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Rapaflo Capsules

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Rapaflo Capsules

Rapaflo Capsules Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Rapaflo (silodosin) is used to improve urination in men with benign prostatic hyperplasia (enlarged prostate). It is in a group of drugs called alpha-adrenergic blockers. Common side effects include mild dizziness, weakness, headache, sleep problems (insomnia), diarrhea, stomach pain, decreased amount of semen released during sex, runny/stuffy nose, or sore throat.

The recommended dose of Rapaflo is 8 mg orally once daily with a meal. Rapaflo may interact with etoconazole, itraconazole, ritonavir, diltiazem, erythromycin, verapamil, cyclosporine, other alpha-blockers, digoxin, sildenafil, tadalafil, or anti-hypertensives. Tell your doctor all medications you are taking. Although Rapaflo is not for use in women, this medication is not expected to be harmful to a fetus. If you are a woman using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk, or if it could harm a nursing baby. Consult your doctor if you are breast-feeding.

Our Rapaflo (silodosin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Rapaflo Capsules in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Rapaflo Capsules (Silodosin Capsules) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Rapaflo Capsules FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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, skin rash, pruritus and urticaria

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

Immune system disorders: allergic-type reactions, not limited to skin reactions including swollen tongue and pharyngeal edema resulting in serious outcomes.

Read the entire FDA prescribing information for Rapaflo Capsules (Silodosin Capsules) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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