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).
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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
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