Tadalafil is used in adult men to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate).

Tadalafil can also be used in men and women to treat pulmonary arterial hypertension (PAH) and improve exercise capacity.

Do not take tadalafil for erectile dysfunction and symptoms of enlarged prostate if you are taking tadalafil for pulmonary arterial hypertension.

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

You should not take tadalafil if you are allergic to it, or if you take other medicines to treat pulmonary arterial hypertension, such as riociguat (Adempas).

Do not take tadalafil if you are also using certain medicines for chest pain or heart problems called nitrates. These include nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate, butyl nitrate or nitrite ("poppers"). Taking tadalafil with a nitrate can cause a sudden and serious decrease in blood pressure.

Some tadalafil can remain in your bloodstream for 2 or more days after each dose you take (longer if you have liver or kidney disease). Avoid nitrate use during this time.

Tell your doctor if you have or have ever had:

• heart problems (chest pain, a heart rhythm disorder, congestive heart failure);
• a heart attack or stroke;
• pulmonary hypertension;
• bleeding problems;
• uncontrolled high or low blood pressure;
• retinitis pigmentosa (an inherited condition of the eye);
• problems with hearing or vision;
• a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
• pulmonary veno-occlusive disease (PVOD);
• a penis deformity (such as Peyronie's disease);
• priapism (an erection that is painful or lasts longer than 4 hours);
• a stomach ulcer;
• if you have been told you should not have sexual intercourse for health reasons;
• liver disease; or
• kidney disease (or if you are on dialysis).

It is not known if tadalafil will harm an unborn baby. However, having pulmonary hypertension during pregnancy may cause complications or medical problems such as heart failure, and stroke in both mother and baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Not approved for use by anyone younger than 18 years old.

Use Tadliq (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

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

• severe vision problems, including sudden vision loss;
• a light-headed feeling, like you might pass out;
• ringing in your ears or sudden hearing loss;
• a painful erection or one that lasts longer than 4 hours; or
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Get emergency medical help if you have nausea, chest pain, dizziness during sex.

Common side effects may include:

• headache;
• feeling light-headed;
• flushing (warmth, redness, or tingly feeling);
• nausea, upset stomach;
• runny or stuffy nose; or
• muscle pain, back pain, pain in your arms or legs.

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.

Avoid drinking alcohol. Alcohol can further lower your blood pressure and may increase your risk of headache, dizziness, or fainting.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Grapefruit may interact with tadalafil and cause side effects. Avoid consuming grapefruit products.