Drug Notebook

FDA Alerts

Special Alerts:

[Posted 10/18/2007] FDA informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors sildenafil (Viagra), tadalafil (Levitra), vardenafil (Cialis) for the treatment of erectile dysfunction, and sildenafil (Revatio) for the treatment of pulmonary arterial hypertension. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors. The PRECAUTIONS and ADVERSE REACTIONS sections of the approved product labeling for sildenafil (Viagra), tadalafil, and vardenafil were revised. FDA is working with the manufacturer to revise the labeling for sildenafil (Revatio). For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#PDE5, http://www.fda.gov/cder/consumerinfo/viagra/default.htm, http://www.fda.gov/cder/foi/label/2007/020895s027lbl.pdf, http://www.fda.gov/cder/drug/infopage/cialis/default.htm, http://www.fda.gov/cder/foi/label/2007/021368s012lbl.pdf, http://www.fda.gov/cder/drug/infopage/vardenafil/default.htm and http://www.fda.gov/cder/foi/label/2007/021400s010lbl.pdf.

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sildenafil
(sil DEN uh fil)

What is sildenafil?
Sildenafil relaxes muscles and increases blood flow to particular areas of the body. Sildenafil under the name Viagra is used to treat erectile dysfunction (impotence) in men. Another brand of sildenafil is Revatio, which is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women. Sildenafil may also be used for other purposes not listed in this medication guide.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Revatio 20MG Tablets PFIZER U.S.30/$448.07 or 90/$1226.59
Viagra 100MG Tablets PFIZER U.S.10/$133.99 or 30/$389.97
Viagra 25MG Tablets PFIZER U.S.10/$133.99 or 30/$387.97
Viagra 50MG Tablets PFIZER U.S.10/$133.99 or 30/$389.97

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What are the possible side effects of sildenafil?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of sildenafil.

Stop using sildenafil and call your doctor at once if you have any of these serious side effects:

  • sudden vision loss;

  • ringing in your ears, or sudden hearing loss;

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  • irregular heartbeat;

  • swelling in your hands, ankles, or feet;

  • shortness of breath;

  • vision changes;

  • feeling light-headed, fainting; or

  • penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

  • warmth or redness in your face, neck, or chest;

  • stuffy nose;

  • headache;

  • upset stomach; or

  • back pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I take sildenafil?
Take sildenafil exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Follow the directions on your prescription label. Revatio is usually taken three times each day, about 4 to 6 hours apart. Viagra is usually taken only when needed, 30 minutes to 1 hour before sexual activity. You may take it up to 4 hours before sexual activity. Do not take Viagra more than once per day. Viagra can help you have an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

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What is the most important information I should know about sildenafil?
Do not take sildenafil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking sildenafil with a nitrate medicine can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack.

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What happens if I miss a dose?
Viagra is used as needed, so you are not likely to be on a dosing schedule. If you miss a dose of Revatio, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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What other drugs will affect sildenafil?
Do not take sildenafil if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, Minitran, Deponit, Transderm-Nitro), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket), or recreational drugs such as amyl nitrate or nitrite ("poppers"). Before taking sildenafil, tell your doctor about all other medications you use for erectile dysfunction, or if you are using any of the following medications:

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Sildenafil has been assigned to pregnancy category B by the FDA. Animal data have failed to reveal evidence of teratogenicity or fetotoxicity even after doses that represented up to 40 times the maximum recommended human dose (on a mg/m2 basis). There are no controlled data in human pregnancy. Sildenafil is only recommended for use during pregnancy when benefit outweighs risk.

There are no data on the excretion of sildenafil in human milk. The manufacturer recommends that caution be used when administering sildenafil to nursing women.

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Who should NOT use this medication?

  • Known hypersensitivity to sildenafil or any ingredient in the formulation.
  • Concomitant use of organic nitrates or nitrites. (See Specific Drugs under Interactions.)
  • Should not be used for treatment of erectile dysfunction in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include chest pain, nausea, irregular heartbeat, and feeling light-headed or fainting.

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What should I discuss with my healthcare provider before taking sildenafil?
Do not take sildenafil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking sildenafil with a nitrate medicine can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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