This page shows what was measured, who it was measured in, and what that does not settle.
What Ceftriaxone does in the body
Serious bacterial infections treated by injection.
Bacteria hold their shape with a mesh wall they constantly rebuild. Ceftriaxone jams the tool that does the rebuilding, so the wall thins and the cell bursts. It is built with a chemical shield that stops most bacterial defence enzymes from cutting it apart, and it sticks to blood proteins so tightly that one injection lasts a day. It leaves partly through the bile, and in the gallbladder it can clump into sludge.
What happened in people
About nine in ten evaluated hospital patients with pneumonia were cured.
✓ Reviewed first-read answer
Where this came from
A person wrote this and a reviewer approved it against this exact record. It carries no effect size.
A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.
No source is stored against this line.
The limit that matters most
Rising laboratory resistance in gonorrhoea is measured more often than whether treatment still cures people.
Where it acts
The bacterial cell envelope. Clinically the other site that matters is the biliary tree and the renal collecting system, where the drug precipitates as an insoluble calcium salt.
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 · 023Z5BR09K · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
The limit a reviewer approved as the one that matters most here.
The four opening statements run to 92 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Clinical response at the test-of-cure visit in the intent-to-treat and clinically evaluable populations
✓ The study showed what it set out to show
Who was studied
Pertel 2008 pooled community-acquired pneumonia programme
How many people
834
Study design
Two phase 3, randomised, double-blind, active-controlled trials pooled
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Clinically evaluable 87.9% ceftriaxone against 79.4% daptomycin (95% CI for the difference -13.8% to -3.2%); intent-to-treat 77.4% against 70.9% (95% CI -12.4% to -0.6%)
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. The trials were designed to test daptomycin, not ceftriaxone, so ceftriaxone’s own adverse-event profile is reported as a comparator arm rather than as a primary safety analysis. A post-hoc finding that as little as 24 hours of prior effective therapy erased the difference between arms is a warning about how pneumonia trials are read generally.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous infusion or intramuscular injection; no oral formulation exists
Interval reported. 95% CI for the difference -13
Written into the record, not signed off as a reviewed claim.
Coprimary: survival and rate of functional decline on the ALSFRS-R over stage 3
✗ The study did not show it
Who was studied
Ceftriaxone in amyotrophic lateral sclerosis (NCT00349622)
How many people
513
Study design
Combined phase 1, 2 and 3, randomised, double-blind, placebo-controlled
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
Functional decline difference 0.09 units per month (95% CI -0.06 to 0.24), P=0.2370; survival hazard ratio 0.90 (95% CI 0.71 to 1.15), P=0.4146. Stopped for futility.
Repeated elsewhere
Failed to Replicate
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. The stage 2 signal that justified stage 3 was 0.51 units per month (95% CI 0.02 to 1.00, P=0.0416) and did not survive. Hepatobiliary adverse events reached 62% against 11% on placebo despite universal ursodeoxycholic acid prophylaxis in the ceftriaxone arm — the largest placebo-controlled quantification of this harm anywhere in the literature.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous infusion or intramuscular injection; no oral formulation exists
Interval reported. 95% CI -0
Written into the record, not signed off as a reviewed claim.
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
Ceftriaxone
What a person takes: Intravenous infusion or intramuscular injection; no oral formulation exists.
The measurement behind this step
Given once daily in most indications because concentration-dependent plasma protein binding of about 85 to 95% holds the drug in circulation, not because it is cleared slowly. Eliminated by two routes at once — roughly a third to two-thirds unchanged in urine and the balance in bile — which is why it needs no dose reduction for moderate impairment of either organ alone, and why both organs are where its characteristic harm appears.
Getting in
Given by injection, because it cannot survive the gut
There is no tablet form. The molecule is destroyed by stomach acid and is too charged to be absorbed, so it goes in through a vein or a muscle. One injection covers a day.
──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
Ceftriaxone is administered intravenously or intramuscularly only. Its terminal half-life of roughly 6 to 9 hours in adults comes from concentration-dependent plasma protein binding of about 85 to 95%, not from slow intrinsic clearance — bound drug is a reservoir rather than a cleared fraction.
Very few antibiotics cross into the fluid around the brain and spinal cord in useful amounts. This one does, especially when the lining is inflamed — which is exactly when it is needed.
──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
Penetration into cerebrospinal fluid is limited under normal conditions and rises substantially when the meninges are inflamed, which is what makes ceftriaxone a first-line agent in bacterial meningitis. It also concentrates in bile, reaching many times the plasma concentration, and that biliary concentration is the origin of the pseudolithiasis on this page.
Bacteria carry enzymes that chop penicillins in half. Ceftriaxone carries a bulky chemical group positioned so those enzymes cannot get a grip. Newer versions of the same enzymes can.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The 2-aminothiazolyl ring with a syn-methoxyimino group sterically hinders hydrolysis by staphylococcal penicillinase and by classical TEM-1 and SHV-1 beta-lactamases. Extended-spectrum derivatives of those enzymes, the CTX-M family and AmpC cephalosporinases hydrolyse it efficiently, and that is the entire definition of the "ceftriaxone-nonsusceptible" organisms around which the MERINO trial was designed.
When a rod-shaped bacterium divides it builds a wall across its middle. Ceftriaxone preferentially blocks the tool that builds that cross-wall, so the cell keeps growing longer without ever splitting.
╌╌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
Highest affinity in Gram-negative organisms is for PBP3, the septal transpeptidase. Selective PBP3 inhibition produces the characteristic filamentation seen at sub-lethal concentrations, and lysis follows as autolysins continue to cleave peptidoglycan that is no longer being cross-linked.
With repair blocked and demolition continuing, internal pressure does the rest. This only works on bacteria that are actively growing.
╌╌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
Killing is time-dependent and requires active division. In meningitis, rapid lysis releases cell-wall fragments that drive the inflammatory response, which is the pharmacological reason adjunctive dexamethasone was studied in that setting at all.
Ceftriaxone leaves partly through the bile and partly through the kidneys. In both places it can bind calcium and drop out of solution as sludge or as a stone.
╌╌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
Roughly 33 to 67% is excreted unchanged in urine and the remainder in bile. The triazinedione moiety chelates calcium, forming a poorly soluble calcium-ceftriaxone salt that precipitates in concentrated bile and in urine. This is the mechanism behind biliary pseudolithiasis, paediatric urolithiasis at a pooled 7%, the 62% hepatobiliary adverse event rate in the ALS trial, and the neonatal contraindication with intravenous calcium.
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, children and newborns with serious bacterial infection, given by injection or infusion. It is used at enormous volume in emergency departments because it lasts long enough to give once a day.
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: “Ceftriaxone for Injection USP, Pharmacy Bulk Package bag, SmartPak ® should not be used in pediatric patients who require less than the 1 gram dose of ceftriaxone.”
US prescribing information · 5cd2d96f-83e5-4326-ae87-d0ede4ba493a · read 2026-08-30
On older people, the label states: “Of the total number of subjects in clinical studies of ceftriaxone sodium, 32% were 60 and over.”
US prescribing information · 5cd2d96f-83e5-4326-ae87-d0ede4ba493a · read 2026-08-30
On people who are pregnant, the label states: “Reproductive studies have been performed in mice, rats, and primates at intravenous doses of 625, 586, and 84 mg/kg/day, respectively without evidence of embryotoxicity, fetotoxicity, or teratogenicity.”
US prescribing information · 5cd2d96f-83e5-4326-ae87-d0ede4ba493a · read 2026-08-30
On people who are breastfeeding, the label states: “Ceftriaxone is excreted in human breast milk.”
US prescribing information · 5cd2d96f-83e5-4326-ae87-d0ede4ba493a · read 2026-08-30
Where the result stopped carrying
The ALS programme failed outright at stage 3 after a significant stage 2 signal, and stopped for futility
Biliary and urinary precipitation were not designed out of the molecule: the triazinedione group that gives the long half-life is the group that chelates calcium
Extended-spectrum beta-lactamases and AmpC enzymes hydrolyse ceftriaxone efficiently, and ceftriaxone-nonsusceptible Enterobacterales are now common enough to build a nine-country trial around
Gonococcal minimum inhibitory concentrations are rising, and the resistance determinant has moved out of an imported clone into endemic lineages
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
Intravenous infusion or intramuscular injection; no oral formulation exists
✎ 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
Given once daily in most indications because concentration-dependent plasma protein binding of about 85 to 95% holds the drug in circulation, not because it is cleared slowly.
✎ 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: Eliminated by two routes at once — roughly a third to two-thirds unchanged in urine and the balance in bile — which is why it needs no dose reduction for moderate impairment of either organ alone, and why both organs are where its characteristic harm appears.
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
Contraindicated in neonates aged 28 days or younger who are receiving or expected to receive calcium-containing intravenous solutions, and in hyperbilirubinaemic neonates, because ceftriaxone displaces bilirubin from albumin. Biliary pseudolithiasis and urolithiasis are the characteristic harms: the only large placebo-controlled trial recorded hepatobiliary adverse events in 62% against 11% on placebo, and serious ones in 12%, despite universal ursodeoxycholic acid prophylaxis. Immune haemolytic anaemia is rare and has been fatal. Clostridioides difficile-associated diarrhoea is reported as with essentially all antibacterials. Hypersensitivity reactions occur and cross-reactivity with penicillins is far lower for third-generation agents than for first-generation ones.
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
Intravenous infusion or intramuscular injection; no oral formulation exists
✎ 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: Eliminated by two routes at once — roughly a third to two-thirds unchanged in urine and the balance in bile — which is why it needs no dose reduction for moderate impairment of either organ alone, and why both organs are where its characteristic harm appears.
No source is stored against this line.
What is recorded as being sold
66 products list this as an active ingredient in the United States drug directory. 66 of them contain it and nothing else.
FDA National Drug Code directory · 0409-7334 · read 2026-08-29
They are sold as injection, powder, for solution, injection, solution and powder, taken intramuscular and intravenous.
FDA National Drug Code directory · 0409-7334 · read 2026-08-29
The regulator's established pharmacologic class for it is cephalosporin antibacterial [epc] and cephalosporins [cs].
FDA National Drug Code directory · 0409-7334 · read 2026-08-29
35 published labels name it as an active ingredient. 35 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1 · read 2026-08-29
Ceftriaxone is intravenous at 3 DOSAGE FORMS AND STRENGTHS 100 grams Ceftriaxone for Injection, USP, Pharmacy Bulk Package bag, SmartPak ® THIS IS A PHARMACY BULK PACKAGE – NOT FOR DIRECT INJECTION Pharmacy Bulk Package bags, 100 grams ( 3 ) THIS IS…, recorded as fda label in effect 2023-01-15 in the United States.
US prescribing information · 5cd2d96f-83e5-4326-ae87-d0ede4ba493a · read 2026-08-30
Recorded price in US: 0.8622–3.45 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 34 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 Ceftriaxone 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 raising EAAT2 glutamate-transporter activity would slow human ALS — a strong animal-model inference that a 513-person trial refuted
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 neonatal calcium precipitation risk generalises to adults, the basis of the 2007 universal warning that was narrowed in 2009
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 minimum inhibitory concentration below the breakpoint predicts cure in gonorrhoea — the surrogate the whole guideline rests on, never validated against a randomised endpoint
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 once-daily convenience and a broad in vitro spectrum imply outcome superiority; most of ceftriaxone’s indications were approved on cure rates without a mortality comparison
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 Ceftriaxone 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.
Ceftriaxone cured 87.9% of evaluable pneumonia patients in two pooled phase 3 trials
In plain words
In two randomised trials designed to test a rival drug, ceftriaxone was the comparator and won. Roughly nine in ten evaluable patients hospitalised with pneumonia were cured.
What was measured
Clinical cure at test of cure in hospitalised community-acquired pneumonia, ceftriaxone against daptomycin
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Two double-blind phase 3 trials in adults hospitalised with community-acquired pneumonia randomised patients to intravenous daptomycin or ceftriaxone once daily for 5 to 14 days. Pooled, the intent-to-treat population held 421 ceftriaxone and 413 daptomycin patients and the clinically evaluable population held 371 and 369. Clinical cure at test of cure was 87.9% with ceftriaxone against 79.4% with daptomycin in the clinically evaluable population (95% CI for the difference -13.8% to -3.2%) and 77.4% against 70.9% in the intent-to-treat population (95% CI -12.4% to -0.6%). Both intervals exclude zero in ceftriaxone’s favour.
Written into the record, not signed off as a reviewed claim
62% hepatobiliary adverse events against 11% on placebo, with prophylaxis in place
In plain words
The best measurement of ceftriaxone’s gallbladder problem comes from a trial in a completely different disease, because it is the only large placebo-controlled trial the drug has ever had. Nearly two in three people on ceftriaxone had a liver or gallbladder problem. One in nine had a serious one. Every one of them was also taking a drug meant to prevent exactly that.
What was measured
Hepatobiliary and gastrointestinal adverse event rates against matching placebo over prolonged exposure
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In the three-stage ALS trial, 340 participants received intravenous ceftriaxone and 173 placebo, at home through a central venous catheter, for a median of many months. Hepatobiliary adverse events occurred in 211 of 340 (62%) against 19 of 173 (11%), P<0.0001, and serious hepatobiliary adverse events in 41 participants (12%). Gastrointestinal adverse events occurred in 245 of 340 (72%) against 97 of 173 (56%), P=0.0004. Every ceftriaxone participant also received 300 mg ursodeoxycholic acid twice daily specifically to minimise biliary effects, and placebo participants received matched placebo capsules — so these rates are on top of prophylaxis, not instead of it.
Written into the record, not signed off as a reviewed claim
Roughly one child in fourteen forms a stone in the urinary tract
In plain words
The gallbladder problem is well known. The kidney one is less so. Pooling eight studies, about seven in a hundred children given ceftriaxone developed a stone in the urinary tract — with the caveat that the studies disagree wildly and the smallest ones are probably missing.
What was measured
Pooled proportion of paediatric ceftriaxone recipients developing urolithiasis across eight studies
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
A 2026 systematic review and meta-analysis pooled eight studies of urolithiasis in children receiving ceftriaxone. The pooled frequency was 7% (95% CI 2 to 12%), with substantial heterogeneity (I2 = 89.8%) and a 95% prediction interval of 2.7 to 15.8%. Retrospective studies from Asian regions reported rates up to 34% while prospective Western studies reported consistently lower ones. Excluding the main outlier reduced the pooled estimate to 4% (p=0.004). Egger’s test detected publication bias (p=0.006) in the direction of underreporting low-event studies, which cuts against the headline figure rather than for it. The authors concluded that well-powered prospective studies with standardised imaging are still required.
Written into the record, not signed off as a reviewed claim
The 2007 calcium contraindication was narrowed to newborns in 2009
In plain words
In 2007 regulators told clinicians never to give ceftriaxone and intravenous calcium to any patient, after fatal precipitation in newborns. In April 2009 that was narrowed to newborns only, because the evidence that adults were at risk did not hold up when it was examined.
What was measured
That an in vitro precipitation risk demonstrated in neonates generalises to adults — the inference the 2007 warning rested on, and the one the pharmacovigilance analysis did not support
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The original warning asserted that ceftriaxone and intravenous calcium products should not be coadministered to any patient. In April 2009 the FDA retracted the universal form of that assertion, leaving the contraindication in place for neonates aged 28 days or younger. A subsequent structured analysis of the FDA Adverse Event Reporting System compared 104 ceftriaxone-calcium events against 99 ceftazidime-calcium events as a comparator. Among ceftriaxone-calcium reports, 7.7% were classified probable and 20.2% possible for embolism; ceftazidime-calcium produced fewer probable (4%) but more possible (30.3%) events. Restricting to cases where either drug was primary or secondary suspect left a single probable embolic event — a patient who received ceftriaxone and calcium and died, with causality not attributable. The authors concluded the analysis supported the revised, narrower recommendation.
Written into the record, not signed off as a reviewed claim
The ALS signal was real at stage 2 and gone at stage 3
In plain words
Ceftriaxone raises the level of a protein that clears glutamate from around nerve cells, and in mice that slowed motor neurone disease. A trial ran in three stages. The middle stage found a statistically significant slowing of decline. The final stage, in five hundred people, found nothing at all.
What was measured
That raising EAAT2 glutamate-transporter activity, which delays onset and prolongs survival in mouse models, would slow human amyotrophic lateral sclerosis — a mechanistically strong inference that a 513-person randomised trial did not support
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In stages 1 and 2 of the trial, mean ALSFRS-R declined more slowly on 4 g daily ceftriaxone than on placebo — a difference of 0.51 units per month (95% CI 0.02 to 1.00, P=0.0416). In stage 3, which included 66 continuing participants and 448 new ones, with 340 allocated to ceftriaxone and 173 to placebo, the difference in functional decline was 0.09 units per month (95% CI -0.06 to 0.24, P=0.2370) and there was no survival difference (hazard ratio 0.90, 95% CI 0.71 to 1.15, P=0.4146). The trial stopped for futility. The stage 2 result was not fraud or error: it is what a borderline P value in a small cohort looks like when the underlying effect is zero.
Written into the record, not signed off as a reviewed claim
In gonorrhoea, cure is inferred from a laboratory number that is moving
In plain words
Ceftriaxone is the last drug that reliably cures gonorrhoea. What is measured routinely is not cure but a laboratory value — the concentration needed to stop the bacterium growing in a dish — and that value is rising in several countries.
What was measured
That a minimum inhibitory concentration below the breakpoint predicts cure in gonorrhoea and one above it predicts failure — the surrogate the entire treatment guideline rests on, validated by mechanism and case reports rather than by a randomised endpoint
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Surveillance rather than trials carries this indication. In a Hangzhou surveillance series, high-level ceftriaxone resistance defined as a minimum inhibitory concentration of 0.5 mg/L or above reached 35% of surveyed isolates in 2024 and 19% in 2025, driven by expansion of strains carrying penA allele 60.001. Genomic analysis showed a shift in which lineage carries that allele: early isolates from 2019 to 2021 belonged to the internationally disseminated FC428 clone (ST1903), but from 2022 the resistant isolates were predominantly the endemic ST8123 lineage, a genetically distinct clade. Whether an isolate above a breakpoint predicts an individual treatment failure is supported by case reports and by pharmacodynamic reasoning rather than by any randomised comparison, because no such trial exists or is likely to.
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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.
A third-generation cephalosporin whose side chain resists the beta-lactamases that destroy older penicillins and whose long half-life allows once-daily injection — it cured 87.9% of clinically evaluable community-acquired pneumonia patients in two pooled phase 3 trials, and in the only large placebo-controlled trial it has ever had, 62% of the 340 people who received it developed hepatobiliary adverse events against 11% on placebo.
Recorded evidence blocks (10)
Q1
On the Ceftriaxone label: indicated for what?
"To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection and other antibacterial drugs, Ceftriaxone for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and…": indications and usage on Ceftriaxone's label. DailyMed label · 5cd2d96f-83e5-4326-ae87-d0ede4ba493a · 2023-01-15
Q2
113 registered trials of Ceftriaxone — at which phases?
Registered studies posting no result
86 of 113
113 registered studies of Ceftriaxone: 34 phase4, 31 phase3, 28 phase2, 15 na, 6 phase1, 5 na or unstated, 2 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
896 with a PubMed record
Show the evidence
phase4
34
phase3
31
phase2
28
na
15
phase1
6
na or unstated
5
7 more recorded rows
early phase1
2
completed
67
unknown
22
terminated
13
recruiting
7
not yet recruiting
2
withdrawn
2
recorded 2026-09-01 · last checked 2026-09-04
Q3
12 of Ceftriaxone's trials stopped: accrual/recruitment, funding/business, other?
"Early indication of an unfavorable risk/benefit ratio."; 12 of 113 registered studies
Show the evidence
Trial
NCT00566111
terminated; "Early indication of an unfavorable risk/benefit ratio."
NCT00591318
terminated; "Study was terminated after enrolling 12 patients due to poor enrollment rates"
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"
NCT02605122
terminated; "Development not proceeding"
NCT03012360
terminated; "lack of inclusion pandemic, investigator reluctance, lower than expected incidence of infection"
6 further recorded trials
NCT03560232
terminated; "Unable to recruit patients in a timely fashion and unable to recruit sufficient patients"
NCT04975945
withdrawn; "Technical and organisational issues at the center, leading to inability to enrol study participants"
NCT04999592
terminated; "Lapse in funding"
NCT05079620
terminated; "Under-enrollment"
NCT05149287
terminated; "Funding stopped"
NCT05980871
terminated; "An error of the sample size calculation occurred. A previous calculation based on a previous trial by Cao et al estimated to assign 150 participants to each group. A corrected calculation showed that 43 participants for each group is…"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Ceftriaxone used Ceftriaxone 2000 mg — over how long?
Human studies of Ceftriaxone used "Ceftriaxone 2000 mg". ClinicalTrials.gov · 2026-09-01
3 recorded entries; human; IV; also "Ceftriaxone 1000 MG", "ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly"
Show the evidence
human
NCT01988428
Ceftriaxone 2000 mg
NCT06396078
Ceftriaxone 1000 MG
NCT06828952
IV; ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly
recorded 2026-09-01 · last checked 2026-09-04
Q5
Ceftriaxone's half-life is 5.8 to 8.7 hours — which schedules were studied?
5.8 to 8.7 hours, the half-life Ceftriaxone's label states: "257 192 154 117 89 74 46 31 15 Over a 0.15 to 3 g dose range in healthy adult subjects, the mean elimination half-life ranged from 5.8 to 8.7 hours, plasma clearance ranged from 0.58 to 1.45 L/hour, and renal clearance ranged from 0.32 to 0.73 L/hour." DailyMed label · 5cd2d96f-83e5-4326-ae87-d0ede4ba493a · 2023-01-15
Show the evidence
half lifepharmacokinetics
5.8 to 8.7 hours; 257 192 154 117 89 74 46 31 15 Over a 0.15 to 3 g dose range in healthy adult subjects, the mean elimination half-life ranged from 5.8 to 8.7 hours, plasma clearance ranged from 0.58 to 1.45 L/hour, and renal clearance ranged from 0.32 to 0.73 L/hour.
recorded 2023-01-15 · last checked 2026-09-04
Q6
Which running trial of Ceftriaxone could settle lifespan?
NCT02735707 measures All-cause mortality, reading out 2028-02.
1 open trial; n 20000; "Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia"
Show the evidence
TrialNCT02735707
"Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia"; n 20000; "All-cause mortality"; 2028-02
Q7
Which 38 trials of Ceftriaxone posted no result?
Posted no result
38 of 38 completed trials
Registrations
NCT00000648, NCT00001101, NCT00035347, NCT00374959, NCT00000938 and NCT00358202, and 32 more
Completion dates
oldest 1996-02; newest 2024-04-05
Show the evidence
Trial
NCT00000648
1996-02
NCT00001101
2001-03
NCT00035347
2002-06
NCT00374959
2003-10
NCT00000938
2005-11
NCT00358202
2006-04
14 further recorded trials
NCT00111644
2007-01
NCT00372541
2007-03
NCT00004216
2008-01
NCT00138801
2008-12
NCT00895089
2011-12
NCT02123628
2012-09
NCT00838864
2013-04
NCT01390623
2013-12
NCT01530763
2014-07
NCT01421693
2015-01
NCT01150747
2015-08
NCT02098486
2015-09
NCT02561442
2015-12
NCT02210325
2017-02-22
Q8
At the median, Ceftriaxone's trials enrolled 105 people — anything larger?
Median enrolment
105
Largest enrolment
20000
Registered trials counted
111
Q9
What do 2091 spontaneous reports say about Ceftriaxone — 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.
Ceftriaxone appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2091 reaction mentions were counted: drug reaction with eosinophilia and systemic symptoms 401; rash maculo-papular 250; cholelithiasis 239; anaphylactic reaction 189. FAERS via Open Targets · CHEMBL161 · 2026-06-24
Show the evidence
drug reaction with eosinophilia and systemic symptoms
401
rash maculo-papular
250
cholelithiasis
239
anaphylactic reaction
189
eosinophilia
183
renal failure acute
179
4 more recorded rows
hepatitis
178
acute generalised exanthematous pustulosis
176
toxic epidermal necrolysis
154
premature baby
142
recorded 2026-06-24 · last checked 2026-09-04
Q10
Which 10 reactions does Ceftriaxone's label not list?
acute generalised exanthematous pustulosis, anaphylactic reaction and cholelithiasis and 7 more reported for Ceftriaxone, absent from its label. FAERS via Open Targets · CHEMBL161 · 2026-06-24
2 label terms; 10 reported and unlisted; 5cd2d96f-83e5-4326-ae87-d0ede4ba493a
Show the evidence
acute generalised exanthematous pustulosis
count not stated
anaphylactic reaction
count not stated
cholelithiasis
count not stated
drug reaction with eosinophilia and systemic symptoms
count not stated
eosinophilia
count not stated
hepatitis
count not stated
4 more recorded rows
premature baby
count not stated
rash maculo-papular
count not stated
renal failure acute
count not stated
toxic epidermal necrolysis
count not stated
recorded 2026-06-24 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 source rows
✓ no critical contamination: no quarantine open
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✓ no raw internal fields: enforced by the copy-contract test over the rendered page
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