This page shows what was measured, who it was measured in, and what that does not settle.
What Vardenafil does in the body
Erectile dysfunction
From the FDA-approved label: Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpus cavernosum. Nitric oxide activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in erection. The tissue concentration of cGMP is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDEs).
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 5M8S2CU0TS · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 118 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Improvement of Erectile Disfunction
✗ The study did not show it
Who was studied
NCT00663598
How many people
30825
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
What a body can do day to day
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Effect of education of the primary care physician or of the subject, in treating erectile dysfunction with vardenafil, relative to usual care, on the subject's treatment outcome of ED and quality of life.
✗ The study did not show it
Who was studied
NCT00664833
How many people
1029
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
What a body can do day to day
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake
✗ The study did not show it
Who was studied
NCT00668018
How many people
887
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15
✗ The study did not show it
Who was studied
NCT00678704
How many people
790
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
What a body can do day to day
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Sexual Encounter Profile Question 3 (SEP-3)
✗ The study did not show it
Who was studied
NCT00663130
How many people
759
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
- Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP 3)
✗ The study did not show it
Who was studied
NCT00665496
How many people
732
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Vardenafil hydrochloride orally disintegrating tablets are indicated for the treatment of erectile dysfunction. • Vardenafil hydrochloride orally disintegrating tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. ( 1 ).
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “Safety and efficacy have not been established in this population.”
US prescribing information · 31be68b0-ac7e-42d0-9435-1f0a329b63d8 · read 2026-08-30
On older people, the label states: “Phase 3 clinical trials included more than 834 elderly patients, and no differences in safety or effectiveness of vardenafil 5, 10, or 20 mg were noted when these elderly patients were compared to younger patients.”
US prescribing information · 31be68b0-ac7e-42d0-9435-1f0a329b63d8 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Vardenafil hydrochloride is not indicated for use in females.”
US prescribing information · 31be68b0-ac7e-42d0-9435-1f0a329b63d8 · read 2026-08-30
On people with reduced liver function, the label states: “Dosage adjustment is necessary in patients with moderate hepatic impairment.”
US prescribing information · 31be68b0-ac7e-42d0-9435-1f0a329b63d8 · read 2026-08-30
On people with reduced kidney function, the label states: “Do not use vardenafil hydrochloride in patients on renal dialysis as vardenafil has not been evaluated in such patients.”
US prescribing information · 31be68b0-ac7e-42d0-9435-1f0a329b63d8 · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Sold as tablet, tablet, orally disintegrating, tablet, film coated, given by the oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
70 products list this as an active ingredient in the United States drug directory. 70 of them contain it and nothing else.
FDA National Drug Code directory · 33342-504 · read 2026-08-29
They are sold as powder, tablet, tablet, film coated and tablet, orally disintegrating, taken oral.
FDA National Drug Code directory · 33342-504 · read 2026-08-29
The regulator's established pharmacologic class for it is phosphodiesterase 5 inhibitor [epc] and phosphodiesterase 5 inhibitors [moa].
FDA National Drug Code directory · 33342-504 · read 2026-08-29
19 published labels name it as an active ingredient. 19 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 31be68b0-ac7e-42d0-9435-1f0a329b63d8 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 31be68b0-ac7e-42d0-9435-1f0a329b63d8 · read 2026-08-29
Vardenafil Hydrochloride is oral at 3 DOSAGE FORMS AND STRENGTHS Vardenafil hydrochloride tablets are available as: 2.5 mg – beige to light-peach, film-coated, round, standard convex tablets, debossed with “TV” on one side of the tablet and with “1V” on t…, recorded as fda label in effect 2024-04-03 in the United States.
US prescribing information · 31be68b0-ac7e-42d0-9435-1f0a329b63d8 · read 2026-08-30
Recorded price in US: 1.91375–24.87317 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 16 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Vardenafil studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Vardenafil are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
How many documents were read
20 documents were read for this substance.
RNAWiki source record
17 of them state the same bioavailability, and they agree.
RNAWiki source record
20 of them state the same proteinBinding, and they agree.
RNAWiki source record
20 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
5M8S2CU0TS
RxNorm concept
349480
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✗ Not passed
Safety mode resolved
No register row and no identity class settled the question.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
12 approved applications cover products containing this substance. The earliest was NDA021400, approved 20030819 to BAYER HLTHCARE.
This order is fixed in code and does not count clicks or time on the page.
What is not here
9 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (10)
Q1
On the Vardenafil label: indicated for what?
"Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction. Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.": indications and usage on Vardenafil's label. DailyMed label · 666a622b-2464-4c55-8c90-0f1cc85bc1e9 · 2026-08-26
Q2
74 registered trials of Vardenafil — at which phases?
Registered studies posting no result
69 of 74
74 registered studies of Vardenafil: 29 phase4, 23 phase3, 11 phase2, 8 na or unstated, 4 phase1, 1 early phase1, 1 na. CLINICALTRIALS_SNAPSHOT · 2026-09-01
157 with a PubMed record
Show the evidence
phase4
29
phase3
23
phase2
11
na or unstated
8
phase1
4
early phase1
1
5 more recorded rows
na
1
completed
62
unknown
7
terminated
4
temporarily not available
1
recorded 2026-09-01 · last checked 2026-09-04
Q3
4 of Vardenafil's trials stopped: accrual/recruitment, other?
terminated; "Unable to accrue to the study. Original PI no longer with the institute."
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Vardenafil used Vardenafil 10mg — over how long?
Human studies of Vardenafil used "Vardenafil 10mg". ClinicalTrials.gov · 2026-09-01
5 recorded entries; human; also "Vardenafil (Levitra, BAY 38-9456), 10 mg", "Vardenafil (Levitra, BAY 38-9456), 20 mg", "Vardenafil 5 Mg Oral Tablet"
Show the evidence
human
NCT00517179
Vardenafil 10mg
NCT00667966
Vardenafil (Levitra, BAY 38-9456), 10 mg
NCT00667966
Vardenafil (Levitra, BAY 38-9456), 20 mg
NCT06491108
Vardenafil 5 Mg Oral Tablet
NCT06491108
Vardenafil 5 mg
recorded 2026-09-01 · last checked 2026-09-04
Q5
Vardenafil's half-life is 4-5 hours — which schedules were studied?
4-5 hours, the half-life Vardenafil's label states: "Excretion The total body clearance of vardenafil is 56 L/h, and the terminal half-life of vardenafil and its primary metabolite (M1) is approximately 4-5 hours." DailyMed label · 666a622b-2464-4c55-8c90-0f1cc85bc1e9 · 2026-08-26
tmax 6 hours; bioavailability 15 %.
Show the evidence
half lifepharmacokinetics
4-5 hours; Excretion The total body clearance of vardenafil is 56 L/h, and the terminal half-life of vardenafil and its primary metabolite (M1) is approximately 4-5 hours.
tmaxclinical_pharmacology
6 hours; Among subjects treated with terazosin, outlier values were observed more frequently when vardenafil and terazosin were given to achieve simultaneous T max than when dosing was administered to separate T max by 6 hours.
bioavailabilitypharmacokinetics
15 %; Figure 8: Plasma Vardenafil Concentration (Mean ± SD) Curve for a Single 20 mg Vardenafil Hydrochloride Tablets Dose Vardenafil is rapidly absorbed with absolute bioavailability of approximately 15%.
metabolismpharmacokinetics
Metabolism Vardenafil is metabolized predominantly by the hepatic enzyme CYP3A4, with contribution from the CYP3A5 and CYP2C isoforms.
recorded 2026-08-26 · last checked 2026-09-04
Q6
Which 56 trials of Vardenafil posted no result?
Posted no result
56 of 56 completed trials
Registrations
NCT00656188, NCT00668005, NCT00668057, NCT00668018, NCT00661219 and NCT00665496, and 50 more
Completion dates
oldest 2003-05; newest 2019-12-04
Show the evidence
Trial
NCT00656188
2003-05
NCT00668005
2003-09
NCT00668057
2003-09
NCT00668018
2003-10
NCT00661219
2003-11
NCT00665496
2003-11
14 further recorded trials
NCT00681772
2003-11
NCT00654680
2004-01
NCT00660998
2004-01
NCT00661297
2004-01
NCT00661596
2004-01
NCT00654914
2004-02
NCT00658177
2004-02
NCT00661115
2004-02
NCT00657644
2004-03
NCT00668135
2004-04
NCT00661700
2004-05
NCT00662441
2004-06
NCT00668109
2004-06
NCT00663130
2004-07
Q7
At the median, Vardenafil's trials enrolled 229 people — anything larger?
Median enrolment
229
Largest enrolment
30825
Registered trials counted
73
Q8
What do 887 spontaneous reports say about Vardenafil — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Vardenafil appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 887 reaction mentions were counted: erectile dysfunction 315; headache 183; flushing 94; nasal congestion 66. FAERS via Open Targets · CHEMBL1339 · 2026-06-24
Show the evidence
erectile dysfunction
315
headache
183
flushing
94
nasal congestion
66
erection increased
53
drug use for unknown indication
48
4 more recorded rows
vision blurred
44
visual disturbance
30
palpitations
29
optic ischaemic neuropathy
25
recorded 2026-06-24 · last checked 2026-09-04
Q9
Which 10 reactions does Vardenafil's label not list?
7.2 Effect of Other Drugs on Vardenafil In vitro studies Studies in human liver microsomes showed that vardenafil is metabolized primarily by cytochrome P450 (CYP) isoforms 3A4/5, and to a lesser degree by CYP2C9.
drug_interactions
In vivo studies Strong CYP3A4 inhibitors Ketoconazole (200 mg once daily) produced a 10-fold increase in vardenafil AUC and a 4-fold increase in maximum concentration (C max ) when co-administered with vardenafil hydrochloride tablets (5 mg) in healthy volunteers.
drug_interactions
The interaction is a consequence of blocking hepatic metabolism of vardenafil by ritonavir, a HIV protease inhibitor and a highly strong CYP3A4 inhibitor, which also inhibits CYP2C9.
drug_interactions
Moderate CYP3A4 inhibitors Erythromycin (500 mg t.i.d.) produced a 4-fold increase in vardenafil AUC and a 3-fold increase in C max when co administered with vardenafil hydrochloride tablets 5 mg in healthy volunteers.
drug_interactions
[See Dosage and Administration (2.4) and Warnings and Precautions (5) .] Although specific interactions have not been studied, other CYP3A4 inhibitors, including grapefruit juice would likely increase vardenafil exposure.
drug_interactions
7.3 Effects of Vardenafil on Other Drugs In vitro studies Vardenafil and its metabolites had no effect on CYP1A2, 2A6, and 2E1 (Ki >100 micromolar).
2 more recorded rows
Interaction statementdrug_interactions
Weak inhibitory effects toward other isoforms (CYP2C8, 2C9, 2C19, 2D6, 3A4) were found, but Ki values were in excess of plasma concentrations achieved following dosing.
Interaction statementdrug_interactions
The most potent inhibitory activity was observed for vardenafil metabolite M1, which had a Ki of 1.4 micromolar toward CYP3A4, which is about 20 times higher than the M1 C max values after an 80 mg vardenafil dose.
ChEMBL 37 — CC BY-SA 3.0 Unported · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
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