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Enalapril (Enalapril Maleate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTION

Enalapril maleate has been evaluated for safety in more than 10,000 patients, including over 1000 patients treated for one year or more. Enalapril maleate has been found to be generally well tolerated in conrolled 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 enalapril maleate reporting adverse experiences was comparable to placebo.

HYPERTENSION

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

HEART FAILURE

Adverse experiences occurring in greater than one percent of patients with heart failure treated with enalapril maleate 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 enalapril maleate and placebo, respectively.

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 enalapril maleate with an incidence higher in black than in nonblack 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 maleate 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.)

Fetal/Neonatal Morbidity and Mortality: See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

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 enalapril maleate 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 enalapril maleate 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 enalapril maleate 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).



REPORTS OF SUSPECTED ENALAPRIL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Enalapril. The information is not vetted and should not be considered as verified clinical evidence.

Possible Enalapril side effects / adverse reactions in 21 year old male

Reported by a physician from Brazil on 2011-10-28

Patient: 21 year old male

Reactions: Proteinuria, Blood Potassium Increased, Blood Creatinine Increased

Suspect drug(s):
Spironolactone
    Dosage: 80 mg, 2x/day
    Start date: 2010-12-01
    End date: 2011-06-01

Enalapril
    Dosage: 60 mg, 3x/day

Spironolactone
    Dosage: 25 mg, unk
    End date: 2010-12-01



Possible Enalapril side effects / adverse reactions in 77 year old male

Reported by a physician from Brazil on 2011-10-28

Patient: 77 year old male weighing 81.0 kg (178.2 pounds)

Reactions: Overweight, Blood Triglycerides Increased, Hypertension, Diabetes Mellitus Inadequate Control

Suspect drug(s):
Enalapril
    Dosage: 10 mg, 1x/day

Metformin HCL

Insulin
    Dosage: 6 iu, 2x/day

Enalapril
    Dosage: unk

NPH Insulin
    Dosage: 30 iu in the morning and 10 iu at bedtime

Insulin
    Dosage: 8 iu, before breakfast and before dinner

Atorvastatin Calcium
    Dosage: 20 mg, unk

Other drugs received by patient: Acetylsalicylic Acid; Cilostazol



Possible Enalapril side effects / adverse reactions in 76 year old male

Reported by a physician from Japan on 2011-12-19

Patient: 76 year old male

Reactions: Dehydration, Blood Pressure Decreased, Acute Prerenal Failure

Adverse event resulted in: hospitalization

Suspect drug(s):
Furosemide
    Dosage: 40 mg, 1 tablet daily
    Administration route: Oral
    Indication: Hypertension

Spironolactone
    Dosage: 25 mg, 1 tablet daily
    Administration route: Oral
    Indication: Hypertension

Nifedipine
    Dosage: 20 mg, 1 tablet daily
    Administration route: Oral
    Indication: Hypertension

Enalapril
    Dosage: 5 mg, 1 tablet daily
    Administration route: Oral
    Indication: Hypertension

Carvedilol
    Dosage: 2.5 mg, 1 tablet daily
    Administration route: Oral
    Indication: Hypertension

Losartan Potassium and Hydrochlorothiazide
    Dosage: 1 df, daily
    Indication: Hypertension

Other drugs received by patient: Lansoprazole; Lyrica; Zolpidem; Aspirin; Valproate Sodium; Cilostazol; Clonazepam



See index of all Enalapril side effect reports >>

Drug label data at the top of this Page last updated: 2011-01-01

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