Doxazosin Mesylate (Page 5 of 7)

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.

(N=339) (N=336)
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%
Rash 1% 1%
Pruritus 1% 1%
Arthralgia/Arthritis 1% 0%
Muscle Weakness 1% 0%
Myalgia 1% 0%
Headache 14% 16%
Paresthesia 1% 1%
Kinetic Disorders 1% 0%
Ataxia 1% 0%
Hypertonia 1% 0%
Muscle Cramps 1% 0%
Mouth Dry 2% 2%
Flushing 1% 0%
Vision Abnormal 2% 1%
Conjunctivitis/Eye Pain 1% 1%
Tinnitus 1% 0.3%
Somnolence 5% 1%
Nervousness 2% 2%
Depression 1% 1%
Insomnia 1% 1%
Sexual Dysfunction 2% 1%
Nausea 3% 4%
Diarrhea 2% 3%
Constipation 1% 1%
Dyspepsia 1% 1%
Flatulence 1% 1%
Abdominal Pain 0% 2%
Vomiting 0% 1%
Rhinitis 3% 1%
Dyspnea 1% 1%
Epistaxis 1% 0%
Polyuria 2% 0%
Urinary Incontinence 1% 0%
Micturition Frequency 0% 2%
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. 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, Leukopenia/Neutropenia).

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.

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