What ED Pills Are FDA-Approved?

Four oral medicines hold FDA-approved labels for erectile dysfunction: sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra, and an orally disintegrating version) and avanafil (Stendra).¹²³⁵⁴ Generic versions of these are also FDA-approved. Compounded products, including dissolving or combination doses, are not FDA-approved, even when they contain the same ingredients.⁷

Which four ED pills are FDA-approved?

All four belong to one class, the PDE5 inhibitors, and each label states the indication as the treatment of erectile dysfunction. The labels also give the year of initial U.S. approval.

Each label requires sexual stimulation for a response, and each contraindicates use with nitrates in any form.¹²³⁴ Which one suits a given man is a clinician decision based on health history and other medicines; our look at why no ED pill is sold over the counter covers what can and cannot be bought without a prescription.

Are generic ED pills FDA-approved too?

Yes. FDA states that a generic medicine must be bioequivalent to its brand-name version and match it in dosage, strength, quality and the way it is taken, with the same risks and benefits.⁶ The vardenafil label we checked, for example, is a generic (Lannett) label with the same instructions on food and dosing as the brand's class.³ A generic tablet and a brand tablet are the same approved medicine, which is a different thing from a compounded product.

What about the orally disintegrating vardenafil tablet?

It is approved with a separate label. It is placed on the tongue and taken without liquid, and the label says it is not interchangeable with the 10 mg film-coated tablet because it gives higher systemic exposure.⁵ If a service offers a dissolving ED product, ask whether it is this approved tablet or a compounded dose. Those are not the same.

Which ED products are not FDA-approved?

FDA says compounded drugs are not FDA-approved: FDA does not verify their safety, effectiveness or quality before they are marketed, and compounded drugs are not the same as generics.⁷ A compounded ED product can combine ingredients that each have an approved label on their own, but the combination has no label and no approval. The sildenafil label notes that combinations with other ED treatments have not been studied.¹

The same caution applies to anything sold as an "ED pill" without naming one of the four drugs on a label. A product with no drug label gives no way to check the ingredients, strength or warnings, so the nitrate and blood pressure cautions above cannot be checked against it. For the questions to ask any online service, see what to check before getting an ED prescription online.

Sponsored: Quattro from Vea Health

This section is sponsored: we have a financial relationship with Vea Health. It is included because the approved-versus-compounded question is the one most buyers get wrong.

Vea Health describes Quattro as a single-use sublingual dose combining apomorphine, vardenafil, sildenafil and tadalafil, prescribed by a licensed clinician after an online intake and made by a state-licensed 503A compounding pharmacy.⁸ Its page states that compounded drugs are not reviewed by the FDA for safety, effectiveness or quality in the way FDA-approved drugs are.⁸ So Quattro is not on the list above: it is a compounded product, not an FDA-approved ED pill, and the label dosing and warnings for Viagra, Cialis, Levitra or Stendra do not describe it.⁷ It is a different format for people who want a dissolving dose and accept that trade-off. A clinician has to approve it, and it should be reviewed against any nitrate or blood pressure medicine you take.

How to check whether a product is approved

1. Find the drug name. If it is not sildenafil, tadalafil, vardenafil or avanafil, it is not an approved ED pill.
2. Ask whether it is the brand, a generic of the brand, or compounded.
3. Look for a DailyMed label. Approved products have one; compounded ones do not.
4. Confirm a licensed clinician reviews your medicines first, especially nitrates.¹

Your questions

What ED pills are FDA-approved?

Sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra, including an orally disintegrating tablet) and avanafil (Stendra) hold FDA-approved ED labels, along with their FDA-approved generics.

Are generic ED pills FDA-approved?

Yes. FDA says a generic must match its brand in dosage, strength, quality and the way it is taken.

Are compounded ED pills FDA-approved?

No. FDA says compounded drugs are not FDA-approved and that it does not verify their safety, effectiveness or quality before they are marketed.

Is there an FDA-approved dissolving ED tablet?

Vardenafil orally disintegrating tablets have their own FDA label. They are placed on the tongue and taken without liquid.

Can I tell from the ingredients whether a combination ED product is approved?

No. Each ingredient can be approved on its own while the combination, as a compounded product, is not.

Read next

Part of our guide: Getting ED Treatment: Doctors, Online Prescriptions and FDA-Approved Options

• How to Fix Erectile Dysfunction: Getting Checked, Lifestyle Changes and Medicine
• Erectile Dysfunction Doctor: Who to See First and What They Should Check
• Online Cialis Prescription: Can It Be Sent to Your Pharmacy?
• Viagra Alternatives Over the Counter: What the Evidence Shows