When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to avanafil.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine about 15 minutes before you have sex. Do not take it more than once a day. Always allow at least 24 hours between doses.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you also use a nitrate medicine, often used to treat angina or high blood pressure. Nitrate medicines include nitroglycerin, isosorbide, amyl nitrate, butyl nitrate, and nitrite. Do not use this medicine if you also use riociguat.
• Some foods and medicines can affect how avanafil works. Tell your doctor if you are using any of the following:
  
  • Amprenavir, aprepitant, atazanavir, clarithromycin, desipramine, erythromycin, fluconazole, fosamprenavir, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, omeprazole, ritonavir, rosiglitazone, saquinavir, telithromycin
  • Medicine to treat high blood pressure or prostate problems (including alfuzosin, amlodipine, diltiazem, doxazosin, enalapril, prazosin, silodosin, tamsulosin, terazosin, verapamil)
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you have kidney disease, liver disease, bleeding problems, diabetes, heart or blood vessel disease, high blood pressure, high cholesterol, vision or eye problems, a stomach ulcer, or a penis with an abnormal shape. Tell your doctor if you have sickle cell anemia, leukemia, or multiple myeloma.
• Tell your doctor if you ever had chest pain during sex, or you had a stroke or heart attack within the past 6 months.
• Tell your doctor if you use any other medicine that might cause low blood pressure, because avanafil might also lower your blood pressure. If your blood pressure gets too low, you might faint or have other health problems.
• Tell your doctor if you drink alcohol. You are more likely to have a drop in blood pressure if you have more than 3 drinks of alcohol at a time while you are taking this medicine.
• This medicine may cause your penis to become erect when you do not want an erection or to stay erect for longer than you want.
• This medicine will not protect you from sexually transmitted infections (including HIV or AIDS).
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, especially if it spreads to your jaw or arm, trouble breathing, nausea, unusual sweating
• Erection that is painful or lasts longer than 4 hours
• Fast, pounding, or uneven heartbeat
• Lightheadedness or fainting
• Sudden hearing loss, ringing in your ears, or dizziness
• Sudden loss of vision in one or both eyes

If you notice these less serious side effects, talk with your doctor:

• Headache
• Stuffy or runny nose
• Warmth or redness in your face, neck, arms, or upper chest

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088