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Mavik

Last reviewed on RxList: 4/6/2016
Mavik Side Effects Center

Last reviewed on RxList 01/26/2017

Mavik (trandolapril) is an ACE (angiotensin converting enzyme) inhibitor used to treat high blood pressure (hypertension), and to improve survival after a heart attack. Mavik is available in generic form. Common side effects of Mavik include:

  • dizziness,
  • drowsiness,
  • lightheadedness,
  • diarrhea,
  • dry cough, or
  • blurred vision as your body adjusts to the medication.

Other side effects of Mavik include:

Tell your doctor if you have unlikely but serious side effects of Mavik including:

  • fainting,
  • decreased sexual ability,
  • symptoms of a high potassium blood level (such as muscle weakness, slow or irregular heartbeat),
  • changes in the amount of urine, or
  • signs of infection (e.g., fever, chills, persistent sore throat).

To treat hypertension, the recommended initial dosage of Mavik for patients not receiving a diuretic is 1 or 2 mg once daily. Most patients require dosages of 2 to 4 mg once daily. Following a heart attack, the recommended starting dose is 1 mg, once daily, adjusted toward a target dose of 4 mg, once daily. Mavik may interact with gold injections to treat arthritis, lithium, potassium supplements, salt substitutes that contain potassium, or diuretics (water pills). Tell your doctor all medications and supplements you use. Mavik is not recommended for use during pregnancy due to the risk for harm to a fetus. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Mavik (trandolapril) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Mavik Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: 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 serious side effect such as:

  • urinating less than usual, or not at all;
  • swelling, weight gain, feeling short of breath;
  • feeling like you might pass out;
  • chest pain, trouble breathing;
  • 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).

Less serious 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Mavik (Trandolapril)

Mavik Professional Information

SIDE EFFECTS

The safety experience in U.S. placebo-controlled trials included 1069 hypertensive patients, of whom 832 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 include (listed by body system):

General Body Function

Chest pain.

Cardiovascular

AV first degree block, bradycardia, edema, flushing, and 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, nausea.

Hemopoietic

Decreased leukocytes, decreased neutrophils.

Metabolism and Endocrine

Increased liver enzymes including SGPT (ALT).

Musculoskeletal System

Extremity pain, muscle cramps, gout.

Pulmonary

Dyspnea.

Postmarketing

The following adverse reactions were identified during post approval use of MAVIK. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General Body Function

Malaise, fever.

Cardiovascular

Myocardial infarction, myocardial ischemia, angina pectoris, cardiac failure, ventricular tachycardia, tachycardia, transient ischemic attack, arrhythmia.

Central Nervous System

Cerebral hemorrhage.

Dermatologic

Alopecia, sweating, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Emotional, Mental, Sexual States

Hallucination, depression.

Gastrointestinal

Dry mouth, pancreatitis, jaundice and hepatitis.

Hemopoietic

Agranulocytosis, pancytopenia.

Metabolism and Endocrine

Increased SGOT (AST).

Pulmonary

Bronchitis.

Renal and Urinary

Renal failure.

Clinical Laboratory Test Findings

Hematology
Thrombocytopenia.
Serum Electrolytes
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. (see PRECAUTIONS and WARNINGS.)

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.

Read the entire FDA prescribing information for Mavik (Trandolapril)

Related Resources for Mavik

Read the Mavik User Reviews »

© Mavik Patient Information is supplied by Cerner Multum, Inc. and Mavik Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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