Enalapril Maleate (Page 6 of 8)

Heart Failure

Adverse experiences occurring in greater than 1% of patients with heart failure treated with enalapril are shown below. The incidences represent the experiences from both controlled and uncontrolled clinical trials (maximum duration of therapy was approximately 1 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% and 43% for patients treated with enalapril and placebo, respectively.

Enalapril Maleate (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)

2.1

Fatigue

1.8 (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)

0.9

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)

0.6

Bronchitis

1.3 (0)

0.9

Dyspnea

1.3 (0.1)

0.4

Pneumonia

1 (0)

2.4

Skin

Rash

1.3 (0)

2.4

Urogenital

Urinary Tract Infection

1.3 (0)

2.4

Other serious clinical adverse experiences occurring since the drug was marketed or adverse experiences occurring in 0.5% to 1% 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 enalapril, 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 enalapril should be discontinued and appropriate therapy instituted immediately. (See WARNINGS.)

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

Cough: See PRECAUTIONS: Cough.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.