> ## Documentation Index
> Fetch the complete documentation index at: https://docs.hi-doctor.ai/llms.txt
> Use this file to discover all available pages before exploring further.
# Avanafil (Spedra) — fast-onset ED tablet
> Avanafil for erectile dysfunction: how it works, EU authorisation since 2013, trial success rates and reported side effects.
Avanafil is a prescription tablet for erectile dysfunction, authorised across the EU since 2013 and the most recently approved of the PDE5-inhibitor tablets. It works like the others by keeping the blood vessels in the penis relaxed so blood can flow in during arousal. It must never be taken with nitrate heart medicines.
## What is avanafil?
Avanafil is a PDE5-inhibitor tablet taken by mouth, for adult men with erectile dysfunction — the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. Sexual stimulation is still required. The EU product information says the usual 100 mg dose is taken about 15 to 30 minutes before sex.
Active ingredient: avanafil. Dosages: 50, 100 or 200 mg, taken on demand.
## How it works
Sexual stimulation triggers nerves and blood vessel linings in the penis to release nitric oxide.
Nitric oxide raises cyclic GMP inside the smooth muscle of the erectile tissue, relaxing it and letting blood flow in.
Avanafil blocks the PDE5 enzyme that normally breaks cyclic GMP down, letting the blood vessels stay relaxed and fill with blood during arousal.
## EU authorisation
Spedra is centrally authorised, so a single EU authorisation covers all 27 member states. It was granted on 21 June 2013 and is held by Menarini International Operations Luxembourg S.A. — it is the EU brand for avanafil, the most recently authorised of the erectile-dysfunction tablets.
## What the studies reported
Every NCT identifier links to its ClinicalTrials.gov record. A readout is not the same as peer-reviewed publication. Results below are grouped by source and evidence grade so journal data and manufacturer figures are not confused.
The EMA product information reports general-population success rates of roughly 47%, 58% and 59% for the 50, 100 and 200 mg doses respectively, versus roughly 28% on placebo. Separately, a 15-minute and a 6-hour onset figure come from small subsets of attempts (300 and 80 attempts respectively) inside a 12-week trial, so they are much less precise than the overall 12-week results.
* EMA EPAR — Spedra (avanafil), EMEA/H/C/002581, marketing authorisation issued 21/06/2013
* EMA — Spedra EPAR product information (SmPC sections 4.2, 4.8, 5.1)
* *J Sex Med* 2012 — randomised, double-blind, placebo-controlled evaluation of avanafil (PMID 22248153)
* ClinicalTrials.gov — TA-301 avanafil Phase 3 trial (NCT00790751, NCT00809471)
## What has been reported
| Effect | Frequency in EU product information |
| ---------------------------- | ------------------------------------------------------------------------------------------------------------------------------ |
| Headache | Common (1 in 100 to 1 in 10); one of the most frequently reported reactions across a safety database of 2,566 exposed subjects |
| Flushing | Common |
| Nasal congestion | Common; sinus congestion listed as uncommon |
| Back pain | Uncommon (1 in 1,000 to 1 in 100), though named among the most frequently reported reactions in the safety summary |
| Dizziness and blurred vision | Uncommon |
## Who it is not suitable for
* Anyone taking nitrate medicines or nitric-oxide donors ("poppers") — blood pressure can fall dangerously
* Men with serious cardiovascular conditions such as a recent heart attack, stroke or unstable angina
Nitrates and poppers are contraindicated with avanafil: taken together, blood pressure can fall dangerously.
## How Hi-Doctor handles it
Avanafil is the most recent PDE5 inhibitor, with a fast onset (15–30 minutes) and a somewhat narrower side-effect profile in some studies — useful when timing flexibility matters. It is prescribed at 50, 100 or 200 mg on demand. If there is no response, the doctor reassesses: a dose adjustment, a switch to another PDE5 inhibitor, or evaluation of underlying causes — never a self-prescribed change. At most one dose is taken in 24 hours.
Related: [vardenafil (Levitra)](/library/medicines/levitra), another PDE5 inhibitor in the same group. See also [safety and eligibility checks](/essentials/safety), [how a Hi-Doctor consultation works](/essentials/how-it-works), and [pricing](/essentials/pricing).
## Start a consultation
Answer the sexual health questionnaire and a registered doctor reviews it.
They decide whether treatment is appropriate, which one, and at what dose —
and declining is a normal outcome. See [what it costs](/essentials/pricing)
and [how the review works](/essentials/how-it-works).
This page is reference information, not medical advice and not a prescription.
Whether a medicine is appropriate for you is decided by a registered doctor
after reviewing your consultation.