Alfuzosin Side Effects

Some side effects of alfuzosin 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

Get emergency medical help if you have any of these signs of an allergic reaction while taking alfuzosin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using alfuzosin and call your doctor at once if you have a serious side effect such as:

• new or worsening chest pain;

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• feeling like you might pass out; or

• penis erection that is painful or lasts 4 hours or longer.

Less serious side effects of alfuzosin may include:

• mild dizziness;

• headache;

• tired feeling; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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.

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