Aceon Side Effects

Please note - some side effects for Aceon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Aceon - for the Consumer

Aceon

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Aceon:

Abnormal skin sensation; arm or leg pain; back pain; cough; depression; diarrhea; dizziness; drowsiness; headache; lightheadedness; nausea; runny nose; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine; chest pain; darkening of urine; difficulty swallowing; fainting; fast or irregular heartbeat; fever; hoarseness; pounding in the chest; prolonged nausea, vomiting, or diarrhea; severe lightheadedness or fainting; sore throat; swelling of the hands, legs, face, lips, eyes, throat, tongue, or trunk; unusual joint pain; unusual muscle pain, cramps, or weakness; unusual stomach pain; yellowing of the skin or eyes.

Aceon Side Effects - for the Professional

Aceon

Hypertension

Aceon® (perindopril erbumine) Tablets has been evaluated for safety in approximately 3,400 patients with hypertension in U.S. and foreign clinical trials. Aceon® Tablets was in general well-tolerated in the patient populations studied, the side effects were usually mild and transient. Although dizziness was reported more frequently in placebo patients (8.5%) than in perindopril patients (8.2%), the incidence appeared to increase with an increase in perindopril dose.

The data presented here are based on results from the 1,417 Aceon® Tablets-treated patients who participated in the U.S. clinical trials. Over 220 of these patients were treated with Aceon® Tablets 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® Tablets 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® Tablets and in those treated with placebo (approximately 75% in each group). Adverse events that occurred in 1% or greater of the patients and that were more common for perindopril than placebo by at least 1% (regardless of whether they were felt to be related to study drug) are shown in the first two columns below. Of these adverse events, those considered possibly or probably related to study drug are shown in the last two columns.

Of these, cough was the reason for withdrawal in 1.3% of perindopril and 0.4% of placebo patients. While dizziness was not reported more frequently in the perindopril group (8.2%) than in the placebo group (8.5%), it was clearly increased with dose, suggesting a causal relationship with perindopril. Other commonly reported complaints (1% or greater), regardless of causality, include: headache (23.8%), upper respiratory infection (8.6%), asthenia (7.9%), rhinitis (4.8%), low extremity pain (4.7%), diarrhea (4.3%), edema (3.9%), pharyngitis (3.3%), urinary tract infection (2.8%), abdominal pain (2.7%), sleep disorder (2.5%), chest pain (2.4%), injury, paresthesia, nausea, rash (each 2.3%), seasonal allergy, depression (each 2%), abnormal ECG (1.8%), ALT increase (1.7%), tinnitus, vomiting (each 1.5%), neck pain, male sexual dysfunction (each 1.4%), triglyceride increase, somnolence (each 1.3%), joint pain, nervousness, myalgia, menstrual disorder (each 1.1%), flatulence and arthritis (each 1%), but none of those was more frequent by at least 1% on perindopril than on placebo. Depending on the specific adverse event, approximately 30 to 70% of the common complaints were considered possibly or probably related to treatment.

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.

Below is a list (by body system) of adverse experiences reported in 0.3 to 1% of patients in U.S. placebo-controlled studies in hypertensive patients without regard to attribution to therapy. Less frequent but medically important adverse events are also included; the incidence of these events is given in parentheses.

Body as a Whole: malaise, pain, cold/hot sensation, chills, fluid retention, orthostatic symptoms, anaphylactic reaction, facial edema, angioedema (0.1%).

Gastrointestinal: constipation, dry mouth, dry mucous membrane, appetite increased, gastroenteritis.

Respiratory: posterior nasal drip, bronchitis, rhinorrhea, throat disorder, dyspnea, sneezing, epistaxis, hoarseness, pulmonary fibrosis (<0.1%).

Urogenital: vaginitis, kidney stone, flank pain, urinary frequency, urinary retention.

Cardiovascular: hypotension, ventricular extrasystole, myocardial infarction, vasodilation, syncope, abnormal conduction, heart murmur, orthostatic hypotension.

Endocrine: gout.

Hematology: hematoma, ecchymosis.

Musculoskeletal: arthralgia, myalgia.

CNS: migraine, amnesia, vertigo, cerebral vascular accident (0.2%).

Psychiatric: anxiety, psychosexual disorder.

Dermatology: sweating, skin infection, tinea, pruritus, dry skin, erythema, fever blisters, purpura (0.1%).

Special Senses: conjunctivitis, earache.

Laboratory: potassium decrease, uric acid increase, alkaline phosphatase increase, cholesterol increase, AST increase, creatinine increase, hematuria, glucose increase.

When Aceon® Tablets was given concomitantly with thiazide diuretics, adverse events were generally reported at the same rate as those for Aceon® Tablets alone, except for a higher incidence of abnormal laboratory findings known to be related to treatment with thiazide diuretics alone (e.g., increases in serum uric acid, triglycerides and cholesterol and decreases in serum potassium).

Potential Adverse Effects Reported with ACE Inhibitors: Other medically important adverse effects reported with other available ACE inhibitors 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 ANA, leukocytosis, eosinophilia or an elevated ESR. Many of these adverse effects have also been reported for perindopril.

Fetal/Neonatal Morbidity and Mortality: See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

Clinical Laboratory Test Findings

Hematology, clinical chemistry and urinalysis parameters have been evaluated in U.S. placebo-controlled trials. In general, there were no clinically significant trends in laboratory test findings.

Hyperkalemia: In clinical trials, 1.4% of the patients receiving Aceon® Tablets and 2.3% of the patients receiving placebo showed serum potassium levels greater than 5.7 mEq/L.

BUN/Serum Creatinine Elevations: Elevations, usually transient and minor, of BUN and serum creatinine have been observed. In placebo-controlled clinical trials, the proportion of patients experiencing increases in serum creatinine were similar in the Aceon® Tablets and placebo treatment groups. Rapid reduction of long-standing or markedly elevated blood pressure by any antihypertensive therapy can result in decreases in the glomerular filtration rate and, in turn, lead to increases in BUN or serum creatinine.

Hematology: Small decreases in hemoglobin and hematocrit occur frequently in hypertensive patients treated with Aceon® Tablets, 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

Liver Function Tests: Elevations in ALT (1.6% Aceon® Tablets vs 0.9% placebo) and AST (0.5% Aceon® Tablets vs 0.4% placebo) have been observed in U.S. placebo-controlled clinical trials. The elevations were generally mild and transient and resolved after discontinuation of therapy.

Side Effects by Body System

General

In general, perindopril has been well-tolerated. At the time of its introduction into the US market in 1999, it had been evaluated for safety in approximately 3,400 patients with hypertension. Side effects have generally been mild and transient. In placebo-controlled trials in the US, the incidence of premature discontinuation of perindopril therapy due to adverse events was 6.5% among treated patients and 6.7% among placebo patients. The most common side effects were cough, headache, asthenia, and dizziness.

General side effects that have occurred in less than 1% of treated patients in controlled trials include malaise, pain, cold/hot sensation, and chills.

Respiratory

A retrospective study has revealed a significantly higher incidence of discontinuation of ACE inhibitor therapy due to cough among black patients compared with non-black patients (9.6% vs. 2.4%).

Several agents have been studied for treating cough with ACE inhibitors. No long term trials exist to allow a definitive treatment option. Cromolyn has the most data showing some benefit. Other agents studied include baclofen, theophylline, sulindac, and benzonatate.

Rare cases of eosinophilic pneumonitis have been associated with the use of other ACE inhibitors.

Respiratory side effects including cough is one of the most troublesome side effects associated with the use of angiotensin converting enzyme (ACE) inhibitors, in general. In controlled trials, cough occurred in 8% to 12% of treated patients, although it was thought to be possibly or probably related to the use of perindopril in only 6% of patients (compared to 1.8% of placebo patients). Cough has been the reason for therapy withdrawal in 1.3% to 3.2% of perindopril and 0.4% of placebo patients. Other respiratory system side effects include rhinitis (5%) and pharyngitis (3%). Problems reported in less than 1% of treated patients include posterior nasal drip, bronchitis, rhinorrhea, throat disorder, dyspnea, sneezing, epistaxis, hoarseness, pulmonary fibrosis, and pneumonitis.

Metabolic

Metabolic side effects have included hyperkalemia, commonly reported with the use of ACE inhibitors. Elevated serum potassium is due to inhibition of aldosterone secretion. In clinical trials, 1.4% of treated patients and 2.3% of placebo patients showed serum potassium levels greater than 5.7% mEq/L.

Renal

Rare cases of nephritis and acute renal failure have been associated with the use of other ACE inhibitors.

Renal side effects including new or worsened renal insufficiency, as evidenced by usually minor and transient increases of serum BUN and creatinine, have been associated with the use of ACE inhibitors. Rapid reduction of longstanding or markedly elevated blood pressure can result in reduction of renal blood flow and glomerular filtration rate. The risk of new or worsened renal insufficiency is higher in patients whose renal function may depend on the renin-angiotensin-aldosterone axis, such as in patients with severe congestive heart failure, renal artery stenosis (contraindication), hypovolemia, and in patients with underlying renal failure.

Hematologic

Hematologic side effects associated with the use of ACE inhibitors include rare cases of hemolytic and aplastic anemia, agranulocytosis, thrombocytopenia, and myelosuppression. In controlled clinical trials, no one was discontinued from perindopril therapy due to the development of anemia. Leukopenia, including neutropenia, has been observed in 0.1% of treated patients. Hematoma or ecchymosis have been associated with the use of perindopril in less than 1% of patients.

At least one other ACE inhibitor has been shown to cause agranulocytosis and bone marrow depression. This has only rarely been seen in patients with uncomplicated hypertension, and appears to be more likely in patients with renal insufficiency and/or collagen-vascular disease (such as systemic lupus erythematosus or scleroderma). Although there have been no reported instances of severe neutropenia (absolute neutrophil count less than 500/mm3) among treated patients, monitoring of white blood cells should be considered for those patients at higher risk.

Hepatic

Hepatic enzyme effects of transient and usually mild elevations in serum liver function test indicators (ALT increases of 1.6% and 0.9% and AST increases of 0.5% and 0.4% among treated and placebo patients, respectively) have been associated with the use of perindopril.

Musculoskeletal

Musculoskeletal aches and pains have been associated with the use of perindopril in up to 6% of patients. These included back pain (6%), lower extremity pain (5%), upper extremity pain (3%), and neck pain (1%). Because of the underlying incidence of these problems among all study subjects, a causal relationship with perindopril is doubtful.

Cardiovascular

Cardiovascular side effects most commonly reported have included dizziness and hypotension (perhaps related). Dizziness was not reported more often among treated patients (8.2%) compared with placebo patients (8.5%) in controlled trials, but, because its incidence was directly related to dose, a causal relationship has been suspected. The risk of "first-dose hypotension" may be minimized by starting therapy or increasing dosage at bedtime. Facial edema and angioedema have been associated with the use of perindopril in 0.1% of patients, and likely represent hypersensitivity reactions. Less common cardiovascular side effects include edema (4%), chest pain (2.4%), abnormal ECG (1.8%), and palpitations (1%). The following have been reported during the use of perindopril in less than 1% of patients: hypotension, ventricular extrasystole, myocardial infarction, vasodilation, syncope, abnormal cardiac conduction, heart murmur, and orthostatic hypotension.

Gastrointestinal

Gastrointestinal side effects have included dyspepsia, nausea, vomiting, flatulence, abdominal pain or diarrhea in 2% to 4% of patients. Less commonly reported GI side effects include constipation, dry mouth, dry mucous membrane, increased appetite, pancreatitis, and gastroenteritis.

Nervous system

Nervous system side effects have included headache in up to 24% of patients. Headache may be due to vasodilation secondary to ACE inhibition. Other commonly reported nervous system side effects include asthenia (8%), sleep disturbances (3%), paresthesia (2%), tinnitus (1%), and anxiety (1%). The following have been reported in less than 1% of treated patients: migraine, amnesia, vertigo, and cerebral vascular accident.

Immunologic

Immunologic side effects have included immune system dysfunction (suggested by the incidence of infection during ACE inhibitor therapy). The following have been reported more often among treated patients compared to placebo patients: upper respiratory tract infection (9%), sinusitis (5%), viral infection in general (3%), ear infection (1%), rhinitis (5%), pharyngitis (3%), urinary tract infection (3%), and rare cases of gastroenteritis, vaginitis, bronchitis, and conjunctivitis.

Hypersensitivity

Hypersensitivity reactions to angiotensin converting enzyme (ACE) inhibitors may be life threatening. Angioedema of the face, extremities, lips, tongue, glottis and/or pharynx have been reported rarely in patients receiving ACE inhibitors. In addition, intestinal angioedema has been reported in patients treated with ACE inhibitors. It is recommended that any patient with dyspnea, dysphagia, or significant facial angioedema stop therapy immediately and avoid ACE inhibitor therapy in general.

Urticaria, rash, pemphigus, pruritus, and photosensitivity have been reported in 2% or less of patients. Extremely rare cases of ACE inhibitor induced pancreatitis, and eosinophilic pneumonitis have been reported.

Patients with intestinal angioedema generally present with abdominal pain (with or without nausea or vomiting) and in some cases there was no prior history of facial angioedema, and C-1 esterase levels were normal. These symptoms resolve after stopping the ACE inhibitor.

Genitourinary

Genitourinary side effects associated with the use of perindopril include male sexual dysfunction or menstrual disorder in 1% of patients. The following have been reported in less than 1% of patients in controlled trials: vaginitis, kidney stone, flank pain, urinary frequency, and urinary retention.

Endocrine

Endocrine problems that have rarely occurred during perindopril therapy include increased serum triglyceride concentrations in 1% of patients. Increased serum uric acid or gout and increased serum cholesterol have been reported in less than 1% of treated patients. Causal relationships have not been demonstrated. Hypoglycemia is a rare side effect associated with the use of some ACE inhibitors.

Psychiatric

Psychiatric problems that have occurred during perindopril therapy include depression (2%) and, in less than 1% of patients, anxiety and psychosexual disorders.

Dermatologic

Dermatologic side effects have included sweating, skin infection, tinea, pruritus, dry skin, erythema, fever blisters, and purpura in less than 1% of patients. Dermatologic reactions can be severe if associated with a serious allergic reaction. Psoriasis has been reported with ACE inhibitor use.

Rare cases of bullous pemphigus, exfoliative dermatitis, and a syndrome which may include arthralgias, arthritis, vasculitis, serositis, myalgia, fever, rash, a positive ANA, leukocytosis, eosinophilia, or an elevated ESR have been associated with the use of other ACE inhibitors.

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