Stendra (avanafil)
Stendra is the US avanafil brand. See its strengths, labeler and the key warnings in the US prescribing information.
- Active ingredient
- Avanafil
- Form
- Tablets
- US labeler
- Metuchen Pharmaceuticals, LLC
Stendra is the US avanafil reference brand. The label cited here identifies Metuchen Pharmaceuticals as labeler and separately names the manufacturer. Spedra is an EU avanafil brand with its own authorization-holder record; the two should not be assigned one universal company identity.
Read the timing by strength
The US prescribing information distinguishes timing for 50 mg from the 100/200 mg context. A headline about “fifteen minutes” should not replace those instructions or a prescriber’s assessment of the person’s medicines.
In the rapid-onset trial, avanafil improved the proportion of successful early attempts compared with placebo. The endpoint required early penetration and successful completion of intercourse. It did not mean every participant responded within fifteen minutes, and the study did not rank avanafil against all other ED medicines. See the ingredient explanation for the numbers and denominator.
What can alter the choice
Headache, flushing and nasal congestion are familiar tolerability issues. Strong CYP3A4 inhibitors can markedly affect exposure, and nitrates are incompatible with avanafil. The exact medication review matters even when rapid onset is the feature attracting attention.
The product photographs help illustrate presentations; they do not establish which strength is suitable or authenticate a supplied bottle. A Stendra label supports Stendra’s record. It should not be reused as proof of formulation equivalence or local authorization for another avanafil brand or an avanafil–dapoxetine combination.
Product record
- Company
- Metuchen Pharmaceuticals, LLC (US labeler)
- Manufacturing
- Sanofi Winthrope Industrie, Ambares, France — manufactured for Metuchen Pharmaceuticals, LLC, as stated in the US label.
- Strengths
- 50, 100, 200 mg
- Jurisdiction checked
- United States
- Record reference
- DailyMed label set fa7d93e3-b69b-4e02-8146-89760cd8e9d6; NDA 202276
- Treatment area
- Erectile dysfunction (ED)
- Record reviewed
- 4 October 2026; source retrieval dates are retained with the evidence
These records identify a named product and market. They do not confirm stock, authenticate a particular pack, or establish authorization in another country.
About avanafil
Avanafil has early-response evidence, but timing instructions depend on strength and regional label. Early-attempt trial results are not a guarantee or an active-drug comparison. CYP3A4 inhibitors and blood-pressure interactions matter.
Using a PDE5 inhibitor safely
Never take a PDE5 inhibitor with nitrates, recreational nitrites (“poppers”) or riociguat, and do not combine two ED medicines. Seek urgent medical help for chest pain, an erection lasting more than four hours, or sudden loss of vision or hearing.
Common side effects include headache, flushing, indigestion and a blocked nose.
Sources
1 source
Checked .
- Stendra prescribing information — DailyMed, US National Library of Medicine