ADVERSE REACTIONS
VASERETIC has been evaluated for safety in more than 1500 patients, including over 300 patients treated for one year or more. In clinical trials with VASERETIC no adverse experiences peculiar to this combination drug have been observed. Adverse experiences that have occurred, have been limited to those that have been previously reported with enalapril or hydrochlorothiazide.
The most frequent clinical adverse experiences in controlled trials were: dizziness (8.6 percent), headache (5.5 percent), fatigue (3.9 percent) and cough (3.5 percent). Generally, adverse experiences were mild and transient in nature. Adverse experiences occurring in greater than two percent of patients treated with VASERETIC in controlled clinical trials are shown below.
| Percent of Patients
in Controlled Studies |
|---|
| VASERETIC
(n=1580)
Incidence
(discontinuation) | Placebo
(n=230)
Incidence |
|---|
| Dizziness | 8.6 (0.7) | 4.3 |
| Headache | 5.5 (0.4) | 9.1 |
| Fatigue | 3.9 (0.8) | 2.6 |
| Cough | 3.5 (0.4) | 0.9 |
| Muscle Cramps | 2.7 (0.2) | 0.9 |
| Nausea | 2.5 (0.4) | 1.7 |
| Asthenia | 2.4 (0.3) | 0.9 |
| Orthostatic Effects | 2.3 (<0.1) | 0.0 |
| Impotence | 2.2 (0.5) | 0.5 |
| Diarrhea | 2.1 (<0.1) | 1.7 |
Clinical adverse experiences occurring in 0.5 to 2.0 percent of patients in controlled trials included: Body As A Whole: Syncope, chest pain, abdominal pain; Cardiovascular: Orthostatic hypotension, palpitation, tachycardia; Digestive: Vomiting, dyspepsia, constipation, flatulence, dry mouth; Nervous/Psychiatric: Insomnia, nervousness, paresthesia, somnolence, vertigo; Skin: Pruritus, rash; Other: Dyspnea, gout, back pain, arthralgia, diaphoresis, decreased libido, tinnitus, urinary tract infection.
Angioedema: Angioedema has been reported in patients receiving VASERETIC, 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 VASERETIC should be discontinued and appropriate therapy instituted immediately (see WARNINGS).
Hypotension: In clinical trials, adverse effects relating to hypotension occurred as follows: hypotension (0.9 percent), orthostatic hypotension (1.5 percent), other orthostatic effects (2.3 percent). In addition syncope occurred in 1.3 percent of patients (see WARNINGS).
Cough: See PRECAUTIONS, Cough.
Clinical Laboratory Test Findings
Serum Electrolytes: See PRECAUTIONS.
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 0.6 percent of patients with essential hypertension treated with VASERETIC. More marked increases have been reported in other enalapril experience. Increases are more likely to occur in patients with renal artery stenosis (see PRECAUTIONS).
Serum Uric Acid, Glucose, Magnesium, and Calcium: See PRECAUTIONS.
Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.3 g percent and 1.0 vol percent, respectively) occur frequently in hypertensive patients treated with VASERETIC 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.
Liver Function Tests: Rarely, elevations of liver enzymes and/or serum bilirubin have occurred (see WARNINGS, Hepatic Failure).
Other adverse reactions that have been reported with the individual components are listed below and, within each category, are in order of decreasing severity.
Enalapril Maleate – Enalapril has been evaluated for safety in more than 10,000 patients. In clinical trials adverse reactions which occurred with enalapril were also seen with VASERETIC. However, since enalapril has been marketed, the following adverse reactions have been reported: Body As A Whole: Anaphylactoid reactions (see WARNINGS, Anaphylactoid reactions during membrane exposure); 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; hypotension; angina pectoris, Raynaud's phenomenon; Digestive: lleus, pancreatitis, hepatic failure, hepatitis (hepatocellular [proven on rechallenge] or cholestatic jaundice) (see WARNINGS, Hepatic Failure), melena, anorexia, glossitis, stomatitis, dry mouth; Hematologic: Rare cases of neutropenia, thrombocytopenia and bone marrow depression. Hemolytic anemia, including cases of hemolysis in patients with G-6-PD deficiency, has been reported; a causal relationship to enalapril cannot be excluded. Nervous System/Psychiatric: Depression, confusion, ataxia, peripheral neuropathy (e.g., paresthesia, dysesthesia), dream abnormality; Urogenital: Renal failure, oliguria, renal dysfunction, (see PRECAUTIONS and DOSAGE AND ADMINISTRATION), flank pain, gynecomastia; Respiratory: Pulmonary infiltrates, eosinophilic pneumonitis, bronchospasm, pneumonia, bronchitis, rhinorrhea, sore throat and hoarseness, asthma, upper respiratory infection; Skin: Exfoliative dermatitits, toxic epidermal necrolysis, Stevens-Johnson syndrome, herpes zoster, erythema multiforme, urticaria, pemphigus, alopecia, flushing, photosensitivity; Special Senses: Blurred vision, taste alteration, anosmia, conjunctivitis, dry eyes, tearing.
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.
Fetal/Neonatal Morbidity and Mortality: See WARNINGS, Pregnancy, Enalapril Maleate, Fetal/Neonatal Morbidity and Mortality.
Hydrochlorothiazide – Body as a Whole: Weakness; Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation, anorexia; Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia; Hypersensitivity: Purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions; Musculoskeletal: Muscle spasm; Nervous System/Psychiatric: Restlessness; Renal: Renal failure, renal dysfunction, interstitial nephritis (see WARNINGS); Skin: Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia; Special Senses: Transient blurred vision, xanthopsia.
|
REPORTS OF SUSPECTED VASERETIC SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Vaseretic. The information is not vetted and should not be considered as verified clinical evidence.
Possible Vaseretic side effects / adverse reactions in 50 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-02-01
Patient: 50 year old male
Reactions: Renal Failure, Dehydration, Underdose, Intestinal Obstruction, Pancreatic Enzymes Increased
Adverse event resulted in: hospitalization
Suspect drug(s):
Rilmenidine
Administration route: Oral
End date: 2011-08-09
Allopurinol
Administration route: Oral
End date: 2011-08-09
Januvia
Administration route: Oral
End date: 2011-08-09
Oxycodone HCL
Start date: 2011-07-13
End date: 2011-08-09
Repaglinide
Administration route: Oral
Start date: 2011-08-19
Lercanidipine Hydrochloride
Administration route: Oral
End date: 2011-08-09
Repaglinide
Administration route: Oral
End date: 2011-08-09
Betaxolol HCL
Administration route: Oral
End date: 2011-08-09
Vaseretic
Administration route: Oral
End date: 2011-08-09
Atorvastatin Calcium
Administration route: Oral
End date: 2011-08-09
Other drugs received by patient: Mycophenolate Mofetil; Tacrolimus; Prednisone
Possible Vaseretic side effects / adverse reactions in male
Reported by a physician from Italy on 2012-03-01
Patient: male
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Suspect drug(s):
Tenoretic 100
Dosage: 50 mg/12.5 mg tablets daily
Administration route: Oral
Indication: Hypertension
Start date: 2011-12-01
Lasix
Administration route: Oral
Indication: Cardiac Failure
Start date: 2012-01-01
End date: 2012-02-09
Vaseretic
Dosage: 20 mg/12.5 mg tablets daily
Administration route: Oral
Indication: Hypertension
Start date: 2011-12-01
End date: 2012-02-10
Other drugs received by patient: Seleparina; Diazepam
Possible Vaseretic side effects / adverse reactions in male
Reported by a physician from Italy on 2012-03-05
Patient: male
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Suspect drug(s):
Tenoretic 100
Dosage: 50 mg/12.5 mg 1 df daily
Administration route: Oral
Indication: Hypertension
Start date: 2011-12-01
Vaseretic
Dosage: 20 mg/12.5 mg, 1 df daily
Administration route: Oral
Indication: Hypertension
Start date: 2011-12-01
End date: 2012-02-10
Lasix
Administration route: Oral
Start date: 2011-12-01
End date: 2012-02-09
Lasix
Administration route: Oral
Indication: Cardiac Failure
Start date: 2012-01-01
End date: 2012-02-09
Other drugs received by patient: Seleparina; Diazepam
|
