{"id":12485,"date":"2016-02-27T09:19:36","date_gmt":"2012-02-27T16:19:36","guid":{"rendered":"http:\/\/www.accessrx.com\/blog\/?p=4865"},"modified":"2025-08-06T14:13:39","modified_gmt":"2025-08-06T07:13:39","slug":"fda-approved-medications-ed","status":"publish","type":"post","link":"https:\/\/www.edrugstore.com\/blog\/erectile-dysfunction\/fda-approved-medications-ed\/","title":{"rendered":"Powerful Pills: FDA Approved Medications for Erectile Dysfunction"},"content":{"rendered":"

If you’re confused about the differences between the many prescription drugs available for treating erectile dysfunction (ED), read on to learn more. The differences between them are slight, but one type may work better with your unique physiology.\u00a0<\/em><\/strong><\/p>\n

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Erectile Dysfunction, or ED, is a problem that many men face at some time in their lives. In another article in this series<\/a> we discussed the signs and symptoms, as well as the possible causes, of ED. Now it\u2019s time for a more detailed look at some of the many treatment options for men with ED. We\u2019ll begin with the most obvious ones: the prescription drugs for ED<\/a>. These days when most men think about ED treatments, the first that come to mind are the widely advertised FDA approved erectile dysfunction pills <\/span><\/span>such<\/span><\/span> medications such as Viagra, Cialis, Cialis for daily use, Levitra, or Staxyn and Stendra.<\/a>\u00a0Generic versions are now available for Viagra and Cialis, and generics for Levitra are on the horizon as well. These are the drugs currently approved by the United States Food and Drug Administration (FDA), and they\u2019re the ones we\u2019ll be discussing here.<\/p>\n

But first a couple of disclaimers. Since the FDA is a United States government agency, if you live somewhere else, some of the information in this article may not apply to you. Availability of medications and other treatments may vary from country to country, so always be sure to consult with a physician or other qualified health care practitioner in your area. In addition, research is an ongoing process, and in the future there will almost certainly be more medications (and other options) for the treatment of ED.<\/p>\n

Now, let\u2019s take a look at some of those famous medications, most of which you have already seen advertisements for, and exactly how they work.<\/p>\n

The Role of Enzymes and their Inhibitors<\/strong><\/h2>\n

Enzymes, as you may have learned in your biology or physiology classes, are protein molecules that work as catalysts \u2013 that is, they bring about specific biochemical reactions. The human body produces thousands upon thousands of different enzymes, but the ED medications we\u2019ll be discussing here all target a specific type of enzyme known as phosphodiesterase type 5<\/em>, or PDE5. These drugs are called, appropriately enough, PDE5 inhibitors<\/em>.<\/p>\n

\"\"<\/a>What does PDE5 do, and why does it need to be inhibited? When everything is functioning properly, it doesn\u2019t, but sometimes PDE5 does its job too well. Under normal circumstances, sexual stimulation prompts production and release of nitric oxide in a man\u2019s penis. The nitric oxide creates an enzyme, guanylate cyclase<\/em>, which in turn creates a nucleotide called cyclic guanosine monophosphate<\/em>, or cGMP. If everything is functioning well, the cGMP opens up blood pathways in the penis, resulting in that glorious engorgement that manifests as an erection. It\u2019s important to note that it is cGMP that is primarily responsible for the erection; it affects the amount of blood that the vessels deliver to (and remove from) the penis.<\/p>\n

But there\u2019s also another enzyme waiting in the wings \u2013 PDE5 \u2013 which offsets the enzyme that created the cGMP. If not for PDE5, men would have a permanent erection \u2013 medically known as a priapism<\/em>, which can result in painful tissue damage. For any number of reasons, however, this delicate dance of enzymes and bodily processes can malfunction. PDE5\u2019s job is to degrade cGMP, but when there are problems producing the cGMP in the first place, it\u2019s overkill \u2013 and all too often the result is ED.<\/p>\n

Enter the PDE5 inhibitor drugs mentioned above. They block the action of PDE5 and prevent it from destroying cGMP, allowing the latter to accumulate in the body and stay there for a longer period of time. As you might imagine, PDE5 inhibitor medications are very popular; more than 18.5 million prescriptions were written in the US in 2010 alone. Let\u2019s look at these prescription drugs individually.<\/p>\n

Viagra (Sildenafil Citrate)<\/a><\/strong><\/h3>\n

Though the active ingredient in Viagra, sildenafil, is also marketed under a couple of other trade names (some for conditions other than erectile dysfunction), Viagra is the most well-known of them all. It was the first to hit the market and remains the most-prescribed ED pill today. Originally developed by British scientists and brought to market by the US-based pharmaceutical company Pfizer, Viagra has been available since 1998 and is the tried-and-true standby for men who desire harder erections. It also helps a man maintain an erection throughout sexual contact. Viagra is a standard treatment for ED, including for men with diabetes.
\nTrue to its famous nickname, \u201cThe Little Blue Pill,\u201d Viagra comes in easily recognizable diamond-shaped blue pills, in doses of 25, 50, or 100 milligrams. For erectile dysfunction the recommended dose of Viagra is 25 mg to 100 mg, taken not more than once every 24\u00a0 hours, between 30 minutes and four hours prior to sexual intercourse. (For information on side effects, see the section below.) Viagra can be taken with meals, but do note that high-fat meals may slow the absorption rate of the drug. Our advice? Just say no to that jumbo bacon cheeseburger and large fries combo, and go for something light, healthy, and low-fat.<\/p>\n

Cialis\u00a0<\/a>and Cialis for Daily Use<\/a>(Tadalafil)<\/strong><\/h3>\n

In late 2003, the FDA approved Cialis as a prescription treatment for Erectile Dysfunction in the US. Cialis\u2019 active ingredient, tadalafil, had already been in use for ED in Europe for a few years, and was also an ingredient in some over-the-counter sexual stamina supplements in the US. Like the ingredient in Viagra, tadalafil is sometimes prescribed, under a different trade name and a different dosage, for other medical conditions besides ED, most notably, pulmonary arterial hypertension. And in October 2011 the FDA approved tadalafil as a treatment for benign prostatic hyperplasia (BPH), also known as an enlarged prostate. But it is as a treatment for Erectile Dysfunction that tadalafil is best known.
\nThe original Cialis became known as \u201cThe Weekend Pill\u201d because of its 36-hour effectiveness, although like others in its class of drugs it is recommended as an \u201cas needed\u201d medication. Cialis is a yellow almond-shaped pill that comes in 10 or 20 mg strengths, and it may be taken with food. In early 2008 the FDA approved Cialis for daily use, which is similar in appearance to original Cialis but comes in smaller dosages of 2.5 mg and 5 mg. As of this writing, Cialis is the only one of the FDA-approved PDE5 inhibitors available in a daily dose. A big advantage of the daily dosage is that it doesn\u2019t cut into sexual spontaneity; there\u2019s no waiting half an hour or more for your ED med to take effect.
\n\"\"<\/a><\/strong><\/em><\/p>\n

Levitra<\/a> (vardenafil HCl)<\/strong><\/h3>\n

Like Cialis, Levitra was originally approved for use an Erectile Dysfunction treatment in the US in 2003, giving Viagra a run for its money. Levitra\u2019s active ingredient, vardenafil, may also be effective in the treatment of problematic premature ejaculation. Levitra is known for being the fastest acting of the three main ED drugs; it can work in as little as 12 minutes. A single dose lasts up to five hours, and the drug can remain in the system for up to 24 hours.<\/p>\n

Levitra is a round, orange-colored pill with the characteristic Bayer crisscross insignia. It comes in 2.5 mg, 5 mg, 10 mg and 20 mg dosages, though the usual starting dosage is 10 mg (which is roughly equivalent to 50 mg of sildenafil, Viagra\u2019s active ingredient). See the section below for information on possible side effects.<\/p>\n

\"\"<\/a><\/strong><\/em><\/h3>\n

Staxyn<\/a> (vardenafil HCl)<\/h3>\n
\"\"<\/a>
Staxyn is convenient because it doesn’t have to be taken with water.<\/em><\/figcaption><\/figure>\n

Staxyn, which has the same active ingredient as Levitra, is one of the safest and newest ED medications on the market; it has fewer side effects than some of the others. Even so, Staxyn is not approved for daily use, and should only be taken as needed, approximately 60 minutes before engaging in sexual activity.<\/p>\n

Staxyn is the first Erectile Dysfunction disintegrating pill made to be taken without liquid. In other words, it comes as a dissolvable tablet to take by mouth, usually placed under the tongue. So if you have ED and you have a problem swallowing pills (many people do), Staxyn may be just what you were looking for. Staxyn is currently available in a 10 mg dosage. It is a small round white pill with a fresh peppermint flavor.<\/p>\n

Here is a page with a chart that allows you to easily compare Viagra, Cialis, and Levitra.<\/a><\/strong>
\nAs of this writing, none of the above-mentioned drugs is available in a generic form. Beware of anyone who claims to be selling generic and\/or nonprescription Viagra, Cialis, Levitra, or Staxyn, as those medications may be unregulated and\/or harmful to your health. (And some of the sites these questionable meds are sold on may even be harmful to your computer.) For more information about any of the drugs above, you should check with your doctor.<\/p>\n

Are There Differences in Them?<\/h2>\n

Yes, while all <\/span>FDA approved ED pills<\/span><\/b> aim to improve blood flow to the penis, they differ in how quickly they work, how long they last, and how they react with food or alcohol.<\/span>\u00a0<\/span><\/p>\n\n\n\n\n\n\n\n
Medication<\/span><\/b>\u00a0<\/span><\/td>\nTime to Take Effect<\/span><\/b>\u00a0<\/span><\/td>\nDuration<\/span><\/b>\u00a0<\/span><\/td>\nNotes<\/span><\/b>\u00a0<\/span><\/td>\n<\/tr>\n
Viagra<\/span>\u00a0<\/span><\/td>\n30\u201360 minutes<\/span>\u00a0<\/span><\/td>\n4\u20136 hours<\/span>\u00a0<\/span><\/td>\nWorks best on an empty stomach<\/span>\u00a0<\/span><\/td>\n<\/tr>\n
Cialis<\/span>\u00a0<\/span><\/td>\n30\u201360 minutes<\/span>\u00a0<\/span><\/td>\nUp to 36 hours<\/span>\u00a0<\/span><\/td>\nCan be taken daily in low doses<\/span>\u00a0<\/span><\/td>\n<\/tr>\n
Levitra<\/span>\u00a0<\/span><\/td>\n30\u201360 minutes<\/span>\u00a0<\/span><\/td>\n4\u20135 hours<\/span>\u00a0<\/span><\/td>\nLess affected by food than Viagra<\/span>\u00a0<\/span><\/td>\n<\/tr>\n
Staxyn<\/span>\u00a0<\/span><\/td>\n30\u201360 minutes<\/span>\u00a0<\/span><\/td>\nAround 4 hours<\/span>\u00a0<\/span><\/td>\nOrally disintegrating tablet\u2014taken without water<\/span>\u00a0<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Each of these <\/span>FDA approved erectile dysfunction pills<\/span><\/b> may suit different lifestyles and preferences. For example, Cialis is ideal for men who prefer more spontaneity due to its long-lasting effects, while Viagra or Levitra might be better for occasional use. Your healthcare provider can help determine the best choice based on your needs and medical history.<\/span>\u00a0<\/span><\/p>\n

Side Effects to Watch out For<\/strong><\/h2>\n

Like most powerful drugs, these ED pills, including Staxyn, can have side effects. The most common side effects are minor and transient, such as headaches, facial flushing, or upset stomach. Less common but potentially more serious is the above-mentioned priapism; you probably know that warning by heart from the ED drug commercials: \u201cSee your doctor if you have an erection lasting more than four hours.\u201d That\u2019s been the fodder for many a joke, but in real life a priapism is anything but funny. Other uncommon but potentially serious side effects of PDE5 inhibitors include vision changes \u2013 most notably, seeing a bluish tint \u2013 or hearing problems.
\nThe manufacturers also warn not to take their ED pills if you take nitrates for chest pain, as this combination can cause dangerously low blood pressure. And as with any medication, do not drink in excess while taking an ED medication. Actually, drinking in excess can defeat your whole purpose, making it more difficult to get an erection. Also note that grapefruit or grapefruit juice can boost the blood levels of PDE5 medications, which might have unintended consequences, so it is best to avoid drinking grapefruit juice while taking ED medications.<\/p>\n

What Precautions Should I Take?<\/h2>\n

Before using any <\/span>FDA approved ED pills<\/span><\/b>, it\u2019s essential to take a few precautions to ensure safety and effectiveness:<\/span>\u00a0<\/span><\/p>\n