In controlled hypertension clinical trials, the most common reactions associated with Cardura were of a postural type (rarely associated with syncope) or nonspecific, and included dizziness, headache, fatigue, malaise, postural dizziness, vertigo, edema, asthenia, somnolence, nausea and rhinitis. Extremely rare cases of urinary incontinence were reported; this effect may be related to Cardura's pharmacologic action. The following additional adverse events have been reported in marketing experience among patients treated for hypertension but these, in general, are not distinguishable from symptoms that might have occurred in the absence of exposure to doxazosin: Tachycardia, palpitation, chest pain, angina pectoris, myocardial infarction, cerebrovascular accidents and cardiac arrhythmias.
Benign Prostatic Hyperplasia:
Experience in controlled clinical trials in BPH indicates a similar adverse event profile to that seen in hypertension.
The adverse event profile in elderly (>65 years) BPH patients showed no difference from the profile in the younger population.
In post-marketing experience, the following additional adverse events have been reported: Blood and Lymphatic Disorders:
Ear and Labyrinth Disorder:
Blurred vision, IFIS (see Precautions).
Constipation, diarrhea, dyspepsia, flatulence, dry mouth, vomiting.
General Disorders and Administration Site Conditions:
Fatigue, malaise, pain.
Cholestasis, hepatitis, jaundice.
Immune System Disorder:
Abnormal liver function tests, increased weight.
Metabolism and Nutrition:
Musculoskeletal and Connective Tissue Disorders:
Arthralgia, muscle cramps, muscle weakness.
Nervous System Disorders:
Postural dizziness, hypoesthesia, paresthesia, syncope, tremor.
Agitation, anxiety, depression, insomnia, nervousness.
Renal and Urinary Disorders:
Dysuria, hematuria, micturition disorder and frequency, nocturia, polyuria, urinary incontinence.
Reproductive System and Breast Disorders:
Gynecomastia, impotence, priapism, retrograde ejaculation.
Respiratory, Thoracic and Mediastinal Disorders:
Aggravated bronchospasm, cough, dyspnea, epistaxis.
Alopecia, pruritus, purpura, skin rash, urticaria.
Hot flushes, hypotension.
The following additional adverse events have been reported in marketing experience among patients treated for hypertension, but these, in general, are not distinguishable from symptoms that might have occurred in the absence of exposure to doxazosin: Bradycardia, tachycardia, palpitation, chest pain, angina pectoris, myocardial infarction, cerebrovascular accidents and cardiac arrhythmias.