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The Best FDA Approved Male Enhancement Pills & Products

Kelly Brown MD, MBA

Reviewed by Kelly Brown, MD

Written by Geoffrey Whittaker

Published 08/03/2021

Updated 03/22/2024

Ads for male enhancement supplements are everywhere. Don’t believe us? By all means — turn off your AdBlock software and explore online pornography for, say, ten seconds or so.

Be prepared to be bombarded with spots for “the best sex pills for men” or “the best penis enlargement pills,” typically touting ridiculous claims about growing your penis 12 inches in two minutes or giving you the sexual stamina of a wildebeest.

And they can look tempting. But be warned: there currently aren't any FDA-approved male enhancement pills on the market. Literally none.

But there are other options.

Below, we’ve discussed some of the issues with non-prescription 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 sex-related issues like erectile dysfunction to achieve more satisfying sex.

The BEST FDA-Approved Male Enhancement Pills, According to a Doctor

Some of the most popular male enhancement pills are marketed as these magic capsules that can cure any sex-related issue. They say they can do things like:

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

Seems legit, right?

Not quite.

These penis enhancement pills aren’t held to the same standards as FDA-approved medications, which means that the manufacturers can try to make all sorts of vague claims.

Technically, they’re all considered “dietary supplements.” And most of these dietary supplements claim that natural ingredients like horny goat weed, ginseng or maca root are all that’s needed to boost your sexual desire, have greater orgasms and reverse low libido. But again, this is far from the truth.

Worse yet, investigations have found that some of these products — including the famous Rhino pill brand — contain hidden ingredients that are potentially dangerous.

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

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

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 required to be tested for safety or effectiveness.

This, as you can imagine, creates a lot of space for disingenuous business practices and less-than-truthful advertising.

Unscrupulous business practices are so commonplace in the non-prescription male enhancement pill racket that the FDA actually maintains a list of tainted sexual enhancement products with hundreds — literally hundreds — of entries, all for non-prescription male enhancement supplements that contain potentially harmful substances.

The FDA also investigated numerous male enhancement pills available in gas stations, sex stores and online marketplaces and found that some non-prescription male enhancement products contain hidden ingredients.

That’s concerning, sure. But some of those investigations also found that some of these products contain illegal amounts of legitimate pharmaceutical drugs and unlabeled stimulants. It’s one thing to consume a little too much caffeine every once in a while, but it’s another thing entirely to take an unprescribed, underregulated and unknown dose of say, sildenafil or tadalafil.

They’re the main ingredients in Viagra® and Cialis®, respectively, and they’ve both been found in some of these non-prescription boner pills.

While that may sound like you’re getting more bang for your buck, remember: a big reason why ED medications are available by prescription only is because dosages should be tailored to your individual needs.

Plus, pharmaceutical-grade medications are required to be made in pharmaceutical-quality laboratories. Let’s just say that "enhancement" pills don’t have nearly the same rigorous and regulated manufacturing quality standards.

So yeah. Probably best to err on the side of caution here.

Choose your chew

The good news is that just because non-prescription male enhancement pills probably suck and aren’t worth the risk, that doesn’t mean you don’t have options. In fact, you have plenty.

ED medications that are designed specifically to treat sexual health conditions like erectile dysfunction have gone through a rigorous FDA testing and approval process, making them safe to use when properly prescribed.

These include PDE5 inhibitors, which work by increasing blood flow to your penis, making it easier for you to get and maintain an erection when you feel sexually aroused.

A list of FDA-approved oral ED treatments include:

FDA-Approved Treatment: Sildenafil

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

A single dose of sildenafil starts working in approximately 30 minutes to one hour and can provide relief from erectile dysfunction for around four hours.

In clinical trials that were performed as part of the drug’s FDA approval process, more than 80 percent of men reported improvements in penile erections at the highest dose (100mg of sildenafil).

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

This makes sildenafil a great pill to use if you’re concerned about losing your erection during sex.

Sildenafil is generally a safe and effective medication. However, as with all medications, it does have the potential to cause side effects. To learn more about the potential sildenafil side effects, check out our complete guide.

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. In fact, it’s sometimes referred to as “the weekend pill.” It’s sold as a generic medication and under the brand name Cialis in several different strengths.

Because of its longer half-life, you might prefer tadalafil to other ED medications if you like to have sex more than once a day (yewww!) or if you prefer not to have to time your medication around the possibility of sexual activity. It’s very much a “set it and forget it” type of medication.

Daily tadalafil that’s prescribed at a reduced dose can provide ongoing relief from ED symptoms.

Because tadalafil works in the same way as sildenafil, it produces similar side effects. You can learn more about the side effects of tadalafil here.

FDA-Approved Treatment: Vardenafil

Next up on the list is vardenafil. A single dose of vardenafil, sold under the brand name Levitra®, starts working in one hour and lasts for up to six hours — which actually gives it a slight advantage over sildenafil.

It’s important to inform your healthcare provider about any medications you currently use or have recently used before considering vardenafil (the same is true of the other medications mentioned here).

FDA-Approved Treatment: Avanafil

Available as Stendra, avanafil is the newest FDA-approved ED med on the market.

It’s more selective than other ED medications, meaning it more specifically targets the enzyme responsible for controlling blood flow to your penis. This means that it has a lower risk of causing certain side effects compared to medications like sildenafil, tadalafil and vardenafil.

It also gets to work faster. A single dose of avanafil produces improvements in erections in as little as 15 to 30 minutes in some men. So, if things are going better than you anticipated and your partner wants to head straight back to your place, you don’t have to hit the panic button.

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 sildenafil, tadalafil, Viagra and Cialis® as part of our range of ED treatments, following a consultation with a licensed healthcare provider who will determine if a prescription is appropriate.

However, it’s also important to note that PDE5 inhibitors can interact with certain medications, including (but not limited to) nitrates used to treat angina and/or high blood pressure. That’s why it’s crucial to speak to a healthcare professional before you start using them. They can also interact with nitrites, found in recreational “poppers.”

There are some other treatments for ED as well that the FDA has looked kindly upon. Alprostadil is an FDA-approved injectable medication for ED. And Eroxon is a recently FDA-authorized topical gel for ED that is available without a prescription.

Hate to break it to you gents, but there currently aren’t any dietary supplements or sexual enhancement pills that increase the size of your package. In fact, there aren’t any FDA-approved pills that’ll do it, either.

As we’ve discussed in our guide to penis growth pills, increasing your penis length or girth with a pill just isn’t possible. Not yet, anyway.

That said, there are alternatives to consider like jelqing, penis sleeves, vacuum pumps and even penile enlargement surgery. But even then, these methods are either unproven, temporary, negligible or hilariously expensive.

We’re not in the business of telling people what to do, but if it were us, we’d stick to making the best with what we got.

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If you are still wondering, “Do male enhancement pills work?” The answer is no — at least, not to the degree that they promise on their labels. In fact, some of them are outright dangerous. When it comes to non-prescription male enhancement pills, here’s the key info you should take away:

  • They’re not regulated by the FDA in the same way as prescription medications. Because they’re technically considered “dietary supplements” or “herbal supplements,” they’re not regulated by the FDA in the same way prescription medications are. Which means they’re not required to undergo  the same rigorous efficacy and safety testing.

  • They sometimes contain hidden ingredients. There are so many half-assed male enhancement pills out there that the FDA actually maintains a public database of all the confirmed sketchy male enhancement pills you may find on the shelves.  When the FDA investigated these pills, they found hidden ingredients not listed on the label, including stimulants and prescription-only drugs like sildenafil and tadalafil.

  • There are proven, safer alternatives. If you’re not happy with your performance in the bedroom or are experiencing erectile dysfunction, there are several FDA-approved options out there for you to consider, including sildenafil, tadalafil, vardenafil and avanafil.

If you’re interested in improving your erections, lasting for longer in bed or just ramping up your sex life, you’ll get far better results by consulting your healthcare provider than by relying on male enhancement products.

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

  1. Tainted Sexual Enhancement Products. (2022, July 28). Retrieved from https://www.fda.gov/drugs/medication-health-fraud/tainted-sexual-enhancement-products
  2. Kotta, S., Ansari, S.H. & Ali, J. (2013). Exploring scientifically proven herbal aphrodisiacs. Pharmacognosy Review. 7 (13), 1-10. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3731873/
  3. VIAGRA- sildenafil citrate tablet, film coated. (2017, August). Retrieved from https://www.accessdata.fda.gov/spl/data/40578e70-350a-4940-9630-55d90989c146/40578e70-350a-4940-9630-55d90989c146.xml
  4. Sildenafil. (2018, January 15). Retrieved from https://medlineplus.gov/druginfo/meds/a699015.html
  5. CIALIS- tadalafil tablet, film coated. (2017, May). Retrieved from https://www.accessdata.fda.gov/spl/data/05dbd8b6-1b9d-436a-a67c-8a16713f753f/05dbd8b6-1b9d-436a-a67c-8a16713f753f.xml
  6. LEVITRA (vardenafil hydrochloride) tablets, for oral use. (2014, April). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021400s017lbl.pdf
  7. STENDRA- avanafil tablet. (2017, August). Retrieved from https://www.accessdata.fda.gov/spl/data/41d308f4-9a6a-48bb-b7a0-d63da9818078/41d308f4-9a6a-48bb-b7a0-d63da9818078.xml
Editorial Standards

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. See a mistake? Let us know at [email protected]!

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.

Kelly Brown MD, MBA
Kelly Brown, MD

Dr. Kelly Brown is a board certified Urologist and fellowship trained in Andrology. She is an accomplished men’s health expert with a robust background in healthcare innovation, clinical medicine, and academic research. Dr. Brown is a founding member of Posterity Health where she is Medical Director and leads strategy and design of their Digital Health Platform, an innovative education and telehealth model for delivering expert male fertility care.

She completed her undergraduate studies at University of North Carolina at Chapel Hill (go Heels!) with a Bachelor of Science in Radiologic Science and a Minor in Chemistry. She took a position at University of California Los Angeles as a radiologic technologist in the department of Interventional Cardiology, further solidifying her passion for medicine. She also pursued the unique opportunity to lead departmental design and operational development at the Ronald Reagan UCLA Medical Center, sparking her passion for the business of healthcare.

Dr. Brown then went on to obtain her doctorate in medicine from the prestigious Northwestern University - Feinberg School of Medicine and Masters in Business Administration from Northwestern University - Kellogg School of Management, with a concentration in Healthcare Management. During her surgical residency in Urology at University of California San Francisco, she utilized her research year to focus on innovations in telemedicine and then served as chief resident with significant contributions to clinical quality improvement. Dr. Brown then completed her Andrology Fellowship at Medical College of Wisconsin, furthering her expertise in male fertility, microsurgery, and sexual function.

Her dedication to caring for patients with compassion, understanding, as well as a unique ability to make guys instantly comfortable discussing anything from sex to sperm makes her a renowned clinician. In addition, her passion for innovation in healthcare combined with her business acumen makes her a formidable leader in the field of men’s health.

Dr. Brown is an avid adventurer; summiting Mount Kilimanjaro in Tanzania (twice!) and hiking the incredible Torres del Paine Trek in Patagonia, Chile. She deeply appreciates new challenges and diverse cultures on her travels. She lives in Denver with her husband, two children, and beloved Bernese Mountain Dog. You can find Dr. Brown on LinkedIn for more information.

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