Rapaflo Side Effects

Generic Name: silodosin

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

Rapaflo

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 Rapaflo:

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

Seek medical attention right away if any of these SEVERE side effects occur when using Rapaflo:

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.

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Rapaflo Side Effects - for the Professional

Rapaflo

  Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In U.S. clinical trials, 897 patients with BPH were exposed to 8 mg Rapaflo daily. This includes 486 patients exposed for 6 months and 168 patients exposed for 1 year. The population was 44 to 87 years of age, and predominantly Caucasian. Of these patients, 42.8% were 65 years of age or older and 10.7% were 75 years of age or older.

In double-blind, placebo controlled, 12-week clinical trials, 466 patients were administered Rapaflo and 457 patients were administered placebo. At least one treatment-emergent adverse reaction was reported by 55.2% of Rapaflo treated patients (36.8% for placebo treated). The majority (72.1%) of adverse reactions for the Rapaflo treated patients (59.8% for placebo treated) were qualified by the investigator as mild. A total of 6.4% of Rapaflo treated patients (2.2% for placebo treated) discontinued therapy due to an adverse reaction (treatment-emergent), the most common reaction being retrograde ejaculation (2.8%) for Rapaflo treated patients. Retrograde ejaculation is reversible upon discontinuation of treatment.

Adverse Reactions observed in at least 2% of patients:

The incidence of treatment-emergent adverse reactions listed in the following table were derived from two 12-week, multicenter, double-blind, placebo-controlled clinical studies of Rapaflo 8 mg daily in BPH patients. Adverse reactions that occurred in at least 2% of patients treated with Rapaflo and more frequently than with placebo are shown in Table 1.

Table 1 Adverse Reactions Occurring in ≥ 2% of Patients in 12-week, Placebo-Controlled Clinical Trials

Adverse Reactions	Rapaflo N = 466 n (%)	Placebo N = 457 n (%)
Retrograde Ejaculation	131 (28.1)	4 (0.9)
Dizziness	15 (3.2)	5 (1.1)
Diarrhea	12 (2.6)	6 (1.3)
Orthostatic Hypotension	12 (2.6)	7 (1.5)
Headache	11 (2.4)	4 (0.9)
Nasopharyngitis	11 (2.4)	10 (2.2)
Nasal Congestion	10 (2.1)	1 (0.2)

In the two 12-week, placebo-controlled clinical trials, the following adverse events were reported by between 1% and 2% of patients receiving Rapaflo and occurred more frequently than with placebo: insomnia, PSA increased, sinusitis, abdominal pain, asthenia, and rhinorrhea. One case of syncope in a patient taking prazosin concomitantly and one case of priapism were reported in the Rapaflo treatment group.

In a 9-month open-label safety study of Rapaflo, one case of Intraoperative Floppy Iris Syndrome (IFIS) was reported.

  Postmarketing Experience

The following adverse reactions have been identified during post approval use of silodosin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

Skin and subcutaneous tissue disorders: toxic skin eruption, purpura

Hepatobiliary disorders: jaundice, impaired hepatic function associated with increased transaminase values

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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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