Hypertension
ACCUPRIL has been evaluated for safety in 4960 subjects and patients. Of these, 3203 patients, including 655 elderly patients, participated in controlled clinical trials. ACCUPRIL has been evaluated for long-term safety in over 1400 patients treated for 1 year or more.
Adverse experiences were usually mild and transient.
In placebo-controlled trials, discontinuation of therapy because of adverse events was required in 4.7% of patients with hypertension.
Adverse experiences probably or possibly related to therapy or of unknown relationship to therapy occurring in 1% or more of the 1563 patients in placebo-controlled hypertension trials who were treated with ACCUPRIL are shown below.
Adverse Events in Placebo-Controlled Trials | Accupril (N=1563) Incidence (Discontinuance) | Placebo (N=579) Incidence (Discontinuance) |
---|
Headache | 5.6 (0.7) | 10.9 (0.7) |
Dizziness | 3.9 (0.8) | 2.6 (0.2) |
Fatigue | 2.6 (0.3) | 1.0 |
Coughing | 2.0 (0.5) | 0.0 |
Nausea and/or Vomiting | 1.4 (0.3) | 1.9 (0.2) |
Abdominal Pain | 1.0 (0.2) | 0.7 |
Hypertension and/or Heart Failure
Clinical adverse experiences probably, possibly, or definitely related, or of uncertain relationship to therapy occurring in 0.5% to 1.0% (except as noted) of the patients with CHF or hypertension treated with ACCUPRIL (with or without concomitant diuretic) in controlled or uncontrolled trials (N=4847) and less frequent, clinically significant events seen in clinical trials or post-marketing experience (the rarer events are in italics) include (listed by body system):
General: back pain, malaise, viral infections, anaphylactoid reaction
Cardiovascular: palpitation, vasodilation, tachycardia, heart failure, hyperkalemia, myocardial infarction, cerebrovascular accident, hypertensive crisis, angina pectoris, orthostatic hypotension, cardiac rhythm disturbances, cardiogenic shock
Hematology: hemolytic anemia
Gastrointestinal: flatulence, dry mouth or throat, constipation, gastrointestinal hemorrhage, pancreatitis, abnormal liver function tests, dyspepsia
Metabolism and Nutrition Disorders: hyponatremia
Nervous/Psychiatric: somnolence, vertigo, syncope, nervousness, depression, insomnia, paresthesia
Integumentary: alopecia, increased sweating, pemphigus, pruritus, exfoliative dermatitis, photosensitivity reaction, dermatopolymyositis
Urogenital: urinary tract infection, impotence, acute renal failure, worsening renal failure
Respiratory: eosinophilic pneumonitis
Other: amblyopia, edema, arthralgia, pharyngitis, agranulocytosis, hepatitis, thrombocytopenia