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.

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:

Cough; diarrhea; dizziness; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur when using Trandolapril:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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; lightheadedness when sitting up or standing; nausea; persistent, dry cough; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur when using Trandolapril/Verapamil:

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

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Top

Trandolapril Side Effects - for the Professional

Trandolapril

The safety experience in U.S. placebo-controlled trials included 1069 hypertensive patients, of whom 832 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.

ADVERSE EVENTS IN PLACEBO-CONTROLLED HYPERTENSION TRIALS

	Occurring at 1% or greater Trandolapril (N = 832) % Incidence (% Discontinuance)	PLACEBO (N = 237) % Incidence (% Discontinuance)
Cough	1.9 (0.1)	0.4 (0.4)
Dizziness	1.3 (0.2)	0.4 (0.4)
Diarrhea	1.0 (0.0)	0.4 (0.0)

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 include (listed by body system):

General Body Function: chest pain, malaise, fever.

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

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

Dermatologic: pruritus, rash, pemphigus, alopecia, sweating.

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, nausea, dry mouth, pancreatitis.

Hemopoietic: agranulocytosis, decreased leukocytes, decreased neutrophils.

Metabolism and Endocrine: increased creatinine, increased potassium, increased liver enzymes including SGPT (ALT) and increased SGOT (AST).

Musculoskeletal System: extremity pain, muscle cramps, gout.

Pulmonary: dyspnea, bronchitis.

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

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 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.

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.

Top

Side Effects by Body System - for Healthcare Professionals

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

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

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.

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

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.

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).

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. Postmarketing clinical trials revealed reports of increased SGOT (AST).

Dermatologic

Dermatologic side effects reported in postmarketing trials have included alopecia and sweating.

Top

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.