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Univasc

Last reviewed on RxList: 2/14/2017
Univasc Side Effects Center

Last reviewed on RxList 2/15/2016

Univasc (moexipril hydrochloride) is an ACE (angiotensin converting enzyme) inhibitor used to treat high blood pressure (hypertension). Univasc is available in generic form. Common side effects of Univasc include dizziness, lightheadedness, flushing, muscle aches, dry cough, or blurred vision as the body adjusts to the medication. Other side effects of Univasc include drowsiness, headache, sleep problems (insomnia), dry mouth, sore throat, vomiting, diarrhea, constipation, or skin itching or rash.

The recommended initial dose of Univasc in patients not receiving diuretics is 7.5 mg, one hour prior to meals, once daily. Dosage should be adjusted according to blood pressure response. The recommended dose range is 7.5 to 30 mg daily. Univasc may interact with gold injections to treat arthritis, lithium, potassium supplements, salt substitutes that contain potassium, or diuretics (water pills). Tell your doctor all medications and supplements you use. Univasc is not recommended for use during pregnancy due to the risk for harm to a fetus. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Univasc (moexipril hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

QUESTION

Salt and sodium are the same. See Answer
Univasc 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.

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--nausea, slow or unusual heart rate, weakness, loss of movement.

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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Univasc (Moexipril)

SLIDESHOW

How to Lower Blood Pressure: Exercise Tips See Slideshow
Univasc Professional Information

SIDE EFFECTS

univasc® has been evaluated for safety in more than 2 500 patients with hypertension; more than 2 50 of these patients were treated for approximately one year. The overall incidence of reported adverse events was only slightly greater in patients treated with univasc® than patients treated with placebo.

Reported adverse experiences were usually mild and transient, and there were no differences in adverse reaction rates related to gender, race, age, duration of therapy, or total daily dosage within the range of 3.75 mg to 60 mg. Discontinuation of therapy because of adverse experiences was required in 3.4% of patients treated with univasc® and in 1.8% of patients treated with placebo. The most common reasons for discontinuation in patients treated with univasc® were cough (0.7%) and dizziness (0.4%).

All adverse experiences considered at least possibly related to treatment that occurred at any dose in placebo-controlled trials of once-daily dosing in more than 1% of patients treated with univasc® alone and that were at least as frequent in the univasc® group as in the placebo group are shown in the following table:

ADVERSE EVENTS IN PLACEBO-CONTROLLED STUDIES

ADVERSE EVENT UNIVASC
(N=674)
N (%)
PLACEBO
(N=226)
N (%)
Cough Increased 41 (6.1) 5 (2.2)
Dizziness 29 (4.3) 5 (2.2)
Diarrhea 21 (3.1) 5 (2.2)
Flu Syndrome 21 (3.1) 0 (0)
Fatigue 16 (2.4) 4 (1.8)
Pharyngitis 12 (1.8) 2 (0.9)
Flushing 11 (1.6) 0 (0)
Rash 11 (1.6) 2 (0.9)
Myalgia 9 (1.3) 0 (0)

Other adverse events occurring in more than 1% of patients on moexipril that were at least as frequent on placebo include: headache, upper respiratory infection, pain, rhinitis, dyspepsia, nausea, peripheral edema, sinusitis, chest pain, and urinary frequency. See WARNINGS and PRECAUTIONS for discussion of anaphylactoid reactions, angioedema, hypotension, neutropenia/agranulocytosis, second and third trimester fetal/neonatal morbidity and mortality, hyperkalemia, and cough.

Other potentially important adverse experiences reported in controlled or uncontrolled clinical trials in less than 1% of moexipril patients or that have been attributed to other ACE inhibitors include the following:

Cardiovascular: Symptomatic hypotension, postural hypotension, or syncope were seen in 9/1750 (0.51%) patients; these reactions led to discontinuation of therapy in controlled trials in 3/12 54 (0.2 4%) patients who had received univasc® monotherapy and in 1/344 (0.3%) patients who had received univasc® with hydrochlorothiazide (see WARNINGS and PRECAUTIONS). Other adverse events included angina/myocardial infarction, palpitations, rhythm disturbances, and cerebrovascular accident.

Renal: Of hypertensive patients with no apparent preexisting renal disease, 1% of patients receiving univasc® alone and 2 % of patients receiving univasc® with hydrochlorothiazide experienced increases in serum creatinine to at least 140% of their baseline values (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).

Gastrointestinal: Abdominal pain, constipation, vomiting, appetite/weight change, dry mouth, pancreatitis, hepatitis.

Respiratory: Bronchospasm, dyspnea, eosinophilic pneumonitis.

Urogenital: Renal insufficiency, oliguria.

Dermatologic: Apparent hypersensitivity reactions manifested by urticaria, rash, pemphigus, pruritus, photosensitivity, alopecia.

Neurological and Psychiatric: Drowsiness, sleep disturbances, nervousness, mood changes, anxiety.

Other: Angioedema (see WARNINGS), taste disturbances, tinnitus, sweating, malaise, arthralgia, hemolytic anemia.

Clinical Laboratory Test Findings

Serum Electrolytes

Hyperkalemia (see PRECAUTIONS), hyponatremia.

Creatinine and Blood Urea Nitrogen

As with other ACE inhibitors, minor increases in blood urea nitrogen or serum creatinine, reversible upon discontinuation of therapy, were observed in approximately 1% of patients with essential hypertension who were treated with univasc®. Increases are more likely to occur in patients receiving concomitant diuretics and in patients with compromised renal function (see PRECAUTIONS, General).

Other (causal relationship unknown)

Clinically important changes in standard laboratory tests were rarely associated with univasc® administration.

Elevations of liver enzymes and uric acid have been reported. In trials, less than 1% of moexipril-treated patients discontinued univasc® treatment because of laboratory abnormalities. The incidence of abnormal laboratory values with moexipril was similar to that in the placebo-treated group.

Read the entire FDA prescribing information for Univasc (Moexipril)

Related Resources for Univasc

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Read the Univasc User Reviews »

© Univasc Patient Information is supplied by Cerner Multum, Inc. and Univasc Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

Salt and sodium are the same. See Answer

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