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The Best FDA Approved Male Enhancement Products

Katelyn Hagerty

Medically reviewed by Katelyn Hagerty, FNP

Written by Our Editorial Team

Last updated 11/17/2022

Male enhancement supplements are seemingly everywhere. If you don’t believe us, we invite you to turn off your adblock software and explore online pornography for, say, ten seconds or so. 

In doing so, you can prepare to be bombarded with ads for “the best sex pills for men” or “the best penis enlargement pills,” typically with ambitious claims about how much you can expect your penis to grow or your sexual stamina to increase.

Male enhancement pills can look tempting. However, most aren’t supported by sound science, and many contain unsafe ingredients that could affect your health and wellbeing. 

Because of this, there aren’t any FDA-approved male enhancement pills available, at least not at the moment. 

However, several medications that are approved by the FDA, such as erectile dysfunction (ED) pills and premature ejaculation (PE) treatments, do have the potential to enhance your sexual function and help you perform better in bed.

Below, we’ve discussed some of the issues with over-the-counter male enhancement pills and supplements, from lack of efficacy data to hidden, potentially harmful ingredients.

We’ve also discussed how you can use FDA-approved medications to treat the vast majority of sex-related issues, including erectile dysfunction and premature ejaculation.

Finally, we’ve shared some other techniques that you might want to consider if you’re aiming to improve your sexual health, boost your sexual self-confidence and enjoy more satisfying sex. 

What to Know About “Male Enhancement” Pills

If you’ve ever searched for information about improving your sexual performance, you’ve likely seen ads and recommendations for various pills and similar sexual enhancement supplements that claim to, well, make you perform better in bed.

Many of these products, which are mostly dietary supplements, are marketed as panaceas for any sex-related issue. You may see claims that these pills and capsules can:

  • Increase your penis size

  • Help you last longer in bed

  • Strengthen your sex drive

  • Increase sexual satisfaction

  • Stimulate healthy blood flow

  • Promote stronger erections

In general, these sexual enhancement products are often promoted as the solution to all of your sexual worries, whether you’re concerned about your penis size, your erections, or your general ability to please your partner.

One thing that’s important to keep in mind about these pills is that, as herbal supplements, they aren’t regulated in the same way as over-the-counter or prescription drugs.

This means that they don’t need to go through the FDA’s strict approval process, which involves numerous phases of clinical trials. Unlike FDA-approved medications, they aren’t tested, at least not in any systematic way, for safety or effectiveness.

These supplements also aren’t held to the same standards as medications. This means that the manufacturers of male enhancement pills can make all sorts of vague claims about their effects, generally without having to support them with any high quality evidence.

The end result of this difference in regulation is that lots of supplements, including many popular male enhancement pills, contain ingredients that haven’t been demonstrated to do anything.

Worse yet, investigations have found that some of these pills contain hidden ingredients that are potentially dangerous, including poorly dosed, unlisted prescription medications.

We’ve discussed this in more detail further down the page, where we’ve also provided advice on how to keep yourself safe and avoid potentially dangerous supplements when you’re comparing sexual enhancement pills.

Are There Any FDA Approved Male Enhancement Pills?

Currently, there aren’t any “male enhancement” or “sexual enhancement” pills that are approved by the FDA.

However, there are medications for sexual health conditions, such as erectile dysfunction, which have received FDA approval.

These include PDE5 inhibitors, such as sildenafil (the active ingredient in Viagra®), tadalafil (the active ingredient in Cialis®), vardenafil (the active ingredient in Levitra®), and avanafil (a newer medication for erectile dysfunction sold as Stendra®).

These medications work by increasing blood flow to your penis, making it easier for you to get and maintain an erection when you feel sexually aroused.

Some of these medications are also linked to improvements in premature ejaculation, although none have been specifically approved by the FDA as premature ejaculation treatments.

We’ve discussed these medications below, as well as the latest research on their effects, side effects, and how they can be used for better sexual function and performance. 

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FDA Approved Treatment: Sildenafil

Sildenafil, the generic form of Viagra, is a widely-used medication for ED that’s been approved by the FDA since the late 1990s. 

A single dose of sildenafil starts working in approximately one hour and can provide relief from erectile dysfunction for approximately four hours. This makes sildenafil a great pill to use shortly before you have sex if you’re concerned about weak or inconsistent erections.

Research shows that sildenafil works well for most men with ED. For example, in clinical trials that were performed as part of the drug’s FDA approval process, more than 80 percent of men reported improvements in erections at the highest dose (100mg of sildenafil). 

Even at lower doses, such as 25mg and 50mg of sildenafil, between 63 and 74 percent of men with erectile dysfunction reported improvements. 

Sildenafil is generally a safe and effective medication. However, as with all medications, it does have the potential to cause side effects. Common side effects of sildenafil include:

  • Headaches

  • Dyspepsia (indigestion)

  • Changes in vision

  • Nasal congestion

  • Back pain

  • Flushing

  • Myalgia (muscle pain)

  • Dizziness

  • Skin rash

  • Nausea

Sildenafil can also cause more severe side effects, although these are rare. These include chest pain, sudden hearing loss, sudden vision loss, fainting, shortness of breath, a burning sensation during urination, and prolonged, painful erections (priapism).

It’s important to seek help from a medical professional as soon as you can if you experience any severe, persistent or bothersome side effects while using sildenafil.

Sildenafil and other PDE5 inhibitors can also interact with certain medications, including nitrates used to treat angina and/or high blood pressure. Make sure to let your healthcare provider know about any medications you currently use or have recently used before taking sildenafil. 

We offer sildenafil as part of our range of ED treatments, following a consultation with a licensed healthcare provider who will determine if a prescription is appropriate.

FDA Approved Treatment: Tadalafil

Tadalafil is a long-lasting ED medication that can deliver relief from erectile dysfunction for up to 36 hours per dose. It’s sold as a generic medication and under the brand name Cialis in several different strengths. 

The biggest advantage of tadalafil is its long duration of action, which means it offers relief from erectile dysfunction for more than a day per dose. This has earned it the nickname of “weekend pill.”

You might prefer tadalafil to other ED medications if you like to have sex more than once a day, or if you prefer not to have to time your medication usage to shortly before sex. 

Tadalafil can also be taken on a daily basis at a reduced dose to provide ongoing relief from ED symptoms. 

Because tadalafil works in the same way as sildenafil, it produces similar side effects. However, these side effects may last for longer, as the long half-life of tadalafil means it may take several days for this medication to fully exit your body. 

We offer tadalafil online as part of our range of ED medications, following a consultation with a healthcare provider who will determine if it’s the right treatment option for you.

FDA Approved Treatment: Vardenafil

Vardenafil is another FDA-approved drug for erectile dysfunction. Like other PDE5 medications, it works by increasing blood flow to your penis and making it easier for you to get and maintain an erection when you feel sexually stimulated.

A single dose of vardenafil, which is sold under the brand name Levitra®, starts working in one hour and lasts for up to six hours

The adverse effects of vardenafil are similar to those of sildenafil and tadalafil. As with other ED treatments, it’s important to inform your healthcare provider about any medications you currently use or have recently used before considering vardenafil.

FDA Approved Treatment: Avanafil

Available as Stendra, avanafil is the newest FDA-approved medication for erectile dysfunction that’s on the market.

Avanafil is more selective than other ED medications, meaning it targets the specific enzymes that are responsible for controlling blood flow to your penis. This means that it has a lower risk of causing certain side effects than medications like sildenafil, tadalafil and vardenafil.

It’s also faster to work, with a single dose of avanafil producing improvements in erections in as little as 15 to 30 minutes in some men.

Like with other ED medications, avanafil can still cause adverse effects and interact with other drugs, meaning it’s important to discuss these issues with your healthcare provider before you start treatment.

We offer Stendra online as part of our range of ED medications, following a consultation with a healthcare provider who will determine if this is an appropriate treatment option for you. 

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Health Risks of Unsafe, Unapproved Male Enhancement Pills

So, with several FDA-approved medications for erectile dysfunction available, why is it best to avoid over-the-counter sex enhancement pills?

In addition to the lack of any research about the effectiveness of most over-the-counter sexual enhancement ingredients, the biggest reason to avoid these products — as we briefly covered above — is that many contain undeclared ingredients that may not be safe to use.

Over the years, the FDA has investigated numerous male enhancement pills available in gas stations, sex stores and online marketplaces. Several of these investigations have found that these products contain hidden pharmaceutical ingredients. 

The FDA maintains a list of tainted sexual enhancement products with hundreds of entries, all for over-the-counter sex supplements that contain potentially harmful substances.

Many of these products contain unlabeled stimulants, as well as prescription ED medications such as sildenafil and tadalafil.

Unlike FDA-approved erectile dysfunction medications, which are produced in modern, clean facilities and dosed precisely, these supplements often contain hidden ingredients that aren’t measured carefully and may not be produced in a hygienic environment.

This means that there’s not just a risk of contamination — there’s also a real risk of taking too much of a specific pharmaceutical ingredient, all without even knowing it’s in the supplement.

As one review published in the journal Pharmacognosy Review noted: “The available drugs and treatments have limited efficacy, unpleasant side effects and contraindications in certain disease conditions.”

Authors of the review also noted that because these drugs don’t yet have things like clear-cut safety data and known mechanisms of action, and because we still don’t have the info we need to support widespread use of them, they may pose a danger to people — we don’t know enough to say for certain.

In other words, these treatments aren’t proven to be effective, can often cause side effects, and may pose real risks to your health and wellbeing. As such, they’re best avoided, no matter how bold their claims might be about improving your sexual function and performance. 

Are There Male Enhancement Pills That Increase Penis Size?

While FDA-approved treatments are available for erectile dysfunction, there currently aren’t any medications or male enhancement pills that increase size, at least when it comes to your penis.

As we’ve discussed in our guide to penis growth pills, increasing your penis length or girth with a pill just isn’t possible right now. At this point in time, we don’t have the technology to create a pill, or even a reliable medical procedure, that can make your penis significantly larger. 

With this said, if you feel disappointed by your penis size due to weak erections, medication for erectile dysfunction may help to make it appear larger, at least when it’s erect.

Erections are all about healthy blood flow. By increasing the amount of blood that can flow into your penis when you feel sexually aroused, ED medications like sildenafil may produce a small increase in the size of your penis during sex.

However, any increase is likely to be so small that it’s difficult to even notice, at least without a measuring tape. As such, it’s better to learn to appreciate what you’ve got than to worry about increasing your penis size. 

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The Bottom Line on FDA Approved Male Enhancement Pills

Currently, there aren’t any male enhancement pills that have been approved by the FDA. The male enhancement supplements that you see for sale online, in gas stations and in sex stores aren’t medications but dietary supplements, which aren’t subject to FDA approval. 

There’s very little evidence that these products provide any real sex-related benefits, whether this means stronger erections or a bigger penis. Worse yet, many contain unsafe ingredients that could cause adverse events and put your health at risk. 

If you’re interested in improving your erections, lasting for longer in bed or just increasing your sexual self-confidence, you’ll get far better results by consulting your healthcare provider than by relying on male enhancement products.

This could mean talking to your healthcare provider about erectile dysfunction medications or taking part in therapy — one of several mental health services we offer online — to gain control over issues such as sexual performance anxiety. 

Left untreated, ED and associated issues can potentially lead to more serious problems down the road, putting your health and wellbeing at risk. 

Take the time, address the problem and do it the right way. Not only will you get better results than you would from any unregulated sexual enhancement supplement — you’ll also put your health first. 

Want to find out more before you start? Our guide to the most common ED medications goes into more detail about your options for dealing with erectile dysfunction, improving your sexual health and feeling more confident in bed. 

7 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.

  1. VIAGRA- sildenafil citrate tablet, film coated. (2017, August). Retrieved from
  2. Sildenafil. (2018, January 15). Retrieved from
  3. CIALIS- tadalafil tablet, film coated. (2017, May). Retrieved from
  4. LEVITRA (vardenafil hydrochloride) tablets, for oral use. (2014, April). Retrieved from
  5. STENDRA- avanafil tablet. (2017, August). Retrieved from
  6. Tainted Sexual Enhancement Products. (2022, July 28). Retrieved from
  7. Kotta, S., Ansari, S.H. & Ali, J. (2013). Exploring scientifically proven herbal aphrodisiacs. Pharmacognosy Review. 7 (13), 1-10. Retrieved from

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.