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Azithromycin Anhydrous

  • Prescription medicine
  • Given by a clinician
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Azithromycin Anhydrous does in the body

Chains that cannot get out cause the machine to stall and drop them, so the bacterium stops growing.

Bacteria make proteins on a machine that feeds the finished protein out through a narrow tunnel. Azithromycin sits in that tunnel like a cork. The drug is also taken up by your own white blood cells and released slowly from them, which is why a short course keeps working after the last tablet.

Why people take it. Chest, throat, skin and sexually transmitted bacterial infections, and mass treatment for trachoma

What happened in people

A hazard ratio of 2.49 for cardiovascular death during 5 days of therapy versus amoxicillin in a propensity-matched cohort of over 2 million treatment episodes

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.

The limit that matters most

That the anti-inflammatory properties of macrolides translate into benefit in viral illness — tested directly in RECOVERY and PRINCIPLE, and refuted in both

Where it acts
Bacterial ribosome; drug concentrates in phagocytes and tissue
Kind of result
Living longer, or avoiding a major event
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 · 5FD1131I7S · read 2026-08-29

  • Its recorded molecular formula is C38H72N2O12, weighing 749.00.

    US prescribing information · 7ab854bf-eb04-42c4-a403-096b60581bb4 · 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.

The recorded use, written for a reader without medical training. Not signed off.

A limit recorded against this substance. Not signed off as a reviewed claim.

The four opening statements run to 110 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 peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Aggregate all-cause mortality in children aged 1 to 59 months

The study showed what it set out to show

Who was studied
MORDOR (NCT02047981)
How many people
190238
Study design
Phase 4 cluster-randomised placebo-controlled
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
P < 0.001 (13.5% lower mortality, 95% CI 6.7 to 19.8)
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. Macrolide resistance was not reported in the primary paper; the prespecified substudy published a year later found nasopharyngeal pneumococcal macrolide resistance of 12.3% versus 2.9%.

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

Form and route. Oral tablet, powder for oral suspension, single-dose powder packet, and intravenous infusion

Interval reported. 95% CI 6

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

All-cause mortality over 2 years by age stratum

The study showed what it set out to show

Who was studied
AVENIR (NCT04224987)
How many people
864493
Study design
Phase 4 adaptive cluster-randomised placebo-controlled
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
Reported in N Engl J Med 2024; see the primary publication for strata
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. No limitation is recorded for this study.

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

Form and route. Oral tablet, powder for oral suspension, single-dose powder packet, and intravenous infusion

Interval reported. Not recorded in this summary

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

28-day all-cause mortality in patients hospitalised with COVID-19

The study did not show it

Who was studied
RECOVERY azithromycin comparison (NCT04381936, ISRCTN50189673)
How many people
7763
Study design
Randomised controlled open-label platform
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
P = 0.50 (rate ratio 0.97, 95% CI 0.87 to 1.07)
Repeated elsewhere
Replicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral tablet, powder for oral suspension, single-dose powder packet, and intravenous infusion

Interval reported. 95% CI 0

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

Time to first self-reported recovery and hospitalisation or death in community COVID-19

The study did not show it

Who was studied
PRINCIPLE azithromycin comparison (ISRCTN86534580)
How many people
2265
Study design
Randomised controlled open-label adaptive platform
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Hazard ratio 1.08 (95% Bayesian credible interval 0.95 to 1.23); probability of a clinically meaningful benefit 0.23
Repeated elsewhere
Replicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral tablet, powder for oral suspension, single-dose powder packet, and intravenous infusion

Interval reported. Not recorded in this summary

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

Rate of total asthma exacerbations and asthma-related quality of life over 48 weeks

The study showed what it set out to show

Who was studied
AMAZES
How many people
420
Study design
Randomised double-blind placebo-controlled
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
P < 0.0001 (incidence rate ratio 0.59, 95% CI 0.47 to 0.74)
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. Long-term thrice-weekly dosing raises the same macrolide-resistance question the MORDOR substudy quantified at community level.

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

Form and route. Oral tablet, powder for oral suspension, single-dose powder packet, and intravenous infusion

Interval reported. 95% CI 0

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

What we know
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 bodyRead 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.

Where a source records it acting

  • Lungs and airways: Indicated for community-acquired pneumonia caused by designated, susceptible bacteria

    US prescribing information · 003307c5-3f73-4a5d-a704-bfdea3c656e8 · read 2026-08-27

  • Skin: Indicated for uncomplicated skin and skin structure infections caused by designated, susceptible bacteria

    US prescribing information · 003307c5-3f73-4a5d-a704-bfdea3c656e8 · read 2026-08-27

  • Mouth and throat: Indicated for pharyngitis/tonsillitis caused by designated, susceptible bacteria

    US prescribing information · 003307c5-3f73-4a5d-a704-bfdea3c656e8 · read 2026-08-27

  1. Start

    Azithromycin Anhydrous

    What a person takes: Oral tablet, powder for oral suspension, single-dose powder packet, and intravenous infusion.

    The measurement behind this step

    Once-daily dosing, typically as a three-day or five-day course, or a single dose for some indications. The long tissue half-life is a property of the molecule rather than of the formulation: the dibasic azalide is trapped in acidic intracellular compartments and released slowly, so tissue exposure continues for days after the last dose.

  2. Getting in

    Taken up by white blood cells and carried to the infection

    Rather than staying in the blood, azithromycin is swallowed up by your own immune cells, which then travel to wherever the infection is.

    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

    The dibasic azalide structure traps the drug in acidic intracellular compartments of phagocytes, producing tissue concentrations far above plasma and a terminal half-life of roughly 68 hours. This is why a three-day or five-day course provides about a week of tissue exposure.

  3. Reaching the cell

    Released into the bacterial environment and taken inside

    The immune cell releases the drug where bacteria are, and the drug crosses into the bacterium.

    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

    Release from phagocytes at the infection site delivers the drug to the bacterial surface. Entry across the Gram-positive cell wall is straightforward; the extra amine relative to erythromycin improves penetration of the Gram-negative outer membrane, which is why azithromycin has activity erythromycin lacks against Haemophilus influenzae.

  4. What it acts on

    It binds the exit tunnel of the bacterial ribosome

    The drug lodges in the tunnel that a newly made protein has to pass through on its way out of the machine.

    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

    Azithromycin binds the 23S ribosomal RNA of the 50S subunit at the nascent peptide exit tunnel, close to the peptidyl transferase centre. Human 80S ribosomes have a different tunnel architecture and are not bound at therapeutic concentrations.

  5. The change it makes

    Growing protein chains stall and drop off

    Chains that cannot get out of the tunnel jam the machine, and the half-finished protein is released.

    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

    Obstruction of the exit tunnel causes context-dependent translational arrest and premature peptidyl-tRNA dissociation. The effect is bacteriostatic against most organisms at achievable concentrations, which matters clinically: it slows growth rather than lysing the cell.

  6. What that does for a person

    Bacterial growth stops, and resistance is selected for

    The infection is controlled. At the same time, any bacterium already carrying a resistance gene now has a survival advantage.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Resistance arises through erm-mediated methylation of the 23S rRNA binding site and through mef-encoded efflux. The MORDOR resistance substudy measured exactly this consequence at community scale: nasopharyngeal pneumococcal macrolide resistance of 12.3% in treated communities versus 2.9% in placebo communities.

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 unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Adults and children with the labelled bacterial infections, people treated for chlamydia, adults with severe uncontrolled asthma in some guidelines, and entire communities of preschool children in trachoma and child-survival programmes in sub-Saharan Africa.

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: “[see Clinical Pharmacology (12.3) , Indications and Usage (1.2) , and Dosage and Administration (2.2) ] Safety and effectiveness in the treatment of pediatric patients with acute otitis media, acute bacterial sinusitis and community-acquired pneumonia under 6 months of age have not been established.”

    US prescribing information · 7ab854bf-eb04-42c4-a403-096b60581bb4 · read 2026-08-30

  • On older people, the label states: “In multiple-dose clinical trials of oral azithromycin, 9% of patients were at least 65 years of age (458/4,949) and 3% of patients (144/4,949) were at least 75 years of age.”

    US prescribing information · 7ab854bf-eb04-42c4-a403-096b60581bb4 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) .”

    US prescribing information · 7ab854bf-eb04-42c4-a403-096b60581bb4 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Azithromycin is present in human milk (see Data ) .”

    US prescribing information · 7ab854bf-eb04-42c4-a403-096b60581bb4 · read 2026-08-30

Where the result stopped carrying

  • RECOVERY: no effect on mortality, hospital stay, discharge alive or progression to ventilation in hospitalised COVID-19
  • PRINCIPLE: no meaningful benefit in the community either, with a 0.23 probability of a clinically meaningful gain in time to recovery across 2,265 randomised participants
  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

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

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied in different people

The people in the studies were not much like the reader.

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

The evidence may simply be wrong

Small early studies often do not hold up.

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

Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

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, powder for oral suspension, single-dose powder packet, and intravenous infusion

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

Once-daily dosing, typically as a three-day or five-day course, or a single dose for some indications.

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: The long tissue half-life is a property of the molecule rather than of the formulation: the dibasic azalide is trapped in acidic intracellular compartments and released slowly, so tissue exposure continues for days after the last dose.

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 takeRead 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 gastrointestinal. The class-level concern is QT-interval prolongation and torsades de pointes, quantified observationally by Ray and colleagues as an estimated 47 additional cardiovascular deaths per million five-day courses relative to amoxicillin, concentrated in patients at high baseline cardiovascular risk. Hepatotoxicity and, rarely, severe cutaneous reactions are also described in the label.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

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

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

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Oral tablet, powder for oral suspension, single-dose powder packet, and intravenous infusion

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: The long tissue half-life is a property of the molecule rather than of the formulation: the dibasic azalide is trapped in acidic intracellular compartments and released slowly, so tissue exposure continues for days after the last dose.

No source is stored against this line.

What is recorded as being sold

  • 230 products list this as an active ingredient in the United States drug directory. 230 of them contain it and nothing else.

    FDA National Drug Code directory · 0527-2395 · read 2026-08-29

  • They are sold as injection, powder, lyophilized, for solution, powder, powder, for suspension, solution/ drops, suspension and tablet, taken intravenous, ophthalmic, oral and parenteral.

    FDA National Drug Code directory · 0527-2395 · read 2026-08-29

  • The regulator's established pharmacologic class for it is macrolide antimicrobial [epc] and macrolides [cs].

    FDA National Drug Code directory · 0527-2395 · read 2026-08-29

  • 163 published labels name it as an active ingredient. 163 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 7ab854bf-eb04-42c4-a403-096b60581bb4 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 7ab854bf-eb04-42c4-a403-096b60581bb4 · read 2026-08-29

  • Azithromycin is tablets (film-coated) at 250 mg and 500 mg, recorded as prescription product; fda label in effect 2026-03-16 in the United States.

    US prescribing information · 003307c5-3f73-4a5d-a704-bfdea3c656e8 · read 2026-08-27

  • Recorded price in US: 0.20952–0.39009 USD per one millilitre, across 24 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: 0.26759–0.75519 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 58 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 takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.

Questions worth asking

  • Which of the trials of Azithromycin 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 unclearRead 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 the anti-inflammatory properties of macrolides translate into benefit in viral illness — tested directly in RECOVERY and PRINCIPLE, and refuted in both

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 MORDOR mortality benefit generalises across settings, when the country-level estimates ranged from 18.1% in Niger to 3.4% in Tanzania with confidence intervals crossing zero in two of three countries

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 unclearRead 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 Azithromycin 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 peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Every line above can be traced to the study named beside it. Follow the link and read it.

MORDOR: 13.5% lower all-cause childhood mortality across 1,533 communities
In plain words
Giving every preschool child in a community two doses a year of azithromycin reduced deaths from all causes by about one in seven, in a placebo-controlled trial covering 190,238 children.
What was measured
All-cause mortality in children aged 1 to 59 months, per 1,000 person-years
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Cluster-randomised, placebo-controlled trial in Malawi, Niger and Tanzania. 1,533 communities, 190,238 children identified at census, 323,302 person-years monitored, mean coverage 90.4%. Annual mortality was 14.6 per 1,000 person-years with azithromycin and 16.5 with placebo, a 13.5% reduction overall (95% CI 6.7 to 19.8; P<0.001). Country effects differed sharply: 18.1% lower in Niger (95% CI 10.0 to 25.5), 5.7% in Malawi (95% CI -9.7 to 18.9) and 3.4% in Tanzania (95% CI -21.2 to 23.0). The largest effect was in infants aged 1 to 5 months, at 24.9% (95% CI 10.6 to 37.0).
Source
Keenan JD et al., N Engl J Med 2018;378:1583-1592 (NCT02047981)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
RECOVERY: no survival benefit in 7,763 patients hospitalised with COVID-19
In plain words
Azithromycin was given to hospitalised COVID-19 patients on the theory that it calms inflammation. In the largest randomised test, exactly 22% died in each group.
What was measured
28-day all-cause mortality
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Randomised, controlled, open-label platform trial at 176 UK hospitals. 2,582 patients allocated azithromycin 500 mg daily for 10 days and 5,181 to usual care alone. 28-day all-cause mortality was 561 of 2,582 (22%) versus 1,162 of 5,181 (22%), rate ratio 0.97 (95% CI 0.87 to 1.07; P=0.50). No difference in duration of hospital stay, in discharge alive by 28 days, or in the composite of invasive ventilation or death. The conclusion was explicit: azithromycin use in this setting should be restricted to patients with a clear antimicrobial indication.
Source
RECOVERY Collaborative Group, Lancet 2021;397:605-612 (ISRCTN50189673, NCT04381936)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
PRINCIPLE: no benefit in community treatment of suspected COVID-19 either
In plain words
The same question was asked in people at home rather than in hospital, and the answer was the same.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
A UK primary-care adaptive platform trial in people aged 65 and over, or 50 and over with at least one comorbidity, unwell for 14 days or less with suspected COVID-19. 2,265 participants were randomised, 540 to azithromycin plus usual care and 875 to usual care alone. The hazard ratio for time to first self-reported recovery was 1.08 (95% Bayesian credible interval 0.95 to 1.23), an estimated 0.94 days of benefit, and the probability of a clinically meaningful benefit of at least 1.5 days was 0.23. Hospitalisation occurred in 3% of each group and there were no deaths in either. Taken with RECOVERY, this closes the question in both settings for which the drug was proposed.
Source
PRINCIPLE Trial Collaborative Group, Lancet 2021;397:1063-1074
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The mortality benefit was bought at the price of measurable macrolide resistance
In plain words
In the same trial that showed fewer child deaths, resistance to macrolides in the treated communities rose about fourfold.
What was measured
That the community mortality benefit can be scaled up indefinitely without the resistance cost scaling with it
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
A prespecified resistance substudy within MORDOR I in Niger sampled 3,371 children across 30 communities. Macrolide resistance in nasopharyngeal Streptococcus pneumoniae was 12.3% in azithromycin communities versus 2.9% in placebo communities, and macrolide resistance determinants in the intestinal flora were present in 68.0% versus 46.7%. The mortality benefit and the resistance cost were measured in the same trial and are not separable by choosing to report only one.
Source
Doan T et al., N Engl J Med 2019;380:2271-2273
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
A small absolute excess of cardiovascular death during a five-day course
In plain words
In a large observational cohort, five days of azithromycin was associated with about 47 extra cardiovascular deaths per million courses compared with amoxicillin.
What was measured
Hazard ratio for cardiovascular death during 5 days of therapy
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
A Tennessee Medicaid cohort covering 347,795 azithromycin prescriptions, 1,391,180 propensity-matched no-antibiotic control periods, and 1,348,672 amoxicillin, 264,626 ciprofloxacin and 193,906 levofloxacin prescriptions. During the 5 days of therapy, azithromycin versus no antibiotics gave a hazard ratio for cardiovascular death of 2.88 (95% CI 1.79 to 4.63) and versus amoxicillin 2.49 (95% CI 1.38 to 4.50), an estimated 47 additional cardiovascular deaths per million courses, rising to 245 per million in the highest decile of baseline cardiovascular risk. Amoxicillin showed no such increase. This is an observational cohort, so it establishes association with careful confounding control rather than randomised causation.
Source
Ray WA et al., N Engl J Med 2012;366:1881-1890
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
AVENIR then narrowed the child-survival result to infants
In plain words
A second, much larger trial in Niger repeated the child-survival question and found the benefit concentrated in the youngest children.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
AVENIR was a double-blind, response-adaptive, cluster-randomised, placebo-controlled trial in Niger with 864,493 participants registered, comparing twice-yearly azithromycin to children aged 1 to 59 months, twice-yearly azithromycin to infants aged 1 to 11 months with placebo for older children, and twice-yearly placebo to all. It is the largest randomised test of the MORDOR hypothesis and was designed to separate the age groups that MORDOR had pooled.
Source
AVENIR Study Group, N Engl J Med 2024 (NCT04224987)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
AMAZES: fewer asthma exacerbations on long-term azithromycin
In plain words
In adults with persistent uncontrolled asthma, taking azithromycin three times a week for a year roughly halved the rate of flare-ups.
What was measured
Not recorded
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 of azithromycin 500 mg three times weekly for 48 weeks in 420 adults with symptomatic asthma despite inhaled corticosteroid and long-acting bronchodilator. Exacerbations fell from 1.86 per patient-year on placebo to 1.07 on azithromycin, incidence rate ratio 0.59 (95% CI 0.47 to 0.74; P<0.0001), and asthma-related quality of life improved by an adjusted mean 0.36 (95% CI 0.21 to 0.52; P=0.001). Diarrhoea was more common on azithromycin (34% versus 19%; P=0.001). This is the strongest evidence for a use that depends on effects other than killing a specific pathogen, and it carries the same resistance-selection question as mass administration.
Source
Gibson PG et al., Lancet 2017;390:659-668
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim

How many documents were read

  • 162 documents were read for this substance.

    RNAWiki source record

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

    RNAWiki source record

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

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
5FD1131I7S
CAS registry number
83905-01-5
PubChem compound
447043
RxNorm concept
1298839

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What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 75 approved applications cover products containing this substance. The earliest was NDA050670, approved 19911101 to PFIZER.

    Drugs@FDA application register · NDA050670 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA050670 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19951019.

    FDA National Drug Code directory · 0527-2395 · read 2026-08-29

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A macrolide that stalls bacterial protein synthesis, with a 13.5% reduction in all-cause childhood mortality across 1,533 randomised communities in the MORDOR trial and no benefit whatever in hospitalised COVID-19 across 7,763 randomised patients in RECOVERY.

Recorded evidence blocks (8)

On the Azithromycin Anhydrous label: indicated for what?


"Azithromycin tablets are a macrolide antibacterial indicated for mild to moderate infections caused by designated, susceptible bacteria: Mycobacterial Infections ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs,…": indications and usage on Azithromycin Anhydrous's label. DailyMed label · c9990a1d-5238-403e-9221-72a9314d7b5e · 2026-08-18

430 registered trials of Azithromycin Anhydrous — at which phases?


Registered studies posting no result
322 of 430

430 registered studies of Azithromycin Anhydrous: 112 phase3, 112 phase4, 88 phase2, 67 na, 44 phase1, 20 na or unstated, 7 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

1393 with a PubMed record

Show the evidence
  • phase3
    112
  • phase4
    112
  • phase2
    88
  • na
    67
  • phase1
    44
  • na or unstated
    20
9 more recorded rows
  • early phase1
    7
  • completed
    254
  • unknown
    58
  • terminated
    44
  • recruiting
    24
  • withdrawn
    24
  • not yet recruiting
    12
  • active not recruiting
    8
  • suspended
    6

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

66 of Azithromycin Anhydrous's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (5), futility/efficacy (7), accrual/recruitment (15), funding/business (4), sponsor decision unspecified (3) and other (32): Azithromycin Anhydrous's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Principal Investigator moved institutions"; 66 of 430 registered studies

Show the evidence

Trial

  • NCT00181272
    terminated; "Principal Investigator moved institutions"
  • NCT00245440
    terminated; "Sponsor Terminated"
  • NCT00245453
    withdrawn; "Terminated by sponsor"
  • NCT00286026
    withdrawn; "Prevalence of infection for screened population too low (\<7%) to enroll anyone."
  • NCT00315003
    terminated; "Pediatric development program terminated by sponsor"
  • NCT00315601
    terminated; "Sanofi-Aventis wanted the study terminated."
14 further recorded trials
  • NCT00524095
    terminated; "we decided not to go on treatment phase"
  • NCT00599053
    terminated; "Enrollment was terminated early due to a change in practice on the obstetrical side that included administering azithromycin to women with preterm labor."
  • NCT00610623
    terminated; "The sponsor decided to stop the study prematurely because of financial issues"
  • NCT00682656
    terminated; "Efficacy issues on test arm"
  • NCT01217099
    terminated; "terminated"
  • NCT01323582
    terminated; "Original investigator left this institution, replacement investigator retired."
  • NCT01327625
    terminated; "Preliminary reports of this study was too bad."
  • NCT01379196
    withdrawn; "Patients were not interested in enrolling"
  • NCT01432080
    terminated; "Not meeting recruitment targets"
  • NCT01556334
    withdrawn; "Terminated before starting due to need for IND determined by FDA."
  • NCT01560962
    terminated; "research staffs unable to continue."
  • NCT01721616
    withdrawn; "Poor enrollment"
  • NCT01783340
    withdrawn; "No funding"
  • NCT01797107
    withdrawn; "Lack of enrollment"

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

Human studies of Azithromycin Anhydrous used Azithromycin 500 mg — over how long?


Human studies of Azithromycin Anhydrous used "Azithromycin 500 mg". ClinicalTrials.gov · 2026-09-01

20 recorded entries; human; also "Azithromycin 1000 mg", "azithromycin 250 mg tablets", "1% Azithromycin and 0.1% Dexamethasone"

Show the evidence

human

  • NCT00359970
    Azithromycin 500 mg
  • NCT00359970
    Azithromycin 1000 mg
  • NCT00431964
    azithromycin 250 mg tablets
  • NCT00578955
    1% Azithromycin and 0.1% Dexamethasone
  • NCT00578955
    1% Azithromycin
  • NCT00649935
    Azithromycin Tablets 600 mg
14 more recorded rows
  • human NCT00649935
    Zithromax® Tablets 600 mg
  • human NCT00760838
    Azithromycin 250 mg
  • human NCT00796224
    60 mg/kg azithromycin ER
  • human NCT00796224
    30 mg/kg azithromycin IR
  • human NCT00834132
    Azithromycin 600 mg Tablet
  • human NCT00834132
    Zithromax® 600 mg Tablet
  • human NCT00865670
    Azithromycin Monohydrate 600 mg Tablets
  • human NCT00865670
    Zithromax (azithromycin dihydrate) 600 mg Tablets
  • human NCT00983294
    Zithromax® Tablets USP, 250 mg
  • human NCT01089608
    T1225 1.5% - Azyter -
  • human NCT01109160
    Azithromycin 250 mg, ZTM250, Zitromax TM (ATC J01FA10)
  • human NCT01408082
    ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)
  • human NCT01416350
    Azithromycin - 250 mg
  • human NCT01416350
    Azithromycin - 1000 mg

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

Azithromycin Anhydrous's half-life is 34 hr — which schedules were studied?


34 hr, the half-life Azithromycin Anhydrous's label states: "The mean half-lives for 6 males and 6 females were 34 hr and 57 hr, respectively." DailyMed label · c9990a1d-5238-403e-9221-72a9314d7b5e · 2026-08-18

bioavailability 34 %.

Show the evidence
  • half life pharmacokinetics
    34 hr; The mean half-lives for 6 males and 6 females were 34 hr and 57 hr, respectively.
  • bioavailability pharmacokinetics
    34 %; The absolute bioavailability of two 600 mg tablets was 34% (CV=56%).
  • metabolism pharmacokinetics
    Metabolism In vitro and in vivo studies to assess the metabolism of azithromycin have not been performed.

recorded 2026-08-18 · last checked 2026-09-04

Which running trial of Azithromycin Anhydrous could settle lifespan?


NCT04716712 measures All-cause mortality, reading out 2026-01-30.

5 open trials; n 694400; "Infant Mortality Reduction by the Mass Administration of Azithromycin"

Show the evidence

Trial

  • NCT04716712
    "Infant Mortality Reduction by the Mass Administration of Azithromycin"; n 694400; "All-cause mortality"; 2026-01-30
  • NCT04235816
    "Improving Care Through Azithromycin Research for Infants in Africa"; n 20560; "The rate of all-cause mortality"; 2026-04-30
  • NCT06358872
    "Azithromycin for Child Survival in Niger II"; n 3300000; "All-cause mortality"; 2028-04-29
  • NCT05580666
    "Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)"; n 8000; "All-cause mortality"; 2029-05-31
  • NCT04381936
    "Randomised Evaluation of COVID-19 Therapy"; n 70000; "Community-acquired pneumonia: All-cause mortality (with subsidiary analyses of cause of death and of death at various timepoints following discharge)"; 2038-09-30

Which 131 trials of Azithromycin Anhydrous posted no result?


Posted no result
131 of 131 completed trials
Registrations
NCT00000641, NCT00001023, NCT00000947, NCT00000895, NCT00000811 and NCT00357539, and 125 more
Completion dates
oldest 1994-12; newest 2024-02-27
Show the evidence

Trial

  • NCT00000641
    1994-12
  • NCT00001023
    1998-07
  • NCT00000947
    2000-07
  • NCT00000895
    2001-08
  • NCT00000811
    2001-11
  • NCT00357539
    2002-03
14 further recorded trials
  • NCT00357292
    2002-04
  • NCT00035347
    2002-06
  • NCT00356850
    2002-06
  • NCT00245908
    2002-09
  • NCT00357383
    2002-10
  • NCT00356772
    2003-03
  • NCT00649831
    2003-06
  • NCT00643539
    2003-07
  • NCT00359970
    2003-08
  • NCT00648726
    2003-08
  • NCT00865670
    2003-09
  • NCT00644293
    2004-04
  • NCT00127504
    2004-05
  • NCT00229944
    2004-05

At the median, Azithromycin Anhydrous's trials enrolled 116 people — anything larger?


Median enrolment
116
Largest enrolment
3300000
Registered trials counted
413
Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1200502
PubChem CID
9897015
CAS number
121470-24-4
RxCUI
1298839
InChIKey
MQTOSJVFKKJCRP-BICOPXKESA-N
Also called
Sumamed, AZITHROMYCIN MONOHYDRATE, Aruzilina, Aziromycin, Azithrocin, Azithromycine, Azithromycin, unspecified, Azithromycin, unspecified form, Azitromicina, Aziwin, Durasite, Hemomycin
Also called
Azithromycin
Salt form
Anhydrous azithromycin, Azithromycin dihydrate, Azithromycin hydrate, azithromycin tablets
Trade name
Azasite, Azyter, Clamelle, Sunamed, Zithromax, Zithromax / Z-Pak
Development code
CP 62993, CP-62,993, NSC-758625, XZ 405, XZ 450
Component
Azithromycin
Sources (5)

Sources

  • CLINICALTRIALS_SNAPSHOT K1:J2KLZ20U1M ·
  • ClinicalTrials.gov clinicaltrials.gov ·
  • drugsfda drugsfda ·
  • DailyMed label c9990a1d-5238-403e-9221-72a9314d7b5e ·
  • Drugs@FDA K1:J2KLZ20U1M ·

ClinicalTrials.gov — US Government work · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 5 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.