Mavik Side Effects

Generic Name: trandolapril

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

Mavik

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 Mavik:

Cough; diarrhea; dizziness; stomach upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; dark urine; decreased urination; difficulty swallowing; fast, slow, or irregular heartbeat; muscle pain or cramping; numbness of an arm or a leg; one-sided weakness; shortness of breath; slurred speech; stomach pain (with or without nausea or vomiting); symptoms of infection (eg, fever, chills, persistent sore throat); symptoms of low blood pressure (eg, fainting, severe dizziness, lightheadedness); yellowing of the skin or eyes.

Mavik Side Effects - for the Professional

Mavik

The safety experience in U.S. placebo-controlled trials included 1069 hypertensive patients, of whom 832 received Mavik. Nearly 200 hypertensive patients received Mavik for over one year in open-label trials. In controlled trials, withdrawals for adverse events were 2.1% on placebo and 1.4% on Mavik. Adverse events considered at least possibly related to treatment occurring in 1% of Mavik-treated patients and more common on Mavik than placebo, pooled for all doses, are shown below, together with the frequency of discontinuation of treatment because of these events.

Headache and fatigue were all seen in more than 1% of Mavik-treated patients but were more frequently seen on placebo. Adverse events were not usually persistent or difficult to manage.

Left Ventricular Dysfunction Post Myocardial Infarction

Adverse reactions related to Mavik occurring at a rate greater than that observed in placebo-treated patients with left ventricular dysfunction, are shown below. The incidences represent the experiences from the TRACE study. The follow-up time was between 24 and 50 months for this study.

Clinical adverse experiences possibly or probably related or of uncertain relationship to therapy occurring in 0.3% to 1.0% (except as noted) of the patients treated with Mavik (with or without concomitant calcium ion antagonist or diuretic) in controlled or uncontrolled trials (N=1134) and less frequent, clinically significant events seen in clinical trials or post-marketing experience include (listed by body system):

Chest pain, malaise, fever.

AV first degree block, bradycardia, edema, flushing, hypotension, palpitations.

Drowsiness, insomnia, paresthesia, vertigo.

Pruritus, rash, pemphigus, alopecia, sweating.

Epistaxis, throat inflammation, upper respiratory tract infection.

Anxiety, impotence, decreased libido.

Abdominal distention, abdominal pain/cramps, constipation, dyspepsia, diarrhea, vomiting, nausea, dry mouth, pancreatitis.

Agranulocytosis, decreased leukocytes, decreased neutrophils.

Increased creatinine, increased potassium, increased liver enzymes including SGPT (ALT) and increased SGOT (AST).

Extremity pain, muscle cramps, gout.

Dyspnea, bronchitis.

Angioedema has been reported in 4 (0.13%) patients receiving Mavik in U.S. and foreign studies. Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis, and/or larynx occurs, treatment with Mavik should be discontinued and appropriate therapy instituted immediately.

In hypertensive patients, symptomatic hypotension occurred in 0.6% and near syncope occurred in 0.2%. Hypotension or syncope was a cause for discontinuation of therapy in 0.1% of hypertensive patients.

Hematology

Low white blood cells, low neutrophils, low lymphocytes, thrombocytopenia.

Serum Electrolytes

Hyperkalemia, hyponatremia.

Creatinine and Blood Urea Nitrogen

Increases in creatinine levels occurred in 1.1% of patients receiving Mavik alone and 7.3% of patients treated with Mavik, a calcium ion antagonist and a diuretic. Increases in blood urea nitrogen levels occurred in 0.6% of patients receiving Mavik alone and 1.4% of patients receiving Mavik, a calcium ion antagonist, and a diuretic. None of these increases required discontinuation of treatment. Increases in these laboratory values are more likely to occur in patients with renal insufficiency or those pretreated with a diuretic and, based on experience with other ACE inhibitors, would be expected to be especially likely in patients with renal artery stenosis.

Liver Function Tests

Occasional elevation of transaminases at the rate of 3X upper normals occurred in 0.8% of patients and persistent increase in bilirubin occurred in 0.2% of patients. Discontinuation for elevated liver enzymes occurred in 0.2% of patients.

Other

Another potentially important adverse experience, eosinophilic pneumonitis, has been attributed to other ACE inhibitors.

Side Effects by Body System

General

Based on limited data, trandolapril appears to be generally well-tolerated. Trandolapril has been evaluated for safety in more than 2,200 patients with mild to moderate hypertension and has demonstrated a side effect profile similar to other angiotensin converting enzyme (ACE) inhibitors. The overall incidence of reported adverse events from large multicenter trials ranged from 4% to 11%. Most side effects have been described as "mild" and "transient". Approximately 3% to 8% of patients discontinued therapy due to adverse events.

Respiratory

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.

Respiratory side effects including cough is observed in up to 4% of patients. Other respiratory complaints include dyspnea and wheezing.

Nervous system

Nervous system side effects include headache, dizziness (probably symptomatic hypotension), weakness, sleep disturbances, taste disturbances, nervousness, mood changes, tinnitus, asthenia, and anxiety in approximately 2% of patients.

Cardiovascular

Angina pectoris has been reported in as many as 36% of patients in the Trandolapril Cardiac Evaluation (TRACE) study, but the incidence of underlying coronary artery disease (patients with a history of myocardial infarction) in the patient population studied was essentially 100%. The incidence of angina pectoris among placebo patients in the TRACE study was 38% (not significantly different).

Cardiovascular side effects include peripheral edema in 3% of patients and symptomatic hypotension, postural hypotension, or syncope in 1% to 31% of patients. Angina or myocardial infarction, palpitations, rhythm disturbances, or cerebrovascular accidents have been reported in approximately 0.5% of patients. Angioedema is a rare side effect that indicates discontinuation of therapy.

Gastrointestinal

Gastrointestinal side effects are uncommon. Reported effects include nausea in 3% of patients and abdominal pain, constipation, vomiting, appetite or weight changes, and dry mouth in approximately 0.5% of patients.

Renal

Renal side effects including new or worsened renal insufficiency has been associated with the use of ACE inhibitors, particularly in patients with underlying cardiovascular or renal disease.

Hypersensitivity

Angioedema associated with laryngeal edema can be fatal. If laryngeal stridor or angioedema of the face, tongue or glottis occurs, trandolapril should be discontinued immediately, the patient treated in accordance with accepted medical care and carefully observed until the swelling disappears. In cases where the swelling is confined to the face and lips, the condition generally resolves without treatment; antihistamines may be useful in relieving symptoms. Where there is involvement of the tongue, glottis, or larynx, likely to cause airway obstruction, emergency therapy, including, but not limited to subcutaneous epinephrine solution 1:1000 (0.3 to 0.5 mL) should be administered promptly.

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 been reported in less than 1% of patients.

Metabolic

Metabolic side effects including mild hyperkalemia, the result of inhibition of aldosterone secretion, has been reported.

Hematologic

Hematologic side effects rarely associated with some ACE inhibitors include agranulocytosis and bone marrow depression.

Musculoskeletal

Musculoskeletal pains have rarely been associated with trandolapril.

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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