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CARDURA® Adverse Reactions (doxazosin mesylate tablets)

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Benign Prostatic Hyperplasia (BPH)

The incidence of adverse events has been ascertained from worldwide clinical trials in 965 BPH patients. The incidence rates presented below (Table 2) are based on combined data from seven placebo-controlled trials involving once-daily administration of CARDURA in doses of 1 to 16 mg in hypertensives and 0.5 to 8 mg in normotensives. Adverse reactions occurring more than 1% more frequently in BPH patients treated with CARDURA vs placebo are summarized in Table 1.

Table 1. Adverse Reactions Occurring more than 1% More Frequently in BPH Patients Treated with Cardura Versus Placebo
BODY SYSTEM Cardura
N=665
Placebo
N=300
*
Includes vertigo
NERVOUS SYSTEM DISORDERS
Dizziness* 15.6% 9.0%
Somnolence 3.0% 1.0%
CARDIAC DISORDERS
Hypotension 1.7% 0%
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Dyspnoea 2.6% 0.3%
GASTROINTESTINAL DISORDERS
Dry Mouth 1.4% 0.3%
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Fatigue 8.0% 1.7%
Oedema 2.7% 0.7%

Other adverse reactions occurring less than 1% more frequently in BPH patients treated with CARDURA vs placebo but plausibly related to CARDURA include: palpitations.

Hypertension

CARDURA has been administered to approximately 4000 hypertensive patients in clinical trials, of whom 1679 were included in the hypertension clinical development program. In placebo-controlled studies, adverse events 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.

Adverse reactions occurring more than 1% more frequently in hypertensive patients treated with CARDURA vs placebo are summarized in Table 1. . 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 to 16 mg.

Table 2. Adverse Reactions Occurring more than 1% More Frequently in Hypertensive Patients Treated with Cardura versus Placebo
BODY SYSTEM Cardura
N=339
Placebo
N=336
NERVOUS SYSTEM DISORDERS
Dizziness 19% 9%
Somnolence 5% 1%
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Rhinitis 3% 1%
RENAL AND URINARY DISORDERS
Polyuria 2% 0%
REPRODUCTIVE SYSTEM AND BREAST DISORDERS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Fatigue / Malaise 12% 6%

Other adverse reactions occurring less than 1% more frequently in hypertensive patients treated with CARDURA vs placebo but plausibly related to CARDURA use include vertigo, hypotension, hot flushes, epistaxis and oedema.

CARDURA has been associated with decreases in white blood cell counts

Laboratory changes observed in clinical studies

Leukopenia/Neutropenia: Decreases in mean white blood cell (WBC) and mean neutrophil count were observed in controlled clinical trials of hypertensive patients receiving CARDURA. In cases where follow-up was available, WBC and neutrophil counts returned to normal after discontinuation of CARDURA. No patients became symptomatic as a result of the low WBC or neutrophil counts.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of CARDURA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In post-marketing experience, the following additional adverse reactions have been reported:
Blood and Lymphatic System Disorders: leukopenia, thrombocytopenia;
Immune System Disorders: allergic reaction;
Nervous System Disorders: hypoesthesia;
Eye Disorders: Intraoperative Floppy Iris Syndrome [see Warnings and precautions (5.4)];
Cardiac Disorders: bradycardia;
Respiratory, Thoracic and Mediastinal Disorders: bronchospasm aggravated;
Gastrointestinal Disorders: vomiting;
Hepatobiliary Disorders: cholestasis, hepatitis cholestatic;
Skin and Subcutaneous Tissue Disorders: urticaria;
Musculoskeletal and Connective Tissue Disorders: muscle cramps, muscle weakness;
Renal and Urinary Disorders: hematuria, micturition disorder, micturition frequency, nocturia;
Reproductive System and Breast Disorders: gynecomastia, priapism.

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