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Mavik

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Mavik

Mavik

Mavik Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Mavik (trandolapril) is used to treat high blood pressure (hypertension), and to improve survival after a heart attack. It is an ACE (angiotensin converting enzyme) inhibitor. This medication is available in generic form. Common side effects include dizziness, light-headedness, diarrhea, dry cough or blurred vision as your body adjusts to the medication.

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 breast-feeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Mavik in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Mavik Overview - Patient Information: Side Effects

SIDE EFFECTS: You may experience dizziness, light-headedness, diarrhea, dry cough or blurred vision as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, decreased sexual ability.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: change in the amount of urine, signs of infection (e.g., fever, chills, persistent sore throat).

This drug may rarely cause serious (possibly fatal) liver problems. If you notice any of the following highly unlikely but very serious side effects, seek immediate medical attention: yellowing eyes or skin, dark urine, stomach/abdominal pain, persistent fatigue, persistent nausea.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Mavik (Trandolapril)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Mavik FDA Prescribing Information: Side Effects
(Adverse Reactions)

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

Adverse Event Placebo-Controlled (TRACE) Mortality Study
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) »

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Mavik - User Reviews

Mavik User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Mavik sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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