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Vasotec

Last reviewed on RxList: 9/28/2015
Vasotec Side Effects Center

Last reviewed on RxList 9/29/2016

Vasotec (enalapril maleate) is an ACE (angiotensin converting enzyme) inhibitor used to treat high blood pressure (hypertension), congestive heart failure, kidney problems caused by diabetes, and to improve survival after a heart attack. Vasotec is available in generic form. Common side effects of Vasotec include:

  • dizziness,
  • lightheadedness, or
  • weakness as your body adjusts to the medication.
  • Other side effects of Vasotec include dry cough,
  • loss of taste sensation,
  • loss of appetite,
  • drowsiness,
  • headache,
  • sleep problems (insomnia),
  • dry mouth,
  • nausea,
  • vomiting,
  • diarrhea, or
  • skin itching or rash.

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

  • 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), or
  • changes in the amount of urine.

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 breastfeeding.

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.

Vasotec Consumer Information

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)

Vasotec Professional Information

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) 0.0
  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).

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Read the entire FDA prescribing information for Vasotec (Enalapril)

Related Resources for Vasotec

Read the Vasotec User Reviews »

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

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