Mavik Side Effects
Generic Name: trandolapril
Note: This page contains information about the side effects of trandolapril. Some of the dosage forms included on this document may not apply to the brand name Mavik.
Not all side effects for Mavik may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to trandolapril: oral capsule, oral tablet
In addition to its needed effects, some unwanted effects may be caused by trandolapril (the active ingredient contained in Mavik). In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking trandolapril:More common
- Abdominal or stomach pain
- blurred vision
- difficult breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- irregular heartbeat
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- shortness of breath
- unusual tiredness or weakness
- weakness or heaviness of the legs
- Abdominal or stomach cramps
- chest pain or discomfort
- cool, sweaty skin
- difficulty speaking
- double vision
- inability to move the arms, legs, or facial muscles
- muscle cramps in the hands, arms, feet, legs, or face
- numbness and tingling around the mouth, fingertips, or feet
- slow heartbeat
Some of the side effects that can occur with trandolapril may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
- Acid or sour stomach
- stomach discomfort or upset
- Burning feeling in the chest or stomach
- difficulty with moving
- joint pain
- muscle aches, pain, or stiffness
- swollen joints
- tenderness in the stomach area
For Healthcare Professionals
Applies to trandolapril: oral tablet
Based on limited data, trandolapril (the active ingredient contained in Mavik) 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. Postmarketing reports of malaise and fever were reported in clinical trials.
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, wheezing, and bronchitis. Postmarketing reports have included bronchitis.
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. Postmarketing reports have included cerebral hemorrhage.
Angina pectoris has been reported in as many as 36% of patients in the Trandolapril (the active ingredient contained in Mavik) 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. Postmarketing side effects include myocardial infarction, myocardial ischemia, angina pectoris, cardiac failure, ventricular tachycardia, tachycardia, transient ischemic attack, and arrhythmia.
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. Postmarketing reports have included dry mouth and pancreatitis.
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. Postmarketing reports have included renal failure, elevated creatinine, and elevated blood urea nitrogen.
Angioedema associated with laryngeal edema can be fatal. If laryngeal stridor or angioedema of the face, tongue or glottis occurs, trandolapril (the active ingredient contained in Mavik) 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 side effects including mild hyperkalemia, the result of inhibition of aldosterone secretion, has been reported. Postmarketing reports include hyponatremia.
Hematologic side effects rarely associated with some ACE inhibitors include agranulocytosis and bone marrow depression. Postmarketing reports have included thrombocytopenia, agranulocytosis and pancytopenia.
Musculoskeletal pains have rarely been associated with trandolapril (the active ingredient contained in Mavik)
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. Postmarketing clinical trials revealed reports of increased SGOT (AST). Other postmarketing reports include elevated liver transaminases, elevated bilirubin, jaundice and hepatitis.
Dermatologic side effects have included postmarketing reports of alopecia, sweating, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Psychiatric side effects have included postmarketing reports of hallucination and depression.
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