapro

Read the Avapro User Reviews »

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

Health Solutions From Our Sponsors

CONTINUE SCROLLING FOR RELATED ARTICLE