This page shows what was measured, who it was measured in, and what that does not settle.
What Linezolid does in the body
Human mitochondria contain related machinery, which helps explain why long courses can damage nerves, eyes and bone marrow.
Bacteria build proteins on a two-part machine called a ribosome. Linezolid blocks formation of the bacterial 70S initiation complex, stopping protein production at an early step that differs from the targets of most other antibiotics. It can remain active against some resistant Gram-positive bacteria, although linezolid resistance exists.
Why people take it. Serious infections caused by resistant Gram-positive bacteria, including MRSA and vancomycin-resistant enterococci
What happened in people
Clinical success 57.6% against vancomycin’s 46.6% in per-protocol MRSA nosocomial pneumonia, P=.042
✎ 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.
57.6% (95 of 165) against vancomycin 46.6% (81 of 174); 95% CI for the difference 0.5% to 21.6%, P=.042
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. All-cause 60-day mortality was 15.7% against 17.0% — no difference. The primary endpoint rests on 348 of 1,184 treated patients, and the mortality result on the larger population, so the trial’s most robust comparison is its least favourable one.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablets, oral suspension and intravenous infusion, interchangeable at the same amount
Interval reported. 95% CI for the difference 0
Written into the record, not signed off as a reviewed claim.
Nix-TB: bedaquiline, pretomanid and linezolid in highly drug-resistant tuberculosis (NCT02333799) · a recorded source, not a stored snapshot
Incidence of an unfavourable outcome — treatment failure or relapse — through six months after end of treatment
✓ The study showed what it set out to show
Who was studied
Nix-TB (NCT02333799)
How many people
109
Study design
Open-label, single-group, three South African sites
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
90% favourable outcome (95% CI 83 to 95); 11 unfavourable outcomes comprising 7 deaths, 1 withdrawal, 2 relapses and 1 loss to follow-up
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. Single-group with no control arm, in a population where historical outcomes were very poor, so the comparison is against history rather than a concurrent group. Peripheral neuropathy occurred in 81% and myelosuppression in 48%, frequently requiring linezolid dose reduction or interruption — so the regimen as delivered was not the regimen as designed.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablets, oral suspension and intravenous infusion, interchangeable at the same amount
Interval reported. 95% CI 83 to 95); 11 unfavourable outcomes comprising 7 deaths, 1 withdrawal, 2 relapses and 1 loss to follow-up
Written into the record, not signed off as a reviewed claim.
Nix-TB: bedaquiline, pretomanid and linezolid in highly drug-resistant tuberculosis (NCT02333799) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 2 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Linezolid
What a person takes: Oral tablets, oral suspension and intravenous infusion, interchangeable at the same amount.
The measurement behind this step
Oral bioavailability of approximately 100% makes tablet and infusion equivalent, which is unusual for a drug used against resistant organisms and is the single feature that makes months-long outpatient treatment possible. Metabolism is non-enzymatic rather than cytochrome P450 mediated, so the usual hepatic interaction list does not apply — but the monoamine oxidase inhibition does. The oral suspension contains phenylalanine and is unsuitable in phenylketonuria.
Getting in
Swallowed or infused, with no difference between them
Linezolid is absorbed essentially completely from the gut, so a tablet delivers what a drip delivers. That is rare among drugs for resistant infections, and it is why treatment can continue for months outside hospital.
╌╌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
Oral bioavailability is approximately 100%, so intravenous and oral forms are interchangeable at the same amount. Metabolism is non-enzymatic oxidation rather than cytochrome P450 mediated, which removes a large class of drug interactions.
It builds up inside the immune cells that engulf bacteria and in the fluid lining the lungs. That is why it does well in pneumonia and why it works in tuberculosis, where the organism lives inside those cells.
──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
Alveolar lining fluid and intracellular macrophage concentrations exceed plasma concentrations. This distribution is the pharmacological basis of its performance in MRSA nosocomial pneumonia and of its role in intracellular mycobacterial infection.
Other antibiotics interfere with protein-building once it is under way. Linezolid wedges into the point where the first amino acid is loaded, so the machine never begins. Nothing else in use works there.
╌╌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
Linezolid binds the A site of the peptidyl transferase centre in the 50S subunit, formed by 23S ribosomal RNA, and prevents formation of the functional 70S initiation complex. Because the binding site and step are unique among clinical antibacterials, there is no cross-resistance with macrolides, tetracyclines, aminoglycosides or beta-lactams.
It stops bacteria multiplying rather than killing them outright against most organisms, which means the immune system has to finish the job.
╌╌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
Linezolid is bacteriostatic against staphylococci and enterococci and bactericidal against most streptococci. Bacteriostatic action is one proposed reason for the mortality imbalance seen in the catheter-infection study, alongside the absence of Gram-negative activity.
Because the target is part of the bacterium’s protein factory, resistance means altering that factory — either by mutation or by borrowing a gene that chemically masks the binding site.
╌╌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
Resistance arises from 23S rRNA mutations, most commonly G2576T, from rplC mutations affecting ribosomal protein L3, or from acquisition of the transferable cfr methyltransferase, which methylates A2503 of 23S rRNA and confers cross-resistance across several classes. Because staphylococci carry multiple copies of the 23S rRNA gene, mutational resistance emerges slowly and needs sustained exposure.
Mitochondria descend from ancient bacteria and still build proteins on a bacterial-style machine. Linezolid jams that too. Given for weeks it suppresses the bone marrow; given for months it damages nerves and, sometimes permanently, the optic nerve.
──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
Inhibition of mitochondrial ribosomes underlies duration-dependent myelosuppression, peripheral and optic neuropathy, lactic acidosis and rhabdomyolysis. Thrombocytopenia and anaemia become evident from two weeks; the label sets 28 days as the maximum recommended duration for licensed indications, and in tuberculosis regimens run for 26 weeks, with peripheral neuropathy in 81% of Nix-TB participants. Separately, linezolid is a reversible non-selective monoamine oxidase inhibitor, with fatal serotonin syndrome reported alongside serotonergic drugs.
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 unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Adults and children with serious Gram-positive infection, and — outside its licensed indications — patients with highly drug-resistant tuberculosis.
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: “The pharmacokinetics of linezolid have been evaluated in pediatric patients from birth to 17 years of age.”
US prescribing information · b721756c-3b5e-456d-a2f6-0d8a56cc7f35 · read 2026-08-30
On older people, the label states: “Of the 2,046 patients treated with linezolid in Phase 3 comparator-controlled clinical trials, 589 (29%) were 65 years or older and 253 (12%) were 75 years or older.”
US prescribing information · b721756c-3b5e-456d-a2f6-0d8a56cc7f35 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Available data from published and postmarketing case reports with linezolid use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.”
US prescribing information · b721756c-3b5e-456d-a2f6-0d8a56cc7f35 · read 2026-08-30
On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential Infertility Males Based on findings from studies in rats, linezolid may reversibly impair fertility in male patients [ see Nonclinical Toxicology (13.1) ].”
US prescribing information · b721756c-3b5e-456d-a2f6-0d8a56cc7f35 · read 2026-08-30
Where the result stopped carrying
Mortality was higher on linezolid than on comparators in an open-label catheter-infection study, concentrated in patients with Gram-negative or unidentified organisms
It has no activity whatever against Gram-negative bacteria, and the label states it must not be used where they may be present without specific cover
Duration-dependent myelosuppression appears from two weeks and sets 28 days as the licensed ceiling, which the tuberculosis regimens exceed by design
Transferable cfr-mediated resistance appeared, conferring cross-resistance across several unrelated classes at once
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ 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 tablets, oral suspension and intravenous infusion, interchangeable at the same amount
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Oral bioavailability of approximately 100% makes tablet and infusion equivalent, which is unusual for a drug used against resistant organisms and is the single feature that makes months-long outpatient treatment possible.
✎ 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: Metabolism is non-enzymatic rather than cytochrome P450 mediated, so the usual hepatic interaction list does not apply — but the monoamine oxidase inhibition does. The oral suspension contains phenylalanine and is unsuitable in phenylketonuria.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Myelosuppression including anaemia, leukopenia, pancytopenia and thrombocytopenia, becoming evident from about two weeks and reversing when the drug is stopped, more frequent in severe renal or moderate to severe hepatic impairment. Peripheral and optic neuropathy, reported primarily beyond the maximum recommended 28-day duration, with vision loss in patients treated well beyond it; visual blurring has occurred inside 28 days. Serotonin syndrome, including fatal cases, with serotonergic drugs — linezolid is a reversible non-selective monoamine oxidase inhibitor. Lactic acidosis, rhabdomyolysis, hypoglycaemia in patients on insulin or oral hypoglycaemics, hyponatraemia and SIADH. A mortality imbalance was seen in an investigational study in catheter-related bloodstream infection, an indication for which the drug is not approved.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral tablets, oral suspension and intravenous infusion, interchangeable at the same amount
✎ 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
Metabolism is non-enzymatic rather than cytochrome P450 mediated, so the usual hepatic interaction list does not apply — but the monoamine oxidase inhibition does. The oral suspension contains phenylalanine and is unsuitable in phenylketonuria.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
61 products list this as an active ingredient in the United States drug directory. 61 of them contain it and nothing else.
FDA National Drug Code directory · 52562-019 · read 2026-08-29
They are sold as granule, for suspension, injection, injection, powder, for solution, injection, solution, powder and powder, for suspension, taken intravenous and oral.
FDA National Drug Code directory · 52562-019 · read 2026-08-29
The regulator's established pharmacologic class for it is oxazolidinone antibacterial [epc] and oxazolidinones [cs].
FDA National Drug Code directory · 52562-019 · read 2026-08-29
36 published labels name it as an active ingredient. 36 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · b721756c-3b5e-456d-a2f6-0d8a56cc7f35 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · b721756c-3b5e-456d-a2f6-0d8a56cc7f35 · read 2026-08-29
Linezolid is intravenous at 3 DOSAGE FORMS AND STRENGTHS Linezolid injection: 600 mg/300 mL (2 mg/mL) linezolid single-dose, ready-to-use flexible plastic infusion bags in a foil laminate overwrap., recorded as fda label in effect 2026-07-13 in the United States.
US prescribing information · b721756c-3b5e-456d-a2f6-0d8a56cc7f35 · read 2026-08-30
Recorded price in US: 1.38177 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 11 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
Recorded price in US: 2.56231 USD per one millilitre, across 4 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Linezolid studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That linezolid is the better drug for MRSA pneumonia — established on clinical response in under a third of treated patients, with identical 60-day mortality
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 Nix-TB result is attributable to linezolid, when it is a three-drug regimen tested with no control arm against historical outcomes
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 myelosuppression is the limiting toxicity, when optic neuropathy progressing to vision loss is the one that does not reverse
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 an oral drug with complete bioavailability is a safe drug for long courses; complete absorption is exactly what makes prolonged mitochondrial exposure possible
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Linezolid are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
ZEPHyR: 57.6% clinical success against vancomycin’s 46.6% in MRSA pneumonia
In plain words
In the only large head-to-head trial in hospital-acquired MRSA pneumonia, more patients on linezolid were counted as cured, and less than half as many had kidney injury. The same proportion of each group was alive at sixty days.
What was measured
Clinical outcome at end of study in evaluable per-protocol patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ZEPHyR was a prospective, double-blind, controlled, multicentre trial in hospitalised adults with hospital-acquired or healthcare-associated MRSA pneumonia, comparing linezolid with a dose-optimised vancomycin regimen adjusted on trough levels. Of 1,184 patients treated, 448 entered the modified intention-to-treat population and 348 the per-protocol population. Clinical success at end of study in the per-protocol population was 95 of 165 (57.6%) with linezolid against 81 of 174 (46.6%) with vancomycin — 95% confidence interval for the difference 0.5% to 21.6%, P=.042. Nephrotoxicity occurred in 8.4% against 18.2%.
Written into the record, not signed off as a reviewed claim
Better cure did not become better survival
In plain words
Linezolid won on the endpoint the trial was designed around and did not change the number of people who died. That result is routinely reported as though it settled which drug is better.
What was measured
That linezolid is the better drug for MRSA nosocomial pneumonia — supported on a per-protocol clinical-response endpoint in under a third of treated patients, and not on 60-day mortality, which was the same
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In ZEPHyR, all-cause 60-day mortality was 15.7% with linezolid and 17.0% with vancomycin — similar, and not the primary endpoint. The primary endpoint was investigator-assessed clinical outcome in the per-protocol population, which comprised 348 of the 1,184 patients treated, under 30% of those exposed. A clinical-response endpoint assessed in a subset that excludes protocol deviations is more susceptible to differential dropout than an all-cause mortality endpoint in everyone randomised. The published conclusion states both results plainly; the citation practice that followed generally did not.
Written into the record, not signed off as a reviewed claim
Nix-TB: 90% favourable outcomes, and 81% peripheral neuropathy
In plain words
In patients with tuberculosis that had defeated everything else, a three-drug regimen containing linezolid produced a good outcome in nine out of ten — a result nothing had achieved before. Four in five of them developed nerve damage in the process, and half had their bone marrow suppressed.
What was measured
Favourable outcome six months after end of therapy, and incidence of peripheral neuropathy and myelosuppression
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Nix-TB was an open-label, single-group study at three South African sites in 109 patients with extensively drug-resistant tuberculosis, or multidrug-resistant tuberculosis that had failed or been discontinued for side effects. The regimen was bedaquiline, pretomanid and linezolid for 26 weeks. Six months after the end of treatment, in the intention-to-treat analysis, 98 patients (90%, 95% CI 83 to 95) had a favourable outcome and 11 (10%) an unfavourable one — seven deaths, one withdrawal of consent, two relapses and one loss to follow-up. The expected linezolid toxic effects occurred in most participants: peripheral neuropathy in 81% and myelosuppression in 48%, described by the investigators as manageable and often leading to linezolid dose reduction or interruption.
Written into the record, not signed off as a reviewed claim
The toxicity is the human mitochondrial ribosome, and it is time-dependent
In plain words
Linezolid works by jamming the bacterial protein factory. Human cells have an almost identical factory inside their mitochondria, inherited from bacteria a billion years ago, and linezolid jams that too. The longer the course, the more it shows.
What was measured
Onset of thrombocytopenia and anaemia by treatment duration in pooled phase 3 data
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Pooled clinical trial data showed thrombocytopenia and a slight increase in anaemia risk becoming evident at two weeks or more of treatment, with abnormalities consistent with mild, reversible, duration-dependent myelosuppression. The label records myelosuppression including anaemia, leukopenia, pancytopenia and thrombocytopenia, more often in severe renal impairment and moderate to severe hepatic impairment, with recovery toward pretreatment levels when the drug is stopped. It records peripheral and optic neuropathy primarily beyond the maximum recommended duration of 28 days, and notes that where optic neuropathy progressed to loss of vision, patients had been treated for extended periods beyond that limit. Lactic acidosis, rhabdomyolysis, hypoglycaemia in patients on insulin or oral hypoglycaemics, and hyponatraemia with SIADH are also recorded. All of these are consistent with inhibition of mitochondrial protein synthesis.
Written into the record, not signed off as a reviewed claim
A mortality imbalance in catheter infections it was never approved for
In plain words
An open-label study in seriously ill patients with infected intravascular catheters found more deaths on linezolid than on the comparators. The excess was in patients whose infection turned out to be Gram-negative or unidentified — organisms linezolid cannot touch at all.
What was measured
All-cause mortality in an open-label investigational study of catheter-related infection
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
In an open-label investigational study in seriously ill patients with intravascular catheter-related infections, mortality was 78 of 363 (21.5%) with linezolid against 58 of 363 (16.0%) with vancomycin, dicloxacillin or oxacillin — odds ratio 1.426, 95% CI 0.97 to 2.098. The label states causality has not been established, and that the imbalance occurred primarily in linezolid-treated patients in whom Gram-negative pathogens, mixed Gram-negative and Gram-positive pathogens, or no pathogen were identified at baseline, and was not seen in patients with Gram-positive infections only. Linezolid has no clinical activity against Gram-negative organisms. The label states it is not approved and should not be used for catheter-related bloodstream infection or catheter-site infection.
Source
Linezolid United States prescribing information, Warnings and Precautions 5.4 (NDA 021130)
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
It was licensed as a hospital Gram-positive drug and became a tuberculosis drug
In plain words
Linezolid was approved in 2000 for skin infections, pneumonia and resistant enterococci. Twenty years later its most important use is in a regimen for the most drug-resistant tuberculosis, which is not on its label and was not what anyone designed it for.
What was measured
That a drug’s licensed indications describe what it is for — here the most consequential use lies outside them, at a duration the label describes as beyond the maximum recommended, with the toxicity that implies
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The approved indications remain nosocomial and community-acquired pneumonia, skin and skin structure infection, and vancomycin-resistant Enterococcus faecium infection. Mycobacterium tuberculosis was not among them. Three things converged: linezolid accumulates inside macrophages, where the organism lives; the oral formulation makes months-long treatment feasible; and generic pricing at about US$1.38 a unit brought it within reach of programmes in high-burden countries. Nix-TB then demonstrated 90% favourable outcomes at six months post-treatment in 109 patients with extensively drug-resistant or treatment-failed tuberculosis, an outcome without precedent in that population. The toxicity that constrains it — peripheral neuropathy in 81% and myelosuppression in 48% over 26 weeks — is the same mitochondrial mechanism that made 28 days the licensed ceiling for its original indications.
Written into the record, not signed off as a reviewed claim
How many documents were read
36 documents were read for this substance.
RNAWiki source record
36 of them state the same bioavailability, and they agree.
RNAWiki source record
36 of them state the same proteinBinding, and they agree.
RNAWiki source record
36 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
ISQ9I6J12J
RxNorm concept
1662285
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no quarantine open
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Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
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Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
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Safety mode resolved
No register row and no identity class settled the question.
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Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
Withdrawn in United States, 2017, for "Presence of Particulate Matter; white particulate matter identified as mold was found in one bag" (openFDA drug enforcement Class I recall)
What the approval register records
29 approved applications cover products containing this substance. The earliest was NDA021132, approved 20000418 to PFIZER.
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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.
The first new antibacterial class in thirty-five years, blocking assembly of the bacterial ribosome before protein synthesis can begin — it achieved clinical success in 57.6% of per-protocol MRSA pneumonia patients against vancomycin’s 46.6% (P=.042) without changing 60-day mortality, and in the Nix-TB study 90% of 109 patients with highly drug-resistant tuberculosis had a favourable outcome while 81% developed peripheral neuropathy and 48% myelosuppression.
Recorded evidence blocks (10)
Q1
On the Linezolid label: indicated for what?
"Linezolid for Oral Suspension is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia ( 1.1 ); Community-acquired pneumonia ( 1.": indications and usage on Linezolid's label. DailyMed label · 16007ca5-7956-4414-af38-406a6623400e · 2026-07-15
Q2
142 registered trials of Linezolid — at which phases?
Registered studies posting no result
93 of 142
142 registered studies of Linezolid: 48 phase2, 44 phase3, 19 na or unstated, 17 phase4, 14 phase1, 10 na, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
282 with a PubMed record
Show the evidence
phase2
48
phase3
44
na or unstated
19
phase4
17
phase1
14
na
10
9 more recorded rows
early phase1
1
completed
82
recruiting
14
unknown
13
terminated
11
withdrawn
7
not yet recruiting
6
active not recruiting
5
enrolling by invitation
4
recorded 2026-09-01 · last checked 2026-09-04
Q3
15 of Linezolid's trials stopped: accrual/recruitment, funding/business, other?
"difficulties by enrolling patients fundings consumed, no staff could be recruited and payed to continue enrolling patients,"; 15 of 142 registered studies
Show the evidence
Trial
NCT00435305
terminated; "difficulties by enrolling patients fundings consumed, no staff could be recruited and payed to continue enrolling patients,"
NCT00865280
terminated; "Terminated"
NCT00876850
withdrawn; "Terminated"
NCT00925093
withdrawn; "Primary investigator left institution"
NCT01039610
withdrawn; "Internal decision to progress alternate molecule with more preferable profile"
NCT01619410
terminated; "slow accrual"
9 further recorded trials
NCT01734694
terminated; "Independent biostatistician recommended early termination of the trial due to low probability of success."
NCT01756924
terminated; "This study has been terminated; alternative study designs are being considered. Fusidic acid remains available under an Expanded Access Protocol."
NCT02099240
terminated; "Not enough patient enrollment and lack of staffing"
NCT02168816
terminated; "The study was stopped for feasibility (i.e., low recruitment)"
NCT02732327
terminated; "No longer aligned with the revised clinical development plan and commercial strategy"
NCT02975570
withdrawn; "The study could not be conducted since funding was not obtained."
NCT02991131
terminated; "Company decision"
NCT03012360
terminated; "lack of inclusion pandemic, investigator reluctance, lower than expected incidence of infection"
NCT04042077
terminated; "COVID-19 seriously affected the study execution as required by the protocol"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Linezolid used Linezolid 900 mg — over how long?
Human studies of Linezolid used "Linezolid 900 mg". ClinicalTrials.gov · 2026-09-01
9 recorded entries; human; also "Linezolid 1200 mg", "Linezolid 600 mg", "600 mg linezolid"
Show the evidence
human
NCT00795145
Linezolid 900 mg
NCT00795145
Linezolid 1200 mg
NCT00795145
Linezolid 600 mg
NCT02087566
600 mg linezolid
NCT02836483
Zyvox 600mg, BID
NCT03747497
linezolid 600 mg
3 more recorded rows
humanNCT05007821
Linezolid 1200 mg (QD)
humanNCT05007821
Linezolid 1200 mg (TIW)
humanNCT05069974
Linezolid 600 mg (post-interim)
recorded 2026-09-01 · last checked 2026-09-04
Q5
Linezolid's half-life is 1 week — which schedules were studied?
1 week, the half-life Linezolid's label states: "With the exclusion of pre-term neonates less than one week of age, weight-based clearance is most rapid in the youngest age groups ranging from < 1 week old to 11 years, resulting in lower single-dose systemic exposure (AUC) and a shorter half-life as compared with adults." DailyMed label · 16007ca5-7956-4414-af38-406a6623400e · 2026-07-15
tmax 2 hrs; bioavailability 100 %.
Show the evidence
half lifepharmacokinetics
1 week; With the exclusion of pre-term neonates less than one week of age, weight-based clearance is most rapid in the youngest age groups ranging from < 1 week old to 11 years, resulting in lower single-dose systemic exposure (AUC) and a shorter half-life as compared with adults.
tmaxpharmacokinetics
2 hrs; Mean (Standard Deviation) Pharmacokinetic Parameters of Linezolid in Adults Dose of Linezolid C max mcg/mL C min mcg/mL T max hrs AUC AUC for single dose = AUC 0-∞ ; for multiple dose = AUC 0-τ mcg•h/mL t 1/2 hrs CL mL/min 400 mg tablet single dose Data dose-normalized from 375 mg 8.10 --- 1.52 55.10 5.20 146 (1.83) (1.01) (25.00) (1.50) (67) every 12 hours 11.00 3.08 1.12 73.40 4.69 110 (4.37)…
bioavailabilitypharmacokinetics
100 %; Maximum plasma concentrations are reached approximately 1 to 2 hours after dosing, and the absolute bioavailability is approximately 100%.
metabolismpharmacokinetics
Metabolism Linezolid is primarily metabolized by oxidation of the morpholine ring, which results in two inactive ring-opened carboxylic acid metabolites: the aminoethoxyacetic acid metabolite (A), and the hydroxyethyl glycine metabolite (B).
recorded 2026-07-15 · last checked 2026-09-04
Q6
Which 37 trials of Linezolid posted no result?
Posted no result
37 of 37 completed trials
Registrations
NCT00035425, NCT00572559, NCT00147511, NCT00037050, NCT00150332 and NCT00255996, and 31 more
Completion dates
oldest 2002-11; newest 2024-06-22
Show the evidence
Trial
NCT00035425
2002-11
NCT00572559
2005-01
NCT00147511
2005-06
NCT00037050
2005-07
NCT00150332
2006-01
NCT00255996
2007-01
14 further recorded trials
NCT00501150
2007-06
NCT00671814
2008-06-06
NCT00948142
2010-03
NCT00949130
2010-03
NCT00990990
2010-05
NCT00811980
2010-06
NCT01200654
2010-08
NCT01128530
2011-01
NCT01544673
2012-04
NCT01363271
2012-05
NCT02123628
2012-09
NCT01554995
2013-02
NCT02087566
2014-01
NCT00711854
2014-02
Q7
At the median, Linezolid's trials enrolled 146 people — anything larger?
Median enrolment
146
Largest enrolment
7260
Registered trials counted
142
Q8
What do 4703 spontaneous reports say about Linezolid — 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.
Linezolid appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4703 reaction mentions were counted: thrombocytopenia 944; anaemia 774; serotonin syndrome 486; drug interaction 469. FAERS via Open Targets · CHEMBL126 · 2026-06-24
Show the evidence
thrombocytopenia
944
anaemia
774
serotonin syndrome
486
drug interaction
469
neuropathy peripheral
416
pancytopenia
403
4 more recorded rows
lactic acidosis
375
platelet count decreased
347
drug resistance
267
electrocardiogram qt prolonged
222
recorded 2026-06-24 · last checked 2026-09-04
Q9
Which 10 reactions does Linezolid's label not list?
In vitro studies have demonstrated that linezolid is minimally metabolized and may be mediated by human cytochrome P450.
pharmacokinetics
Drug Interactions Drugs Metabolized by Cytochrome P450 Linezolid is not an inducer of cytochrome P450 (CYP450) in rats.
pharmacokinetics
Concurrent administration of linezolid does not substantially alter the pharmacokinetic characteristics of (S)-warfarin, which is extensively metabolized by CYP2C9.
pharmacokinetics
Drugs such as warfarin and phenytoin, which are CYP2C9 substrates, may be given with linezolid without changes in dosage regimen.
pharmacokinetics
Strong CYP 3A4 Inducers Rifampin The effect of rifampin on the pharmacokinetics of linezolid was evaluated in a study of 16 healthy adult males.
clinical_pharmacology
In vitro studies have demonstrated that linezolid is minimally metabolized and may be mediated by human cytochrome P450.
2 more recorded rows
Interaction statementclinical_pharmacology
Drug Interactions Drugs Metabolized by Cytochrome P450 Linezolid is not an inducer of cytochrome P450 (CYP450) in rats.
Interaction statementclinical_pharmacology
Concurrent administration of linezolid does not substantially alter the pharmacokinetic characteristics of (S)-warfarin, which is extensively metabolized by CYP2C9.
Withdrawn in United States, 2017, for "Presence of Particulate Matter; white particulate matter identified as mold was found in one bag" (openFDA drug enforcement Class I recall)
ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · 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 · openFDA enforcement — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 7 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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