Trandolapril Side Effects

Some side effects of trandolapril 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 trandolapril: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking trandolapril: hives; difficult breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.

Call your doctor at once if you have:

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

• little or no urinating;

• swelling, weight gain, feeling short of breath;

• chest pain, pounding heartbeats or fluttering in your chest;

• fever, chills, body aches, flu symptoms;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

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

• low calcium (numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes).

Common side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;

• cough;

• muscle pain;

• dizziness, drowsiness, headache;

• sleep problems (insomnia);

• upset stomach, diarrhea, constipation; 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 trandolapril: oral tablet

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. Postmarketing reports of malaise and fever were reported in clinical trials.

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, wheezing, and bronchitis. Postmarketing reports have included bronchitis.

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. Postmarketing reports have included cerebral hemorrhage.

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. Postmarketing side effects include myocardial infarction, myocardial ischemia, angina pectoris, cardiac failure, ventricular tachycardia, tachycardia, transient ischemic attack, and arrhythmia.

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. Postmarketing reports have included dry mouth and pancreatitis.

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. Postmarketing reports have included renal failure, elevated creatinine, and elevated blood urea nitrogen.

Hypersensitivity

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.

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.

Metabolic

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

Hematologic

Hematologic side effects rarely associated with some ACE inhibitors include agranulocytosis and bone marrow depression. Postmarketing reports have included thrombocytopenia, agranulocytosis and pancytopenia.

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. Postmarketing clinical trials revealed reports of increased SGOT (AST). Other postmarketing reports include elevated liver transaminases, elevated bilirubin, jaundice and hepatitis.

Dermatologic

Dermatologic side effects have included postmarketing reports of alopecia, sweating, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Psychiatric

Psychiatric side effects have included postmarketing reports of hallucination and depression.

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