Trandolapril Side Effects

Brand Names: Mavik

Please note - some side effects for Trandolapril 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 Trandolapril - for the consumer

Trandolapril

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 Trandolapril:

Diarrhea; dizziness; fatigue; headache; indigestion; lightheadedness when sitting up or standing; muscle aches; nausea; persistent, dry cough; tiredness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fever; hoarseness; irregular or slow heartbeat; shortness of breath; sore throat; unusual stomach pain; yellowing of the skin or eyes.

Trandolapril/Verapamil

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 Trandolapril/Verapamil:

Diarrhea; dizziness; fatigue; headache; indigestion; lightheadedness when sitting up or standing; muscle aches; nausea; persistent, dry cough; tiredness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; fainting; fever; hoarseness; shortness of breath; sore throat; swelling of the hands or feet; unusual stomach pain; unusually fast, slow, or irregular heartbeat; yellowing of the skin or eyes.

For the professional

Trandolapril

The safety experience in U.S. placebo-controlled trials included 1067 hypertensive patients, of whom 831 received Trandolapril. Nearly 200 hypertensive patients received Trandolapril for over one year in open-label trials. In controlled trials, withdrawals for adverse events were 2.1% on placebo and 1.4% on Trandolapril. Adverse events considered at least possibly related to treatment occurring in 1% of Trandolapril-treated patients and more common on Trandolapril 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 Trandolapril-treated patients but were more frequently seen on placebo. Adverse events were not usually persistent or difficult to manage.

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 Trandolapril (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 postmarketing experience (the rarer events are in italics) include (listed by body system):

General Body Function: chest pain.

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

Central Nervous System: drowsiness, insomnia, paresthesia, vertigo.

Dermatologic: pruritus, rash, pemphigus.

Eye, Ear, Nose, Throat: epistaxis, throat inflammation, upper respiratory tract infection.

Emotional, Mental, Sexual States: anxiety, impotence, decreased libido.

Gastrointestinal: abdominal distention, abdominal pain/cramps, constipation, dyspepsia, diarrhea, vomiting, pancreatitis.

Hemopoietic: decreased leukocytes, decreased neutrophils.

Metabolism and Endocrine: increased creatinine, increased potassium, increased SGPT (ALT).

Musculoskeletal System: extremity pain, muscle cramps, gout.

Pulmonary: dyspnea.

Angioedema: Angioedema has been reported in 4 (0.13%) patients receiving Trandolapril 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 Trandolapril should be discontinued and appropriate therapy instituted immediately.

Hypotension: 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.

Fetal/Neonatal Morbidity and Mortality:

Cough:

Clinical Laboratory Test Findings

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

Hyperkalemia, hyponatremia.

Increases in creatinine levels occurred in 1.1% of patients receiving Trandolapril alone and 7.3% of patients treated with Trandolapril, a calcium ion antagonist and a diuretic. Increases in blood urea nitrogen levels occurred in 0.6% of patients receiving Trandolapril alone and 1.4% of patients receiving Trandolapril, 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.

Occasional elevation of transaminases at the rate of 3 times 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.

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

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