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Nefazodone

  • Prescription medicine
  • Withdrawn
  • 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 Nefazodone does in the body

Depression

From the FDA-approved label: Pharmacodynamics The mechanism of action of nefazodone, as with other antidepressants, is unknown. Preclinical studies have shown that nefazodone inhibits neuronal uptake of serotonin and norepinephrine. Nefazodone occupies central 5-HT 2 receptors at nanomolar concentrations, and acts as an antagonist at this receptor. Nefazodone was shown to antagonize alpha 1 -adrenergic receptors, a property which may be associated with postural hypotension. In vitro binding studies showed that nefazodone had no significant affinity for the following receptors: alpha 2 and beta adrenergic, 5-HT 1A , cholinergic, dopaminergic, or benzodiazepine.

What happened in people

RNAWiki has not yet published a reviewed conclusion for this use.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
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

  • The substance registry classes this as chemical.

    FDA substance registry · 59H4FCV1TF · read 2026-08-29

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 105 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

What happened in 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.

Montgomery-Asberg Depression Rating Scale (MADRS)

The study did not show it

Who was studied
NCT02977299
How many people
278
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Marijuana use

The study did not show it

Who was studied
NCT00249509
How many people
132
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Urine benzoylecgonine (BE) concentration

The study did not show it

Who was studied
NCT00015210
How many people
69
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Nefazodone in the Treatment of Social Phobia

The study did not show it

Who was studied
NCT00231348
How many people
24
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
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 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.

  • Nefazodone hydrochloride tablets are indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see WARNINGS ). In many cases, this would lead to the conclusion that other drugs should be tried first.

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 in the pediatric population have not been established (see BOXED WARNING and WARNINGS , Clinical Worsening and Suicide Risk ).”

    US prescribing information · 51ff7db5-aaf9-4c3c-86e6-958ebf16b60f · read 2026-08-30

  • On older people, the label states: “Of the approximately 7000 patients in clinical studies who received nefazodone for the treatment of depression, 18% were 65 years and older, while 5% were 75 years and older.”

    US prescribing information · 51ff7db5-aaf9-4c3c-86e6-958ebf16b60f · read 2026-08-30

  • On people who are pregnant, the label states: “Teratogenic Effects Pregnancy category C Reproduction studies have been performed in pregnant rabbits and rats at daily doses up to 200 and 300 mg/kg, respectively (approximately 6 and 5 times, respectively, the maximum human daily dose on a mg/m 2 basis).”

    US prescribing information · 51ff7db5-aaf9-4c3c-86e6-958ebf16b60f · read 2026-08-30

  • On people who are breastfeeding, the label states: “It is not known whether nefazodone or its metabolites are excreted in human milk.”

    US prescribing information · 51ff7db5-aaf9-4c3c-86e6-958ebf16b60f · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to 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

Withdrawn

Quoted from a source

Where this came from

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

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

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, S8.

No source is stored against this line.

What is in the pack

Sold as tablet, given by the oral route.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or 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

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 7 products list this as an active ingredient in the United States drug directory. 7 of them contain it and nothing else.

    FDA National Drug Code directory · 0093-1024 · read 2026-08-29

  • They are sold as powder and tablet, taken oral.

    FDA National Drug Code directory · 0093-1024 · read 2026-08-29

  • The regulator's established pharmacologic class for it is serotonin reuptake inhibitor [epc].

    FDA National Drug Code directory · 0093-1024 · read 2026-08-29

  • 2 published labels name it as an active ingredient. 2 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 51ff7db5-aaf9-4c3c-86e6-958ebf16b60f · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 51ff7db5-aaf9-4c3c-86e6-958ebf16b60f · read 2026-08-29

  • Nefazodone Hydrochloride is oral at HOW SUPPLIED Nefazodone hydrochloride tablets USP, 50 mg, are light-pink to pink (mottled), capsule-shaped, beveled-edged tablets, debossed “7178” on one side and debossed “93” on the other side., recorded as fda label in effect 2025-07-31 in the United States.

    US prescribing information · 51ff7db5-aaf9-4c3c-86e6-958ebf16b60f · read 2026-08-30

  • Recorded price in US: 1.33063 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, for the one priced product, 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, withdrawn medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Nefazodone 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

What nobody knows yet

Open questions, each with why it is open and what would close it.

How much did people take in the studies?

The sources RNAWiki checked hold nothing for this field.

Why it matters. A result belongs to an amount. Without the amount the result floats free.

What would answer it

A stored source that records 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 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 Nefazodone 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.

How many documents were read

  • 2 documents were read for this substance.

    RNAWiki source record

  • 2 of them state the same halfLife, and they agree.

    RNAWiki source record

  • 2 of them state the same bioavailability, and they agree.

    RNAWiki source record

  • 2 of them state the same tMax, and they agree.

    RNAWiki source record

  • 2 of them state the same volumeOfDistribution, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
59H4FCV1TF
CAS registry number
83366-66-9
PubChem compound
4449
ChEMBL
CHEMBL623
ChEBI
7494
WHO international nonproprietary name list entry
5432
RxNorm concept
31565
EMA substance identifier
100000084127
DrugBank
DB01149

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, S8.

  • 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.

  1. Withdrawn in Canada; Spain; Turkey, 2003, for "hepatotoxicity" (ChEMBL; Open Targets)

What the approval register records

  • 10 approved applications cover products containing this substance. The earliest was NDA020152, approved 19941222 to BRISTOL MYERS SQUIBB.

    Drugs@FDA application register · NDA020152 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA020152 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20030916.

    FDA National Drug Code directory · 0093-1024 · 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

9 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (10)

On the Nefazodone label: indicated for what?


"Nefazodone hydrochloride tablets are indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see WARNINGS ).": indications and usage on Nefazodone's label. DailyMed label · 0bd4c34a-4f43-4c84-8b98-1d074cba97d5 · 2025-09-04

5 registered trials of Nefazodone — at which phases?


Registered studies posting no result
5 of 5

5 registered studies of Nefazodone: 3 phase2, 1 phase3, 1 phase4. CLINICALTRIALS_SNAPSHOT · 2026-09-01

150 with a PubMed record

Show the evidence
  • phase2
    3
  • phase3
    1
  • phase4
    1
  • completed
    5

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

Approved in 1994, withdrawn in 2003: what happened to Nefazodone in Canada; Spain; Turkey?


Approved 1994, withdrawn 2003 in Canada; Spain; Turkey; the register's words: "hepatotoxicity". Open Targets drug warning · CHEMBL1200492 · 2026-06-24

2 recorded reasons; Canada; Spain; Turkey

Show the evidence

Reason

  • "hepatotoxicity"
  • "hepatotoxicity"

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

Nefazodone's half-life is 2 to 4 hours — which schedules were studied?


2 to 4 hours, the half-life Nefazodone's label states: "Peak plasma concentrations occur at about one hour and the half-life of nefazodone is 2 to 4 hours." DailyMed label · 0bd4c34a-4f43-4c84-8b98-1d074cba97d5 · 2025-09-04

tmax 2 to 4 hours; bioavailability 20 %.

Show the evidence
  • half life pharmacokinetics
    2 to 4 hours; Peak plasma concentrations occur at about one hour and the half-life of nefazodone is 2 to 4 hours.
  • tmax pharmacokinetics
    2 to 4 hours; Peak plasma concentrations occur at about one hour and the half-life of nefazodone is 2 to 4 hours.
  • bioavailability pharmacokinetics
    20 %; Nefazodone is rapidly and completely absorbed but is subject to extensive metabolism, so that its absolute bioavailability is low, about 20%, and variable.
  • metabolism pharmacokinetics
    Nefazodone is rapidly and completely absorbed but is subject to extensive metabolism, so that its absolute bioavailability is low, about 20%, and variable.

recorded 2025-09-04 · last checked 2026-09-04

Which 4 trials of Nefazodone posted no result?


Posted no result
4 of 4 completed trials
Registrations
NCT00231348, NCT00000286, NCT00000293 and NCT00249509
Completion dates
oldest 2000-04; newest 2004-09
Show the evidence

Trial

  • NCT00231348
    2000-04
  • NCT00000286
    2001-12
  • NCT00000293
    2001-12
  • NCT00249509
    2004-09

At the median, Nefazodone's trials enrolled 24 people — anything larger?


Median enrolment
24
Largest enrolment
132
Registered trials counted
5

What do 313 spontaneous reports say about Nefazodone — 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.

Nefazodone appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 313 reaction mentions were counted: hepatocellular damage 111; alanine aminotransferase increased 47; aspartate aminotransferase increased 33; hepatic steatosis 24. FAERS via Open Targets · CHEMBL1200492 · 2026-06-24

Show the evidence
  • hepatocellular damage
    111
  • alanine aminotransferase increased
    47
  • aspartate aminotransferase increased
    33
  • hepatic steatosis
    24
  • anxiety
    21
  • hepatic enzyme increased
    18
4 more recorded rows
  • hepatitis
    17
  • hepatitis c
    16
  • chromaturia
    13
  • liver function test abnormal
    13

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

Which 10 reactions does Nefazodone's label not list?


alanine aminotransferase increased, anxiety and aspartate aminotransferase increased and 7 more reported for Nefazodone, absent from its label. FAERS via Open Targets · CHEMBL1200492 · 2026-06-24

3 label terms; 10 reported and unlisted; 0bd4c34a-4f43-4c84-8b98-1d074cba97d5

Show the evidence
  • alanine aminotransferase increased
    count not stated
  • anxiety
    count not stated
  • aspartate aminotransferase increased
    count not stated
  • chromaturia
    count not stated
  • hepatic enzyme increased
    count not stated
  • hepatic steatosis
    count not stated
4 more recorded rows
  • hepatitis
    count not stated
  • hepatitis c
    count not stated
  • hepatocellular damage
    count not stated
  • liver function test abnormal
    count not stated

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

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


CYP3A4, CYP2D6 and CYTOCHROME P450 appear in Nefazodone's recorded interaction sentences, 8 in all. DailyMed label · 0bd4c34a-4f43-4c84-8b98-1d074cba97d5 · 2025-09-04

CYP2D6, CYP3A4, CYP3A4; 3 shared nodes; drug_interactions

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Interaction statement

  • drug_interactions
    Pimozide – See CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS , Pharmacokinetics of Nefazodone in ‘Poor Metabolizers’ and Potential Interaction With Drugs That Inhibit and/or Are Metabolized by Cytochrome P450 Isozymes.
  • drug_interactions
    Cardiovascular-Active Drugs Digoxin – When nefazodone (200 mg BID) and digoxin (0.2 mg QD) were coadministered for 9 days to healthy male volunteers (n = 18) who were phenotyped as CYP2D6 extensive metabolizers, C max , C min , and AUC of digoxin were increased by 29%, 27%, and 15%, respectively.
  • drug_interactions
    Propranolol – The coadministration of nefazodone (200 mg BID) and propranolol (40 mg BID) for 5.5 days to healthy male volunteers (n = 18), including 3 poor and 15 extensive CYP2D6 metabolizers, resulted in 30% and 14% reductions in C max and AUC of propranolol, respectively, and a 14% reduction in C max for the metabolite, 4-hydroxypropranolol.
  • drug_interactions
    HMG-CoA Reductase Inhibitors – When single 40 mg doses of simvastatin or atorvastatin, both substrates of CYP3A4, were given to healthy adult volunteers who had received nefazodone hydrochloride, 200 mg BID for 6 days, approximately 20 fold increases in plasma concentrations of simvastatin and simvastatin acid and 3 to 4 fold increases in plasma concentrations of atorvastatin and atorvastatin…
  • drug_interactions
    These effects appear to be due to the inhibition of CYP3A4 by nefazodone because, in the same study, nefazodone had no significant effect on the plasma concentrations of pravastatin, which is not metabolized by CYP3A4 to a clinically significant extent.
  • drug_interactions
    There have been rare reports of rhabdomyolysis involving patients receiving the combination of nefazodone and either simvastatin or lovastatin, also a substrate of CYP3A4 (see ADVERSE REACTIONS , Postintroduction Clinical Experience ).
2 more recorded rows
  • Interaction statement drug_interactions
    Rhabdomyolysis has been observed in patients receiving HMG-CoA reductase inhibitors administered alone (at recommended dosages) and in particular, for certain drugs in this class, when given in combination with inhibitors of the CYP3A4 isozyme.
  • Interaction statement drug_interactions
    Caution should be used if nefazodone is administered in combination with HMG-CoA reductase inhibitors that are metabolized by CYP3A4, such as simvastatin, atorvastatin, and lovastatin, and dosage adjustments of these HMG-CoA reductase inhibitors are recommended.
  • CYP2D6
    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 2025-09-04 · last checked 2026-09-04

Where do the label and the trials disagree about Nefazodone?


"hepatotoxicity" against "approved": withdrawal status vs register status for Nefazodone.

OPEN_TARGETS_DRUG_WARNING, Drugs@FDA; 1 recorded pair

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  • OPEN_TARGETS_DRUG_WARNING CHEMBL1200492
    hepatotoxicity; 2026-06-24
  • Drugs@FDA ANDA076072
    approved; 2026-08-28
Where it is registered

Where it’s registered

Withdrawn in Canada; Spain; Turkey, 2003, for "hepatotoxicity" (ChEMBL; Open Targets)

Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1200492
PubChem CID
54911
CAS number
82752-99-6
RxCUI
236082
InChIKey
VRBKIVRKKCLPHA-UHFFFAOYSA-N
Also called
NEFAZODONE HYDROCHLORIDE, Nefazodona, NEFAZODONE HYDROCHLORIDE [MART.], NEFAZODONE HYDROCHLORIDE [MI], NEFAZODONE HYDROCHLORIDE [ORANGE BOOK], NEFAZODONE HYDROCHLORIDE [USAN], NEFAZODONE HYDROCHLORIDE [USP IMPURITY], NEFAZODONE HYDROCHLORIDE [USP MONOGRAPH]
Development code
BMY 13754, MJ 13,754-1, MJ-13754-1, NSC-760344
Trade name
Dutonin, Serzone
Salt form
Nefazodone hcl, Nefazodone Hydrochloride / Serzone
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

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