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.
Dosage for Aceon
Aceon is taken orally in tablet form. The usual recommended initial daily dosage of Aceon is 4 mg daily.
What Drugs, Substances, or Supplements Interact with Aceon?
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.
Aceon During Pregnancy and Breastfeeding
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.
Additional Information
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.
Aceon Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.
Call your doctor at once if you have:
a light-headed feeling, like you might pass out;
fever, chills, body aches, flu symptoms, sores in your mouth and throat;
little or no urination;
swelling, rapid weight gain;
high potassium--nausea, slow or unusual heart rate, weakness, loss of movement;
pale skin, easy bruising or bleeding; or
jaundice (yellowing of the skin or eyes).
Common 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.
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:
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.
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.
&Copy; 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.
