This page shows what was measured, who it was measured in, and what that does not settle.
What Alfuzosin does in the body
Alfuzosin blocks the receptor those nerve signals use, so the muscle relaxes and the channel widens.
The prostate and the neck of the bladder are wrapped in muscle that nerves hold permanently tense, and that tension narrows the tube urine leaves through. The gland is the same size afterwards. Unlike some drugs in its class, alfuzosin does not prefer one receptor subtype over another — what it has instead is an extended-release tablet and a once-daily schedule designed to keep blood-pressure effects small, which is a different kind of selectivity and worth knowing the difference.
Why people take it. A weak or hesitant stream, going often, and getting up at night, caused by an enlarged prostate
What happened in people
International Prostate Symptom Score fell 3.6, 6.9 and 6.5 points against 1.6, 4.9 and 4.6 on placebo in the three registration trials
✎ 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 recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
ALTESS / EFC4485 — two-year placebo-controlled trial of alfuzosin 10 mg on acute urinary retention and need for surgery (NCT00029822) · a recorded source, not a stored snapshot
Eleven cents a tablet at United States pharmacy acquisition cost, across only twelve listed products — twice tamsulosin's price on a third of the supplier base
Where it acts
Smooth muscle of the prostatic stroma, prostatic capsule, prostatic urethra, bladder neck and bladder base
Kind of result
Symptoms and quality of life
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The recorded use, written for a reader without medical training. Not signed off.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 139 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.
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.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
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.
Occurrence of a first episode of acute urinary retention
✗ The study did not show it
Who was studied
ALTESS / EFC4485 (NCT00029822)
How many people
1522
Study design
Phase 3 randomised double-blind placebo-controlled, 2 years
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Acute urinary retention 2.1% on alfuzosin against 1.8% on placebo, P=0.82. Surgery 5.1% against 6.5%, P=0.18. Post hoc: symptom deterioration 11.7% against 16.8%, P=0.0013; overall clinical progression 16.3% against 22.1%, P<0.001
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. The endpoints that produced the trial's positive headline are identified by the publication as post hoc analyses. The pre-specified primary endpoint was not met and the secondary surgery endpoint did not reach significance.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral extended-release tablet, once daily, taken with food
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
ALTESS / EFC4485 — two-year placebo-controlled trial of alfuzosin 10 mg on acute urinary retention and need for surgery (NCT00029822) · a recorded source, not a stored snapshot
49.3% in both groups; rate difference 0.1% (95% CI -11.2 to 11.0), P=0.99. Global response 34.8% against 33.6%, P=0.90
Repeated elsewhere
Failed to Replicate
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. Enrolment was restricted to men diagnosed within two years and never previously treated with an alpha-blocker, a design chosen to give the drug its best chance. Adverse event rates were similar between groups.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral extended-release tablet, once daily, taken with food
Interval reported. 95% CI -11
Written into the record, not signed off as a reviewed claim.
ALTESS / EFC4485 — two-year placebo-controlled trial of alfuzosin 10 mg on acute urinary retention and need for surgery (NCT00029822) · a recorded source, not a stored snapshot
Successful voiding at an active voiding trial after a first episode of acute urinary retention, absence of relapse over 6 months, and no requirement for surgery
No results are posted on the registry record and no linked publication is recorded there. `endpoint met: false` records the absence of a public result, not a missed endpoint.
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. An 800-patient placebo-controlled trial addressing exactly the question ALTESS failed on — whether this drug helps in acute urinary retention — with no result in the public registry record.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral extended-release tablet, once daily, taken with food
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
ALTESS / EFC4485 — two-year placebo-controlled trial of alfuzosin 10 mg on acute urinary retention and need for surgery (NCT00029822) · a recorded source, not a stored snapshot
IPSS -3.6 vs -1.6 (p=0.001), -6.9 vs -4.9 (p=0.002), -6.5 vs -4.6 (p=0.007). Peak flow +1.7 vs +0.2 (p=0.0004), +2.3 vs +1.4 (p=0.03), +1.5 vs +0.9 (p=0.22)
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. The peak flow comparison — the only objective endpoint in this indication — missed significance in the third trial at p=0.22. The sample size given is the enrolment of the largest registered US symptom-score trial on this record, NCT00399464, not the pooled registration total.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral extended-release tablet, once daily, taken with food
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
ALTESS / EFC4485 — two-year placebo-controlled trial of alfuzosin 10 mg on acute urinary retention and need for surgery (NCT00029822) · a recorded source, not a stored snapshot
RNAWiki holds 4 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 it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Alfuzosin
What a person takes: Oral extended-release tablet, once daily, taken with food.
The measurement behind this step
The extended-release geomatrix tablet is the drug's actual point of difference. Older quinazoline alpha-blockers required upward titration because their concentration peaked sharply after each dose and dropped blood pressure. Slowing release removes the peak and removes the titration. The tablet is swallowed whole, not crushed or chewed, and is taken with food because absorption depends on it.
Getting in
An extended-release tablet built to avoid a peak
The tablet releases the drug gradually so the level in the blood never spikes. That is the whole design: the older drugs in this family dropped blood pressure because their concentration rose sharply after each dose.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Once-daily extended-release tablet, taken with food. Cleared predominantly by CYP3A4, which is why potent inhibitors of that enzyme are a contraindication rather than a caution, and why moderate to severe hepatic impairment is also contraindicated. In 14 healthy young men, 10 mg produced no significant change in systolic pressure, diastolic pressure or heart rate against placebo.
ALTESS / EFC4485 — two-year placebo-controlled trial of alfuzosin 10 mg on acute urinary retention and need for surgery (NCT00029822) · a recorded source, not a stored snapshot
The target is on the outer face of the smooth muscle cell. The drug arrives from the bloodstream and occupies it directly; nothing has to be transported inside.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Alpha-1 adrenoceptors are plasma-membrane G-protein-coupled receptors with an extracellular-facing orthosteric pocket, so there is no transporter step and no intracellular accumulation requirement. This is why alpha-blocker effects appear within days rather than months, and disappear as quickly on stopping.
ALTESS / EFC4485 — two-year placebo-controlled trial of alfuzosin 10 mg on acute urinary retention and need for surgery (NCT00029822) · a recorded source, not a stored snapshot
It blocks the alpha-1 receptor without preferring a subtype
Noradrenaline released by nerves keeps prostate muscle tense. Alfuzosin occupies the receptor it uses. Unlike some drugs in its class it does not favour one variant of that receptor over another.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Competitive antagonism at post-synaptic alpha-1 adrenoceptors. The label names the anatomical sites — prostate, bladder base, bladder neck, prostatic capsule and prostatic urethra — and claims no subtype preference among alpha-1A, alpha-1B and alpha-1D. That absence is the structural reason the drug leaves ejaculation largely alone where the alpha-1A-preferring drugs do not.
ALTESS / EFC4485 — two-year placebo-controlled trial of alfuzosin 10 mg on acute urinary retention and need for surgery (NCT00029822) · a recorded source, not a stored snapshot
The calcium signal holding the muscle tense falls away
Smooth muscle tension is maintained by a continuous internal calcium signal. With the receptor blocked, that signal weakens and the muscle relaxes.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Loss of Gq/11 coupling ends phospholipase C activation, inositol trisphosphate falls, sarcoplasmic reticulum calcium release drops and myosin light-chain kinase activity declines. Prostatic and bladder-neck smooth muscle relaxes. Prostate volume is unchanged, which is why two years of this drug in ALTESS did not reduce acute urinary retention.
ALTESS / EFC4485 — two-year placebo-controlled trial of alfuzosin 10 mg on acute urinary retention and need for surgery (NCT00029822) · a recorded source, not a stored snapshot
Two points of symptom score, and no fewer episodes of retention
The questionnaire improves by about two points more than placebo, and the flow rate by one to two millilitres a second in two of three trials. Over two years, the number of men who ended up unable to pass urine was the same as on placebo.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
IPSS fell 3.6, 6.9 and 6.5 against 1.6, 4.9 and 4.6 on placebo across three registration trials. Peak flow rose 1.7, 2.3 and 1.5 mL/sec against 0.2, 1.4 and 0.9, with the third comparison at p=0.22. In ALTESS, acute urinary retention over two years occurred in 2.1% on alfuzosin and 1.8% on placebo, P=0.82.
ALTESS / EFC4485 — two-year placebo-controlled trial of alfuzosin 10 mg on acute urinary retention and need for surgery (NCT00029822) · a recorded source, not a stored snapshot
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
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.
Men with moderate to severe lower urinary tract symptoms attributed to benign prostatic hyperplasia, particularly those who cannot tolerate the ejaculatory effects of the alpha-1A-preferring drugs.
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: “Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population.”
US prescribing information · 43675e9d-a361-4109-9ae1-54d80580fbbd · read 2026-08-30
On older people, the label states: “Of the total number of subjects in clinical studies of alfuzosin hydrochloride extended-release tablets, 48% were 65 years of age and over, whereas 11% were 75 and over.”
US prescribing information · 43675e9d-a361-4109-9ae1-54d80580fbbd · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Alfuzosin hydrochloride extended-release tablets are not indicated for use in women.”
US prescribing information · 43675e9d-a361-4109-9ae1-54d80580fbbd · read 2026-08-30
On people with reduced liver function, the label states: “The pharmacokinetics of alfuzosin hydrochloride extended-release tablets have not been studied in patients with mild hepatic impairment.”
US prescribing information · 43675e9d-a361-4109-9ae1-54d80580fbbd · read 2026-08-30
On people with reduced kidney function, the label states: “Systemic exposure was increased by approximately 50% in pharmacokinetic studies of patients with mild, moderate, and severe renal impairment [see Clinical Pharmacology (12.3) ] .”
US prescribing information · 43675e9d-a361-4109-9ae1-54d80580fbbd · read 2026-08-30
Where the result stopped carrying
The registered two-year primary endpoint of ALTESS: acute urinary retention, 2.1% against 1.8%, P=0.82
The chronic prostatitis indication, refuted by an NIH-network trial after years of off-label use built on small studies
The peak flow endpoint in the third registration trial, at p=0.22
The 800-patient ALFAURUS trial in acute urinary retention, with no result posted on the public registry record
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 extended-release tablet, once daily, taken with food
✎ 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
The extended-release geomatrix tablet is the drug's actual point of difference. Older quinazoline alpha-blockers required upward titration because their concentration peaked sharply after each dose and dropped blood pressure. Slowing release removes the peak and removes the titration. The tablet is swallowed whole, not crushed or chewed, and is taken with food because absorption depends on it.
✎ 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◇Read from sources, not yet reviewed
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.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Commonest effects are dizziness at 5.7% against 2.8% on placebo, upper respiratory infection, headache and fatigue. The label contraindicates concomitant potent CYP3A4 inhibitors and moderate to severe hepatic insufficiency outright. Warnings cover postural hypotension and syncope, intraoperative floppy iris syndrome in cataract and glaucoma surgery, priapism, and caution in patients with congenital or acquired QT prolongation despite a dedicated QT study showing only 1.8 msec at the therapeutic dose. It states explicitly that the drug is not indicated for hypertension.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
ALTESS / EFC4485 — two-year placebo-controlled trial of alfuzosin 10 mg on acute urinary retention and need for surgery (NCT00029822) · a recorded source, not a stored snapshot
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 extended-release tablet, once daily, taken with food
✎ 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
Older quinazoline alpha-blockers required upward titration because their concentration peaked sharply after each dose and dropped blood pressure. Slowing release removes the peak and removes the titration. The tablet is swallowed whole, not crushed or chewed, and is taken with food because absorption depends on it.
✎ 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 which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
25 products list this as an active ingredient in the United States drug directory. 25 of them contain it and nothing else.
FDA National Drug Code directory · 49867-0049 · read 2026-08-29
They are sold as powder, tablet, tablet, extended release and tablet, film coated, extended release, taken oral.
FDA National Drug Code directory · 49867-0049 · read 2026-08-29
The regulator's established pharmacologic class for it is adrenergic alpha-antagonists [moa] and alpha-adrenergic blocker [epc].
FDA National Drug Code directory · 49867-0049 · read 2026-08-29
17 published labels name it as an active ingredient. 17 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 43675e9d-a361-4109-9ae1-54d80580fbbd · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 43675e9d-a361-4109-9ae1-54d80580fbbd · read 2026-08-29
Alfuzosin Hydrochloride is oral at 3 DOSAGE FORMS AND STRENGTHS Alfuzosin hydrochloride extended-release tablets USP 10 mg are white to off-white, round, biconvex, film-coated tablets, debossed with ‘X’ on one side and ‘23’ on other side., recorded as fda label in effect 2026-01-01 in the United States.
US prescribing information · 43675e9d-a361-4109-9ae1-54d80580fbbd · read 2026-08-30
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 Alfuzosin 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
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That "uroselective" denotes receptor-subtype selectivity — the label claims alpha-1 class selectivity and anatomical distribution, and the clinical advantage comes from the extended-release formulation
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That relaxing prostatic smooth muscle prevents urinary retention — ALTESS tested exactly that in 1,522 men over two years and found no difference
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That alpha-blockade relieves chronic pelvic pain — a 272-man trial produced identical response rates in both arms
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That ALTESS showed alfuzosin slows disease progression — the endpoints supporting that are post hoc, and the pre-specified primary endpoint failed
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
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 Alfuzosin 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.
Every line above can be traced to the study named beside it. Follow the link and read it.
ALTESS missed its primary endpoint: no reduction in acute urinary retention
In plain words
Fifteen hundred men at raised risk of urinary retention took alfuzosin or placebo for two years. Retention happened to 2.1% on the drug and 1.8% on placebo. The endpoint the trial was built around was not met.
What was measured
Incidence of first episode of acute urinary retention over two years, alfuzosin versus placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
ALTESS (NCT00029822) randomised 1,522 men at risk of BPH progression to alfuzosin 10 mg once daily (759) or placebo (763) for two years, with occurrence of a first episode of acute urinary retention as the primary endpoint and BPH-related surgery as a secondary. Alfuzosin did not reduce the risk of retention: 2.1% against 1.8%, P=0.82. Surgery trended in the drug's favour without reaching significance: 5.1% against 6.5%, P=0.18, relative risk reduction 22% (95% CI -18 to 48). The findings that were significant — symptom deterioration 11.7% against 16.8%, P=0.0013, and the composite "overall clinical progression" 16.3% against 22.1%, P<0.001 — are described by the publication itself as post hoc analyses. The paper's own title states the conclusion in full: prevents overall clinical progression but not acute urinary retention.
Written into the record, not signed off as a reviewed claim
For chronic prostatitis the response rate was 49.3% in both arms
In plain words
Alfuzosin was widely used for chronic pelvic pain in men on the strength of small trials. A properly powered NIH-network trial found the improvement rate identical in the drug and placebo groups — 49.3% each.
What was measured
Proportion achieving a 4-point or greater fall in NIH-CPSI score at 12 weeks, alfuzosin versus placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Nickel and colleagues randomised 272 men with chronic prostatitis-chronic pelvic pain syndrome diagnosed within the previous two years and with no prior alpha-blocker exposure, to alfuzosin 10 mg daily or placebo for 12 weeks. The primary outcome was a reduction of at least 4 points on the NIH Chronic Prostatitis Symptom Index, which is the instrument's minimal clinically significant difference. In both groups 49.3% of participants achieved it: rate difference associated with alfuzosin 0.1% (95% CI -11.2 to 11.0), P=0.99. A global response assessment agreed: 33.6% on placebo and 34.8% on alfuzosin, P=0.90. Adverse event rates were similar. Two arms landing on the same number to a tenth of a percentage point is as clean a null as this literature produces, and the enrolment criterion — no previous alpha-blocker — was specifically designed to give the drug its best chance.
Written into the record, not signed off as a reviewed claim
About two points of symptom score over placebo, in all three registration trials
In plain words
On the label's own three trials, men on alfuzosin improved by roughly two more points on a thirty-five point symptom questionnaire than men on placebo. The placebo groups improved substantially on their own.
What was measured
Change in International Prostate Symptom Score total at 12 weeks against placebo, in three registration trials
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Clinical Studies section reports three 12-week placebo-controlled trials. International Prostate Symptom Score total fell 3.6 against 1.6 on placebo (p=0.001), 6.9 against 4.9 (p=0.002) and 6.5 against 4.6 (p=0.007). The treatment effect is 2.0, 2.0 and 1.9 points respectively — remarkably consistent, and consistently around two points on an instrument that runs to 35 and whose commonly cited minimally important difference is around three. Note the placebo arms: 1.6, 4.9 and 4.6 points of improvement with no active drug, meaning that in the second and third trials placebo accounted for roughly seven-tenths of the total movement patients experienced.
Source
US prescribing information for alfuzosin hydrochloride extended-release tablets, Clinical Studies section (openFDA drug label endpoint)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The flow-rate endpoint missed in one of the three registration trials
In plain words
Peak urine flow is the one objective measurement in this indication. In the third registration trial, alfuzosin did not beat placebo on it.
What was measured
Change in peak urine flow rate at 12 weeks against placebo, in three registration trials
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Peak urine flow rate rose 1.7 mL/sec against 0.2 on placebo in Trial 1 (p=0.0004), 2.3 against 1.4 in Trial 2 (p=0.03), and 1.5 against 0.9 in Trial 3 (p=0.22). The third result did not reach significance. Peak flow matters more than it appears to, because it is the only endpoint in this indication that a patient cannot influence by how they feel about their treatment — the symptom score is entirely self-reported. A drug whose objective endpoint separates in two trials out of three, by 1.5 and 0.9 mL/sec, is being described accurately when both facts are stated together.
Source
US prescribing information for alfuzosin hydrochloride extended-release tablets, Clinical Studies section (openFDA drug label endpoint)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
"Uroselective" describes the tablet, not the receptor
In plain words
Alfuzosin is routinely called uroselective, which sounds like it means the drug picks out bladder receptors. The label makes no such claim: it says the drug is selective for one broad receptor family and then lists where in the body those receptors sit.
What was measured
That alfuzosin is receptor-subtype selective for the lower urinary tract — the label claims alpha-1 class selectivity and anatomical distribution, and the clinical difference from the older quinazolines is delivered by formulation
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The US label states alfuzosin is "a selective antagonist of post-synaptic alpha 1-adrenoreceptors, which are located in the prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra." Read carefully, that is a claim of alpha-1 versus alpha-2 selectivity followed by an anatomical statement about where alpha-1 receptors are found. It is not a claim of preference for the alpha-1A subtype, which is the claim tamsulosin's and silodosin's labels do make. The term "uroselective" nonetheless appears routinely in the peer-reviewed literature describing this drug — the opening sentence of Mondaini and colleagues' 2006 European Urology paper calls it "a uroselective alpha(1)-adrenoceptor antagonist". What the extended-release formulation and once-daily schedule genuinely deliver is a lower peak concentration and a smaller haemodynamic effect: in a randomised crossover of 14 healthy young men, 10 mg produced no significant change in systolic or diastolic pressure or heart rate, and no hypotensive episode. That is a real and useful property. It is a pharmacokinetic property, and calling it selectivity moves a claim from one category into another.
Written into the record, not signed off as a reviewed claim
The QT study is a clean negative, and the label reports the numbers
In plain words
At the normal dose, alfuzosin lengthened a heart electrical interval by under 2 milliseconds, against 11 for the antibiotic used as the positive control. Even at four times the dose it reached 4.3.
What was measured
Mean QTc change at 10 mg and 40 mg against a moxifloxacin positive control
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The US label reports mean QTc change of 1.8 msec at the therapeutic 10 mg dose using subject-specific correction, and 4.3 msec at 40 mg, against 11.1 msec for moxifloxacin 400 mg as positive control. No Torsade de Pointes signal emerged in non-US post-marketing experience. This is included as a measured audit point rather than omitted as good news, because it is the counterexample within this file: tolterodine's label reports 11.84 msec at twice its therapeutic dose with confidence intervals overlapping the same positive control. Identical study design, opposite result, both stated in the manufacturer's own words. It is what a genuinely negative safety study looks like when it is reported in full.
Source
US prescribing information for alfuzosin hydrochloride extended-release tablets, Clinical Pharmacology section (openFDA drug label endpoint)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Two hard contraindications where most of this class carries only cautions
In plain words
Alfuzosin must not be taken with certain antifungal and HIV drugs, and must not be taken by anyone with moderate or severe liver impairment. These are contraindications, not warnings.
What was measured
Contraindicated interactions and hepatic clearance reduction, with adverse-event incidences against placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The US label contraindicates use with potent CYP3A4 inhibitors including ketoconazole, itraconazole and ritonavir, and contraindicates use in moderate to severe hepatic insufficiency (Child-Pugh B and C), where plasma clearance falls to one-third to one-quarter of normal and alfuzosin concentrations rise three- to four-fold. Tamsulosin's label handles strong CYP3A4 inhibitors with a warning rather than a contraindication. The difference is not arbitrary: alfuzosin has a single dominant clearance route and a formulation designed around a specific concentration profile, so removing that route defeats the design. The commonest adverse effects on the label are dizziness at 5.7% against 2.8% on placebo, upper respiratory infection 3.0% against 0.6%, headache 3.0% against 1.8% and fatigue 2.7% against 1.8%.
Source
US prescribing information for alfuzosin hydrochloride extended-release tablets, Contraindications and Adverse Reactions sections (openFDA drug label endpoint)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
How many documents were read
17 documents were read for this substance.
RNAWiki source record
17 of them state the same halfLife, and they agree.
RNAWiki source record
17 of them state the same proteinBinding, and they agree.
RNAWiki source record
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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
10 approved applications cover products containing this substance. The earliest was NDA021287, approved 20030612 to ADVANZ PHARMA.
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An alpha-1 adrenoceptor antagonist whose "uroselectivity" is a matter of formulation and dosing rather than of receptor subtype: across its three US registration trials it lowered the International Prostate Symptom Score by 3.6, 6.9 and 6.5 points against 1.6, 4.9 and 4.6 on placebo, a margin of about two points; over two years in 1,522 men it did not reduce acute urinary retention at all (2.1% against 1.8%, P=0.82); and in a 272-man randomised trial for chronic prostatitis it produced a response rate identical to placebo to within a tenth of a percentage point.
Recorded evidence blocks (8)
Q1
On the Alfuzosin label: indicated for what?
"Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablets are an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.": indications and usage on Alfuzosin's label. DailyMed label · d163369b-e44b-4591-b166-7ddd0c1c13c0 · 2026-07-15
Q2
37 registered trials of Alfuzosin — at which phases?
10 hours; Following oral administration of alfuzosin hydrochloride extended-release tablets 10 mg, the apparent elimination half-life is 10 hours.
tmaxpharmacokinetics
8 hours; Following multiple dosing of 10 mg alfuzosin hydrochloride extended-release tablets under fed conditions, the time to maximum concentration is 8 hours.
bioavailabilitypharmacokinetics
49 %; Absorption The absolute bioavailability of alfuzosin hydrochloride extended-release tablets 10 mg under fed conditions is 49%.
metabolismpharmacokinetics
Metabolism Alfuzosin undergoes extensive metabolism by the liver, with only 11% of the administered dose excreted unchanged in the urine.
recorded 2026-07-15 · last checked 2026-09-04
Q6
Which 18 trials of Alfuzosin posted no result?
Posted no result
18 of 18 completed trials
Registrations
NCT00290030, NCT00540891, NCT00542165, NCT00637715, NCT00029822 and NCT00575913, and 12 more
Completion dates
oldest 2004-10; newest 2016-11-19
Show the evidence
Trial
NCT00290030
2004-10
NCT00540891
2004-10
NCT00542165
2004-12
NCT00637715
2004-12
NCT00029822
2005-03
NCT00575913
2005-03
12 further recorded trials
NCT00280605
2006-02
NCT00629720
2007-02
NCT00427882
2007-05
NCT00256399
2007-05-08
NCT00399464
2007-10
NCT00467467
2007-10
NCT00177086
2008-01
NCT00486785
2008-03
NCT00836823
2008-08
NCT00941343
2008-09
NCT02977832
2016-09
NCT03144596
2016-11-19
Q7
At the median, Alfuzosin's trials enrolled 118 people — anything larger?
Median enrolment
118
Largest enrolment
1522
Registered trials counted
37
Q8
Alfuzosin and CYP3A4, CYP1A and CYP1A2: shared by which compounds?
Concomitant use of PDE5 inhibitors with alpha adrenergic antagonists, including alfuzosin hydrochloride extended-release tablets, can potentially cause symptomatic hypotension (5.4 , 7.4) 7.1 CYP3A4 Inhibitors Alfuzosin hydrochloride extended-release tablets are contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, or ritonavir, since alfuzosin blood levels are…
pharmacokinetics
CYP3A4 is the principal hepatic enzyme isoform involved in its metabolism.
pharmacokinetics
Drug-Drug Interactions Metabolic Interactions CYP3A4 is the principal hepatic enzyme isoform involved in the metabolism of alfuzosin.
pharmacokinetics
Potent CYP3A4 Inhibitors Repeated oral administration of 400 mg/day of ketoconazole, a potent inhibitor of CYP3A4, increased alfuzosin C max by 2.3-fold and AUC last by 3.2-fold, following a single 10 mg dose of alfuzosin.
pharmacokinetics
Therefore, alfuzosin hydrochloride extended-release tablets are contraindicated for co-administration with potent inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, or ritonavir) because of increased alfuzosin exposure [see Contraindications (4) , Warnings and Precautions (5.4) and Drug Interactions (7.1) ] .
pharmacokinetics
Moderate CYP3A4 Inhibitors Diltiazem: Repeated co-administration of 240 mg/day of diltiazem, a moderately-potent inhibitor of CYP3A4, with 7.5 mg/day (2.5 mg three times daily) alfuzosin (equivalent to the exposure with alfuzosin hydrochloride extended-release tablets) increased the C max and AUC 0-24 of alfuzosin 1.5- and 1.3-fold, respectively.
2 more recorded rows
Interaction statementpharmacokinetics
In human liver microsomes, at concentrations that are achieved at the therapeutic dose, alfuzosin did not inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6 or 3A4 isoenzymes.
Interaction statementpharmacokinetics
In primary culture of human hepatocytes, alfuzosin did not induce CYP1A, 2A6 or 3A4 isoenzymes.
ClinicalTrials.gov — US Government work · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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