Silodosin Side Effects

Brand Names: Rapaflo

Please note - some side effects for Silodosin 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 Silodosin - for the Consumer

Silodosin

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 Silodosin:

Decreased sexual ability; diarrhea; dizziness; headache; lightheadedness; runny or stuffy nose; sinus inflammation; stomach pain; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; fainting; irregular heartbeat; prolonged, painful erection; severe of persistent dizziness; unusual bruising; 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.

Side Effects by Body System - for Healthcare Professionals

Genitourinary

Retrograde ejaculation was reversible upon discontinuation of silodosin.

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.

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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