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adverse reactions
ADVERSE REACTIONS TEVETEN ® has been evaluated for safety in more than 3,300 healthy volunteers and patients worldwide, including more than 1,460 patients treated for more than 6 months, and more than 980 patients treated for 1 year or longer. TEVETEN ® was well tolerated at doses up to 1200 mg daily. Most adverse events were of mild or moderate severity and did not require discontinuation of therapy. The overall incidence of adverse experiences and the incidences of specific adverse events reported with eprosartan were similar to placebo. Adverse experiences were similar in patients regardless of age, gender, or race. Adverse experiences were not dose-related. In placebo-controlled clinical trials, about 4% of 1,202 patients treated with TEVETEN ® discontinued therapy due to clinical adverse experiences, compared to 6.5% of 352 patients given placebo. Adverse Events Occurring at an Incidence of 1% or More Among Eprosartan-treated Patients The following table lists adverse events that occurred at an incidence of 1% or more among eprosartan-treated patients who participated in placebo-controlled trials of 8 to 13 weeks' duration, using doses of 25 mg to 400 mg twice daily, and 400 mg to 1200 mg once daily. The overall incidence of adverse events reported with TEVETEN ® (54.4%) was similar to placebo (52.8%). Table 1. Adverse Events Reported by ≥1% of Patients Receiving TEVETEN ® (eprosartan mesylate) and Were More Frequent on Eprosartan than Placebo Event Eprosartan (n=1,202) % Placebo (n=352) % Body as a Whole Infection viral 2 1 Injury 2 1 Fatigue 2 1 Gastrointestinal Abdominal pain 2 1 Metabolic and Nutritional Hypertriglyceridemia 1 0 Musculoskeletal Arthralgia 2 1 Nervous System Depression 1 0 Respiratory Upper respiratory tract infection 8 5 Rhinitis 4 3 Pharyngitis 4 3 Coughing 4 3 Urogenital Urinary tract infection 1 0 The following adverse events were also reported at a rate of 1% or greater in patients treated with eprosartan, but were as, or more, frequent in the placebo group: headache, myalgia, dizziness, sinusitis, diarrhea, bronchitis, dependent edema, dyspepsia, and chest pain. Facial edema was reported in 5 patients receiving eprosartan. Angioedema has been reported with other angiotensin II antagonists. Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers. In addition to the adverse events above, potentially important events that occurred in at least two patients/subjects exposed to eprosartan or other adverse events that occurred in <1% of patients in clinical studies are listed below. It cannot be determined whether events were causally related to eprosartan: Body as a Whole: alcohol intolerance, asthenia, substernal chest pain, peripheral edema, fatigue, fever, hot flushes, influenza-like symptoms, malaise, rigors, pain; Cardiovascular: angina pectoris, bradycardia, abnormal ECG, specific abnormal ECG, extrasystoles, atrial fibrillation, hypotension (including orthostatic hypotension), tachycardia, palpitations; Gastrointestinal: anorexia, constipation, dry mouth, esophagitis, flatulence, gastritis, gastroenteritis, gingivitis, nausea, periodontitis, toothache, vomiting; Hematologic: anemia, purpura; Liver and Biliary: increased SGOT, increased SGPT; Metabolic and Nutritional: increased creatine phosphokinase, diabetes mellitus, glycosuria, gout, hypercholesterolemia, hyperglycemia, hyperkalemia, hypokalemia, hyponatremia; Musculoskeletal: arthritis, aggravated arthritis, arthrosis, skeletal pain, tendinitis, back pain; Nervous System/Psychiatric: anxiety, ataxia, insomnia, migraine, neuritis, nervousness, paresthesia, somnolence, tremor, vertigo; Resistance Mechanism: herpes simplex, otitis externa, otitis media, upper respiratory tract infection; Respiratory: asthma, epistaxis; Skin and Appendages: eczema, furunculosis, pruritus, rash, maculopapular rash, increased sweating; Special Senses: conjunctivitis, abnormal vision, xerophthalmia, tinnitus; Urinary: albuminuria, cystitis, hematuria, micturition frequency, polyuria, renal calculus, urinary incontinence; Vascular: leg cramps, peripheral ischemia. Laboratory Test Findings In placebo-controlled studies, clinically important changes in standard laboratory parameters were rarely associated with administration of TEVETEN ® . Patients were rarely withdrawn from TEVETEN ® because of laboratory test results. Creatinine, Blood Urea Nitrogen Minor elevations in creatinine and in BUN occurred in 0.6% and 1.3%, respectively, of patients taking TEVETEN ® and 0.9% and 0.3%, respectively, of patients given placebo in controlled clinical trials. Two patients were withdrawn from clinical trials for elevations in serum creatinine and BUN, and three additional patients were withdrawn for increases in serum creatinine. Liver Function Tests Minor elevations of ALAT, ASAT, and alkaline phosphatase occurred for comparable percentages of patients taking TEVETEN ® or placebo in controlled clinical trials. An elevated ALAT of >3.5 x ULN occurred in 0.1% of patients taking TEVETEN ® (one patient) and in no patient given placebo in controlled clinical trials. Four patients were withdrawn from clinical trials for an elevation in liver function tests. Hemoglobin A greater than 20% decrease in hemoglobin was observed in 0.1% of patients taking TEVETEN ® (one patient) and in no patient given placebo in controlled clinical trials. Two patients were withdrawn from clinical trials for anemia. Leukopenia A WBC count of ≤3.0 x 10 3 /mm 3 occurred in 0.3% of patients taking TEVETEN ® and in 0.3% of patients given placebo in controlled clinical trials. One patient was withdrawn from clinical trials for leukopenia. Neutropenia A neutrophil count of ≤1.5 x 10 3 /mm 3 occurred in 1.3% of patients taking TEVETEN ® and in 1.4% of patients given placebo in controlled clinical trials. No patient was withdrawn from any clinical trial for neutropenia. Thrombocytopenia A platelet count of ≤100 x 10 9 /L occurred in 0.3% of patients taking TEVETEN ® (one patient) and in no patient given placebo in controlled clinical trials. Four patients receiving TEVETEN ® in clinical trials were withdrawn for thrombocytopenia. In one case, thrombocytopenia was present prior to dosing with TEVETEN ® . Serum Potassium A potassium value of ≥5.6 mmol/L occurred in 0.9% of patients taking TEVETEN ® and 0.3% of patients given placebo in controlled clinical trials. One patient was withdrawn from clinical trials for hyperkalemia and three for hypokalemia.