Skip to content

Venlafaxine

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Venlafaxine does in the body

Venlafaxine blocks two recycling pumps rather than one: the serotonin pump, like an SSRI, and the noradrenaline pump as well.

The second block needs a higher dose to appear, which is why low doses behave much like an SSRI and higher doses bring in the noradrenaline effects — a faster pulse and a higher blood pressure. The label does not claim to know why any of this lifts mood; it says only that the antidepressant action is believed to be associated with potentiating neurotransmitter activity.

Why people take it. Depression; the extended-release form is also used for several anxiety disorders

What happened in people

Clinically relevant serum cholesterol increases in 5.3% against 0% on placebo over at least three months

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.

The limit that matters most

That blocking two transporters corrects a combined monoamine deficit — a pathophysiological reading the label does not make of its own pharmacology

Where it acts
Serotonin and noradrenaline transporters on presynaptic terminals in the central nervous system; the peripheral noradrenergic effect is measurable at the blood vessel
Kind of result
A number that stands in for health
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • Its recorded molecular formula is C17H27NO2HCl, weighing 313.86.

    US prescribing information · 33068acd-d361-4cd9-b994-02a7865ff04f · read 2026-08-30

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 112 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.

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.

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.

What happened in peopleRead 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.

Change in supine diastolic blood pressure at week 6 on venlafaxine 75, 225 and 375 mg/day against placebo

The study showed what it set out to show

Who was studied
Fixed-dose premarketing blood pressure study (NDA 020151, Warnings)
How many people
0
Study design
Randomised, double-blind, placebo-controlled, three fixed doses
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Mean supine diastolic rise of 7.2 mmHg at 375 mg/day, essentially no change at 75 and 225 mg, and a mean fall of 2.2 mmHg on placebo
Repeated elsewhere
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. This is a safety finding reported in the Warnings section rather than an efficacy trial, and the label does not state the randomised sample size, so none is asserted here. Pooled across the premarketing programme, sustained diastolic elevation occurred in 3%, 5%, 7% and 13% across ascending dose bands against 2% on placebo.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet at 25, 37.5, 50, 75 and 100 mg given two or three times daily, and extended-release capsules and tablets at 37.5, 75, 150 and 225 mg given once daily

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Remission, defined as a Hamilton Rating Scale for Depression score of 7 or below, on venlafaxine against SSRIs and against placebo

The study showed what it set out to show

Who was studied
Pooled analysis of eight manufacturer trials (Br J Psychiatry 2001;178:234-241)
How many people
2045
Study design
Pooled analysis of eight randomised, double-blind studies
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Remission 45% (382/851) on venlafaxine, 35% (260/748) on an SSRI and 25% (110/446) on placebo; p<0.001, odds ratio 1.50 (1.3 to 1.9) favouring venlafaxine over the SSRIs
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. Two of three authors were with the manufacturer and all eight pooled trials were company trials. The paper drew published comment in the same journal in 2001, 2002 and 2004. The independent 2018 network meta-analysis placed venlafaxine among the more efficacious drugs head to head but also among those with the highest dropout rates.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet at 25, 37.5, 50, 75 and 100 mg given two or three times daily, and extended-release capsules and tablets at 37.5, 75, 150 and 225 mg given once daily

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Mean change from baseline in corrected QT interval and heart rate on venlafaxine extended-release against placebo

The study showed what it set out to show

Who was studied
Extended-release electrocardiographic analysis (NDA 020699, Precautions)
How many people
642
Study design
Pooled analysis of 8- to 12-week double-blind placebo-controlled trials
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Mean QTc change +4.7 msec on venlafaxine extended-release against −1.9 msec on placebo; mean heart rate change +4 against +1 beat per minute, significantly higher than placebo
Repeated elsewhere
Unreplicated

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. Patients with recent myocardial infarction or unstable heart disease were systematically excluded from many premarketing studies, so this analysis describes electrocardiographic behaviour in a population selected to exclude those at highest cardiac risk.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet at 25, 37.5, 50, 75 and 100 mg given two or three times daily, and extended-release capsules and tablets at 37.5, 75, 150 and 225 mg given once daily

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 3 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 bodyRead 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.

Where a source records it acting

  • Brain: Potentiation of neurotransmitter activity in the CNS; inhibition of neuronal serotonin and norepinephrine reuptake

    US prescribing information · 017a84aa-0e1f-f560-e063-6294a90a9069 · read 2026-08-27

  1. Start

    Venlafaxine

    What a person takes: Oral tablet at 25, 37.5, 50, 75 and 100 mg given two or three times daily, and extended-release capsules and tablets at 37.5, 75, 150 and 225 mg given once daily.

    The measurement behind this step

    At least 92% of a dose is absorbed and the drug is extensively metabolised in the liver, principally by CYP2D6 to O-desmethylvenlafaxine, the only major active metabolite. About 87% of a dose appears in urine within 48 hours. The extended-release presentations exist to flatten the peak-to-trough swing of an immediate-release drug with a short half-life, which is also why so many distinct products are listed under one generic name.

  2. Getting in

    Absorbed almost completely, then largely converted

    Nearly all of a dose is absorbed, and most of it is turned by the liver into a second active compound that is itself sold as a separate antidepressant.

    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

    At least 92% of a single dose is absorbed. About 87% is recovered in urine within 48 hours as unchanged venlafaxine (5%), unconjugated O-desmethylvenlafaxine (29%) and conjugated metabolite. O-desmethylvenlafaxine is the only major active metabolite, is formed mainly by CYP2D6, and is marketed separately as desvenlafaxine.

  3. What it acts on

    At low doses it behaves like an SSRI

    The serotonin pump is blocked first. At the lower end of the dose range the drug is doing much what an ordinary SSRI does.

    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

    Venlafaxine and its metabolite are potent inhibitors of neuronal serotonin reuptake and weak inhibitors of dopamine reuptake, with no significant affinity for muscarinic, histaminergic or alpha-1 adrenergic receptors and no monoamine oxidase inhibitory activity. The noradrenergic contribution is the part that is dose-dependent, which the pooled analysis that made the drug’s reputation acknowledged in its own opening line.

  4. The change it makes

    At higher doses the noradrenaline pump joins in

    Push the dose up and the second pump is blocked too. That is the drug’s selling point, and it is also where the side effects change character.

    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

    Both venlafaxine and O-desmethylvenlafaxine are potent inhibitors of noradrenaline reuptake in preclinical work. The clinical signature of that block arriving is peripheral: sustained diastolic hypertension rising from 3% below 100 mg/day to 13% above 300 mg/day against 2% on placebo, and a mean supine diastolic rise of 7.2 mmHg at 375 mg/day against a 2.2 mmHg fall on placebo.

  5. Reaching the cell

    Heart rate and cholesterol move too

    Beyond blood pressure, the pulse runs about four beats a minute faster, and one in twenty people on long-term treatment develops a meaningful rise in cholesterol.

    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

    Mean heart rate increase of about 4 beats per minute against 1 on placebo; mean QTc change of +4.7 msec against −1.9 msec on placebo across 357 treated and 285 placebo patients in the extended-release trials; clinically relevant serum cholesterol increases in 5.3% against 0% on placebo over at least three months. No conduction abnormality signal was seen in 769 patients over 4 to 6 weeks.

  6. What that does for a person

    A Hamilton score falls

    Six-week outpatient trials and a four-week inpatient trial in melancholic depression are what the licence rests on.

    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

    The indication was established in 6-week controlled trials of adult outpatients and a 4-week controlled trial of inpatients meeting criteria for major depression with melancholia. Pooled across eight manufacturer trials, remission on a Hamilton score of 7 or below was 45% on venlafaxine, 35% on an SSRI and 25% on placebo.

  7. What that does for a person

    And stopping becomes its own problem

    The longer you take it and the higher the dose, the more likely stopping produces new symptoms — including the electric-shock sensations this drug is known for.

    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

    The label states discontinuation-emergent symptoms increased in frequency with dose level and with longer treatment duration, listing among others impaired coordination and balance, fasciculation, nightmares, hypomania and shock-like electrical sensations, with seizures added from postmarketing reports across the class.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 6 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 unclearRead 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.

  • Adults with major depressive disorder, and with the extended-release form generalized anxiety disorder, social anxiety disorder and panic disorder. Not people taking a monoamine oxidase inhibitor. People with pre-existing high blood pressure should have it controlled first, and the label directs regular blood pressure monitoring for everyone on the drug.

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 effectiveness of venlafaxine hydrochloride extended-release capsules in pediatric patients have not been established.”

    US prescribing information · 33068acd-d361-4cd9-b994-02a7865ff04f · read 2026-08-30

  • On older people, the label states: “The percentage of patients in clinical studies for venlafaxine hydrochloride extended-release capsules for MDD, GAD, SAD, and PD who were 65 years of age or older are shown in Table 16.”

    US prescribing information · 33068acd-d361-4cd9-b994-02a7865ff04f · read 2026-08-30

  • On people who are pregnant, the label states: “Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including venlafaxine hydrochloride extended-release capsules, during pregnancy.”

    US prescribing information · 33068acd-d361-4cd9-b994-02a7865ff04f · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Data from published literature report the presence of venlafaxine and its active metabolite in human milk and have not shown adverse reactions in breastfed infants (see Data) .”

    US prescribing information · 33068acd-d361-4cd9-b994-02a7865ff04f · read 2026-08-30

  • On people with reduced liver function, the label states: “Dosage adjustment is recommended in patients with mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe (Child-Pugh Class C) hepatic impairment or hepatic cirrhosis [see Dosage and Administration (2.8) and Clinical Pharmacology (12.3) ] .”

    US prescribing information · 33068acd-d361-4cd9-b994-02a7865ff04f · read 2026-08-30

  • On people with reduced kidney function, the label states: “Dosage adjustment is recommended in patients with mild (CLcr= 60 to 89 mL/min), moderate (CLcr= 30 to ­59 mL/min), or severe (CLcr < 30 mL/min) renal impairment, and in patients undergoing hemodialysis [see Dosage and Administration (2.9) and Clinical Pharmacology (12.3) ].”

    US prescribing information · 33068acd-d361-4cd9-b994-02a7865ff04f · read 2026-08-30

Where the result stopped carrying

  • Overdose carries a higher risk of fatal outcome than the SSRIs, by the label’s own statement of the published literature
  • Discontinuation symptoms increase in frequency with both dose and treatment duration, so the difficulty of stopping accumulates during use
  • The drug was never evaluated to any appreciable extent in recent myocardial infarction or unstable heart disease despite a documented pressor effect
  • In the 2018 network meta-analysis venlafaxine sat among the drugs with the highest dropout rates (odds ratios 1.30 to 2.32)
  • 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 takeRead 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 takeRead 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 tablet at 25, 37.5, 50, 75 and 100 mg given two or three times daily, and extended-release capsules and tablets at 37.5, 75, 150 and 225 mg given once daily

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

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S6.

No source is stored against this line.

What is in the pack

At least 92% of a dose is absorbed and the drug is extensively metabolised in the liver, principally by CYP2D6 to O-desmethylvenlafaxine, the only major active metabolite. About 87% of a dose appears in urine within 48 hours.

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. The rest of the recorded wording: The extended-release presentations exist to flatten the peak-to-trough swing of an immediate-release drug with a short half-life, which is also why so many distinct products are listed under one generic name.

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 takeRead 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

Boxed warning for suicidal thoughts and behaviours in children, adolescents and young adults. Contraindicated with monoamine oxidase inhibitors, including linezolid and intravenous methylene blue. Dose-dependent sustained hypertension with regular blood pressure monitoring directed and pre-existing hypertension to be controlled first. Mean heart rate rise of about 4 beats per minute and a small mean QTc increase. Serum cholesterol elevation in 5.3% over at least three months. Serotonin syndrome risk with other serotonergic drugs. Angle-closure glaucoma in anatomically narrow angles. Rare reports of interstitial lung disease and eosinophilic pneumonia. Discontinuation symptoms increasing with dose and duration. Overdose associated with a higher risk of fatal outcome than the SSRIs and a lower one than the tricyclics.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

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 unclearRead 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 tablet at 25, 37.5, 50, 75 and 100 mg given two or three times daily, and extended-release capsules and tablets at 37.5, 75, 150 and 225 mg given once daily

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

About 87% of a dose appears in urine within 48 hours.

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. The rest of the recorded wording: The extended-release presentations exist to flatten the peak-to-trough swing of an immediate-release drug with a short half-life, which is also why so many distinct products are listed under one generic name.

No source is stored against this line.

What is recorded as being sold

  • 366 products list this as an active ingredient in the United States drug directory. 366 of them contain it and nothing else.

    FDA National Drug Code directory · 71785-1006 · read 2026-08-29

  • They are sold as capsule, extended release, powder, tablet, tablet, coated and tablet, extended release, taken oral.

    FDA National Drug Code directory · 71785-1006 · read 2026-08-29

  • The regulator's established pharmacologic class for it is norepinephrine uptake inhibitors [moa], serotonin uptake inhibitors [moa] and serotonin and norepinephrine reuptake inhibitor [epc].

    FDA National Drug Code directory · 71785-1006 · read 2026-08-29

  • 185 published labels name it as an active ingredient. 185 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 33068acd-d361-4cd9-b994-02a7865ff04f · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 33068acd-d361-4cd9-b994-02a7865ff04f · read 2026-08-29

  • Venlafaxine is tablets at Tablets, USP equivalent to 37.5 mg of venlafaxine (the strength supplied in this label), recorded as prescription product; fda label in effect 2025-02-04 in the United States.

    US prescribing information · 017a84aa-0e1f-f560-e063-6294a90a9069 · read 2026-08-27

  • Recorded price in US: 0.07385–0.11693 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 41 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 takeRead 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.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Venlafaxine 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 unclearRead 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 blocking two transporters corrects a combined monoamine deficit — a pathophysiological reading the label does not make of its own pharmacology

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 the pooled 45%-against-35% remission difference generalises beyond the manufacturer’s own trial set, when the independent network analysis found the advantage smaller and paired with worse tolerability

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 the cardiovascular findings are benign because no conduction abnormality appeared in 769 patients, when cardiac patients were systematically excluded from those trials

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 the blood pressure effect is a nuisance rather than a mechanism signal; it is the clearest evidence on the label that the second transporter is engaged at all

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 unclearRead 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 Venlafaxine 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 peopleRead 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.

The second mechanism shows up as blood pressure, and it is dose-dependent
In plain words
The label carries a table almost no other antidepressant has: the higher the dose, the more people develop sustained high blood pressure. Three per cent below 100 mg a day; thirteen per cent above 300 mg. Placebo was two per cent.
What was measured
Incidence of sustained diastolic elevation by daily dose band, and mean supine diastolic change at 375 mg/day
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Two separate label findings. In a premarketing study comparing fixed doses of 75, 225 and 375 mg/day against placebo, mean supine diastolic pressure rose 7.2 mmHg in the 375 mg group at week 6, against essentially no change at 75 and 225 mg and a mean fall of 2.2 mmHg on placebo. Separately, pooling the premarketing studies and defining sustained hypertension as treatment-emergent supine diastolic pressure of 90 mmHg or more and at least 10 mmHg above baseline across three consecutive visits gave incidences of 3% below 100 mg/day, 5% at 101 to 200 mg, 7% at 201 to 300 mg and 13% above 300 mg, against 2% on placebo. Most increases were modest at 10 to 15 mmHg and 19 patients, under 1% of those treated, were discontinued for hypertension. The label also records a mean heart rate rise of about 4 beats per minute and, in the extended-release trials, a mean QTc change of +4.7 msec against −1.9 msec on placebo. This is the noradrenergic pharmacology becoming visible in the periphery, and it is the most direct evidence on the document that the second transporter is engaged at higher doses at all.
Source
Venlafaxine United States prescribing information, Warnings — Sustained Hypertension, and Precautions — Use in Patients with Concomitant Illness (NDA 020151)
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
The superiority-over-SSRIs claim came from the manufacturer’s own pooled analysis
In plain words
The reputation that venlafaxine beats the SSRIs rests on a 2001 pooling of eight company trials: remission 45% on venlafaxine, 35% on an SSRI, 25% on placebo. It was published by the manufacturer’s investigators and drew three separate published critiques.
What was measured
That dual serotonin and noradrenaline reuptake inhibition produces clinically better outcomes than serotonin reuptake inhibition alone — a claim built from a manufacturer-pooled set of its own trials and only partly supported by the later independent network analysis
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Thase, Entsuah and Rudolph pooled eight comparable randomised double-blind studies of major depressive disorder to compare remission, defined as a Hamilton score of 7 or below, on venlafaxine (n=851), an SSRI — fluoxetine, paroxetine or fluvoxamine (n=748) — or placebo in four of the studies (n=446). Remission was 45% (382/851) on venlafaxine, 35% (260/748) on SSRIs and 25% (110/446) on placebo, p<0.001, odds ratio 1.50 (1.3 to 1.9) favouring venlafaxine over the SSRIs; the venlafaxine-SSRI difference reached significance at week 2 and the SSRI-placebo difference at week 4, and results did not depend on any single study or on the definition of remission. Two of the three authors were with the manufacturer, the pooled trials were company trials, and the paper attracted published comment in the same journal in 2001, 2002 and 2004. The independent 2018 network meta-analysis of 522 trials placed venlafaxine among the seven drugs more effective than others in head-to-head comparison, so the efficacy end of the claim partly survives — but placed it equally among the drugs with the highest dropout rates.
Source
Thase ME, Entsuah AR, Rudolph RL. Remission rates during treatment with venlafaxine or selective serotonin reuptake inhibitors. Br J Psychiatry 2001;178:234-241; Cipriani A et al., Lancet 2018;391:1357-1366
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
Its own label says overdose is more often fatal than with the SSRIs
In plain words
The prescribing information states plainly that published studies report venlafaxine overdose carries an increased risk of death compared with the SSRIs — lower than the tricyclics, but higher than the class it was meant to improve on.
What was measured
Relative risk of fatal outcome in overdose against SSRIs and tricyclics, as stated on the label
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The Overdosage section reports 14 acute overdoses in the premarketing programme, all of whom recovered without sequelae; the patient who took 2.75 g had two generalised convulsions and QTc prolongation to 500 msec from a baseline of 405 msec. It then states: "Published retrospective studies report that venlafaxine overdosage may be associated with an increased risk of fatal outcomes compared to that observed with SSRI antidepressant products, but lower than that for tricyclic antidepressants." Postmarketing overdose events include tachycardia, consciousness ranging from somnolence to coma, mydriasis, seizures, vomiting, QT prolongation, bundle branch block, QRS prolongation, ventricular tachycardia, bradycardia, hypotension, rhabdomyolysis, liver necrosis, serotonin syndrome and death. A drug prescribed for a condition whose defining risk is self-harm, carrying a higher fatal-toxicity index than its comparator class, is a trade-off that belongs on the front of the page rather than in the overdose section.
Source
Venlafaxine United States prescribing information, Overdosage — Human Experience (NDA 020151)
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
Discontinuation symptoms that get worse the longer you have taken it
In plain words
Stopping or even cutting the dose produces new symptoms, and the label says the frequency rose both with the dose and with how long the person had been taking it. The list runs from electric-shock sensations to hypomania.
What was measured
Frequency of discontinuation-emergent symptoms as a function of dose level and treatment duration
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Discontinuation symptoms were systematically evaluated, prospectively in the generalized anxiety disorder trials and retrospectively in the depression trials. The label states that abrupt discontinuation or dose reduction at various doses was associated with the appearance of new symptoms whose frequency increased with increased dose level and with longer duration of treatment. The reported list is agitation, anorexia, anxiety, confusion, impaired coordination and balance, diarrhoea, dizziness, dry mouth, dysphoric mood, fasciculation, fatigue, flu-like symptoms, headache, hypomania, insomnia, nausea, nervousness, nightmares, sensory disturbances including shock-like electrical sensations, somnolence, sweating, tremor, vertigo and vomiting. Spontaneous postmarketing reports across the class add tinnitus and seizures. The dose-and-duration gradient is the important part: it means the difficulty of stopping is not a fixed property of the drug but something that accumulates during treatment, which is not how most people are told about it at the start.
Source
Venlafaxine United States prescribing information, Precautions — Discontinuation of Treatment (NDA 020151)
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
Cholesterol rose in one in twenty on long-term treatment, and in nobody on placebo
In plain words
In placebo-controlled trials of at least three months, clinically relevant increases in serum cholesterol appeared in 5.3% of people on venlafaxine and 0% of those on placebo.
What was measured
Proportion with clinically relevant serum cholesterol increase over at least three months, drug against placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The label states that clinically relevant increases in serum cholesterol were recorded in 5.3% of venlafaxine-treated patients and 0% of placebo-treated patients treated for at least three months in placebo-controlled trials, and that measurement of serum cholesterol should be considered during long-term treatment. It does not define "clinically relevant", state the magnitude of the rise, or say what should follow from finding one. Against a zero placebo rate this is an unusually clean signal for a laboratory finding, and it sits alongside the blood pressure and heart rate effects as a set of cardiovascular risk-factor changes on a drug taken for years without any cardiovascular outcome data.
Source
Venlafaxine United States prescribing information, Precautions — Serum Cholesterol Elevation (NDA 020151)
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
Never studied in the people its blood pressure effect matters most to
In plain words
The drug raises blood pressure and heart rate. People with a recent heart attack or unstable heart disease were systematically excluded from the trials, so what it does in them is unknown.
What was measured
Electrocardiographic and heart rate findings in trial populations, against the cardiac populations excluded from those trials
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The label states that venlafaxine has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease, and that patients with these diagnoses were systematically excluded from many clinical studies during premarketing testing. What was measured instead: electrocardiograms in 769 patients in 4- to 6-week placebo-controlled trials showed no difference from placebo in trial-emergent conduction abnormalities, with a mean heart rate rise of about 4 beats per minute; in the extended-release trials, 357 treated and 285 placebo patients over 8 to 12 weeks showed a mean QTc change of +4.7 msec against −1.9 msec on placebo and a mean heart rate change of +4 against +1 beat per minute. Those are reassuring numbers in a population selected to exclude the people at risk. The combination of a documented pressor effect, a documented heart rate effect, a small QTc effect and a systematic exclusion of cardiac patients is a specific evidence gap rather than a general caution.
Source
Venlafaxine United States prescribing information, Precautions — Use in Patients with Concomitant Illness (NDA 020151)
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
Two transmitters, and no stated mechanism for either
In plain words
The whole pitch for this drug is that two neurotransmitters beat one. The label’s own wording is that the antidepressant action is "believed to be associated with" potentiating neurotransmitter activity.
What was measured
That correcting a combined serotonin and noradrenaline deficit is what makes this drug work — a reading of transporter pharmacology as pathophysiology that the label declines to make
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Clinical Pharmacology section reads: "The mechanism of the antidepressant action of venlafaxine in humans is believed to be associated with its potentiation of neurotransmitter activity in the CNS." What follows is preclinical transporter pharmacology and a list of receptors venlafaxine does not bind. No claim is made that depression involves a deficit of either transmitter. The 2022 umbrella review of the serotonin theory found no consistent evidence of a serotonergic abnormality in depression across 17 reviews and large data-set analyses; no equivalent body of evidence establishes a noradrenergic one either. The dual-transporter argument is therefore a pharmacological description that has been read as a pathophysiological explanation, and the label does not make that step.
Source
Venlafaxine United States prescribing information, Clinical Pharmacology — Pharmacodynamics (NDA 020151); Moncrieff J et al., Mol Psychiatry 2023;28:3243-3256
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim

How many documents were read

  • 178 documents were read for this substance.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
7D7RX5A8MO
CAS registry number
93413-69-5
PubChem compound
5656
RxNorm concept
235988

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

  • Passed

    Safety mode resolved

    Suppression classes recorded: S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead 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

  • 51 approved applications cover products containing this substance. The earliest was NDA020151, approved 19931228 to WYETH PHARMS INC.

    Drugs@FDA application register · NDA020151 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA020151 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19971020.

    FDA National Drug Code directory · 71785-1006 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

7 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.
  • 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.
  • 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.

The older medicine-wide conclusion held in this record

Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.

A serotonin and noradrenaline reuptake inhibitor whose second mechanism is dose-dependent — sustained diastolic hypertension rises from 3% below 100 mg/day to 13% above 300 mg/day against 2% on placebo — and whose claimed advantage over the SSRIs rests on a manufacturer-pooled analysis of eight trials reporting remission of 45% against 35%, while the label separately records that overdose carries a higher risk of fatal outcome than the SSRIs.

Recorded evidence blocks (11)

On the Venlafaxine label: indicated for what?


"1 INDICATIONS & USAGE Venlafaxine extended-release tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: Major Depressive Disorder (MDD) ( 1.1 ) Social Anxiety Disorder (SAD) ( 1.2 ) 1.1 Major Depressive Disorder Venlafaxine extended-release tablets (venlafaxine hydrochloride)…": indications and usage on Venlafaxine's label. DailyMed label · 1ce5786e-22e6-4afa-8052-6eababc6aa4e · 2026-08-17

154 registered trials of Venlafaxine — at which phases?


Registered studies posting no result
105 of 154

154 registered studies of Venlafaxine: 52 phase4, 41 phase3, 26 phase2, 17 phase1, 14 na, 13 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

760 with a PubMed record

Show the evidence
  • phase4
    52
  • phase3
    41
  • phase2
    26
  • phase1
    17
  • na
    14
  • na or unstated
    13
8 more recorded rows
  • completed
    113
  • unknown
    18
  • terminated
    9
  • recruiting
    7
  • withdrawn
    4
  • active not recruiting
    1
  • not yet recruiting
    1
  • suspended
    1

recorded 2026-09-01 · last checked 2026-09-04

12 of Venlafaxine's trials stopped: safety, accrual/recruitment, funding/business, other?


safety (2), accrual/recruitment (5), funding/business (1) and other (4): Venlafaxine's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"European reports of liver toxicity from kava meant that the study had to stop"; 12 of 154 registered studies

Show the evidence

Trial

  • NCT00083980
    terminated; "European reports of liver toxicity from kava meant that the study had to stop"
  • NCT00211809
    terminated; "low enrollment"
  • NCT00354432
    terminated; "Stopped by the DSMB for lack of effect per interim stopping rule."
  • NCT00766870
    terminated; "Study was previously paused and is now terminated"
  • NCT01436643
    terminated; "Due to slow enrollment the study was terminated early"
  • NCT01533753
    terminated; "Slow accrual"
6 further recorded trials
  • NCT02433353
    withdrawn; "PI was transferred to another base. No one else available to serve as PI."
  • NCT02893371
    terminated; "Per PI, this study is not a clinical trial and was inadvertently entered in the system"
  • NCT03274817
    terminated; "Insufficient Enrollment"
  • NCT04973930
    suspended; "NYSPI paused human subjects research (HSR) 6/23. The US Dept. of Health and Human Services Office of Human Research Protections issued an FWA restriction pausing such research 6/23/23. The IO and IRB paused HSR 6/12/23. Hence no current…"
  • NCT04977271
    withdrawn; "study never opened"
  • NCT05724849
    withdrawn; "Issues with funding"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Venlafaxine used Venlafaxine 25 mg Tablets — over how long?


studies of Venlafaxine used the recorded amount. ClinicalTrials.gov · 2026-09-01

11 recorded entries; human; also "Venlafaxine 25 mg Tablets", "Effexor® 25 mg Tablets", "VENLAFAXINE TABLETS 50 mg , single dose"

Show the evidence

human

  • NCT00834249
    Venlafaxine 25 mg Tablets
  • NCT00834249
    Effexor® 25 mg Tablets
  • NCT00871364
    VENLAFAXINE TABLETS 50 mg , single dose
  • NCT00871364
    Effexor® Tablets equivalent to 50 mg venlafaxine
  • NCT01011751
    Effexor® LP 37.5 mg
  • NCT01418625
    Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test formulation, Torrent Pharmaceutical Limited., India)
5 more recorded rows
  • human NCT01867255
    venlafaxine ER (extended-release) 75 mg
  • human NCT01867255
    Effexor XR 75 mg
  • human NCT05023278
    Venlafaxine 37.5 MG
  • human NCT05875610
    Venlafaxine 75 MG
  • human NCT06295562
    Venlafaxine 37.5mg

recorded 2026-09-01 · last checked 2026-09-04

Venlafaxine's half-life is 10.7±3.2 hours — which schedules were studied?


10.7±3.2 hours, the half-life Venlafaxine's label states: "The mean ± SD apparent elimination half-life for venlafaxine and ODV after administration of 75 mg venlafaxine extended-release tablets under fed conditions were 10.7±3.2 hours and 12.5±3.0 hours respectively." DailyMed label · 1ce5786e-22e6-4afa-8052-6eababc6aa4e · 2026-08-17

tmax 6.3 ± 2.3 hours; bioavailability 45 %.

Show the evidence
  • half life pharmacokinetics
    10.7±3.2 hours; The mean ± SD apparent elimination half-life for venlafaxine and ODV after administration of 75 mg venlafaxine extended-release tablets under fed conditions were 10.7±3.2 hours and 12.5±3.0 hours respectively.
  • tmax pharmacokinetics
    6.3 ± 2.3 hours; T max was 6.3 ± 2.3 hours.
  • bioavailability pharmacokinetics
    45 %; The absolute bioavailability of venlafaxine is about 45%.
  • metabolism pharmacokinetics
    Absorption and Distribution Venlafaxine is well absorbed and extensively metabolized in the liver.

recorded 2026-08-17 · last checked 2026-09-04

Which running trial of Venlafaxine could settle inflammatory markers?


NCT07497282 measures Change in Disease Activity Score 28 (DAS28-CRP), reading out 2026-12-26.

2 open trials; n 70; "Venlafaxine as Adjunct Therapy in Rheumatoid Arthritis"

Show the evidence

Trial

  • NCT07497282
    "Venlafaxine as Adjunct Therapy in Rheumatoid Arthritis"; n 70; "Change in Disease Activity Score 28 (DAS28-CRP)"; 2026-12-26
  • NCT07531173
    "Serotonin Norepinephrine Reuptake Inhibitors and the Risk of Serious Adverse Events"; n 8688; "Number of participants with a 30-day composite outcome of all-cause emergency department visit, all-cause hospitalization, or all-cause mortality."; 2027-12-31

Which 61 trials of Venlafaxine posted no result?


Posted no result
61 of 61 completed trials
Registrations
NCT00792168, NCT00001483, NCT00759317, NCT00038896, NCT00044772 and NCT00238719, and 55 more
Completion dates
oldest 1998-12; newest 2022-06-15
Show the evidence

Trial

  • NCT00792168
    1998-12
  • NCT00001483
    2002-05
  • NCT00759317
    2002-09
  • NCT00038896
    2002-12
  • NCT00044772
    2003-04
  • NCT00238719
    2003-06
14 further recorded trials
  • NCT00177567
    2004-01
  • NCT00067912
    2004-03
  • NCT00071695
    2004-05
  • NCT00249483
    2005-02
  • NCT00546494
    2005-03
  • NCT00087737
    2005-05
  • NCT00046020
    2005-10
  • NCT00122850
    2005-11
  • NCT00198250
    2005-11
  • NCT00759122
    2005-12
  • NCT00195598
    2006-04
  • NCT00871364
    2006-05
  • NCT01512459
    2006-06
  • NCT00057642
    2006-08

At the median, Venlafaxine's trials enrolled 105 people — anything larger?


Median enrolment
105
Largest enrolment
3255526
Registered trials counted
153

What do 9513 spontaneous reports say about Venlafaxine — 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.

Venlafaxine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 9513 reaction mentions were counted: drug hypersensitivity 1181; suicide attempt 1098; depression 1012; drug interaction 990. FAERS via Open Targets · CHEMBL1201066 · 2026-06-24

Show the evidence
  • drug hypersensitivity
    1181
  • suicide attempt
    1098
  • depression
    1012
  • drug interaction
    990
  • drug withdrawal syndrome
    983
  • toxicity to various agents
    944
4 more recorded rows
  • anxiety
    896
  • serotonin syndrome
    862
  • somnolence
    787
  • suicidal ideation
    760

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Venlafaxine's label not list?


anxiety, depression and drug hypersensitivity and 7 more reported for Venlafaxine, absent from its label. FAERS via Open Targets · CHEMBL1201066 · 2026-06-24

3 label terms; 10 reported and unlisted; 1ce5786e-22e6-4afa-8052-6eababc6aa4e

Show the evidence
  • anxiety
    count not stated
  • depression
    count not stated
  • drug hypersensitivity
    count not stated
  • drug interaction
    count not stated
  • drug withdrawal syndrome
    count not stated
  • serotonin syndrome
    count not stated
4 more recorded rows
  • somnolence
    count not stated
  • suicidal ideation
    count not stated
  • suicide attempt
    count not stated
  • toxicity to various agents
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Venlafaxine and CYP2D6, CYP3A4 and CYTOCHROME P450: shared by which compounds?


CYP2D6, CYP3A4 and CYTOCHROME P450 appear in Venlafaxine's recorded interaction sentences, 8 in all. DailyMed label · 1ce5786e-22e6-4afa-8052-6eababc6aa4e · 2026-08-17

CYP2D6, CYP2D6, CYP3A4, CYP3A4; 4 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    Caution when using venlafaxine with substances that inhibit both CYP2D6 and CYP3A4.
  • drug_interactions
    7.7 Drugs that Inhibit Cytochrome P450 Isoenzymes CYP2D6 Inhibitors: In vitro and in vivo studies indicate that venlafaxine is metabolized to its active metabolite, ODV, by CYP2D6, the isoenzyme that is responsible for the genetic polymorphism seen in the metabolism of many antidepressants.
  • drug_interactions
    Therefore, the potential exists for a drug interaction between drugs that inhibit CYP2D6-mediated metabolism of venlafaxine, reducing the metabolism of venlafaxine to ODV, resulting in increased plasma concentrations of venlafaxine and decreased concentrations of the active metabolite.
  • drug_interactions
    CYP2D6 inhibitors such as quinidine would be expected to do this, but the effect would be similar to what is seen in patients who are genetically CYP2D6 poor metabolizers [ see Clinical Pharmacology ( 12.3 ) ].
  • drug_interactions
    Therefore, no dosage adjustment is required when venlafaxine is coadministered with a CYP2D6 inhibitor.
  • drug_interactions
    Ketoconazole: A pharmacokinetic study with ketoconazole 100 mg b.i.d. with a single dose of venlafaxine 50 mg in extensive metabolizers (EM; n=14) and 25 mg in poor metabolizers (PM;n=6) of CYP2D6 resulted in higher plasma concentrations of both venlafaxine and O-desmethylvenlafaxine (ODV) in most subjects following administration of ketoconazole.
2 more recorded rows
  • Interaction statement drug_interactions
    Concomitant use of CYP3A4 inhibitors and venlafaxine may increase levels of venlafaxine and ODV.
  • Interaction statement drug_interactions
    Therefore, caution is advised if a patient’s therapy includes a CYP3A4 inhibitor and venlafaxine concomitantly.

CYP2D6

  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine

CYP3A4

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium

recorded 2026-08-17 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201066
PubChem CID
13520301
CAS number
93413-47-9
RxCUI
235988
InChIKey
PNVNVHUZROJLTJ-UHFFFAOYSA-N
Also called
VENLAFAXINE HYDROCHLORIDE, venlafaxine xr, VENLAFAXINE BESYLATE, Efectin, Kanghong, Trevilor, Velafax, Venlafaxina, Venlor, efexor xr, snri, ven
Trade name
Effexor, Effexor xr, Alventa xl, Amphero xl, Bonilux xl, Depefex xl, Efexor, Efexor xl, Foraven xl, Mentaven xl, Politid xl, Ranfaxine xl
Development code
NSC-745751, WY-45,030, WY-45030, NSC-758676
Salt form
Venlafaxine hcl, effexor xr 150 mg extended-release capsules (reference), effexor xr 150mg capsule (reference formulation, wyeth pharmaceuticals inc., usa), venlafaxine hydrochloride 150 mg extended-release capsules (test), venlafaxine hydrochloride extended-release capsules 150mg (test formulation, torrent pharmaceutical limited., india), Venlafaxine besylate anhydrous, Venlafaxine Besylate Monohydrate, Venlafaxine Hydrochloride, Extended Release, Venlafaxine HCL ER, Venlafaxine hydrochloride ER
Sources (6)

Sources

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

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • 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
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.