Side Effects > Mavik

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).

For the consumer Mavik For the professional Mavik

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:

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

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

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.

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For the professional

Mavik

The safety experience in U.S. placebo-controlled trials included 1067 hypertensive patients, of whom 831 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.

ADVERSE EVENTS IN PLACEBO-CONTROLLED HYPERTENSION TRIALS

	Occurring at 1% or greater
	Mavik (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 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.

Percentage of Patients with Adverse Events Greater Than Placebo

Placebo-Controlled (TRACE) Mortality Study
Adverse Event	Trandolapril N=876	Placebo N=873
Cough	35	22
Dizziness	23	17
Hypotension	11	6.8
Elevated serum uric acid	15	13
Elevated BUN	9.0	7.6
PICA or CABG	7.3	6.1
Dyspepsia	6.4	6.0
Syncope	5.9	3.3
Hyperkalemia	5.3	2.8
Bradycardia	4.7	4.4
Hypocalcemia	4.7	3.9
Myalgia	4.7	3.1
Elevated creatinine	4.7	2.4
Gastritis	4.2	3.6
Cardiogenic shock	3.8	< 2
Intermittent claudication	3.8	< 2
Stroke	3.3	3.2
Asthenia	3.3	2.6

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

General Body Function

Chest pain, malaise, allergic hypersensitivity reactions, 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 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.

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 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.

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