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The Best FDA Approved Male Enhancement Products

Kristin Hall, FNP

Medically reviewed by Kristin Hall, FNP

Written by Our Editorial Team

Last updated 8/3/2021

Male enhancement supplements are everywhere, and if you don’t believe us, we invite you to turn off your adblock software and explore internet pornography for ten seconds and prepare to be bombarded with ads for “the best sex pills for men” or “best penis enlargement pills.” The truth is, there is no “best sex pill for men” or true-blue “male enlargement pills.” 

Still, the fact that so many websites willfully peddle male enhancement supplements meant to increase libido and performance suggests that a lot of men struggle with these issues — and a lot of men, likewise, are willing to try the over the counter male enhancement pills they find on the internet rather than going to a healthcare provider for erectile problems. 

We get it — ED can be considered an embarrassing condition, and culturally, we’re taught that men who can’t function should feel shame.

It’s not the case. Beyond the statistics about the number of men suffering from ED, there’s the simple fact that real solutions to the problems don’t come from pop-up ads, they come from medical experts. 

That’s why it’s important to use erectile dysfunction products that are well researched and FDA approved.

Look, it’s probably the case that some not-yet-approved products out there may provide a lot of benefits. 

Still, they don’t yet have approval for reasons, which might include a lack of research or considerations for yet-undetermined side effects. 

Also, this is your penis we’re talking about — you don’t want to go rogue when the risk is your sexual function. 

Dietary pills and other gas station male sexual enhancement supplements might be perfectly safe in some instances. 

But in others, they might also be dangerous, carry hidden ingredients that might harm your health or be illegally mixed concoctions of prescription medications and herbs that you shouldn’t take without a healthcare professional’s supervision.

The good news is that there are safe and effective FDA-approved prescription drugs on the market right now (several, in fact). 

We’ll discuss the benefits of each shortly, but first, let’s cover some basics about ED.

Erections and Erectile Dysfunction

Erections occur when the penis’ blood vessels receive increased blood flow, and that blood becomes trapped in the corpora cavernosa — two long chambers that run the length of the penis. 

Your brain sends chemical communications to those blood vessels when you become aroused, which in turn causes them to dilate so that blood flows in. 

The blood becomes trapped there, and that’s what keeps your penis erect. 

Erectile dysfunction is what happens when something’s going wrong in those penile processes.

Many factors that can impact your chances for having ED; the most common causes include: high blood pressure, depression, anxiety, illicit or prescription drug use,obesity, heart disease, alcohol, high cholesterol, diabetes or performance anxiety.

ED is a common condition (perhaps due to that long list). In fact, the National Institutes of Health estimates that 30 million men nationwide experience some level of erectile dysfunction. 

By the way, the NIH defines erectile dysfunction as a “condition in which you are unable to get or keep an erection firm enough for satisfactory sexual intercourse.” 

So no partial credit, fellas — you have ED whether your erection is just incomplete OR a total non-starter. 

FDA Approved Treatment: Sildenafil

Put simply, sildenafil is one of the OG FDA-approved prescription drugs for ED treatment

Sildenafil (generic Viagra) is a phosphodiesterase type 5 (PDE5) inhibitor, which works within your penis to sustain dilation and blood flow, resulting in better, firmer erections. 

Unlike tadalafil (Cialis®) for instance, which can work for up to 36 hours in one dose, sildenafil is a sort of pre-game solution to the problem, like carbo-loading for your erections. 

According to the National Library of Medicine, it’s best taken when the action is going to take place within a few (up to four) hours.

It’s a great treatment option for men with ED, and about 70 percent of men respond well to PDE5 inhibitors. 

However, effective treatment largely depends on what’s causing your erectile dysfunction

The best results come for men with “no identifiable organic cause,” who have seen approximately a 90 percent success rate. 

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Sildenafil Side Effects and Drug Interactions

Sildenafil can have some potentially negative drug interactions you should be aware of. 

The most commonly reported adverse effects for PDE5 inhibitors (including sildenafil) are complications related to blood pressure (especially when taken with alpha-blockers). 

PDE5 inhibitors, which can be used to treat hypertension because of how they interact with blood vessels, might sound like they provide a double benefit, but this is actually the main reason it’s important to disclose other medications before taking sildenafil. 

Taking multiple blood medications could result in serious issues, particularly if you have high blood pressure.

Commonly reported side effects of male enhancement pills include indigestion, back pain, headache, muscle pain, flushing, stuffy nose or abnormal vision. 

Stop the medication immediately if your vision becomes abnormal, and seek emergency assistance.

You should never take sildenafil alongside other PDE5 inhibitors — you could stop your own heart. 

And if you’re taking any other blood pressure meds including PDE5 inhibitors, as well as alpha-blockers and antihypertensive medications, talk to your healthcare provider before starting sildenafil. 

And if you’re taking nitrates in particular, DO NOT take sildenafil or any of these blood pressure drugs.

There are also some rare side effects to be on the lookout for including renal impairment, sudden hearing loss and priapism (prolonged erection). 

According to the FDA, “If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.” Get medical assistance if your erection lasts more than four hours.

How You Take Sildenafil Matters

Sildenafil takes between 30 minutes to 60 minutes to activate and lasts for around four hours once taken.

According to the FDA, doses range between 25mg and 100mg, and those should be taken as needed If your sex life is unpredictable, you may be better served with a daily option, like tadalafil.

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Generic for Cialis (tadalafil)

Affordable and helps get the job done. Generic Cialis helps you get and maintain your erections through a simple, daily dosage.


The OG Little Blue Pill that made its name as the first prescription Erectile Dysfunction treatment.


Cialis helps you get and keep stronger erections with a daily or as-needed pill.

FDA Approved Treatment: Cialis and Tadalafil

Cialis is the brand name version of the generic tadalafil. 

Tadalafil (and Cialis) is an effective treatment for erectile dysfunction, and it has a longer effective time from dose to dose than medications like Viagra. 

It can be taken daily, and was the first drug approved for daily ED treatment.

Tadalafil, unlike Viagra, can be effective from a single dose for up to 36 hours according to the National Library of Medicine.

Tadalafil Side Effects

The side effects of Cialis or tadalafil also have some potentially serious side effects to be aware of. Blurred vision, indigestion, nausea, cough, stomach pain, flushing, diarrhea, dizziness and ringing in the ears are all potential side effects of tadalafil.

Difficulty breathing or swallowing, headaches, chest pain, hives or rash or blistering or swelling of the face: if you experience any of these, talk to a healthcare professional immediately. 

In rare occurrences, some people may lose their vision (if you’re experiencing this, seek medical care immediately).

FDA Approved Treatment: Vardenafil

Vardenafil, sold under the brand name Levitra, is also a phosphodiesterase type 5 (PDE5) inhibitor, a type of medication that essentially helps your body sustain those dilated blood vessels, resulting in stronger, firmer erections (and therefore, sexual enhancement).

Levitra is also considered an “in the moment” medication, which you take in as little as 30 minutes before you plan to get to business. 

According to the FDA, its half-life is four to five hours, so it may last a little longer than Viagra.

Vardenafil (Levitra) Side Effects and Drug Interactions

These are going to sound similar to what you’ve heard about other medications. 

Commonly reported Levitra side effects include mild issues like back pain, headache, muscle pain, flushing, indigestion, stuffy nose and abnormal vision. 

Stop immediately and seek emergency assistance if your vision becomes abnormal.

The Unsafe and Unapproved Stuff

There are plenty of other products on the market claiming to make your sex life better, from penis pumps and dietary supplements to penis enlargement pills you can literally buy at the gas station. 

But outside of the above medications are plenty of over-the-counter herbal ED treatments and dietary supplements, which can cause symptoms similar to those experienced with prescription ED medications, like headaches and blood pressure fluctuations.

But there are more serious symptoms that can really screw with your general health. And it’s common to see herbal ingredients in dietary supplements that have those warnings. 

Take a look at these common ingredients: yohimbine, can cause hypertension, insomnia and sweating; ginseng can be dangerous for people with diabetes and causes rashes. In rare cases, Ginkgo biloba can in rare cases cause seizures. 

A study of L-arginine was actually stopped early because six people died while taking it, compared with no deaths in the placebo group. 

Because these “medications” aren’t medically tested, they aren’t as safe. The FDA in 2015 actually advised consumers that many on demand male enhancement supplements or penis enlargement pills marketed as Herb Viagra contained sildenafil, which was not disclosed or listed on the label (and were therefore very illegal and dangerous. 

A 2013 review in the Pharmacognosy Review concluded

“The available drugs and treatments have limited efficacy, unpleasant side effects and contraindications in certain disease conditions.

Due to unavailability of the safety data, unclear mechanisms, and lack of knowledge to support the extensive use of these substances, uses of these products may be risky to the human being.”

Choosing The Right FDA-Approved ED Medication

If you’re just starting to learn about ED, it’s important to understand as much as you can about proper medication use, and how to avoid putting your health at risk. 

Talking to medical professionals about your problems will help you avoid a lot of these risks. 

Whether you choose vardenafil or sildenafil or tadalafil, the right option for you is the one that’s safest and healthiest, and a healthcare professional will be best suited to help you figure that out. 

If you’re curious how these medications stack up, our guide to the most common ED medications goes into more detail on how Viagra, Levitra and Cialis compare. 

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Final ED Thoughts and Other Considerations

As much as ED might seem like a problem solved with over-the-counter enhancement pills, there’s no guarantee that a pill will work, especially if the cause of your particular ED is something psychological

Anxiety and depression, for instance, can play a role in creating performance issues. A healthcare professional can give you a referral to a psychiatrist or mental health professional who can help you to examine other treatment options. 

A word about stigma: shame and embarrassment aren’t good reasons to avoid addressing ED.

Left untreated, ED and any associated issues can only bring you to more serious problems down the road, putting your health at risk. 

Take the time, address the problem, do it right.

25 Sources

Hims & Hers has strict sourcing guidelines to ensure our content is accurate and current. We rely on peer-reviewed studies, academic research institutions, and medical associations. We strive to use primary sources and refrain from using tertiary references.

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This article is for informational purposes only and does not constitute medical advice. The information contained herein is not a substitute for and should never be relied upon for professional medical advice. Always talk to your doctor about the risks and benefits of any treatment. Learn more about our editorial standards here.