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Aceon

Last reviewed on RxList: 3/3/2017
Aceon Side Effects Center

Last reviewed on RxList 01/25/2017

Aceon (perindopril erbumine) is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or heart attack (myocardial infarction). Aceon may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. Aceon is available in generic form. Common side effects of Aceon include:

Tell your doctor if you have unlikely but serious side effects of Aceon including:

  • symptoms of a high potassium blood level (such as muscle weakness, slow or irregular heartbeat),
  • fast heartbeat,
  • fainting,
  • signs of infection (e.g., fever, chills, persistent sore throat),
  • numbness/tingling/swelling of the hands or feet, or
  • chest pain.

Aceon is taken orally in tablet form. The usual recommended initial daily dosage of Aceon is 4 mg daily. Aceon may interact with gold injections, lithium, nonsteroidal antiiinflamatory drugs (NSAIDs), potassium supplements, salt substitutes that contain potassium, or diuretics (water pills). Tell your doctor all medications and supplements you use. Acoen could cause birth defects in the baby if taken during pregnancy. It is not known whether perindopril passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breastfeeding a baby.

Our Aceon (perindopril erbumine) 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.

Aceon Consumer Information

Get emergency medical help if you have any of these 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 serious side effect such as:

  • feeling like you might pass out;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • urinating less than usual or not at all;
  • swelling, rapid weight gain;
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
  • pale skin, easy bruising or bleeding; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • dizziness;
  • back pain; or
  • cough.

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 Aceon (Perindopril Erbumine)

Aceon Professional Information

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse event 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.

Clinical Trials Experience

The following adverse reactions are discussed elsewhere in labeling:

Hypertension

ACEON has been evaluated for safety in approximately 3,400 patients with hypertension in U.S. and foreign clinical trials. The data presented here are based on results from the 1,417 ACEON-treated patients who participated in the U.S. clinical trials. Over 220 of these patients were treated with ACEON® (perindopril erbumine) for at least one year.

In placebo-controlled U.S. clinical trials, the incidence of premature discontinuation of therapy due to adverse events was 6.5% in patients treated with ACEON and 6.7% in patients treated with placebo. The most common causes were cough, headache, asthenia and dizziness.

Among 1,012 patients in placebo-controlled U.S. trials, the overall frequency of reported adverse events was similar in patients treated with ACEON and in those treated with placebo (approximately 75% in each group). The only adverse events whose incidence on ACEON was at least 2% greater than on placebo were cough (12% vs. 4.5%) and back pain (5.8% vs. 3.1%).

Dizziness was not reported more frequently in the perindopril group (8.2%) than in the placebo group (8.5%), but its likelihood increased with dose, suggesting a causal relationship with perindopril.

Stable Coronary Artery Disease

Perindopril has been evaluated for safety in EUROPA, a double-blind, placebo-controlled study in 12,218 patients with stable coronary artery disease. The overall rate of discontinuation was about 22% on drug and placebo. The most common medical reasons for discontinuation that were more frequent on perindopril than placebo were cough, drug intolerance and hypotension.

Postmarketing Experience

Voluntary reports of adverse events in patients taking ACEON that have been received since market introduction and are of unknown causal relationship to ACEON include: cardiac arrest, eosinophilic pneumonitis, neutropenia/agranulocytosis, pancytopenia, anemia (including hemolytic and aplastic), thrombocytopenia, acute renal failure, nephritis, hepatic failure, jaundice (hepatocellular or cholestatic), symptomatic hyponatremia, bullous pemphigoid, pemphigus, acute pancreatitis, falls, psoriasis, exfoliative dermatitis and a syndrome which may include: arthralgia/arthritis, vasculitis, serositis, myalgia, fever, rash or other dermatologic manifestations, a positive antinuclear antibody (ANA), leukocytosis, eosinophilia or an elevated erythrocyte sedimentation rate (ESR).

Clinical Laboratory Test Findings

Hematology

Small decreases in hemoglobin and hematocrit occur frequently in hypertensive patients treated with ACEON, but are rarely of clinical importance. In controlled clinical trials, no patient was discontinued from therapy due to the development of anemia. Leukopenia (including neutropenia) was observed in 0.1% of patients in U.S. clinical trials [see WARNINGS AND PRECAUTIONS].

Liver Function Tests

Elevations in ALT (1.6% ACEON versus 0.9% placebo) and AST (0.5% ACEON versus 0.4% placebo) have been observed in placebo-controlled clinical trials. The elevations were generally mild and transient and resolved after discontinuation of therapy.

Read the entire FDA prescribing information for Aceon (Perindopril Erbumine)

Related Resources for Aceon

Read the Aceon User Reviews »

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

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