Cardura/Cardura XL Adverse Reactions

Cardura: Hypertension: In controlled clinical trials, the most common reactions associated with doxazosin were of a postural type (rarely associated with syncope) or non-specific and included: Ear and Labyrinth Disorders: vertigo.
Gastrointestinal Disorders: nausea.
General Disorders and Administration Site Conditions: edema, asthenia, fatigue, malaise.
Nervous System Disorders: dizziness, headache, postural dizziness, somnolence, syncope.
Respiratory, Thoracic and Mediastinal Disorders: rhinitis.
Benign Prostatic Hyperplasia: Experience in controlled clinical trials in BPH indicates a similar adverse event profile to that seen in hypertension.
In post-marketing experience, the following additional adverse events have been reported: Blood and Lymphatic Disorders: leukopenia, thrombocytopenia.
Ear and Labyrinth Disorders: tinnitus.
Eye Disorders: blurred vision, IFIS (see Precautions).
Gastrointestinal Disorders: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, mouth dry, vomiting.
General Disorders and Administrations Site Conditions: pain.
Hepatobiliary Disorders: cholestasis, hepatitis, jaundice.
Immune System Disorders: allergic reaction.
Investigations: abnormal liver function tests, weight increase.
Metabolism and Nutrition: anorexia.
Musculoskeletal and Connective Tissue Disorders: arthralgia, back pain, muscle cramps, muscle weakness, myalgia.
Nervous System Disorders: hypoesthesia, paresthesia, tremor.
Psychiatric Disorders: agitation, anxiety, depression, insomnia, nervousness.
Renal and Urinary Disorders: dysuria, hematuria, micturition disorder, micturition frequency, nocturia, polyuria, urinary incontinence.
Reproductive System and Breast Disorder: gynecomastia, impotence, priapism, retrograde ejaculation.
Respiratory, Thoracic and Mediastinal Disorders: bronchospasm aggravated, coughing, dyspnea, epistaxis.
Skin and Subcutaneous Tissue Disorders: alopecia, pruritus, purpura, skin rash, urticaria.
Vascular Disorders: hot flushes, hypotension, hypotension postural.
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.
Cardura XL: The following lists the common (>1%) adverse events reported in pre-marketing placebo-controlled clinical trials with doxazosin GITS. It is important to emphasize that events reported during therapy may not necessarily be caused by the therapy.
Hypertension: Cardiac Disorder: palpitation, tachycardia.
Ear and Labyrinth Disorders: vertigo.
Gastrointestinal Disorders: abdominal pain, mouth dry, nausea.
General Disorders and Administration Site Conditions: asthenia, chest pain, peripheral edema.
Musculoskeletal and Connective Tissue Disorders: back pain, myalgia.
Vascular Disorders: postural hypotension.
Nervous System Disorders: dizziness, headache.
Respiratory, Thoracic and Mediastinal Disorders: bronchitis, coughing.
Skin and Subcutaneous Tissue Disorders: pruritus.
Renal and Urinary Disorders: cystitis, urinary incontinence.
Benign Prostatic Hyperplasia: Ear and Labyrinth Disorders: vertigo.
General Disorders and Administration Site Conditions: asthenia, peripheral edema.
Gastrointestinal Disorders: abdominal pain, dyspepsia, nausea.
Infection and Infestations: influenza-like symptoms, respiratory tract infection, urinary tract infection.
Musculoskeletal and Connective Tissue Disorders: back pain, myalgia.
Nervous System Disorders: dizziness, headache, somnolence.
Respiratory, Thoracic and Mediastinal Disorders: bronchitis, dyspnea, rhinitis.
Vascular Disorders: hypotension, postural hypotension.
The incidence of adverse events following treatment with doxazosin GITS (41%) in clinical studies of patients with BPH was broadly similar to that following placebo (39%) and less than that following standard doxazosin (54%).
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: leukopenia, thrombocytopenia.
Ear and Labyrinth Disorders: tinnitus.
Eye Disorders: blurred vision, IFIS (see Precautions).
Gastrointestinal Disorders: gastrointestinal obstruction, constipation, diarrhea, dyspepsia, flatulence, dry mouth, vomiting.
General Disorders and Administration Site Conditions: fatigue, malaise, pain.
Hepatobiliary Disorders: cholestasis, hepatitis, jaundice.
Immune System Disorders: allergic reaction.
Investigations: abnormal liver function tests, weight increase.
Metabolism and Nutrition: anorexia.
Musculoskeletal and Connective Tissue Disorders: arthralgia, muscle cramps, muscle weakness.
Nervous System Disorder: dizziness postural, hypoesthesia, paresthesia, syncope, tremor.
Psychiatric Disorders: agitation, anxiety, depression, insomnia, nervousness.
Renal and Urinary Disorders: dysuria, hematuria, micturition disorder, micturition frequency, nocturia, polyuria, urinary incontinence.
Reproductive System and Breast Disorder: gynecomastia, impotence, priapism, retrograde ejaculation.
Respiratory, Thoracic and Mediastinal Disorders: bronchospasm aggravated, coughing, dyspnea, epistaxis.
Skin/Appendages: alopecia, pruritus, purpura, skin rash, urticaria.
Vascular Disorders: 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.