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What is the most important information I should know about tadalafil?

Do not take tadalafil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking tadalafil with a nitrate medicine can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack. If you become dizzy or nauseated during sexual activity, or if you 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 tadalafil. Do not take tadalafil more than once a day. Allow 24 hours to pass between doses. 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.

Tadalafil 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 tadalafil, 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 tadalafil is the actual cause of vision loss.

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

What is tadalafil?

Tadalafil relaxes muscles and increases blood flow to particular areas of the body.

Tadalafil is used to treat erectile dysfunction (impotence).

Tadalafil may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking tadalafil?

Do not take tadalafil if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, Minitran, Deponit, Transderm-Nitro), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket), or recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking tadalafil with a nitrate medicine can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack.

Before taking tadalafil, tell your doctor if you are allergic to any drugs, or if you have:

• heart disease or heart rhythm problems;

• a recent history a heart attack (within the past 90 days);

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

• angina (chest pain);

• high or low blood pressure;

• liver disease;

• kidney disease (or if you are on dialysis);

• 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.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take tadalafil.

Tadalafil 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 tadalafil, 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 tadalafil is the actual cause of vision loss. Stop using tadalafil and get emergency medical help if you have sudden vision loss.

FDA pregnancy category B: Although tadalafil is not for use in women, this medication is not expected to be harmful to an unborn baby. Do not use tadalafil without telling your doctor if you are pregnant or plan to become pregnant during treatment. Although tadalafil is not for use in women, it is not known if tadalafil passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.