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adverse reactions
ADVERSE REACTIONS 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 to 16 mg in hypertensives and 0.5 to 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 *p ≤ 0.05 for treatment differences † includes vertigo Benign Prostatic Hyperplasia Body System Doxazosin mesylate (N=665) Placebo (N=300) BODY AS A WHOLE Back pain 1.8% 2.0% Chest pain 1.2% 0.7% Fatigue 8.0%* 1.7% Headache 9.9% 9.0% Influenza-like symptoms 1.1% 1.0% Pain 2.0% 1.0% CARDIOVASCULAR Hypotension 1.7%* 0.0% Palpitation 1.2% 0.3% DIGESTIVE SYSTEM Abdominal pain 2.4% 2.0% Diarrhea 2.3% 2.0% Dyspepsia 1.7% 1.7% Nausea 1.5% 0.7% METABOLIC AND NUTRITIONAL DISORDERS Edema 2.7%* 0.7% NERVOUS SYSTEM Dizziness† 15.6%* 9.0% Mouth dry 1.4% 0.3% Somnolence 3.0% 1.0% RESPIRATORY SYSTEM Dyspnea 2.6%* 0.3% Respiratory disorder 1.1% 0.7% SPECIAL SENSES Vision abnormal 1.4% 0.7% UROGENITAL SYSTEM Impotence 1.1% 1.0% Urinary tract infection 1.4% 2.3% SKIN & APPENDAGES Sweating increased 1.1% 1.0% PSYCHIATRIC DISORDERS Anxiety 1.1% 0.3% 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%); • 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. 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 mesylate 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 mesylate at doses ranging from 1 to 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 mesylate group was at least 0.5% or where the reaction is of particular interest. TABLE 4 Adverse Reactions During Placebo-Controlled Studies Hypertension Doxazosin mesylate (N=339) Placebo (N=336) CARDIOVASCULAR SYSTEM Dizziness 19% 9% Vertigo 2% 1% Postural hypotension 0.3% 0% Edema 4% 3% Palpitation 2% 3% Arrhythmia 1% 0% Hypotension 1% 0% Tachycardia 0.3% 1% Peripheral ischemia 0.3% 0% SKIN & APPENDAGES Rash 1% 1% Pruritus 1% 1% MUSCULOSKELETAL SYSTEM Arthralgia/arthritis 1% 0% Muscle weakness 1% 0% Myalgia 1% 0% CENTRAL & PERIPHERAL N.S. Headache 14% 16% Paresthesia 1% 1% Kinetic disorders 1% 0% Ataxia 1% 0% Hypertonia 1% 0% Muscle cramps 1% 0% AUTONOMIC Mouth dry 2% 2% Flushing 1% 0% SPECIAL SENSES Vision abnormal 2% 1% Conjunctivitis/eye pain 1% 1% Tinnitus 1% 0.3% PSYCHIATRIC Somnolence 5% 1% Nervousness 2% 2% Depression 1% 1% Insomnia 1% 1% Sexual dysfunction 2% 1% GASTROINTESTINAL Nausea 3% 4% Diarrhea 2% 3% Constipation 1% 1% Dyspepsia 1% 1% Flatulence 1% 1% Abdominal pain 0% 2% Vomiting 0% 1% RESPIRATORY Rhinitis 3% 1% Dyspnea 1% 1% Epistaxis 1% 0% URINARY Polyuria 2% 0% Urinary incontinence 1% 0% Micturition frequency 0% 2% GENERAL Fatigue/malaise 12% 6% Chest pain 2% 2% Asthenia 1% 1% Face edema 1% 0% Pain 2% 2% 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 mesylate. 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 mesylate 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; Special Senses: Intraoperative Floppy Iris Syndrome (see PRECAUTIONS , Cataract Surgery); Urinary System: hematuria, micturition disorder, micturition frequency, nocturia.