Generic Name: sildenafil (oral) (sil DEN a fil)
Brand Names: Revatio, Viagra

What is Revatio?

Revatio (sildenafil) relaxes muscles and increases blood flow to particular areas of the body.

Revatio is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.

Sildenafil under the brand name Viagra is used to treat erectile dysfunction (impotence) in men. Do not take Viagra while also taking Revatio, unless your doctor tells you to.

Revatio may also be used for purposes not listed in this medication guide.

Important information

You should not use Revatio if you are allergic to sildenafil.

Do not take Revatio if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking Revatio with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

Slideshow: Flashback: FDA Drug Approvals 2013

Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Stop using Revatio and get emergency medical help if you have sudden vision loss.

Before taking this medicine

You should not use Revatio if you are allergic to sildenafil.

Do not take Revatio if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking Revatio with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

To make sure Revatio is safe for you, tell your doctor about your other medical conditions, especially:

  • heart disease or heart rhythm problems, coronary artery disease;

  • a recent history (in the past 6 months) of a heart attack, stroke, or congestive heart failure;

  • high or low blood pressure;

  • liver or kidney disease;

  • a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;

  • a bleeding disorder such as hemophilia;

  • a stomach ulcer;

  • retinitis pigmentosa (an inherited condition of the eye);

  • a physical deformity of the penis (such as Peyronie's disease); or

  • if you have been told you should not have sexual intercourse for health reasons.

Sildenafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking sildenafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether sildenafil is the actual cause of vision loss. Stop using sildenafil and get emergency medical help if you have sudden vision loss.

FDA pregnancy category B: This medication is not expected to be harmful to an unborn baby. Do not use Revatio without telling your doctor if you are pregnant or plan to become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether sildenafil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medication to anyone under 18 years old without medical advice.

How should I take Revatio?

Take Revatio exactly as it was prescribed for you. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Revatio is usually taken three times each day, about 4 to 6 hours apart.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Store Revatio at room temperature away from moisture and heat.

What happens if I miss a dose?

Since Viagra is used as needed, you are not likely to miss a dose.

If you miss a dose of Revatio, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Grapefruit and grapefruit juice may interact with Revatio and lead to unwanted side effects. Avoid the use of grapefruit products while taking Revatio.

Drinking alcohol can increase certain side effects of Revatio.

Avoid using any other medicines to treat impotence, such as alprostadil or yohimbine, without first talking to your doctor.

Revatio side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Revatio: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of Revatio.

Stop using Revatio and call your doctor at once if you have:

  • vision changes or sudden vision loss;

  • ringing in your ears, or sudden hearing loss;

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  • irregular heartbeat;

  • swelling in your hands, ankles, or feet;

  • shortness of breath; or

  • a light-headed feeling, like you might pass out.

Common Revatio side effects may include:

  • warmth or redness in your face, neck, or chest;

  • headache;

  • upset stomach; or

  • diarrhea.

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.

See also: Side effects (in more detail)

What other drugs will affect Revatio?

Do not take Revatio with similar medications such as avanafil (Stendra), tadalafil (Cialis) or vardenafil (Levitra). Tell your doctor about all other medications you use for erectile dysfunction.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Revatio, especially:

  • cimetidine;

  • bosentan;

  • imatinib;

  • nefazodone;

  • St. John's wort;

  • an antibiotic--clarithromycin, erythromycin, telithromycin;

  • antifungal medication--fluconazole, itraconazole, ketoconazole, miconazole, posaconazole, voriconazole;

  • heart or blood pressure medication--amlodipine, amiodarone, nicardipine, quinidine;

  • hepatitis C medications--boceprevir, telaprevir;

  • HIV/AIDS medication--atazanavir, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir;

  • seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone; or

  • tuberculosis medication--isoniazid, rifabutin, rifampin, rifapentine.

This list is not complete. Other drugs may interact with Revatio, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Revatio.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Revatio only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 11.02. Revision Date: 2014-10-06, 9:30:01 AM.

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