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Uroxatral (Alfuzosin Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The incidence of treatment-emergent adverse events has been ascertained from 3 placebo-controlled clinical trials involving 1,608 men in which daily doses of 10 and 15 mg alfuzosin were evaluated. In these 3 trials, 473 men received UROXATRAL (alfuzosin HCl 10 mg extended-release tablets). In these studies, 4% of patients taking UROXATRAL (alfuzosin HCl extended-release tablets) 10 mg tablets withdrew from the study due to adverse events, compared with 3% in the placebo group.

Table 4 summarizes the treatment-emergent adverse events that occurred in ≥2% of patients receiving UROXATRAL, and at an incidence numerically higher than that of the placebo group. In general, the adverse events seen in long-term use were similar in type and frequency to the events described below for the 3-month trials.

Table 4 — Treatment-Emergent Adverse Events Occurring in ≥2% of UROXATRAL-Treated Patients and More Frequently than with Placebo in 3-Month Placebo-Controlled Clinical Studies
Adverse EventPlacebo (n=678)UROXATRAL (n=473)
Dizziness19 (2.8%)27 (5.7%)
Upper respiratory tract infection4 (0.6%)14 (3.0%)
Headache12 (1.8%)14 (3.0%)
Fatigue12 (1.8%)13 (2.7%)

The following adverse events, reported by between 1% and 2% of patients receiving UROXATRAL and occurring more frequently than with placebo, are listed alphabetically by body system and by decreasing frequency within body system:

Body as a whole: pain

Gastrointestinal system: abdominal pain, dyspepsia, constipation, nausea

Reproductive system: impotence

Respiratory system: bronchitis, sinusitis, pharyngitis

Signs and Symptoms of Orthostasis in Clinical Studies: The adverse events related to orthostasis that occurred in the double-blind phase 3 studies with alfuzosin 10 mg are summarized in Table 5. Approximately 20% to 30% of patients in these studies were taking antihypertensive medication.

Table 5 — Number (%) of Patients with Symptoms Possibly Associated with Orthostasis in 3-Month Placebo-Controlled Clinical Studies
SymptomsPlacebo (n=678)UROXATRAL (n=473)
Dizziness19 (2.8%)27 (5.7%)
Hypotension or postural hypotension02 (0.4%)
Syncope01 (0.2%)

Multiple testing for blood pressure changes or orthostatic hypotension was conducted in the three controlled studies at each scheduled clinic visit (Days 14, 28, 56, and 84). Patients with a decrease in systolic blood pressure of >20 mm Hg after 2 minutes standing following being supine were excluded from the three trials. These tests were considered positive for blood pressure decrease if (1) supine systolic blood pressure was ≤90 mm Hg, with a decrease ≥20 mm Hg versus baseline, and/or (2) supine diastolic blood pressure was ≤50 mm Hg, with a decrease≥15 mm Hg versus baseline. The tests were considered positive for orthostatic hypotension if there was a decrease in systolic blood pressure of ≥20 mm Hg upon standing from the supine position during the orthostatic tests. According to these definitions, decreased systolic blood pressure was observed in none of the 674 placebo patients and 1 (0.2%) of the 469 UROXATRAL patients. Decreased diastolic blood pressure was observed in 3 (0.4%) of the placebo patients and in 4 (0.9%) of the UROXATRAL patients. A positive orthostatic test was seen in 52 (7.7%) of placebo patients and in 31 (6.6%) of the UROXATRAL patients.

No vital sign measurements were obtained following first dose administration in the phase 3 studies, except for a subset of patients in study 1 who had blood pressure measurements 12 to 16 hours after the first dose to assess the potential to produce orthostatic hypotension. None of these 35 UROXATRAL treated patients showed a positive test for systolic, diastolic or orthostatic blood pressure change.

Post-Marketing Adverse Event Reports

The following adverse reactions have been identified during post approval use of UROXATRAL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

General disorders: edema

Cardiac disorders: tachycardia, chest pain, angina pectoris in patients with pre-existing coronary artery disease

Gastrointestinal disorders: diarrhea

Hepatobiliary disorders: hepatocellular and cholestatic liver injury (including cases with jaundice leading to drug discontinuation)

Respiratory system disorders: rhinitis

Reproductive system disorders: priapism

Skin and subcutaneous tissue disorders: rash, pruritis, urticaria, angioedema

Vascular disorders: flushing

During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in some patients on or previously treated with alpha-1 blockers (see PRECAUTIONS).



REPORTS OF SUSPECTED UROXATRAL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Uroxatral. The information is not vetted and should not be considered as verified clinical evidence.

Possible Uroxatral side effects / adverse reactions in 82 year old male

Reported by a physician from United States on 2011-10-19

Patient: 82 year old male weighing 65.8 kg (144.7 pounds)

Reactions: Liver Function Test Abnormal, Urine Bilirubin Increased

Suspect drug(s):
Uroxatral



Possible Uroxatral side effects / adverse reactions in 65 year old male

Reported by a consumer/non-health professional from United States on 2011-10-20

Patient: 65 year old male

Reactions: Loss of Consciousness

Adverse event resulted in: hospitalization

Suspect drug(s):
Uroxatral



Possible Uroxatral side effects / adverse reactions in 83 year old male

Reported by a consumer/non-health professional from United States on 2011-11-03

Patient: 83 year old male

Reactions: Pain, Urinary Tract Infection, Sepsis

Adverse event resulted in: hospitalization

Suspect drug(s):
Uroxatral

Other drugs received by patient: ALL Other Therapeutic Products



See index of all Uroxatral side effect reports >>

Drug label data at the top of this Page last updated: 2008-08-26

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