Aceon Side Effects
Generic Name: perindopril
Note: This document contains side effect information about perindopril. Some of the dosage forms listed on this page may not apply to the brand name Aceon.
Some side effects of Aceon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to perindopril: oral tablet
Along with its needed effects, perindopril (the active ingredient contained in Aceon) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking perindopril:More common
- Body aches or pain
- difficulty breathing
- ear congestion
- loss of voice
- nasal congestion
- runny nose
- sore throat
- unusual tiredness or weakness
- Abdominal or stomach pain
- bladder pain
- bloody or cloudy urine
- change in hearing
- chest pain
- cold or flu-like symptoms
- difficult, burning, or painful urination
- dryness of the throat
- earache or pain in the ear
- ear drainage
- frequent urge to urinate
- lower back or side pain
- tender, swollen glands in the neck
- trouble with swallowing
- voice changes
- Blurred vision
- decreased urination
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- irregular heartbeat
- muscle cramps or pain
- numbness, tingling, pain, or weakness in the hands or feet
- rapid breathing
- sunken eyes
- weakness and heaviness of the legs
Some side effects of perindopril may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Back pain
- lack or loss of strength
- pain or tenderness around the eyes and cheekbones
- tightness of the chest
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- difficulty moving
- excess air or gas in the stomach or intestines
- feeling sad or empty
- full feeling
- hearing loss
- lack of appetite
- leg pain
- loss of interest or pleasure
- muscle aching, stiffness, tension, or tightness
- neck pain
- pain, swelling, or redness in the joints
- passing gas
- sleepiness or unusual drowsiness
- stomach discomfort or upset
- swollen joints
- trouble concentrating
- trouble sleeping
For Healthcare Professionals
Applies to perindopril: oral tablet
In general, perindopril (the active ingredient contained in Aceon) 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.
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 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.
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 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 (the active ingredient contained in Aceon) 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 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 (the active ingredient contained in Aceon)
Musculoskeletal aches and pains have been associated with the use of perindopril (the active ingredient contained in Aceon) 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 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 (the active ingredient contained in Aceon) 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 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 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 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 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 side effects associated with the use of perindopril (the active ingredient contained in Aceon) 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 problems that have rarely occurred during perindopril (the active ingredient contained in Aceon) 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 problems that have occurred during perindopril (the active ingredient contained in Aceon) therapy include depression (2%) and, in less than 1% of patients, anxiety and psychosexual disorders.
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.
Other side effects associated with ACE inhibitors have included falls.
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