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adverse reactions
ADVERSE REACTIONS A. Benign Prostatic Hyperplasia: The incidence of adverse events has been ascertained from worldwide clinical trials in 965 BPH patients. The incidence rates presented below (Table 3) are based on combined data from seven placebo-controlled trials involving once daily administration of doxazosin mesylate in doses of 1-16 mg in hypertensives and 0 . 5-8 mg in normotensives. The adverse events when the incidence in the doxazosin mesylate group was at least 1% are summarized in Table 3. No significant difference in the incidence of adverse events compared to placebo was seen except for dizziness, fatigue, hypotension, edema and dyspnea. Dizziness and dyspnea appeared to be dose-related. TABLE 3 ADVERSE REACTIONS DURING PLACEBO-CONTROLLED STUDIES BENIGN PROSTATIC HYPERPLASIA Body System DOXAZOSIN MESYLATE PLACEBO Body System DOXAZOSIN MESYLATE PLACEBO (N = 665) (N = 300) (N = 665) (N = 300) *p < 0 . 05 for treatment differences †Includes vertigo BODY AS A WHOLE NERVOUS SYSTEM Back pain 1.8% 2.0% Dizziness† 15 . 6%* 9 . 0% Chest pain 1.2% 0.7% Mouth Dry 1.4% 0.3% Fatigue 8.0% 1.7% Somnolence 3 . 0% 1 . 0% Headache 9.9% 9.0% RESPIRATORY SYSTEM Influenza-like symptoms 1.1% 1.0% Dyspnea 2 . 6%* 0 . 3% Pain 2.0% 1.0% Respiratory Disorder 1 . 1% 0 . 7% CARDIOVASCULAR SYSTEM SPECIAL SENSES Hypotension 1.7% 0.0% Vision Abnormal 1 . 4% 0 . 7% Palpitation 1.2% 0.3% UROGENITAL SYSTEM DIGESTIVE SYSTEM Impotence 1 . 1% 1 . 0% Abdominal Pain 2.4% 2.0% Urinary Tract Infection 1.4% 2.3% Diarrhea 2.3% 2.0% SKIN & APPENDAGES Dyspepsia 1.7% 1.7% Sweating Increased 1 . 1% 1 . 0% Nausea 1.5% 0.7% PSYCHIATRIC DISORDERS METABOLIC AND NUTRITIONAL DISORDERS Anxiety 1 . 1% 0 . 3% Edema 2 . 7%* 0 . 7% Insomnia 1 . 2% 0 . 3% In these placebo-controlled studies of 665 doxazosin mesylate patients, treated for a mean of 85 days, additional adverse reactions have been reported. These are less than 1% and not distinguishable from those that occurred in the placebo group. Adverse reactions with an incidence of less than 1% but of clinical interest are (doxazosin mesylate vs. placebo): Cardiovascular System: angina pectoris (0 . 6% vs. 0 . 7%), postural hypotension (0 . 3% vs. 0 . 3%), syncope (0 . 5% vs. 0 . 0%), tachycardia (0 . 9% vs. 0 . 0%); Urogenital System: dysuria (0 . 5% vs. 1 . 3%), and Psychiatric Disorders: libido decreased (0 . 8% vs. 0 . 3%). The safety profile in patients treated for up to three years was similar to that in the placebo-controlled studies. The majority of adverse experiences with doxazosin mesylate were mild. B. Hypertension: Doxazosin mesylate has been administered to approximately 4000 hypertensive patients, of whom 1679 were included in the hypertension clinical development program. In that program, minor adverse effects were frequent, but led to discontinuation of treatment in only 7% of patients. In placebo-controlled studies adverse effects occurred in 49% and 40% of patients in the doxazosin and placebo groups, respectively, and led to discontinuation in 2% of patients in each group. The major reasons for discontinuation were postural effects (2%), edema, malaise/fatigue, and some heart rate disturbance, each about 0 . 7%. In controlled hypertension clinical trials directly comparing doxazosin mesylate to placebo there was no significant difference in the incidence of side effects, except for dizziness (including postural), weight gain, somnolence and fatigue/malaise. Postural effects and edema appeared to be dose related. The prevalence rates presented below are based on combined data from placebo-controlled studies involving once daily administration of doxazosin at doses ranging from 1-16 mg. Table 4 summarizes those adverse experiences (possibly/probably related) reported for patients in these hypertension studies where the prevalence rate in the doxazosin group was at least 0 . 5% or where the reaction is of particular interest. TABLE 4 ADVERSE REACTIONS DURING PLACEBO-CONTROLLED STUDIES HYPERTENSION HYPERTENSION DOXAZOSIN DOXAZOSIN PLACEBO PLACEBO (N = 339) (N = 336) (N = 339) (N = 336) CARDIOVASCULAR SYSTEM PSYCHIATRIC Dizziness 19% 9% Somnolence 5% 1% Vertigo 2% 1% Nervousness 2% 2% Postural Hypotension 0.3% 0% Depression 1% 1% Edema 4% 3% Insomnia 1% 1% Palpitation 2% 3% Sexual Dysfunction 2% 1% Arrhythmia 1% 0% GASTROINTESTINAL Hypotension 1% 0% Nausea 3% 4% Tachycardia 0.3% 1% Diarrhea 2% 3% Peripheral Ischemia 0.3% 0% Constipation 1% 1% SKIN & APPENDAGES Dyspepsia 1% 1% Rash 1% 1% Flatulence 1% 1% Pruritus 1% 1% Abdominal Pain 0% 2% Rash 1% 1% Vomiting 0% 1% MUSCULOSKELETAL SYSTEM RESPIRATORY Arthralgia/Arthritis 1% 0% Rhinitis 3% 1% Muscle Weakness 1% 0% Dyspnea 1% 1% Myalgia 1% 0% Epistaxis 1% 0% CENTRAL & PERIPHERAL N.S. URINARY Headache 14% 16% Polyuria 2% 0% Paresthesia 1% 1% Urinary Incontinence 1% 0% Kinetic Disorders 1% 0% Micturition Frequency 0% 2% Ataxia 1% 0% GENERAL Hypertonia 1% 0% Fatigue/Malaise 12% 6% Muscle Cramps 1% 0% Chest Pain 2% 2% AUTONOMIC Asthenia 1% 1% Mouth Dry 2% 2% Face Edema 1% 0% Flushing 1% 0% Pain 2% 2% SPECIAL SENSES Vision Abnormal 2% 1% Conjunctivitis/Eye Pain 1% 1% Tinnitus 1% 0.3% Additional adverse reactions have been reported, but these are, in general, not distinguishable from symptoms that might have occurred in the absence of exposure to doxazosin. The following adverse reactions occurred with a frequency of between 0 . 5% and 1%: syncope, hypoesthesia, increased sweating, agitation, increased weight. The following additional adverse reactions were reported by <0 . 5% of 3960 patients who received doxazosin in controlled or open, short- or long- term clinical studies, including international studies. Cardiovascular System: angina pectoris, myocardial infarction, cerebrovascular accident; Autonomic Nervous System: pallor; Metabolic: thirst, gout, hypokalemia; Hematopoietic: lymphadenopathy, purpura; Reproductive System: breast pain; Skin Disorders: alopecia, dry skin, eczema; Central Nervous System: paresis, tremor, twitching, confusion, migraine, impaired concentration; Psychiatric: paroniria, amnesia, emotional lability, abnormal thinking, depersonalization; Special Senses: parosmia, earache, taste perversion, photophobia, abnormal lacrimation; Gastrointestinal System: increased appetite, anorexia, fecal incontinence, gastroenteritis; Respiratory System: bronchospasm, sinusitis, coughing, pharyngitis; Urinary System: renal calculus; General Body System: hot flushes, back pain, infection, fever/rigors, decreased weight, influenza-like symptoms. Doxazosin mesylate has not been associated with any clinically significant changes in routine biochemical tests. No clinically relevant adverse effects were noted on serum potassium, serum glucose, uric acid, blood urea nitrogen, creatinine or liver function tests. Doxazosin mesylate has been associated with decreases in white blood cell counts (see PRECAUTIONS ). In post-marketing experience the following additional adverse reactions have been reported: Autonomic Nervous System: priapism; Central Nervous System: hypoesthesia; Endocrine System: gynecomastia; Gastrointestinal System: vomiting; General Body System: allergic reaction; Heart Rate/Rhythm: bradycardia; Hematopoietic: leukopenia, thrombocytopenia; Liver/Biliary System: hepatitis, hepatitis cholestatic; Respiratory System: bronchospasm aggravated; Skin Disorders: urticaria; Urinary System: hematuria, micturition disorder, micturition frequency, nocturia.