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Vasotec (Enalapril Maleate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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).

 



REPORTS OF SUSPECTED VASOTEC SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Vasotec side effects / adverse reactions in 67 year old female

Reported by a physician from Japan on 2011-11-11

Patient: 67 year old female

Reactions: Drug Eruption, Liver Disorder

Adverse event resulted in: hospitalization

Suspect drug(s):
Phenobarbital TAB
    Administration route: Oral
    Indication: Brain Contusion
    Start date: 2010-12-05
    End date: 2011-01-04

Merislon
    Administration route: Oral
    Indication: Dizziness
    Start date: 2010-12-05
    End date: 2011-01-05

Pepcid RPD
    Administration route: Oral
    Indication: Brain Contusion
    Start date: 2010-12-03
    End date: 2011-01-05

Candesartan Cilexetil
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-12-05
    End date: 2011-01-04

Vasotec
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-12-09
    End date: 2011-01-04

Other drugs received by patient: LAC-B



Possible Vasotec side effects / adverse reactions in 79 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-16

Patient: 79 year old female

Reactions: Agitation, Restless Legs Syndrome, Orthostatic Hypotension, Disorientation, Pharyngeal Oedema, Dyspepsia, Palpitations, Dizziness, Feeling of Body Temperature Change, Nervousness, Muscle Spasms, Blood Pressure Increased, Nightmare, Nausea, Hypotension, Tremor, Anxiety, Heart Rate Decreased, Diarrhoea, Arthralgia

Suspect drug(s):
Mirtazapine
    Indication: Product Used FOR Unknown Indication

Micardis
    Indication: Product Used FOR Unknown Indication

Cardura
    Indication: Product Used FOR Unknown Indication

Macrobid
    Indication: Product Used FOR Unknown Indication

Prozac
    Indication: Product Used FOR Unknown Indication

Cipro
    Indication: Product Used FOR Unknown Indication

Norvasc
    Indication: Product Used FOR Unknown Indication

Vasotec
    Indication: Product Used FOR Unknown Indication

Diovan
    Indication: Product Used FOR Unknown Indication

Diltiazem
    Indication: Product Used FOR Unknown Indication

Tiazac
    Indication: Product Used FOR Unknown Indication

Zoloft
    Indication: Product Used FOR Unknown Indication

Cymbalta
    Indication: Product Used FOR Unknown Indication

Celebrex
    Indication: Product Used FOR Unknown Indication

Fentanyl
    Indication: Product Used FOR Unknown Indication

Naproxen
    Indication: Product Used FOR Unknown Indication

Wellbutrin XL
    Indication: Product Used FOR Unknown Indication

Levaquin
    Indication: Product Used FOR Unknown Indication

Tekturna
    Indication: Product Used FOR Unknown Indication

Toprol-XL
    Indication: Product Used FOR Unknown Indication

Cartia XT
    Indication: Product Used FOR Unknown Indication

Paxil
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Effexor XR; Protonix



Possible Vasotec side effects / adverse reactions in 67 year old female

Reported by a physician from Japan on 2011-11-23

Patient: 67 year old female

Reactions: Drug Eruption, Liver Disorder

Adverse event resulted in: hospitalization

Suspect drug(s):
Pepcid RPD
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2010-12-03
    End date: 2011-01-05

Vasotec
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-12-09
    End date: 2011-01-04

Merislon
    Administration route: Oral
    Indication: Dizziness
    Start date: 2010-12-05
    End date: 2011-01-05

Phenobarbital TAB
    Administration route: Oral
    Indication: Brain Contusion
    Start date: 2010-12-05
    End date: 2011-01-04

Candesartan Cilexetil
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-12-05
    End date: 2011-01-04

Other drugs received by patient: LAC-B



See index of all Vasotec side effect reports >>

Drug label data at the top of this Page last updated: 2014-10-24

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