Alfadil XL Adverse Reactions

The following lists the common (>1%) adverse events reported in pre-marketing placebo-controlled clinical trials with Doxazosin, as mesilate (Alfadil XL). It is important to emphasize that events reported during therapy may not necessarily be caused by the therapy.
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, as mesilate (Alfadil XL) (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 (Intraoperative Floppy Iris Syndrome) (see Precautions).
Gastrointestinal Disorders: Gastrointestinal obstruction, constipation, diarrhea, dyspepsia, flatulence, mouth dry, 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 Disorders: 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.