Alfuzosin Side Effects

Brand Names: UroXatral, Uroxatral

Please note - some side effects for Alfuzosin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Alfuzosin - for the Consumer

Alfuzosin

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 Alfuzosin:

Dizziness; drowsiness; headache; stomach pain; stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; chest pain; dark urine; decreased sexual ability; fainting; fast or irregular heartbeat; 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.

Side Effects by Body System

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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