Rapaflo Side Effects

Generic name: silodosin

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

Some side effects of Rapaflo 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 silodosin: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking silodosin (the active ingredient contained in Rapaflo) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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

• feeling like you might pass out; or

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

Less serious side effects of silodosin may include:

• mild dizziness;

• headache;

• diarrhea;

• abnormal ejaculation; or

• runny or stuffy nose, 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 silodosin: oral capsule

Genitourinary

Retrograde ejaculation was reversible upon discontinuation of silodosin (the active ingredient contained in Rapaflo)

Genitourinary side effects have included retrograde ejaculation (28.1%) and one case of priapism in U.S. clinical trials.

Nervous system

Nervous system side effects have included dizziness (3.2%), headache (2.4%), and insomnia (1% to 2%) in U.S. clinical trials.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (2.6%) and abdominal pain (1% to 2%) in U.S. clinical trials.

Cardiovascular

Cardiovascular side effects have included orthostatic hypotension (2.6%) in U.S. clinical trials. One case of syncope occurred in a patient taking prazosin concomitantly with silodosin (the active ingredient contained in Rapaflo)

Respiratory

Respiratory side effects have included nasopharyngitis (2.4%), nasal congestion (2.1%), sinusitis (1% to 2%), and rhinorrhea (1% to 2%) in U.S. clinical trials.

Ocular

Ocular side effects including Intraoperative floppy iris syndrome (IRIS) 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.

Other

Other side effects occurring in 1% to 2% of patients in clinical trials included asthenia and increased PSA levels.

Dermatologic

Dermatologic side effects reported postmarketing have included toxic skin eruption and purpura.

Hepatic

Hepatic side effects reported postmarketing have included jaundice and impaired hepatic function associated with increased transaminase values.

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