Univasc Side Effects

Generic name: moexipril

Note: This document contains side effect information about moexipril. Some of the dosage forms listed on this page may not apply to the brand name Univasc.

Some side effects of Univasc 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 moexipril: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking moexipril (the active ingredient contained in Univasc) hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• sudden weakness or ill feeling, fever, chills, sore throat, painful mouth sores, cough, trouble breathing;

• little or no urinating; or

• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).

Common side effects may include:

• cough, runny or stuffy nose;

• headache, dizziness, tired feeling;

• increased urination;

• diarrhea;

• muscle pain; or

• mild skin itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to moexipril: oral tablet

General

Based on limited data, moexipril (the active ingredient contained in Univasc) appears to be generally well-tolerated. Moexipril has been evaluated for safety in more than 2,500 patients with hypertension; more than 250 of these patients were treated for approximately one year. The overall incidence of reported adverse events was only slightly greater in patients treated with moexipril than patients treated with placebo. Less than 4% of patients discontinued therapy due to adverse events.

Cardiovascular

Cardiovascular side effects include symptomatic hypotension, postural hypotension, or syncope in 0.5% of patients. Less commonly associated with moexipril (the active ingredient contained in Univasc) are angina/myocardial infarction, palpitations, rhythm disturbances, and cerebrovascular accidents. Angioedema is a rare side effect that indicates a need to discontinue therapy.

Renal

Renal side effects have included new or worsened renal insufficiency, defined as an increase in serum creatinine to at least 140% of baseline value, reported in 1% and 2% of patients taking moexipril (the active ingredient contained in Univasc) and hydrochlorothiazide-moexipril, respectively.

Gastrointestinal

Gastrointestinal side effects are uncommon, and include abdominal pain, constipation, vomiting, appetite or weight changes, dry mouth, and rare cases of pancreatitis and hepatitis. While elevations of liver enzymes have been reported, the overall incidence of abnormal laboratory values associated with moexipril (the active ingredient contained in Univasc) has been similar to that in placebo-treated groups.

Respiratory

Respiratory side effects have commonly included cough in up to 6% of patients. Cough is the most common reason patients have discontinued therapy. Other respiratory system side effects have included dyspnea and wheezing.

A retrospective study has revealed a significantly higher incidence of discontinuation of angiotensin converting enzyme 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.

Hypersensitivity

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.

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 also been associated with moexipril.

Nervous system

Nervous system side effects include drowsiness, sleep or taste disturbances, headache, nervousness, mood changes, tinnitus, and anxiety.

Hematologic

Hematologic problems include rare cases of hemolytic anemia. The use of some ACE inhibitors has been associated with agranulocytosis and bone marrow depression.

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 < 500/mm3) among treated patients, monitoring of white blood cells should be considered for those patients at higher risk.

Hepatic

Hepatic side effects associated with the use of ACE inhibitors have included a rare syndrome that begins with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. Experts recommend discontinuation of therapy with this drug if jaundice or markedly elevated hepatic serum enzymes develop.

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