Avanafil (a-VAN-a-fil)

Treats erectile dysfunction (trouble having an erection).

Brand Name(s):

Stendra

When This Medicine Should Not Be Used:

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 are also taking riociguat, vericiguat, or nitrate medicine (including nitroglycerin, isosorbide, amyl nitrate, butyl nitrate, and nitrite) often used to treat angina or high blood pressure. If you need to use a nitrate medicine for emergency, take it at least 12 hours after your last dose of avanafil.
• 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)
  • Other medicine to treat erectile dysfunction
• Do not have 3 or more alcohol-containing drinks in a short period of time while you are using this medicine.
• 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, cancer (including leukemia, multiple myeloma), 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 have angina or chest pain during sex, heart disease, heart rhythm problems, high or low blood pressure, or a history of heart attack or stroke.
• This medicine may cause the following problems:
  • Low blood pressure (especially if taken with other medicines that lower blood pressure)
  • Painful or prolonged erection
  • Hearing or vision problems
• This medicine will not protect you from sexually transmitted infections (including HIV or AIDS).
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• 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
• Fast, pounding, or uneven heartbeat
• Lightheadedness or fainting
• Painful erection or an erection that lasts longer than 4 hours with or without pain
• 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