Consumer Safety Information
Sildenafil Tablets (Erectile Dysfunction)
PRONUNCIATION: (sil DEN a fil)
BRAND NAME(S): Viagra
WHAT IS THIS DRUG USED FOR?
It is used to treat erectile dysfunction (ED).
It may be given to you for other reasons. Talk with the doctor.
WHAT DO I NEED TO TELL MY DOCTOR BEFORE I TAKE THIS DRUG?
If you have an allergy to sildenafil or any other part of this drug.
If you are allergic to any drugs like this one, any other drugs, foods, or other substances.
Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
If you have a health problem called pulmonary veno-occlusive disease (PVOD).
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 another drug that has the same drug in it.
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 have been told that you are not healthy enough to have sex.
If you are a woman. This drug is not approved for use in women.
If the patient is a child. This drug is not approved for use in children.
This is not a list of all drugs or health problems that interact with this drug.
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 this drug 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 THIS DRUG?
Tell all of your health care providers that you take this drug. 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 this drug 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.
Talk with your doctor before you drink alcohol.
Rarely, certain side effects like abnormal heartbeat, heart attack, stroke, bleeding in the lungs, and very bad high blood pressure have happened with this drug. Sometimes, this has been deadly. Most of the time, these problems happened in people who had heart problems before taking this drug. It is not known if this drug caused these problems. If you have questions, talk with the doctor.
A very bad eye problem has rarely happened with this drug. This may lead to a change in eyesight and sometimes loss of eyesight, which may not come back. Talk with the doctor.
If you are 65 or older, use this drug with care. You could have more side effects.
This drug does not stop the spread of diseases like HIV or hepatitis that are passed through having sex.
Do not have any kind of sex without using a latex or polyurethane condom.
If you have questions, talk with your doctor.
WHAT ARE SOME SIDE EFFECTS THAT I NEED TO CALL MY DOCTOR ABOUT RIGHT AWAY?
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.
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.
Loss of eyesight.
Change in hearing.
Ringing in ears.
Shortness of breath.
Swelling in the arms or legs.
Any unexplained bruising or bleeding.
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 THIS DRUG?
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, Heartburn, Upset stomach, Stuffy nose, Runny nose, Muscle pain, or Back pain.
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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
HOW IS THIS DRUG BEST TAKEN?
Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
Take with or without food.
Take this drug before sex when you were told by your doctor. If you are not sure when to take this drug, talk with your doctor.
Do not use more than what your doctor told you to use. Do not use more often or longer than what you were told. Doing any of these things may raise the chance of very bad side effects.
WHAT DO I DO IF I MISS A DOSE?
This drug is used on an as needed basis. Do not use more often than told by the doctor.
Do not take 2 doses on the same day.
HOW DO I STORE AND/OR THROW OUT THIS DRUG?
Store at room temperature.
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.
GENERAL DRUG FACTS
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.
Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this drug, 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.