Univasc Side Effects
Generic Name: moexipril
Please note - some side effects for Univasc 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 Univasc - for the Consumer
Univasc
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 Univasc:
Seek medical attention right away if any of these SEVERE side effects occur when using Univasc:Diarrhea; dizziness; fatigue; flu-like symptoms; lightheadedness when sitting or standing; persistent, dry cough.
TopSevere allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty swallowing; fainting; unusual stomach pain; yellowing of the skin or eyes.
Univasc Side Effects - for the Professional
Univasc
Univasc® has been evaluated for safety in more than 2500 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 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 EVENT |
Univasc (N=674) |
PLACEBO (N=226) |
| N(%) | 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 3/1254 (0.24%) patients who had received Univasc® monotherapy and in 1/344 (0.3%) patients who had received Univasc® with hydrochlorothiazide. 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.
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, taste disturbances, tinnitus, sweating, malaise, arthralgia, hemolytic anemia.
Clinical Laboratory Test Findings
Serum ElectrolytesHyperkalemia, hyponatremia.
Creatinine and Blood Urea NitrogenAs 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.
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.
TopSide Effects by Body System
General
Based on limited data, moexipril 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 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 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 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.
TopMore resources:
Univasc - Includes detailed dosage instructions.
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