Uroxatral Side Effects

Generic Name: alfuzosin

Note: This document contains side effect information about alfuzosin. Some of the dosage forms listed on this page may not apply to the brand name Uroxatral.

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

For the Consumer

Applies to alfuzosin: oral tablet extended release

Along with its needed effects, alfuzosin (the active ingredient contained in Uroxatral) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking alfuzosin:

Rare
  • Chest pain
  • chills
  • cold sweats
  • confusion
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • painful or prolonged erection of the penis
Incidence not known
  • Arm, back, or jaw pain
  • chest discomfort
  • chest tightness or heaviness
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • nausea
  • shortness of breath
  • sweating
  • swelling

Some side effects of alfuzosin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Dizziness
Less common
  • Abdominal or stomach pain
  • acid or sour stomach
  • belching
  • body aches or pain
  • congestion
  • cough
  • cough producing mucus
  • decreased interest in sexual intercourse
  • difficulty breathing
  • difficulty having a bowel movement (stool)
  • dryness or soreness of the throat
  • ear congestion
  • fever
  • headache
  • heartburn
  • hoarseness
  • inability to have or keep an erection
  • indigestion
  • loss in sexual ability, desire, drive, or performance
  • loss of voice
  • nasal congestion
  • pain
  • pain or tenderness around the eyes and cheekbones
  • sneezing
  • sore throat
  • stomach discomfort, upset, or pain
  • stuffy or runny nose
  • tender, swollen glands in the neck
  • tightness in the chest
  • trouble with swallowing
  • unusual tiredness or weakness
  • voice changes
  • wheezing
Rare
  • Rash
Incidence not known
  • Diarrhea
  • feeling of warmth
  • hives or welts
  • itching skin
  • redness of the skin
  • redness of the face, neck, arms, and occasionally, upper chest

For Healthcare Professionals

Applies to alfuzosin: oral tablet extended release

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.

Hematologic

Postmarketing reports: Thrombocytopenia

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