Warnings


Silodosin (Rapaflo) Risks, Warnings, and Complications


Silodosin can cause or worsen health problems in certain people. Talk to your doctor or pharmacist about other treatment options for benign prostatic hyperplasia (BPH) if you are at increased risk of adverse reactions from silodosin use. Some of the risks of taking silodosin include:

  • LOW BLOOD PRESSURE: Taking silodosin can cause orthostatic or postural hypotension, which is a sudden drop in blood pressure that occurs with changes in position. For example, when going from a sitting or lying position to standing. Symptoms can include dizziness, lightheadedness, and fainting. The risk is highest when you first start treatment. Be careful while driving, operating machinery, and doing other potentially hazardous activities until you know how the medicine affects you. 

  • KIDNEY PROBLEMS: The blood concentration of silodosin can be up to three times higher in people with moderate renal impairment (moderately reduced kidney function) compared to people with normal kidney function. If you have kidney disease, your doctor may prescribe a lower dose of silodosin (4 mg daily) and monitor you closely for adverse effects. You may not be a candidate for silodosin therapy if you have severe renal impairment.

  • LIVER PROBLEMS: Silodosin has not been tested in patients with severe hepatic impairment (reduced liver function or liver failure). Therefore, this medicine is not prescribed to people with severe liver disease. 

  • DRUG INTERACTIONS: Taking silodosin with certain other medications can affect how it works. For example, it can increase the blood concentration of silodosin and put you at risk of more severe side effects. Drugs with which silodosin (Rapaflo) can interact include antifungal agents such as ketoconazole and itraconazole, antibiotics such as clarithromycin, and HIV protease inhibitors such as ritonavir.

    Interactions between silodosin and other alpha-blockers have not been studied well, and therefore, silodosin should not be used with other drugs from the same class. 

    Specific studies have not been done to see how this medication affects antihypertensive drugs (medications used to treat high blood pressure). Antihypertensives can also cause orthostatic hypotension (low blood pressure with changes in posture). However, clinical studies have shown that combination therapy with silodosin and antihypertensive drugs does not lead to a significant increase in side effects like dizziness or fainting. Nonetheless, you should be careful if you are taking medications for high blood pressure at the same time as silodosin. Tell your doctor without delay if you notice symptoms such as dizziness or fainting. 

    You should also exercise caution if you are taking silodosin with PDE5 inhibitors (medications used to treat erectile dysfunction). These drug classes are both vasodilators and can lower blood pressure, potentially causing symptomatic hypotension.

  • PROSTATE CANCER: Prostate cancer and benign prostatic hyperplasia (BPH) can cause similar symptoms and may occur together. Other conditions that can cause the same symptoms include bladder overactivity, kidney stones, and bladder cancer. Your healthcare provider will perform a thorough evaluation, including checking prostate-specific antigen (PSA) to rule out prostate cancer, before prescribing silodosin (Rapaflo) to treat BPH. 

  • CATARACT SURGERY COMPLICATIONS: People who are on silodosin or other alpha-adrenergic receptor blockers during cataract surgery can develop a complication called intraoperative floppy iris syndrome. If you are scheduled for cataract surgery, be sure to tell your ophthalmologist (eye doctor) that you are on silodosin.


Precautions Before Starting Silodosin (Rapaflo)

Tell your doctor if you have ever had an allergic reaction to silodosin, any of the active or inactive ingredients in silodosin capsules, other alpha-blockers, or any other drugs. Your pharmacy can give you a list of ingredients.

Give your doctor and pharmacist a complete list of your medications, including prescription drugs, over-the-counter medicines, vitamins, supplements, and herbal products. This can help avoid possible drug interactions.

Give your doctor a complete medical history. Silodosin may not be safe for people with certain medical conditions such as low blood pressure, kidney disease, or liver disease.

Silodosin is not intended for use by women. If a pregnant woman takes this drug, she should contact her doctor.

Precautions During Use of Silodosin (Rapaflo)

Keep all your medical and lab appointments while on silodosin. Your doctor may want to monitor you for side effects.

Talk to your healthcare provider about eating grapefruit and drinking grapefruit juice while on silodosin.

Silodosin can cause dizziness and lightheadedness. Do not drive, operate machinery, or do any hazardous activity until you know how this medicine affects you. Remember, alcohol can make dizziness worse, so avoid drinking alcohol while on silodosin.

Silodosin can cause lightheadedness and dizziness when going from a lying or sitting position to standing. Put your feet on the floor for a few minutes before standing up to lower the risk of falls. Tell your healthcare professional if you have severe dizziness or experience fainting. 

Tell all your healthcare providers you are on silodosin, especially before eye surgery.

Silodosin (Rapaflo) Drug Interactions

Certain other drugs can affect how silodosin works. Possible interactions between silodosin and other medicines can increase the risk of severe side effects. Your doctor may change your dose, switch you to a different medication, or monitor you closely for adverse effects if there are known interactions between silodosin and your other medications.

You should not take silodosin with the following drugs:

  • Antifungal medications such as ketoconazole (Nizoral) and itraconazole (Sporanox)
  • Antibiotics such as clarithromycin (Biaxin, in Prevpac) and telithromycin (Ketek)
  • HIV protease inhibitors such as indinavir (Crixivan), ritonavir (Norvir, in Kaletra), nelfinavir (Viracept), and saquinavir (Fortovase)
  • Antidepressants such as nefazodone

Silodosin can also interact with other medications, such as: 

  • Immunosuppressants such as cyclosporine (Neoral, Sandimmune)
  • Calcium channel blockers such as diltiazem (Cardizem, Tiazac, Dilacor) and verapamil (Isoptin, Verelan, Calan, Covera)
  • Medications used to treat high blood pressure
  • Antibiotics such as erythromycin (E-Mycin, E.E.S., Erythrocin)
  • Antifungal drugs such as fluconazole (Diflucan)
  • Other alpha adrenergic receptor blockers such as prazosin (Minipress), terazosin (Hytrin), doxazosin (Cardura), and tamsulosin (Flomax)

Give your healthcare professional a complete list of your medications, including prescription drugs, over-the-counter medications, dietary supplements, and herbal remedies. Also, tell your doctor or pharmacist if you smoke, drink alcohol, or use recreational drugs because some of these substances can cause serious health complications when used with prescription medications.