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Clarithromycin

  • Prescription medicine
  • Prescription only
  • 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 Clarithromycin does in the body

Mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae , Haemophilus parainfluenzae , Moraxella catarrhali

4 ) ].

What happened in people

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

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · H1250JIK0A · read 2026-08-29

  • Its recorded molecular formula is C38H69NO13, weighing 747.96.

    US prescribing information · fa69ea92-0b41-43fb-918f-ed80e0dedf04 · read 2026-08-30

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 30 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.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

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.

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.

lung injury score

The study did not show it

Who was studied
NCT04353180
How many people
100000
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

The rate of hospitalisation due to peptic ulcer bleeding in patients who enter the randomised study (only the first event per patient will be analysed), adjudicated by a blinded Committee as definite or probable.

The study did not show it

Who was studied
NCT01506986
How many people
30024
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Gastric cancer mortality

The study did not show it

Who was studied
NCT02047994
How many people
30000
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

All-cause mortality

The study did not show it

Who was studied
NCT02735707
How many people
20000
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Successful helicobacter eradication, change in premalignant gastric lesion, and change in gastric cancer incidence rate

The study did not show it

Who was studied
NCT00155389
How many people
5000
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Eradication rate of Helicobacter pylori

The study did not show it

Who was studied
NCT05061732
How many people
4447
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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 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.

  • Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) Acute Maxillary Sinusitis (1.2) Community-Acquired Pneumonia (1.3) Pharyngitis/Tonsillitis (1.4) Uncomplicated Skin and Skin Structure Infections (1.5) Acute Otitis Media in Pediatric Patients…

Who is missing from the studies

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

What the label states about particular groups

  • On pediatric, the label states: “Safety and effectiveness of clarithromycin in pediatric patients under 6 months of age have not been established.”

    US prescribing information · fa69ea92-0b41-43fb-918f-ed80e0dedf04 · read 2026-08-30

  • On older people, the label states: “In a steady-state study in which healthy elderly subjects (65 years to 81 years of age) were given 500 mg of clarithromycin every 12 hours, the maximum serum concentrations and area under the curves of clarithromycin and 14-OH clarithromycin were increased compared to those achieved in healthy young adults.”

    US prescribing information · fa69ea92-0b41-43fb-918f-ed80e0dedf04 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on findings from animal studies, clarithromycin is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate.”

    US prescribing information · fa69ea92-0b41-43fb-918f-ed80e0dedf04 · read 2026-08-30

  • On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential Males Administration of clarithromycin resulted in testicular atrophy in rats, dogs and monkeys [see Nonclinical Toxicology (13.1) ] .”

    US prescribing information · fa69ea92-0b41-43fb-918f-ed80e0dedf04 · read 2026-08-30

Where the result stopped carrying

  • 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

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

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

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S3.

No source is stored against this line.

What is in the pack

Sold as capsule, tablet, capsule, delayed rel pellets, tablet, for suspension, tablet, extended release, given by the oral route.

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 and what that means for what is in the pack.

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 takeNothing found in the sources checked

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.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

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

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 67 products list this as an active ingredient in the United States drug directory. 67 of them contain it and nothing else.

    FDA National Drug Code directory · 0781-6022 · read 2026-08-29

  • They are sold as for suspension, pellet, powder, tablet, tablet, film coated and tablet, film coated, extended release, taken oral.

    FDA National Drug Code directory · 0781-6022 · read 2026-08-29

  • The regulator's established pharmacologic class for it is cytochrome p450 3a inhibitors [moa], cytochrome p450 3a4 inhibitors [moa] and macrolide antimicrobial [epc].

    FDA National Drug Code directory · 0781-6022 · read 2026-08-29

  • 42 published labels name it as an active ingredient. 42 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · fa69ea92-0b41-43fb-918f-ed80e0dedf04 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · fa69ea92-0b41-43fb-918f-ed80e0dedf04 · read 2026-08-29

  • Clarithromycin is oral at 3 DOSAGE FORMS AND STRENGTHS Clarithromycin tablets USP are available as: 250 mg: light yellow colored, oval shaped, biconvex film-coated tablets, with ‘D’ debossed on one side and ‘62’ on the other side. 500 mg: light…, recorded as fda label in effect 2026-03-04 in the United States.

    US prescribing information · fa69ea92-0b41-43fb-918f-ed80e0dedf04 · read 2026-08-30

  • Recorded price in US: 0.36276–0.4558 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 22 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

  • Recorded price in US: 0.9391–1.56746 USD per one millilitre, across 3 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.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Clarithromycin 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

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 Clarithromycin 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.

How many documents were read

  • 42 documents were read for this substance.

    RNAWiki source record

  • 35 of them state the same bioavailability, and they agree.

    RNAWiki source record

  • 35 of them state the same tMax, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
H1250JIK0A
RxNorm concept
197517

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S3.

  • Passed

    Canonical metadata present

    slug and display name present

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

  • 33 approved applications cover products containing this substance. The earliest was NDA050662, approved 19911031 to ABBVIE.

    Drugs@FDA application register · NDA050662 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA050662 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20020301.

    FDA National Drug Code directory · 0781-6022 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

9 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.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (10)

On the Clarithromycin label: indicated for what?


"Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults ( 1.1 ) Acute Maxillary Sinusitis ( 1.2 ) Community-Acquired Pneumonia ( 1.3 ) Pharyngitis/Tonsillitis…": indications and usage on Clarithromycin's label. DailyMed label · 9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c6 · 2026-06-24

246 registered trials of Clarithromycin — at which phases?


Registered studies posting no result
198 of 246

246 registered studies of Clarithromycin: 61 phase1, 58 phase4, 46 phase3, 44 phase2, 38 na, 6 na or unstated, 3 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

1819 with a PubMed record

Show the evidence
  • phase1
    61
  • phase4
    58
  • phase3
    46
  • phase2
    44
  • na
    38
  • na or unstated
    6
9 more recorded rows
  • early phase1
    3
  • completed
    177
  • unknown
    36
  • terminated
    10
  • recruiting
    9
  • not yet recruiting
    6
  • active not recruiting
    4
  • withdrawn
    3
  • suspended
    1

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

13 of Clarithromycin's trials stopped: futility/efficacy, accrual/recruitment, other?


futility/efficacy (1), accrual/recruitment (8) and other (4): Clarithromycin's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"early stopping rule"; 13 of 246 registered studies

Show the evidence

Trial

  • NCT01374217
    terminated; "early stopping rule"
  • NCT01851954
    terminated; "declined enrollment"
  • NCT02099240
    terminated; "Not enough patient enrollment and lack of staffing"
  • NCT02188368
    terminated; "Lack of enrollment"
  • NCT02416570
    terminated; "At 6 months 1 participant recruited. Study deemed not feasible and discontinued."
  • NCT02516696
    terminated; "low enrollment"
7 further recorded trials
  • NCT02573935
    terminated; "Suspected side effects to the combination of clarithromycin and VCD (bortezomib, cyclophosphamide and dexamethasone)"
  • NCT03021590
    withdrawn; "No Participants Enrolled"
  • NCT03043989
    terminated; "Low accrual"
  • NCT03173053
    terminated; "Results interim-analysis"
  • NCT03824847
    suspended; "Community recruitment suspended due to COVID-19"
  • NCT04843579
    terminated; "low enrollment"
  • NCT05250050
    withdrawn; "Unable to complete in vitro culture of Helicobacter pylori in our hospital"

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

Human studies of Clarithromycin used clarithromycin 250 mg tablets — over how long?


studies of Clarithromycin used the recorded amount. ClinicalTrials.gov · 2026-09-01

20 recorded entries; human; also "clarithromycin 250 mg tablets", "Clarithromycin 500mg", "clarithromycin 500mg tablets"

Show the evidence

human

  • NCT00774189
    clarithromycin 250 mg tablets
  • NCT00774644
    Clarithromycin 500mg
  • NCT00774696
    clarithromycin 500mg tablets
  • NCT00775372
    Clarithromycin 250mg/5mL
  • NCT00840216
    Clarithromycin ER 500 mg tablets
  • NCT00840216
    BIAXIN® XL 500 mg tablets
14 more recorded rows
  • human NCT00881179
    Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA)
  • human NCT00881179
    Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA)
  • human NCT00881738
    Clarithromycin 250 mg Tablets (Geneva, USA)
  • human NCT00881738
    Biaxin 250 mg Tablets (Abbott Laboratories, Inc, USA)
  • human NCT01385683
    Clarithromycin (Zeclar) 500 mg
  • human NCT01506986
    Lansoprazole 30mg, Clarithromycin 500mg, Metronidazole 400mg
  • human NCT01506986
    Clarithromycin (CAS: 81103-11-9); 500mg tablets.
  • human NCT01506986
    Placebo lansoprazole 30mg, clarithromycin 500mg, metronidazole 400mg
  • human NCT02052336
    CJ-12420 200mg + Clarithromycin 500mg
  • human NCT02052336
    CJ-12420 200mg for 5 days + Clarithromycin 500mg for 5 days
  • human NCT02052336
    Clarithromycin 500mg for 5 days
  • human NCT02197884
    Clarithromycin 500 mg
  • human NCT02547025
    clarithromycin 500mg
  • human NCT02547038
    clarithromycin 500 mg

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

Clarithromycin's half-life is 3 hours — which schedules were studied?


3 hours, the half-life Clarithromycin's label states: "The elimination half-life of clarithromycin was about 3 hours to 4 hours with 250 mg administered every 12 hours but increased to 5 hours to 7 hours with 500 mg administered every 8 hours to 12 hours." DailyMed label · 9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c6 · 2026-06-24

tmax 2 to 3 hours; bioavailability 50 %.

Show the evidence
  • half life pharmacokinetics
    3 hours; The elimination half-life of clarithromycin was about 3 hours to 4 hours with 250 mg administered every 12 hours but increased to 5 hours to 7 hours with 500 mg administered every 8 hours to 12 hours.
  • tmax pharmacokinetics
    2 to 3 hours; In non-fasting healthy human subjects (males and females), peak plasma concentrations were attained within 2 to 3 hours after oral dosing.
  • bioavailability pharmacokinetics
    50 %; Absorption The absolute bioavailability of 250 mg clarithromycin tablets was approximately 50%.
  • metabolism pharmacokinetics
    Tissue and Serum Concentrations of Clarithromycin CONCENTRATION (after 250 mg every 12 hours) Tissue Type Tissue (mcg/g) Serum (mcg/mL) Tonsil 1.6 0.8 Lung 8.8 1.7 Metabolism and Elimination Steady-state peak plasma clarithromycin concentrations were attained within 3 days and were approximately 1 mcg/mL to 2 mcg/mL with a 250 mg dose administered every 12 hours and 3 mcg/mL to 4 mcg/mL with a…

recorded 2026-06-24 · last checked 2026-09-04

Which 108 trials of Clarithromycin posted no result?


Posted no result
108 of 108 completed trials
Registrations
NCT00002336, NCT00002331, NCT00001030, NCT00001047, NCT00000794 and NCT00001023, and 102 more
Completion dates
oldest 1994-11; newest 2024-08-01
Show the evidence

Trial

  • NCT00002336
    1994-11
  • NCT00002331
    1995-03
  • NCT00001030
    1996-06
  • NCT00001047
    1996-08
  • NCT00000794
    1998-04
  • NCT00001023
    1998-07
14 further recorded trials
  • NCT00004689
    1998-09
  • NCT00001058
    1999-01
  • NCT00000826
    1999-05
  • NCT00002682
    2001-10-08
  • NCT00001039
    2002-06
  • NCT00881179
    2002-06
  • NCT00881738
    2002-07
  • NCT00121550
    2002-09
  • NCT00774644
    2003-02
  • NCT00774696
    2003-02
  • NCT00602498
    2003-03
  • NCT00648128
    2003-03
  • NCT00601315
    2003-05
  • NCT00648960
    2003-07

At the median, Clarithromycin's trials enrolled 95.5 people — anything larger?


Median enrolment
95.5
Largest enrolment
30024
Registered trials counted
240

What do 5097 spontaneous reports say about Clarithromycin — 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.

Clarithromycin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 5097 reaction mentions were counted: drug interaction 1494; drug hypersensitivity 1245; erythema 471; dysgeusia 320. FAERS via Open Targets · CHEMBL1741 · 2026-06-24

Show the evidence
  • drug interaction
    1494
  • drug hypersensitivity
    1245
  • erythema
    471
  • dysgeusia
    320
  • electrocardiogram qt prolonged
    311
  • abortion spontaneous
    307
4 more recorded rows
  • rhabdomyolysis
    296
  • pathogen resistance
    279
  • labelled drug-drug interaction medication error
    192
  • stevens-johnson syndrome
    182

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Clarithromycin's label not list?


abortion spontaneous, drug hypersensitivity and drug interaction and 7 more reported for Clarithromycin, absent from its label. FAERS via Open Targets · CHEMBL1741 · 2026-06-24

2 label terms; 10 reported and unlisted; 9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c6

Show the evidence
  • abortion spontaneous
    count not stated
  • drug hypersensitivity
    count not stated
  • drug interaction
    count not stated
  • dysgeusia
    count not stated
  • electrocardiogram qt prolonged
    count not stated
  • erythema
    count not stated
4 more recorded rows
  • labelled drug-drug interaction medication error
    count not stated
  • pathogen resistance
    count not stated
  • rhabdomyolysis
    count not stated
  • stevens-johnson syndrome
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Clarithromycin and CYP3A, PGP and P-GLYCOPROTEIN: shared by which compounds?


CYP3A, PGP and P-GLYCOPROTEIN appear in Clarithromycin's recorded interaction sentences, 8 in all. DailyMed label · 9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c6 · 2026-06-24

CYP3A, CYP3A, CYP3A, P-gp, P-gp; 5 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    Co-administration of clarithromycin is known to inhibit CYP3A, and a drug primarily metabolized by CYP3A may be associated with elevations in drug concentrations that could increase or prolong both therapeutic and adverse effects of the concomitant drug.
  • drug_interactions
    Clarithromycin should be used with caution in patients receiving treatment with other drugs known to be CYP3A enzyme substrates, especially if the CYP3A substrate has a narrow safety margin (e.g., carbamazepine) and/or the substrate is extensively metabolized by this enzyme.
  • drug_interactions
    Adjust dosage when appropriate and monitor serum concentrations of drugs primarily metabolized by CYP3A closely in patients concurrently receiving clarithromycin.
  • drug_interactions
    There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with disopyramide and quinidine.
  • drug_interactions
    Digoxin : Digoxin is a substrate for P-glycoprotein (Pgp) and clarithromycin is known to inhibit Pgp.
  • drug_interactions
    When clarithromycin and digoxin are co-administered, inhibition of Pgp by clarithromycin may lead to increased exposure of digoxin.
2 more recorded rows
  • Interaction statement drug_interactions
    There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with carbamazepine.
  • Interaction statement drug_interactions
    Antifungals: Itraconazole Fluconazole Use With Caution No Dose Adjustment Itraconazole: Both clarithromycin and itraconazole are substrates and inhibitors of CYP3A, potentially leading to a bi-directional drug interaction when administered concomitantly (see also Itraconazole under “Drugs That Affect Clarithromycin” in the table below).

CYP3A

  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib

P-gp

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine

recorded 2026-06-24 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1741
PubChem CID
84029
CAS number
81103-11-9
RxCUI
21212
InChIKey
AGOYDEPGAOXOCK-KCBOHYOISA-N
Also called
6-o-methylerythromycin, Clarithromycine, Clarithromycin identity, Claritromicina, Cyllind, Erythromycin, 6-o-methyl-, Klacid, Macladin, Mavid, Veclam, azithromycin, biaxin filmtab
Development code
A-56268, ABBOTT-56268, NSC-758704, TE-031
Trade name
Biaxin, Biaxin xl, Biaxin xl pac, Clarie xl, Clarithromycin component of prevpac, Clarithromycin extended release, Clarosip, Febzin xl, Klaricid, Klaricid 500, Klaricid adult, Klaricid i.v.
Salt form
biaxin granules 250 mg/5 ml oral suspension, biaxin xl 500 mg tablets, clarithromycin 250 mg/5 ml powder for oral suspension of ranbaxy laboratories, clarithromycin er 500 mg tablets, clarithromycin extended-release tablets, genpharm's clarithromycin tablets
Sources (6)

Sources

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

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: 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

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