This page shows what was measured, who it was measured in, and what that does not settle.
What Amoxicillin Anhydrous does in the body
A bacterium is held together by a rigid outer mesh it has to keep repairing as it grows.
Amoxicillin is shaped like the piece the repair enzyme normally picks up, so the enzyme picks up the drug instead and is permanently stuck. The mesh stops being repaired, the cell swells under its own internal pressure, and it bursts. Human cells have no such mesh and no such enzyme, which is why the drug can be given to a six-month-old.
Why people take it. Used for certain bacterial infections of the ears, throat, sinuses, chest or urine.
What happened in people
In strictly diagnosed childhood ear infections, persistent infection fell from about one half to about one sixth.
✓ 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
It does not help ordinary coughs when pneumonia is not suspected.
Where it acts
Bacterial periplasm and cell wall, at the site of infection
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
Its recorded molecular formula is C16H19N3O5S, weighing 419.45.
US prescribing information · 6a3d1af5-6e93-4f06-8d82-1c87290c46aa · read 2026-08-30
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
A reviewer approved this sentence against this exact record and its sources.
The limit a reviewer approved as the one that matters most here.
The four opening statements run to 109 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.
Time to resolution of symptoms and rate of clinical failure on otoscopy in children aged 6 to 23 months
✓ The study showed what it set out to show
Who was studied
Hoberman acute otitis media trial (NCT00377260)
How many people
291
Study design
Phase 4 randomised placebo-controlled
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
P < 0.001 for clinical failure at day 10 to 12
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. Diarrhoea and diaper-area dermatitis were both more common with amoxicillin-clavulanate than with placebo.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsule, tablet, chewable tablet and powder for oral suspension
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 5 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
Amoxicillin Anhydrous
What a person takes: Oral capsule, tablet, chewable tablet and powder for oral suspension.
The measurement behind this step
Given by mouth two or three times daily. Acid stability is what distinguishes amoxicillin from benzylpenicillin: the para-hydroxyl and alpha-amino substituents on the side chain let it survive gastric acid and be absorbed largely intact, which is why the same molecular target can be reached with a capsule rather than an injection.
Getting in
Swallowed, absorbed and delivered to the infected tissue
Amoxicillin survives stomach acid better than the penicillin it was derived from, so most of an oral dose reaches the bloodstream and then the infected tissue.
╌╌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 para-hydroxyl and alpha-amino groups on the phenylglycine side chain raise acid stability and oral bioavailability relative to benzylpenicillin. Distribution is mainly extracellular, with penetration into middle-ear fluid, sinus secretions and lung tissue; clearance is predominantly renal and largely unchanged drug.
Through the bacterial outer layers to the periplasm
The drug has to get past the bacterium outer coat to reach the space where the wall is being built.
╌╌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
In Gram-negative organisms the drug crosses the outer membrane through porin channels into the periplasmic space. In Gram-positive organisms the thick peptidoglycan layer is directly accessible. Where a bacterium expresses a beta-lactamase in that space, the drug is hydrolysed before it ever reaches its target, which is why the clavulanate combination exists.
The strained four-membered ring at the heart of the molecule looks like the end of the chain the wall-building enzyme normally grabs.
╌╌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 beta-lactam ring is a structural analogue of the D-alanyl-D-alanine terminus of the peptidoglycan pentapeptide. Penicillin-binding proteins recognise it as substrate and the active-site serine attacks the carbonyl.
The enzyme grabs the drug, opens the ring and then cannot let go. Every enzyme that does this is permanently out of service.
╌╌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
Nucleophilic attack by the active-site serine opens the strained beta-lactam ring, forming a covalent penicilloyl-enzyme ester that hydrolyses orders of magnitude more slowly than the natural acyl-enzyme intermediate. Transpeptidation stops, so new peptidoglycan strands are laid down without being cross-linked.
With the mesh no longer being cross-linked while the cell keeps growing, internal pressure tears it 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
Uncross-linked peptidoglycan cannot resist turgor pressure, and the bacterium activates its own autolysins, so killing is bactericidal rather than merely inhibitory. This is a time-dependent effect: efficacy tracks the fraction of the dosing interval during which free drug exceeds the minimum inhibitory concentration, not the peak level.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 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.
Children with acute otitis media diagnosed on strict otoscopic criteria, adults and children with confirmed streptococcal pharyngitis or community-acquired pneumonia, and patients on Helicobacter pylori eradication regimens.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of amoxicillin for the treatment of upper respiratory tract infections, and infections of the genitourinary tract, skin and skin structure and lower respiratory tract have been established in pediatric patients.”
US prescribing information · 6a3d1af5-6e93-4f06-8d82-1c87290c46aa · read 2026-08-30
On older people, the label states: “An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects.”
US prescribing information · 6a3d1af5-6e93-4f06-8d82-1c87290c46aa · read 2026-08-30
On people who are pregnant, the label states: “Teratogenic Effects: Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area).”
US prescribing information · 6a3d1af5-6e93-4f06-8d82-1c87290c46aa · read 2026-08-30
On people who are breastfeeding, the label states: “Penicillins have been shown to be excreted in human milk.”
US prescribing information · 6a3d1af5-6e93-4f06-8d82-1c87290c46aa · read 2026-08-30
Where the result stopped carrying
GRACE: no reduction in symptom duration or severity for acute lower respiratory tract infection in primary care, with a number needed to harm of 21 for nausea, rash or diarrhoea
In the Hoberman trial, initial symptom resolution did not differ significantly from placebo (P=0.14) even though otoscopic failure did
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
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral capsule, tablet, chewable tablet and powder for oral suspension
✎ 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 by mouth two or three times daily.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold. The rest of the recorded wording: Acid stability is what distinguishes amoxicillin from benzylpenicillin: the para-hydroxyl and alpha-amino substituents on the side chain let it survive gastric acid and be absorbed largely intact, which is why the same molecular target can be reached with a capsule rather than an injection.
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
The most common adverse effects are diarrhoea, nausea and rash. A morbilliform rash during amoxicillin treatment of infectious mononucleosis is common and is not evidence of IgE-mediated penicillin allergy. True anaphylaxis is rare but occurred once in the 1,038 patients treated in the GRACE trial. Clostridioides difficile infection is a recognised complication of any broad-spectrum antibacterial course.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral capsule, tablet, chewable tablet and powder for oral suspension
✎ 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: Acid stability is what distinguishes amoxicillin from benzylpenicillin: the para-hydroxyl and alpha-amino substituents on the side chain let it survive gastric acid and be absorbed largely intact, which is why the same molecular target can be reached with a capsule rather than an injection.
No source is stored against this line.
What is recorded as being sold
506 products list this as an active ingredient in the United States drug directory. 296 of them contain it and nothing else.
FDA National Drug Code directory · 72162-2210 · read 2026-08-29
They are sold as capsule, capsule, delayed release, for suspension, powder, powder, for suspension and suspension, taken oral.
FDA National Drug Code directory · 72162-2210 · read 2026-08-29
The regulator's established pharmacologic class for it is penicillin-class antibacterial [epc] and penicillins [cs].
FDA National Drug Code directory · 72162-2210 · read 2026-08-29
387 published labels name it as an active ingredient. 220 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · ab1dbe70-696f-4ff9-a0c7-7406bff590ae · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · ab1dbe70-696f-4ff9-a0c7-7406bff590ae · read 2026-08-29
1 marketed supplement label lists this ingredient, classed as non-nutrient/non-botanical.
Those labels carry all other and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.
Recorded price in US: 0.01846–0.04425 USD per one millilitre, across 51 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: 0.06839–0.31064 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 47 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 Amoxicillin 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 because amoxicillin works in strictly diagnosed acute otitis media it also works for acute cough: the GRACE trial tested that directly in 2,061 adults and found a hazard ratio of 1.06
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 penicillin allergy recorded in childhood is a current allergy
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 benefit measured in an individual patient trial is the whole benefit-harm calculation, when resistance selection is a population-level cost no such trial measures
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 Amoxicillin 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.
Acute otitis media in children aged 6 to 23 months: clinical failure fell from 51% to 16%
In plain words
In 291 young children whose eardrums were examined against strict criteria, treatment cut the rate of persistent infection on examination from about half to about one in six.
What was measured
Rate of clinical failure on otoscopic examination at day 10 to 12
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Randomised, double-blind, placebo-controlled. Amoxicillin-clavulanate for 10 days versus placebo. Clinical failure, defined as persistence of signs of acute infection on otoscopy, occurred in 4% versus 23% at or before day 4 or 5 (P<0.001) and 16% versus 51% at or before day 10 to 12 (P<0.001). Sustained symptom resolution favoured treatment (P=0.04) but initial symptom resolution did not (P=0.14): the drug changed what the ear looked like sooner than it changed how the child felt.
Written into the record, not signed off as a reviewed claim
GRACE: no benefit for acute lower respiratory tract infection in 2,061 primary-care adults
In plain words
In the largest placebo-controlled trial of amoxicillin for an acute cough, the drug did not shorten symptoms, and it caused more side effects than it prevented complications.
What was measured
Duration of symptoms rated moderately bad or worse
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Twelve countries, 1,038 patients on amoxicillin 1 g three times daily for 7 days versus 1,023 on placebo, all with cough of 28 days or less and no clinical suspicion of pneumonia. Duration of symptoms rated moderately bad or worse: hazard ratio 1.06 (95% CI 0.96 to 1.18; P=0.229). Mean symptom severity 1.62 versus 1.69 (P=0.074). New or worsening symptoms were less common on amoxicillin (15.9% versus 19.3%; P=0.043; number needed to treat 30) while nausea, rash or diarrhoea were more common (number needed to harm 21), and there was one case of anaphylaxis. No selective benefit was found in patients aged 60 or over.
Written into the record, not signed off as a reviewed claim
CAP-IT: three days was non-inferior to seven in childhood pneumonia
In plain words
A randomised trial found that three days of amoxicillin worked as well as seven for children discharged with community-acquired pneumonia, on the outcome of needing another antibiotic.
What was measured
Clinically indicated antibiotic re-treatment within 28 days
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
A 2x2 factorial non-inferiority trial in 824 children aged 6 months and over, discharged from emergency departments or wards in 28 UK hospitals and one Irish hospital. Antibiotic re-treatment for respiratory infection within 28 days occurred in 12.5% with 3 days and 12.5% with 7 days (difference 0.1%, one-sided 95% CI up to 3.9%, non-inferiority margin 8%), and in 12.6% with the lower dose versus 12.4% with the higher (difference 0.2%). Cough lasted a median of 12 days on 3 days of treatment versus 10 days on 7 days (HR 1.2; P=0.04), so the shorter course was not free of cost.
Written into the record, not signed off as a reviewed claim
The penicillin allergy label is inherited far more often than it is verified
In plain words
Most people carrying a penicillin allergy label are not allergic, and the label pushes them onto broader, more expensive antibiotics for the rest of their lives.
What was measured
That a childhood rash recorded as a penicillin allergy predicts a current IgE-mediated reaction
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Fewer than 5% of patients labelled penicillin-allergic are truly allergic. In PALACE, a multicentre randomised non-inferiority trial across six specialist centres in North America and Australia, adults scoring below 3 on the PEN-FAST decision rule were assigned to direct oral penicillin challenge or to skin testing followed by challenge. A physician-verified positive immune-mediated challenge occurred in 1 of 187 (0.5%) and 1 of 190 (0.5%), risk difference 0.0084 percentage points (90% CI -1.22 to 1.24), within the 5-percentage-point non-inferiority margin. No serious adverse events occurred.
Written into the record, not signed off as a reviewed claim
Tahtinen: the parallel placebo-controlled trial replicated the otitis media result
In plain words
A second randomised trial published in the same issue of the same journal, run by a different group in a different country, found the same thing.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
A placebo-controlled trial of amoxicillin-clavulanate in children aged 6 to 35 months with acute otitis media diagnosed on stringent criteria, published alongside Hoberman. Two independent trials reaching a concordant conclusion in the same population is the reason this indication is graded as replicated here, and the reason the acute-cough result is graded separately.
Written into the record, not signed off as a reviewed claim
Resistance is a population-level cost that no individual prescription trial measures
In plain words
Every trial here counts what happened to the patients in it. None of them count what the prescribing did to the bacteria everyone else will meet.
What was measured
That the individual benefit measured in a treatment trial is the whole of the benefit-harm calculation for an antibiotic
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The GBD antimicrobial resistance study estimated 4.95 million deaths (95% UI 3.62 to 6.57 million) associated with bacterial antimicrobial resistance in 2019, of which 1.27 million (0.911 to 1.71 million) were attributable to it. Lower respiratory infections were the most burdensome syndrome. That figure is an ecological estimate across 204 countries, not an outcome measured in any amoxicillin trial, and the two cannot be added together or traded off within a single randomised comparison.
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.
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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 beta-lactam that jams the enzyme bacteria use to build their cell wall, with a large randomised benefit in strictly diagnosed acute otitis media and essentially none in acute cough where pneumonia is not suspected.
Recorded evidence blocks (9)
Q1
On the Amoxicillin Anhydrous label: indicated for what?
"Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae ,…": indications and usage on Amoxicillin Anhydrous's label. DailyMed label · 3a4afd36-dffa-44a1-9d09-e93cf66053bf · 2026-08-20
Q2
323 registered trials of Amoxicillin Anhydrous — at which phases?
Registered studies posting no result
284 of 323
323 registered studies of Amoxicillin Anhydrous: 138 phase4, 78 na, 50 phase3, 29 phase2, 24 phase1, 10 na or unstated, 8 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
safety (2), futility/efficacy (2), accrual/recruitment (7), funding/business (2) and other (9): Amoxicillin Anhydrous's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"no inclusion"; 22 of 323 registered studies
Show the evidence
Trial
NCT00713947
withdrawn; "no inclusion"
NCT00764062
terminated; "The trial was stopped earlier than planned because of the slow accrual rate."
NCT00799838
terminated; "Recruitment challenges despite several attenpts to increase enrollment"
NCT01059123
terminated; "Insufficient number of inclusion"
NCT01533818
terminated; "The study was stopped by DSMB based on high treatment failure rate in placebo compared to active drug."
NCT01930955
withdrawn; "no patients were included"
14 further recorded trials
NCT02099240
terminated; "Not enough patient enrollment and lack of staffing"
NCT02131818
terminated; "The enrollment process is too difficult to complete"
NCT02332577
terminated; "The sponsor stopped the study due to low recruitment with no safety concerns"
NCT02605122
terminated; "Development not proceeding"
NCT02783404
terminated; "Significant results (no control neither amoxicillin new arms needed)"
NCT03021590
withdrawn; "No Participants Enrolled"
NCT03060473
terminated; "Patient population that meets study criteria is insufficient to continue project in a reasonable amount of time. To continue is futile in resources, staff time, and effort."
NCT03208361
terminated; "Lack of financial support to continue with the study recruitment. Independent study financially supported by a national grant with a 4.5 years duration."
NCT03431337
terminated; "Futility found by interim analysis"
NCT04057014
withdrawn; "No funding available for the activity"
NCT05165212
withdrawn; "Unable to host study at clinic site."
NCT05250050
withdrawn; "Unable to complete in vitro culture of Helicobacter pylori in our hospital"
NCT05464615
terminated; "PI does not wish to proceed due to a different clinical decision tool becoming available"
NCT05473234
terminated; "Study was halted due to low follow-up rates and issues with data collection"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Amoxicillin Anhydrous used Amoxicillin 600mg — over how long?
Human studies of Amoxicillin Anhydrous used "Amoxicillin 600mg". ClinicalTrials.gov · 2026-09-01
20 recorded entries; human; tablet; also "Amoxicillin 500 mg MYLAN, no. 30 + 20.", "Amoxicillin, Sandoz, 1 g tablet", "Chongkundang Amoxicillin Cap. 500mg"
61.3 minutes; Metabolism and Excretion: The half-life of amoxicillin is 61.3 minutes.
tmaxpharmacokinetics
1 hour; Peak concentrations occurred approximately 1 hour after the dose.
metabolismpharmacokinetics
Metabolism and Excretion: The half-life of amoxicillin is 61.3 minutes.
recorded 2026-08-20 · last checked 2026-09-04
Q6
Which 131 trials of Amoxicillin Anhydrous posted no result?
Posted no result
131 of 131 completed trials
Registrations
NCT00227331, NCT00539149, NCT00001658, NCT00002682, NCT01559753 and NCT00778050, and 125 more
Completion dates
oldest 2000-01; newest 2024-09-01
Show the evidence
Trial
NCT00227331
2000-01
NCT00539149
2001-03
NCT00001658
2001-06
NCT00002682
2001-10-08
NCT01559753
2002-11
NCT00778050
2002-12
14 further recorded trials
NCT01156740
2003-04
NCT00750750
2003-09-01
NCT00643149
2004-03
NCT00130013
2004-06
NCT01375426
2004-06
NCT00751075
2004-06-22
NCT01933698
2005-07
NCT01310361
2006-03
NCT00407394
2006-04
NCT00084201
2007-06
NCT00933049
2008-01
NCT00851487
2008-04
NCT01192789
2010-05
NCT01792700
2010-12
Q7
At the median, Amoxicillin Anhydrous's trials enrolled 187 people — anything larger?
Median enrolment
187
Largest enrolment
100000
Registered trials counted
320
Q8
What do 11855 spontaneous reports say about Amoxicillin 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.
Amoxicillin Anhydrous appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 11855 reaction mentions were counted: drug hypersensitivity 2930; rash 1517; pruritus 1464; urticaria 1335. FAERS via Open Targets · CHEMBL1082 · 2026-06-24
Show the evidence
drug hypersensitivity
2930
rash
1517
pruritus
1464
urticaria
1335
erythema
913
acute kidney injury
831
4 more recorded rows
rash maculo-papular
806
drug reaction with eosinophilia and systemic symptoms
760
anaphylactic reaction
664
angioedema
635
recorded 2026-06-24 · last checked 2026-09-04
Q9
Which 10 reactions does Amoxicillin Anhydrous's label not list?
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
✓ 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.