Uroxatral Side Effects

Generic Name: alfuzosin

Please note - some side effects for Uroxatral may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Uroxatral - for the Consumer

Uroxatral

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Uroxatral:

Dizziness; drowsiness; fatigue; headache; stomach pain; stuffy or runny nose.

Seek medical attention right away if any of these SEVERE side effects occur when using Uroxatral:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); back pain; chest pain; dark urine; decreased sexual ability; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; joint pain; painful, prolonged erection; pale stools; severe or persistent dizziness; severe or persistent stomach pain; unusual fatigue or weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Uroxatral Side Effects - for the Professional

Uroxatral

Clinical Studies Experience

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

The incidence of treatment-emergent adverse events has been ascertained from 3 placebo-controlled clinical trials involving 1,608 men where 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) 10 mg extended-release tablets withdrew from the study due to adverse events, compared with 3% in the placebo group.

Table 1 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 1 — 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 Event	Placebo (n=678)	Uroxatral (n=473)
Dizziness	19 (2.8%)	27 (5.7%)
Upper respiratory tract infection	4 (0.6%)	14 (3.0%)
Headache	12 (1.8%)	14 (3.0%)
Fatigue	12 (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 reactions related to orthostasis that occurred in the double-blind phase 3 studies with alfuzosin 10 mg are summarized in Table 2. Approximately 20% to 30% of patients in these studies were taking antihypertensive medication.

Table 2— Number (%) of Patients with Symptoms Possibly Associated with Orthostasis in 3-Month Placebo-Controlled Clinical Studies

Symptoms	Placebo (n=678)	Uroxatral (n=473)
Dizziness	19 (2.8%)	27 (5.7%)
Hypotension or postural hypotension	0	2 (0.4%)
Syncope	0	1 (0.2%)

Testing for blood pressure changes or orthostatic hypotension was conducted in three controlled studies. Decreased systolic blood pressure (≤90 mm Hg, with a decrease ≥20 mm Hg from baseline) was observed in none of the 674 placebo patients and 1 (0.2%) of the 469 Uroxatral patients. Decreased diastolic blood pressure (≤50 mm Hg, with a decrease ≥15 mm Hg from baseline) was observed in 3 (0.4%) of the placebo patients and in 4 (0.9%) of the Uroxatral patients. A positive orthostatic test (decrease in systolic blood pressure of ≥20 mm Hg upon standing from the supine position) was seen in 52 (7.7%) of placebo patients and in 31 (6.6%) of the Uroxatral patients.

Post-Marketing Experience

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 Warnings and Precautions (5.7)].

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Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects are among the most commonly reported and include dizziness (5.7%), headache (3%) and fatigue (2.7%).

Respiratory

Respiratory side effects have included upper respiratory tract infection (3%), bronchitis, sinusitis and pharyngitis.

Cardiovascular

Cardiovascular side effects reported possibly due to orthostasis have included dizziness (5.7%), hypotension or postural hypotension (0.4%) and syncope (0.2 %). In addition, tachycardia, chest pain, and angina pectoris in patients with preexisting coronary artery disease have been reported in postmarketing experience.

Other

Other side effects have included pain and rash. In addition, flushing, edema, angioedema, pruritus, and rhinitis have been reported in postmarketing experience.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain, dyspepsia, constipation and nausea. Diarrhea has been reported in postmarketing experience.

Genitourinary

Genitourinary effects have included impotence and priapism.

Ocular

Ocular side effects including Intraoperative Floppy Iris Syndrome (IFIS) have been observed in some patients undergoing phacoemulsification cataract surgery while being treated with alpha-1 blockers.

Most reports were in patients treated with an alpha-1 blocker at the time IFIS occurred, but in some instances the alpha-1 blocker had been stopped prior to surgery. The manufacturer recommends that patients be questioned to determine whether or not they have taken alpha-1 blockers prior to being considered for cataract surgery. If it is determined that the patient has taken an alpha-1 blocker, the patient's ophthalmologist should be prepared for possible modifications to their surgical technique that may be necessary should IFIS be observed during the procedure.

Hepatic

Hepatic side effects have not been reported by the manufacturer; however, at least two case reports of alfuzosin-induced hepatotoxicity have been cited.
Hepatocellular and cholestatic liver injury (including cases with jaundice leading to drug discontinuation) have been reported during postmarketing experience.

A 63-year-old man developed jaundice after 9 months of sustained-release alfuzosin therapy at a dose of 5 mg twice daily. He was also receiving amiloride treatment for hypertension. The patient's liver function tests were highly elevated with negative findings for hepatitis A, B and C, Epstein-Barr virus, herpes simplex virus and cytomegalovirus. Alfuzosin therapy was discontinued and the patient's liver function test began to normalize over a period of weeks. After 6 months, the patients blood chemistry was normal. The incident was attributed to alfuzosin-induced hepatotoxicity.

Alfuzosin-associated severe hepatocellular hepatitis developed in an 80-year-old patient with chronic liver disease after receiving sustained-release alfuzosin (10 mg/day) for 3 weeks. After withdrawal of alfuzosin, liver function tests returned to normal over the following months (18 weeks).

Dermatologic

Dermatologic side effects including a case report of alfuzosin-associated dermatomyositis have been reported, although a causal relationship has not been determined. Rash and urticaria have also been reported in postmarketing experience. One fatal case of alfuzosin-induced toxic epidermal necrolysis has been reported.

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