Avanafil

What is avanafil used for?

• Avanafil is used to treat erectile dysfunction (ED).
• Avanafil may be given to you for other reasons. Talk to your doctor.

Before taking avanafil, tell your doctor:

• If you are allergic to avanafil; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have been told that you are not healthy enough to have sex.
• If you have any of these health problems: Kidney disease or liver disease.
• If you have certain hereditary eye problems like retinitis pigmentosa.
• If you have any of these health problems: Chest pain (includes chest pain during sex), heart disease, heart failure, or high or low blood pressure.
• If you have had any of these health problems in the last 6 months: An abnormal heartbeat, heart attack, or stroke.
• If you have had a heart procedure in the last 6 months.
• If you use drugs called "poppers" like amyl nitrite and butyl nitrite.
• If you are taking any of these drugs: Isosorbide dinitrate, isosorbide mononitrate, nitroglycerin, riociguat, or ritonavir.
• If you are taking or will be taking another drug like this one.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with avanafil, like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with avanafil. Your doctor or pharmacist can tell you if you are taking a drug that must not be taken with avanafil.
• If you are a woman. This medicine is not approved for use in women. If you are a woman using avanafil, talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.

This is not a list of all drugs or health problems that interact with avanafil.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take avanafil with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take avanafil?

• Tell all of your health care providers that you take avanafil. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how avanafil affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• If you are taking another drug like this one that is used to treat erectile dysfunction (ED) or high pressure in the lungs.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• Talk with your doctor before you drink alcohol.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors.
• A very bad eye problem has rarely happened with avanafil. This may lead to a change in eyesight and sometimes loss of eyesight, which may not come back. Talk with the doctor.
• This medicine is not approved for use in children. Talk with the doctor.

How is avanafil best taken?

Use avanafil as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Take avanafil before sex when you were told by your doctor. If you are not sure when to take avanafil, talk with your doctor.

What do I do if I miss a dose?

• This medicine is taken on an as needed basis. Do not take more often than every 24 hours unless told to do so by your doctor.

What are the side effects of avanafil that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Very bad dizziness or passing out.
• Very bad headache.
• Very upset stomach or throwing up.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Change in eyesight, eye pain, or very bad eye irritation.
• Loss of eyesight.
• Change in hearing.
• Hearing loss.
• Ringing in ears.
• Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.

What are some other side effects of avanafil?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flushing.
• Headache.
• Sore throat.
• Back pain.
• Stuffy nose.
• Runny nose.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out avanafil?

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about avanafil, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take avanafil or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to avanafil. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.