This page shows what was measured, who it was measured in, and what that does not settle.
What Levofloxacin (anhydrous) does in the body
Serious bacterial infections — pneumonia, kidney and prostate infection, and exposure to anthrax or plague
Bacterial DNA is a long loop that has to be unwound before it can be copied. Two bacterial enzymes, DNA gyrase and topoisomerase IV, cut the loop, pass a strand through and re-seal it. Levofloxacin traps those enzymes at the moment the DNA is cut, so the break is never repaired and the chromosome falls apart. Human cells use different enzymes for the same job, which is why the drug kills bacteria and not you — the serious harms it does cause, to tendons and nerves and the aorta, come from somewhere else and are not fully explained.
What happened in people
Clinical success 92.4% against 91.1% for 5 days at 750 mg versus 10 days at 500 mg in 528 patients with community-acquired pneumonia
✎ 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.
Levofloxacin United States prescribing information — boxed warning, Indications 1.1 to 1.15, Warnings 5.1 to 5.15, Clinical Pharmacology 12.3 and 12.4, Clini… · a recorded source, not a stored snapshot
That preventing fevers and admissions with prophylaxis prevents deaths from infection — severe infection was not significantly reduced and infection deaths were four against four
Where it acts
Inside the bacterial cell — the DNA gyrase and topoisomerase IV enzymes clamped on the chromosome at the replication fork
Kind of result
The kind of result is not recorded
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 6GNT3Y5LMF · read 2026-08-29
Its recorded molecular formula is C18H20FN3O4, weighing 370.38.
US prescribing information · cbd5153f-fada-4682-b858-dc3b6e3173cc · read 2026-08-30
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.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 138 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.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
Formulation
A formulation is the exact made-up form a substance comes in.
A picture of it, and where the picture fails
It is like the difference between a whole bean and instant coffee.
Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.
What people get wrong. Two products with the same name are assumed to behave the same. They often do not.
The specific composition and physical form of a product, including salt, excipients and release profile.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Clinical success (cure plus improvement) in community-acquired pneumonia, levofloxacin 750 mg daily for 5 days against 500 mg daily for 10 days
✓ The study showed what it set out to show
Who was studied
Dunbar LM et al., Clin Infect Dis 2003;37:752-760 (5-day 750 mg CAP trial)
How many people
528
Study design
Phase 3, randomised, double-blind, multicentre
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
92.4% (183/198) against 91.1% (175/192) in the clinically evaluable population; 95% CI for the difference -7.0 to 4.4, meeting the non-inferiority margin
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. The FDA label reports that at 31 to 38 days after enrolment, pneumonia was observed in 7 of 151 patients in the 750 mg group against 2 of 147 in the 500 mg group, and states the significance cannot be determined statistically given the small numbers.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet at 250, 500 and 750 mg, oral solution, intravenous infusion in premixed dextrose, and ophthalmic solution — taken once daily by the systemic routes
Interval reported. 95% CI for the difference -7
Written into the record, not signed off as a reviewed claim.
Levofloxacin United States prescribing information — boxed warning, Indications 1.1 to 1.15, Warnings 5.1 to 5.15, Clinical Pharmacology 12.3 and 12.4, Clini… · a recorded source, not a stored snapshot
First cycle 3.5% against 7.9% (p<0.001); whole course 10.8% against 15.2% (p=0.01); hospitalisation for infection 15.7% against 21.6% (p=0.004)
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. Severe infection 1.0% against 2.0% was not significant (p=0.15) and infection-related deaths were four in each arm. The authors state secondary outcomes did not include a systematic evaluation of antibacterial resistance.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet at 250, 500 and 750 mg, oral solution, intravenous infusion in premixed dextrose, and ophthalmic solution — taken once daily by the systemic routes
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Levofloxacin United States prescribing information — boxed warning, Indications 1.1 to 1.15, Warnings 5.1 to 5.15, Clinical Pharmacology 12.3 and 12.4, Clini… · a recorded source, not a stored snapshot
Bacteraemia during two chemotherapy cycles (acute leukaemia stratum) or one transplant procedure (HSCT stratum) in patients aged 6 months to 21 years
✓ The study showed what it set out to show
Who was studied
Alexander S et al., JAMA 2018;320:995-1004 (ACCL0934)
How many people
624
Study design
Phase 3, randomised, open-label, multicentre
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Acute leukaemia 21.9% against 43.4%, risk difference 21.6% (95% CI 8.8 to 34.4), p=0.001. HSCT 11.0% against 17.3%, risk difference 6.3% (95% CI 0.3 to 13.0), p=0.06
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. The transplant stratum did not reach significance on the primary endpoint. Severe infection did not differ significantly between arms.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet at 250, 500 and 750 mg, oral solution, intravenous infusion in premixed dextrose, and ophthalmic solution — taken once daily by the systemic routes
Interval reported. 95% CI 8
Written into the record, not signed off as a reviewed claim.
Levofloxacin United States prescribing information — boxed warning, Indications 1.1 to 1.15, Warnings 5.1 to 5.15, Clinical Pharmacology 12.3 and 12.4, Clini… · a recorded source, not a stored snapshot
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 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
Levofloxacin (anhydrous)
What a person takes: Oral tablet at 250, 500 and 750 mg, oral solution, intravenous infusion in premixed dextrose, and ophthalmic solution — taken once daily by the systemic routes.
The measurement behind this step
Oral levofloxacin is rapidly and essentially completely absorbed, so the oral and intravenous routes are dose-equivalent and a patient can be switched between them without changing the amount. Peak plasma concentration comes at about one to two hours; the mean elimination half-life is roughly 6 to 8 hours in normal renal function and lengthens markedly as creatinine clearance falls, reaching about 27 hours at a clearance of 20 to 49 mL/min. Elimination is largely renal and unchanged.
Getting in
Swallowed, and almost all of it arrives
Unusually for an antibiotic, nearly the whole tablet reaches the bloodstream, so the oral form is interchangeable with the drip. Antacids, iron and calcium taken at the same time ruin that.
──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
Oral levofloxacin is rapidly and essentially completely absorbed, with peak plasma concentrations at one to two hours; a 750 mg tablet gives a mean Cmax of 9.3 ± 1.6 mcg/mL and AUC of 101 ± 20 mcg·h/mL. The 3-carboxyl and 4-keto groups chelate polyvalent cations, which is the mechanistic basis of the antacid, iron and sucralfate interaction.
Levofloxacin United States prescribing information — boxed warning, Indications 1.1 to 1.15, Warnings 5.1 to 5.15, Clinical Pharmacology 12.3 and 12.4, Clini… · a recorded source, not a stored snapshot
The drug is small and crosses the bacterial envelope on its own, reaching the inside of the cell where the chromosome is being copied.
╌╌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
Entry into Gram-negative bacteria is largely through outer-membrane porin channels; loss of porins or upregulation of efflux pumps is one of the two named resistance routes in section 12.4, the other being target-site mutation.
Levofloxacin United States prescribing information — boxed warning, Indications 1.1 to 1.15, Warnings 5.1 to 5.15, Clinical Pharmacology 12.3 and 12.4, Clini… · a recorded source, not a stored snapshot
Two bacterial enzymes cut the DNA loop, pass a strand through and re-seal it. Levofloxacin freezes them at the moment the cut is open.
╌╌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
Inhibition of bacterial topoisomerase IV and DNA gyrase, both type II topoisomerases, enzymes required for DNA replication, transcription, repair and recombination. The drug stabilises the covalent enzyme-DNA cleavage complex rather than blocking the active site, which converts a normal catalytic intermediate into a permanent double-strand break.
Levofloxacin United States prescribing information — boxed warning, Indications 1.1 to 1.15, Warnings 5.1 to 5.15, Clinical Pharmacology 12.3 and 12.4, Clini… · a recorded source, not a stored snapshot
Because the break is never repaired, the bacterium cannot finish copying itself and is killed rather than merely stopped.
╌╌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
Concentration-dependent bactericidal activity, with efficacy tracking the ratio of AUC to MIC and of Cmax to MIC. That pharmacodynamic relationship is the entire rationale for the 750 mg five-day regimen: raising the peak buys a shorter course.
Levofloxacin United States prescribing information — boxed warning, Indications 1.1 to 1.15, Warnings 5.1 to 5.15, Clinical Pharmacology 12.3 and 12.4, Clini… · a recorded source, not a stored snapshot
The infection clears — in the organisms that are still susceptible
Cure rates in the registration trials were around 90%. Those rates were measured against the bacteria circulating thirty years ago.
──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
Clinical success 92.4% against 91.1% in the 528-patient 5-day 750 mg versus 10-day 500 mg pneumonia trial; bacteriological eradication of 19/20 S. pneumoniae, 12/12 H. influenzae and 26/27 M. pneumoniae in the label 5-day analysis. Resistance by spontaneous mutation in vitro is rare (10⁻⁹ to 10⁻¹⁰), so clinical resistance is acquired through population-level selection, not within a single course.
Levofloxacin United States prescribing information — boxed warning, Indications 1.1 to 1.15, Warnings 5.1 to 5.15, Clinical Pharmacology 12.3 and 12.4, Clini… · a recorded source, not a stored snapshot
Tendon rupture, nerve damage and aortic tears are all in the label. Nobody has established why a drug that acts on a bacterial enzyme does any of them.
╌╌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
Section 5.9 states plainly that the cause of the aortic aneurysm risk has not been identified. The tendon and peripheral nerve warnings likewise describe an association and a risk-factor profile without a mechanism. The proposed explanations — chelation of matrix metalloproteinase cofactors, mitochondrial topoisomerase effects, oxidative injury to collagen — are hypotheses in the literature, not statements the label makes.
Levofloxacin United States prescribing information — boxed warning, Indications 1.1 to 1.15, Warnings 5.1 to 5.15, Clinical Pharmacology 12.3 and 12.4, Clini… · a recorded source, not a stored snapshot
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 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 with pneumonia, pyelonephritis, complicated urinary infection or chronic bacterial prostatitis; adults and children after anthrax or plague exposure. The label directs that it be avoided in people with a history of myasthenia gravis, tendon disorders or aortic aneurysm risk.
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 levofloxacin in pediatric patients below the age of six months have not been established.”
US prescribing information · cbd5153f-fada-4682-b858-dc3b6e3173cc · read 2026-08-30
On older people, the label states: “Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as levofloxacin.”
US prescribing information · cbd5153f-fada-4682-b858-dc3b6e3173cc · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Published information from case reports, case control studies and observational studies on levofloxacin administered during pregnancy have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.”
US prescribing information · cbd5153f-fada-4682-b858-dc3b6e3173cc · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Published literature reports that levofloxacin is present in human milk following intravenous and oral administration (see Data).”
US prescribing information · cbd5153f-fada-4682-b858-dc3b6e3173cc · read 2026-08-30
On people with reduced liver function, the label states: “Pharmacokinetic studies in patients with hepatic impairment have not been conducted.”
US prescribing information · cbd5153f-fada-4682-b858-dc3b6e3173cc · read 2026-08-30
On people with reduced kidney function, the label states: “Clearance of levofloxacin is substantially reduced and plasma elimination half-life is substantially prolonged in patients with renal impairment (creatinine clearance < 50 mL/min), requiring dosage adjustment in such patients to avoid accumulation.”
US prescribing information · cbd5153f-fada-4682-b858-dc3b6e3173cc · read 2026-08-30
Where the result stopped carrying
Three licensed indications — uncomplicated urinary tract infection, acute bacterial exacerbation of chronic bronchitis and acute bacterial sinusitis — were moved into the boxed warning with an instruction to reserve the drug for patients with no alternative
Severe infection and infection-related mortality did not separate from placebo in the 1,565-patient prophylaxis trial
The transplant stratum of the paediatric prophylaxis trial missed its primary endpoint at p=0.06
The 5-day arm of the pneumonia trial showed 7 of 151 versus 2 of 147 late pneumonia at day 31 to 38, a difference the label declines to interpret
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.
A different form was studied
The studied form is not the form on the shelf.
On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.
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 (10)
It was studied for a different goal
The studies measured something else entirely. 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 tablet at 250, 500 and 750 mg, oral solution, intravenous infusion in premixed dextrose, and ophthalmic solution — taken once daily by the systemic routes
✎ 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 levofloxacin is rapidly and essentially completely absorbed, so the oral and intravenous routes are dose-equivalent and a patient can be switched between them without changing the 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.
Recorded notes on how this is sold. The rest of the recorded wording: Peak plasma concentration comes at about one to two hours; the mean elimination half-life is roughly 6 to 8 hours in normal renal function and lengthens markedly as creatinine clearance falls, reaching about 27 hours at a clearance of 20 to 49 mL/min. Elimination is largely renal and unchanged.
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
Carries a boxed warning for disabling and potentially irreversible serious adverse reactions occurring together — tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects — with an instruction to discontinue immediately and avoid the class in anyone who experiences them; for exacerbation of muscle weakness in myasthenia gravis, with an instruction to avoid the drug in anyone with a known history; and with an instruction to reserve the drug for patients with no alternative treatment options in uncomplicated urinary tract infection, acute bacterial exacerbation of chronic bronchitis and acute bacterial sinusitis. Section 5.9 warns of aortic aneurysm and dissection, with a roughly 2-fold increase over background risk in epidemiological studies and an instruction to reserve the drug in anyone at greater aortic risk. Also carries warnings for Clostridioides difficile-associated diarrhoea, hypersensitivity and other serious reactions, hepatotoxicity, QT prolongation, blood glucose disturbances and photosensitivity. Tendon injury may begin within hours of the first dose or months after the last.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Where this came from
Levofloxacin United States prescribing information — boxed warning, Indications 1.1 to 1.15, Warnings 5.1 to 5.15, Clinical Pharmacology 12.3 and 12.4, Clini… · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral tablet at 250, 500 and 750 mg, oral solution, intravenous infusion in premixed dextrose, and ophthalmic solution — taken once daily by the systemic routes
✎ 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
A recorded note compares this form with the others that are sold. It is kept below, word for word.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
The recorded note, unchanged: Peak plasma concentration comes at about one to two hours; the mean elimination half-life is roughly 6 to 8 hours in normal renal function and lengthens markedly as creatinine clearance falls, reaching about 27 hours at a clearance of 20 to 49 mL/min. Elimination is largely renal and unchanged.
No source is stored against this line.
What is recorded as being sold
144 products list this as an active ingredient in the United States drug directory. 144 of them contain it and nothing else.
FDA National Drug Code directory · 76420-815 · read 2026-08-29
They are sold as injection, injection, solution, injection, solution, concentrate, powder, solution and solution/ drops, taken intravenous, ophthalmic and oral.
FDA National Drug Code directory · 76420-815 · read 2026-08-29
78 published labels name it as an active ingredient. 78 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · b6d9740b-2f9d-4f1c-bc9b-4c2150b22f10 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · b6d9740b-2f9d-4f1c-bc9b-4c2150b22f10 · read 2026-08-29
levofloxacin is oral at 3 DOSAGE FORMS AND STRENGTHS Formulation ( 3 ) Strength Tablets 250 mg, 500 mg, and 750 mg Levofloxacin tablets, USP are white to off white, modified capsule-shaped, biconvex and film-coated 250 mg tablets, debossed wit…, recorded as fda label in effect 2025-09-29 in the United States.
US prescribing information · cbd5153f-fada-4682-b858-dc3b6e3173cc · read 2026-08-30
Recorded price in US: 0.11644–0.26738 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 22 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: 1.61891–1.79838 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.
Evidence on this page does not automatically apply to this one.
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 Levofloxacin (anhydrous) 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 preventing fevers and admissions with prophylaxis prevents deaths from infection — severe infection was not significantly reduced and infection deaths were four against four
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 registration cure rates describe the probability of cure against organisms circulating today, when the label directs that current local susceptibility patterns guide empiric selection
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 a result in one prophylaxis population transfers to another — the same trial found a large effect in leukaemia and no significant effect in transplant
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 tendon, nerve and aortic harms have an established mechanism; section 5.9 states the cause has not been identified
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 Levofloxacin (anhydrous) 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.
Five days at 750 mg matched ten days at 500 mg in pneumonia
In plain words
A 528-person trial found the high-dose five-day course cured pneumonia as often as the standard ten-day course. That is the strongest thing this drug has: a shorter course that works as well.
What was measured
Clinical success and bacteriological eradication in community-acquired pneumonia, 5-day 750 mg against 10-day 500 mg
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
A multicentre, randomised, double-blind trial enrolled 528 outpatient and hospitalised adults with clinically and radiologically determined mild to severe community-acquired pneumonia and compared levofloxacin 750 mg daily for five days with 500 mg daily for ten days. In the clinically evaluable population, clinical success was 92.4% (183 of 198) on the 750 mg regimen and 91.1% (175 of 192) on the 500 mg regimen, 95% CI for the difference -7.0 to 4.4. Microbiological eradication was 93.2% and 92.4%. The FDA label reports the same trial with clinical success of 90.9% against 91.1% and a 95% CI of -5.9 to 5.4 for the analysis population it used, and adds a signal the abstract does not emphasise: at 31 to 38 days after enrolment, pneumonia was observed in 7 of 151 patients in the 750 mg group against 2 of 147 in the 500 mg group, which the label states cannot be assessed statistically given the small numbers.
Written into the record, not signed off as a reviewed claim
The FDA took back the three infections it was most used for
In plain words
Sinusitis, bronchitis and simple bladder infection are what most levofloxacin prescriptions were written for. In 2016 the FDA put all three into the boxed warning and told doctors to use this drug for them only when nothing else will do.
What was measured
Licensed indications carrying a reserve-for-no-alternative instruction in the boxed warning
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The boxed warning now reads: "Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions, reserve levofloxacin for use in patients who have no alternative treatment options for the following indications: Uncomplicated urinary tract infection; Acute bacterial exacerbation of chronic bronchitis; Acute bacterial sinusitis." Sections 1.12, 1.13 and 1.14 repeat the reserve instruction for each, and each gives the same second reason: that for some patients the infection is self-limiting. The indications were not withdrawn — the drug still works for them — and that is the point of the change. The regulator did not decide the efficacy evidence was wrong; it decided the harm side of the same ledger had grown large enough to change the answer for infections that mostly get better anyway.
Source
Levofloxacin United States prescribing information, boxed warning and sections 1.12, 1.13, 1.14 (NDA 020634)
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
Prophylaxis in chemotherapy cut fevers, not deaths
In plain words
Given during chemotherapy to prevent infection, levofloxacin clearly reduced fevers and hospital admissions. Severe infections were not significantly reduced, and exactly four people died of infection in each group.
What was measured
That preventing febrile episodes and admissions with prophylactic levofloxacin prevents deaths from infection — a step the trial itself did not demonstrate, with four infection deaths in each arm and severe infection not significantly different
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
A randomised, double-blind, placebo-controlled trial gave 1,565 patients receiving cyclic chemotherapy for solid tumours or lymphoma either levofloxacin 500 mg daily or placebo for seven days during the expected neutropenic period. Across the whole chemotherapy course, 10.8% on levofloxacin had at least one febrile episode against 15.2% on placebo (p=0.01); probable infection 34.2% against 41.5% (p=0.004); hospitalisation for infection 15.7% against 21.6% (p=0.004). Severe infection was 1.0% against 2.0% and did not reach significance (p=0.15), and there were four infection-related deaths in each arm. The authors state that secondary outcomes did not include a systematic evaluation of antibacterial resistance, so the cost side of prophylaxis was not measured in the trial that measured its benefit.
Written into the record, not signed off as a reviewed claim
A doubled aortic aneurysm rate, in a 720,000-episode cohort
In plain words
People given a fluoroquinolone were about two-thirds more likely to be admitted with a tear or bulge in the aorta within two months than people given amoxicillin. The absolute numbers are small; the label now says to avoid the drug in anyone already at risk.
What was measured
Hospitalisation or death from aortic aneurysm or dissection within 60 days of a fluoroquinolone prescription against a matched amoxicillin comparator
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
A Swedish nationwide register cohort matched 360,088 fluoroquinolone treatment episodes (78% ciprofloxacin) to 360,088 propensity-matched amoxicillin episodes. Within a 60-day risk window the rate of aortic aneurysm or dissection was 1.2 per 1,000 person-years on fluoroquinolone against 0.7 on amoxicillin, hazard ratio 1.66 (95% CI 1.12 to 2.46), an estimated absolute difference of 82 cases (95% CI 15 to 181) per million treatment episodes. The association was driven by aneurysm (HR 1.90, 1.22 to 2.96) rather than dissection (HR 0.93, 0.38 to 2.29). Section 5.9 of the label now states that the annual background risk reaches roughly 300 aneurysm events per 100,000 people at highest risk, that the evidence shows the potential for a 2-fold increase over background, that the cause has not been identified, and that in patients with a known aneurysm or at greater risk the drug should be reserved for when no alternative is available. This is observational evidence in an ageing population where confounding by indication is hard to exclude, and it changed the label anyway.
Written into the record, not signed off as a reviewed claim
In children, it worked in leukaemia and did not reach significance in transplant
In plain words
The same prophylaxis question in children gave two different answers in the same trial. Bloodstream infections fell sharply in children on intensive leukaemia chemotherapy and did not fall significantly in children having a stem-cell transplant.
What was measured
Bacteraemia during two chemotherapy cycles or one transplant procedure, in two separately randomised strata
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
A multicentre open-label randomised trial at 76 North American centres enrolled 624 patients aged six months to 21 years in two separate strata. Among 195 evaluable patients with acute myeloid leukaemia or relapsed acute lymphoblastic leukaemia, bacteraemia occurred in 21.9% on levofloxacin prophylaxis against 43.4% on no prophylaxis, risk difference 21.6% (95% CI 8.8 to 34.4, p=0.001). Among 418 evaluable haematopoietic stem-cell transplant recipients, bacteraemia was 11.0% against 17.3%, risk difference 6.3% (95% CI 0.3 to 13.0, p=0.06) — not significant at the trial threshold. Fever and neutropenia were less common overall (71.2% against 82.1%, p=0.002). The trial is a clean demonstration that a prophylaxis result does not transfer between populations, even between two arms of the same protocol run at the same sites in the same years.
Written into the record, not signed off as a reviewed claim
A cure rate from 1996 is a historical measurement
In plain words
The success rates on the label were measured against the bacteria of the 1990s. Bacteria have changed since. The number on the label has not.
What was measured
That a clinical cure rate measured in a 1990s registration trial describes the probability of cure today — an inference the label itself blocks by directing that current local susceptibility patterns guide selection
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Every antibacterial label opens with the instruction to use the drug only for infections proven or strongly suspected to be caused by susceptible bacteria, and directs that where culture and susceptibility data are unavailable, local epidemiology and susceptibility patterns should guide empiric selection. That sentence is an admission that the registration efficacy figures are conditional on a susceptibility distribution measured at a particular time and place. Section 12.4 records that resistance arises by mutation in the quinolone-resistance determining regions of gyrA or parC or by altered efflux, and that cross-resistance is observed between levofloxacin and some other fluoroquinolones — so a population exposed to any member of the class can lose susceptibility to this one. The trial numbers on this page remain accurate reports of what happened in those trials. They are not predictions about the organism in front of a reader today, and no antibiotic label claims otherwise.
Source
Levofloxacin United States prescribing information, sections 1.15 and 12.4 (NDA 020634)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
How many documents were read
76 documents were read for this substance.
RNAWiki source record
74 of them state the same halfLife, and they agree.
RNAWiki source record
71 of them state the same tMax, and they agree.
RNAWiki source record
74 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
6GNT3Y5LMF
RxNorm concept
545118
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✗ Not passed
Safety mode resolved
No register row and no identity class settled the question.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
Withdrawn in United States, 2018, for "Presence of Particulate Matter; contains visible particulate matter identified as mold." (openFDA drug enforcement Class I recall)
What the approval register records
52 approved applications cover products containing this substance. The earliest was NDA020634, approved 19961220 to JANSSEN PHARMS.
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 fluoroquinolone that jams the two bacterial enzymes which unwind DNA, achieving 92.4% clinical success in five days at 750 mg against 91.1% in ten days at 500 mg in a 528-patient community-acquired pneumonia trial — and carrying a boxed warning that directs prescribers to reserve it for patients with no alternative in sinusitis, bronchitis and uncomplicated urinary infection, the three complaints it was most often written for.
Recorded evidence blocks (10)
Q1
On the Levofloxacin (anhydrous) label: indicated for what?
"Levofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1 , 12.4 ). Pneumonia: Nosocomial ( 1.1 ) and Community Acquired ( 1.2 , 1.3 ) Skin and Skin Structure Infections…": indications and usage on Levofloxacin (anhydrous)'s label. DailyMed label · 59f387a4-4dfa-ba71-e063-6294a90a340c · 2026-08-26
Q2
206 registered trials of Levofloxacin (anhydrous) — at which phases?
Registered studies posting no result
170 of 206
206 registered studies of Levofloxacin (anhydrous): 70 phase3, 61 phase4, 36 phase2, 29 na, 15 phase1, 8 na or unstated, 2 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
731 with a PubMed record
Show the evidence
phase3
70
phase4
61
phase2
36
na
29
phase1
15
na or unstated
8
9 more recorded rows
early phase1
2
completed
120
unknown
40
terminated
16
not yet recruiting
13
recruiting
8
active not recruiting
5
withdrawn
3
enrolling by invitation
1
recorded 2026-09-01 · last checked 2026-09-04
Q3
15 of Levofloxacin (anhydrous)'s trials stopped: accrual/recruitment, funding/business, other?
accrual/recruitment (9), funding/business (2) and other (4): Levofloxacin (anhydrous)'s stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"Low rate of accrual"; 15 of 206 registered studies
Show the evidence
Trial
NCT00250718
terminated; "Low rate of accrual"
NCT00764582
terminated; "Study terminated due to lack of enrollment."
NCT01081964
terminated; "Financial considerations"
NCT01500382
terminated; "This study was terminated early due to insufficient recruitment."
NCT01756924
terminated; "This study has been terminated; alternative study designs are being considered. Fusidic acid remains available under an Expanded Access Protocol."
NCT01761201
terminated; "Recruitment rythm not sufficent to reach the simple size needed."
9 further recorded trials
NCT01875263
terminated; "Not participants inclusion"
NCT02099240
terminated; "Not enough patient enrollment and lack of staffing"
NCT02975570
withdrawn; "The study could not be conducted since funding was not obtained."
NCT03003273
terminated; "poor accrual"
NCT03021590
withdrawn; "No Participants Enrolled"
NCT03697993
terminated; "inadequate enrollment."
NCT05079620
terminated; "Under-enrollment"
NCT05250050
withdrawn; "Unable to complete in vitro culture of Helicobacter pylori in our hospital"
NCT06199778
terminated; "ethical issues"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Levofloxacin (anhydrous) used Levofloxacin 750 mg IV — over how long?
Human studies of Levofloxacin (anhydrous) used "Levofloxacin 750 mg IV". ClinicalTrials.gov · 2026-09-01
20 recorded entries; human; IV, ophthalmic; also "Levofloxacin 0.5%", "Levofloxacin 250mg", "1.5% levofloxacin ophthalmic solution"
Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID
humanNCT05867654
Levofloxacin 750mg QID
humanNCT06216639
Tavanic 500 mg filmsko obložene tablete
humanNCT06414707
Tavanic 500 mg
humanNCT06414707
Pantoprazole 40mg, Amoxicillin and Levofloxacin
humanNCT07040839
Levofloxacin 500 mg
recorded 2026-09-01 · last checked 2026-09-04
Q5
Levofloxacin (anhydrous)'s half-life is 6 to 8 hours — which schedules were studied?
6 to 8 hours, the half-life Levofloxacin (anhydrous)'s label states: "The mean terminal plasma elimination half-life of levofloxacin ranges from approximately 6 to 8 hours following single or multiple doses of levofloxacin given orally or intravenously." DailyMed label · 59f387a4-4dfa-ba71-e063-6294a90a340c · 2026-08-26
tmax 24 h; bioavailability 99 %.
Show the evidence
half lifepharmacokinetics
6 to 8 hours; The mean terminal plasma elimination half-life of levofloxacin ranges from approximately 6 to 8 hours following single or multiple doses of levofloxacin given orally or intravenously.
99 %; The absolute bioavailability of levofloxacin from a 500 mg tablet and a 750 mg tablet of levofloxacin are both approximately 99%, demonstrating complete oral absorption of levofloxacin.
metabolismpharmacokinetics
Elimination Metabolism Levofloxacin is stereochemically stable in plasma and urine and does not invert metabolically to its enantiomer, D-ofloxacin.
recorded 2026-08-26 · last checked 2026-09-04
Q6
Which running trial of Levofloxacin (anhydrous) could settle lifespan?
NCT04951986 measures All-cause mortality, reading out 2026-03.
1 open trial; n 732; "Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis"
Show the evidence
TrialNCT04951986
"Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis"; n 732; "All-cause mortality"; 2026-03
Q7
Which 78 trials of Levofloxacin (anhydrous) posted no result?
Posted no result
78 of 78 completed trials
Registrations
NCT00257036, NCT00257062, NCT00269932, NCT00249210, NCT00257140 and NCT00257049, and 72 more
Completion dates
oldest 1993-02; newest 2024-09-01
Show the evidence
Trial
NCT00257036
1993-02
NCT00257062
1994-04
NCT00269932
1994-05
NCT00249210
1994-07
NCT00257140
1994-07
NCT00257049
1995-01
14 further recorded trials
NCT00258089
1995-01
NCT00258102
1995-01
NCT00001033
1997-07
NCT00249197
1998-07
NCT00000796
1998-10
NCT00236808
2001-11
NCT00035347
2002-06
NCT00236821
2002-06
NCT00601432
2002-12
NCT00044473
2003-07
NCT00643409
2004-02
NCT00644449
2004-03
NCT00236522
2004-04
NCT00643734
2004-04
Q8
At the median, Levofloxacin (anhydrous)'s trials enrolled 150 people — anything larger?
Median enrolment
150
Largest enrolment
35000
Registered trials counted
202
Q9
What do 3566 spontaneous reports say about Levofloxacin (anhydrous) — 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.
Levofloxacin (anhydrous) appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3566 reaction mentions were counted: drug hypersensitivity 831; drug interaction 435; tendonitis 379; drug reaction with eosinophilia and systemic symptoms 353. FAERS via Open Targets · CHEMBL2237108 · 2026-06-24
Show the evidence
drug hypersensitivity
831
drug interaction
435
tendonitis
379
drug reaction with eosinophilia and systemic symptoms
353
tendon rupture
302
tendon pain
296
4 more recorded rows
electrocardiogram qt prolonged
279
cognitive disorder
239
pathogen resistance
239
balance disorder
213
recorded 2026-06-24 · last checked 2026-09-04
Q10
Which 10 reactions does Levofloxacin (anhydrous)'s label not list?
2 label terms; 10 reported and unlisted; 59f387a4-4dfa-ba71-e063-6294a90a340c
Show the evidence
balance disorder
count not stated
cognitive disorder
count not stated
drug hypersensitivity
count not stated
drug interaction
count not stated
drug reaction with eosinophilia and systemic symptoms
count not stated
electrocardiogram qt prolonged
count not stated
4 more recorded rows
pathogen resistance
count not stated
tendon pain
count not stated
tendon rupture
count not stated
tendonitis
count not stated
recorded 2026-06-24 · last checked 2026-09-04
Where it is registered
Where it’s registered
Withdrawn in United States, 2018, for "Presence of Particulate Matter; contains visible particulate matter identified as mold." (openFDA drug enforcement Class I recall)
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
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.