Patient InformationlCommon QuestionslImportant Safety Information

Safety Information

Side effects

As with any drug, REVATIO (sildenafil) may cause side effects.

In studies, the side effects reported most were:

Nosebleeds
Headache
Upset stomach
Diarrhea
Flushing (feeling “red in the face” or a “head rush” feeling)
Trouble sleeping

Very few people had to stop taking REVATIO because of side effects. Sudden decrease or loss of hearing has been reported in people taking PDE5 inhibitors, including REVATIO. It is not possible to determine whether these events are related directly to the PDE5 inhibitors or to other factors. Men who took PDE5 inhibitors for erectile dysfunction had a sudden decrease or loss of sight in one or both eyes. It is not possible to know if these cases are related directly to these medicines or something else. Be sure to let your doctor know if you have any side effects while taking REVATIO.

Who should not take REVATIO?

Only your doctor can decide if REVATIO is right for you. REVATIO is not right for everyone.

You should NEVER take REVATIO if you take medicines with nitrates in them. This includes nitroglycerin for chest pain.

REVATIO should not be taken with the medicine ritonavir (used in patients with HIV). Do not take REVATIO with antifungals such as ketoconazole and itraconazole.

If you have ever had blockage of veins in your lungs, which is called pulmonary veno-occlusive disease (PVOD), REVATIO is not recommended for you.

REVATIO contains the same medicine as VIAGRA^® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take REVATIO with VIAGRA or other PDE5 inhibitors.

Erections that last for more than four hours may occur. Call a doctor right away if this happens.

REVATIO and other medicines

Tell your doctor about any medicines or health products you are now taking. If you take any of the medicines listed below, your doctor may need to adjust your dose.

Alpha-blockers for blood pressure or prostate problems
Seizure medication, such as phenytoin or Tegretol^®* (carbamazepine)
Blood thinners, such as Coumadin^®^† (warfarin sodium)
Medicine for tuberculosis like rifampin or rifabutin
Certain HIV medicines
Tracleer^®^‡ (bosentan)

What should I tell my doctor before starting REVATIO?

Discuss your health status with your doctor to see if REVATIO is right for you.

Tell your doctor if you have or ever had:

Heart problems such as heart attack, stroke, irregular heartbeat, or chest pain (angina)
Problems with high or low blood pressure or blood circulation
An eye problem called retinitis pigmentosa
Severe liver or kidney disease
Any disease or problem with the shape of the penis
Any blood problems such as sickle cell anemia or cancer of blood cells or bone marrow
A stomach ulcer or any bleeding problem

Also tell your doctor if you are pregnant, could be pregnant, or are breast-feeding. The effects of REVATIO in these patients are not known.

*Tegretol^® is a registered trademark of Novartis Pharmaceutical Inc.
^†Coumadin^® is a registered trademark of Bristol-Myers Squibb.
^‡Tracleer^® is a registered trademark of Actelion Pharmaceuticals US.

Next: Your Prescription for REVATIO

Indication

REVATIO (sildenafil) is prescribed to treat pulmonary arterial hypertension (WHO Group I) to improve exercise ability and help lessen symptoms and slow down worsening changes in your physical condition. REVATIO has not been studied in patients taking bosentan.

Important Safety Information

If you take any medicines that contain nitrates (like nitroglycerin for chest pain) — daily or just once in a while — DO NOT take REVATIO.

REVATIO contains the same medicine as VIAGRA^® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take REVATIO with VIAGRA or other PDE5 inhibitors.

If you have ever had blockage of veins in your lungs, which is called pulmonary veno-occlusive disease, REVATIO is not recommended for you. If you feel dizzy, have chest pain, or discomfort while taking REVATIO, tell a doctor right away. Also, discuss your general health with your doctor, including if you ever had problems with low blood pressure or blood circulation. REVATIO is not recommended for patients taking ritonavir or antifungal medicines, such as ketoconazole and itraconazole. If you are taking REVATIO with bosentan or medicines like barbiturates, carbamazepine, phenytoin, efavirenz, nevirapine, rifampin or rifabutin, your doctor may adjust your dose. Also, tell your doctor if you are taking alpha-blockers for prostate or blood pressure problems.

Taking vitamin K antagonists (like coumadin or warfarin) with REVATIO may increase risk of nosebleeds. Tell your doctor if you take such medicines.

The safety of REVATIO is not known in patients with bleeding problems and those with stomach ulcers. If you have a condition like these, tell your doctor.

Sudden decrease or loss of hearing has been reported in people taking PDE5 inhibitors, including REVATIO. It is not possible to determine whether these events are related directly to the PDE5 inhibitors or to other factors. If you take a PDE5 inhibitor, including REVATIO, and experience a sudden decrease or loss of hearing, contact a doctor right away.

Men who took PDE5 inhibitors for erectile dysfunction had a sudden decrease or loss of sight in one or both eyes. It is not possible to know if these cases are related directly to these medicines or something else. If you take a PDE5 inhibitor, including REVATIO, and have a sudden decrease or loss of vision, call your doctor right away.

Erections that last for more than four hours may occur with all drugs in this class. Call a doctor right away if this happens to you. Erections that last more than six hours may lead to long-term loss of potency.

Patients who did not take part in the clinical trial were those who have had: a heart attack, stroke, or life-threatening irregular heartbeat within the last 6 months; chest pain; blood pressure greater than 170/110; eye discoloration; or patients on bosentan.

The most common side effects of REVATIO are nosebleeds, headache, upset stomach, flushing, and trouble sleeping.

At doses more than the approved 20 milligrams 3 times a day, some side effects increased. These included flushing, loose stools, muscle pain, and visual disturbances.

Please See Full Prescribing Information for REVATIO

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RVU00115A. December 2009.

The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

This product information is intended only for residents of the United States.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.