Perindopril Side Effects

Brand Names: Aceon

Please note - some side effects for Perindopril 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 Perindopril - for the Consumer

Perindopril

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 Perindopril:

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.

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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