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Vasotec

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Vasotec

Vasotec Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Vasotec (enalapril maleate) is used to treat high blood pressure (hypertension), congestive heart failure, kidney problems caused by diabetes, 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, lightheadedness, or weakness as your body adjusts to the medication. Dry cough may also occur.

Dose of Vasotec varies depending on the condition being treated. Vasotec may interact with gold injections to treat arthritis, lithium, potassium supplements, salt substitutes that contain potassium, aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs), or diuretics (water pills). Tell your doctor all medications and supplements you use. Vasotec is not recommended for use during pregnancy. It may harm a fetus. This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Our Vasotec (enalapril maleate) 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.

Vasotec 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; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • urinating more or less than usual, or not at all;
  • swelling, rapid weight gain;
  • weakness, confusion, increased thirst, loss of appetite, vomiting, pounding heartbeats or fluttering in your chest;
  • fever, chills, body aches, flu symptoms;
  • pale skin, easy bruising or bleeding;
  • fast or uneven heartbeats;
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
  • chest pain; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • cough;
  • loss of taste sensation, loss of appetite;
  • dizziness, drowsiness, headache;
  • sleep problems (insomnia);
  • dry mouth;
  • nausea, vomiting, diarrhea; 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 Vasotec (Enalapril) »

What is Patient Information Overview?

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

Vasotec Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, lightheadedness, or weakness may occur as your body adjusts to the medication. Dry cough may also occur. If any of these effects persist or worsen, tell 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 right away if any of these unlikely but serious side effects occur: fainting, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), signs of infection (such as fever, chills, persistent sore throat), change in the amount of urine.

This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor right away if you notice any of the following rare but serious side effects: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 Vasotec (Enalapril)»

What is Prescribing information?

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

Vasotec FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

VASOTEC has been evaluated for safety in more than 10,000 patients, including over 1000 patients treated for one year or more. VASOTEC has been found to be generally well tolerated in controlled clinical trials involving 2987 patients. For the most part, adverse experiences were mild and transient in nature. In clinical trials, discontinuation of therapy due to clinical adverse experiences was required in 3.3 percent of patients with hypertension and in 5.7 percent of patients with heart failure. The frequency of adverse experiences was not related to total daily dosage within the usual dosage ranges. In patients with hypertension the overall percentage of patients treated with VASOTEC reporting adverse experiences was comparable to placebo.

Hypertension

Adverse experiences occurring in greater than one percent of patients with hypertension treated with VASOTEC in controlled clinical trials are shown below. In patients treated with VASOTEC, the maximum duration of therapy was three years; in placebo treated patients the maximum duration of therapy was 12 weeks.

  VASOTEC
(n=2314) Incidence (discontinuation)
Placebo
(n=230) Incidence
Body As A Whole
  Fatigue 3.0 ( < 0.1) 2.6
  Orthostatic Effects 1.2 ( < 0.1) 0
  Asthenia 1.1 (0.1) 0.9
Digestive
  Diarrhea 1.4 ( < 0.1) 1.7
  Nausea 1.4 (0.2) 1.7
Nervous/Psychiatric
  Headache 5.2 (0.3) 9.1
  Dizziness 4.3 (0.4) 4.3
Respiratory
  Cough 1.3 (0.1) 0.9
Skin
  Rash 1.4 (0.4) 0.4

Heart Failure

Adverse experiences occurring in greater than one percent of patients with heart failure treated with VASOTEC are shown below. The incidences represent the experiences from both controlled and uncontrolled clinical trials (maximum duration of therapy was approximately one year). In the placebo treated patients, the incidences reported are from the controlled trials (maximum duration of therapy is 12 weeks). The percentage of patients with severe heart failure (NYHA Class IV) was 29 percent and 43 percent for patients treated with VASOTEC and placebo, respectively.

  VASOTEC
(n=673) Incidence (discontinuation)
Placebo
(n=339) Incidence
Body As A Whole
  Orthostatic Effects 2.2 (0.1) 0.3
  Syncope 2.2 (0.1) 0.9
  Chest Pain 2.1 (0.0) 2.1
  Fatigue 1.8 (0.0) 1.8
  Abdominal Pain 1.6 (0.4) 2.1
  Asthenia 1.6 (0.1) 0.3
Cardiovascular
  Hypotension   6.7 (1.9) 0.6
  Orthostatic Hypotension 1.6 (0.1) 0.3
  Angina Pectoris 1.5 (0.1) 1.8
  Myocardial Infarction 1.2 (0.3) 1.8
Digestive
  Diarrhea 2.1 (0.1) 1.2
  Nausea 1.3 (0.1) 0.6
  Vomiting 1.3 (0.0) 0.9
Nervous/Psychiatric
  Dizziness 7.9 (0.6) 0.6
  Headache 1.8 (0.1) 0.9
  Vertigo 1.6 (0.1) 1.2
Respiratory
  Cough 2.2 (0.0) 0.6
  Bronchitis 1.3 (0.0) 0.9
  Dyspnea 1.3 (0.1) 0.4
  Pneumonia 1.0 (0.0) 2.4
Skin
  Rash 1.3 (0.0) 2.4
Urogenital
  Urinary Tract Infection 1.3 (0.0) 2.4

Other serious clinical adverse experiences occurring since the drug was marketed or adverse experiences occurring in 0.5 to 1.0 percent of patients with hypertension or heart failure in clinical trials are listed below and, within each category, are in order of decreasing severity.

Body As A Whole: Anaphylactoid reactions (see WARNINGS, Anaphylactoid and Possibly Related Reactions).

Cardiovascular: Cardiac arrest; myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high risk patients (see WARNINGS, Hypotension); pulmonary embolism and infarction; pulmonary edema; rhythm disturbances including atrial tachycardia and bradycardia; atrial fibrillation; palpitation, Raynaud's phenomenon.

Digestive: Ileus, pancreatitis, hepatic failure, hepatitis (hepatocellular [proven on rechallenge] or cholestatic jaundice) (see WARNINGS, Hepatic Failure), melena, anorexia, dyspepsia, constipation, glossitis, stomatitis, dry mouth.

Hematologic: Rare cases of neutropenia, thrombocytopenia and bone marrow depression.

Musculoskeletal: Muscle cramps.

Nervous/Psychiatric: Depression, confusion, ataxia, somnolence, insomnia, nervousness, peripheral neuropathy (e.g., paresthesia, dysesthesia), dream abnormality.

Respiratory: Bronchospasm, rhinorrhea, sore throat and hoarseness, asthma, upper respiratory infection, pulmonary infiltrates, eosinophilic pneumonitis.

Skin: Exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, pemphigus, herpes zoster, erythema multiforme, urticaria, pruritus, alopecia, flushing, diaphoresis, photosensitivity.

Special Senses: Blurred vision, taste alteration, anosmia, tinnitus, conjunctivitis, dry eyes, tearing.

Urogenital: Renal failure, oliguria, renal dysfunction (see PRECAUTIONS and DOSAGE AND ADMINISTRATION), flank pain, gynecomastia, impotence.

Miscellaneous: A symptom complex has been reported which may include some or all of the following: a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia/myositis, fever, serositis, vasculitis, leukocytosis, eosinophilia, photosensitivity, rash and other dermatologic manifestations.

Angioedema: Angioedema has been reported in patients receiving VASOTEC, with an incidence higher in black than in non-black patients. Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis and/or larynx occurs, treatment with VASOTEC should be discontinued and appropriate therapy instituted immediately (see WARNINGS).

Hypotension: In the hypertensive patients, hypotension occurred in 0.9 percent and syncope occurred in 0.5 percent of patients following the initial dose or during extended therapy. Hypotension or syncope was a cause for discontinuation of therapy in 0.1 percent of hypertensive patients. In heart failure patients, hypotension occurred in 6.7 percent and syncope occurred in 2.2 percent of patients. Hypotension or syncope was a cause for discontinuation of therapy in 1.9 percent of patients with heart failure (see WARNINGS).

Cough: See PRECAUTIONS, Cough.

Pediatric Patients

The adverse experience profile for pediatric patients appears to be similar to that seen in adult patients.

Clinical Laboratory Test Findings

Serum Electrolytes

Hyperkalemia (see PRECAUTIONS), hyponatremia.

Creatinine, Blood Urea Nitrogen

In controlled clinical trials minor increases in blood urea nitrogen and serum creatinine, reversible upon discontinuation of therapy, were observed in about 0.2 percent of patients with essential hypertension treated with VASOTEC alone. Increases are more likely to occur in patients receiving concomitant diuretics or in patients with renal artery stenosis (see PRECAUTIONS). In patients with heart failure who were also receiving diuretics with or without digitalis, increases in blood urea nitrogen or serum creatinine, usually reversible upon discontinuation of VASOTEC and/or other concomitant diuretic therapy, were observed in about 11 percent of patients. Increases in blood urea nitrogen or creatinine were a cause for discontinuation in 1.2 percent of patients.

Hematology

Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.3 g percent and 1.0 vol percent, respectively) occur frequently in either hypertension or congestive heart failure patients treated with VASOTEC but are rarely of clinical importance unless another cause of anemia coexists. In clinical trials, less than 0.1 percent of patients discontinued therapy due to anemia. Hemolytic anemia, including cases of hemolysis in patients with G-6-PD deficiency, has been reported; a causal relationship to enalapril cannot be excluded.

Liver Function Tests

Elevations of liver enzymes and/or serum bilirubin have occurred (see WARNINGS, Hepatic Failure).

Read the entire FDA prescribing information for Vasotec (Enalapril) »

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Vasotec - User Reviews

Vasotec 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 Vasotec 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.


Hypertension

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