Skip to content

Isoniazid

  • 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 Isoniazid does in the body

Isoniazid tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible.

From the FDA-approved label: Isoniazid inhibits the synthesis of mycoloic acids, an essential component of the bacterial cell wall. At therapeutic levels isoniazid is bactericidal against actively growing intracellular and extracellular Mycobacterium tuberculosis organisms. Resistance Resistance to isoniazid occurs because of mutations in the katG, inhA, kasA and ahpC genes. Resistance in M. tuberculosis develops rapidly when isoniazid monotherapy is administered. gov/STIC.

Why people take it. Isoniazid tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible.

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 · V83O1VOZ8L · read 2026-08-29

Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 104 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.

Percentage of Patients Newly Starting ART Also Initiating TPT Within 90 Days of ART Initiation

The study did not show it

Who was studied
NCT04466488
How many people
50798
Study design
Not applicable
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

Measured incidence of active TB in HIV clinic population before and following implementation of IPT policy

The study did not show it

Who was studied
NCT00107887
How many people
17415
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

Incidence of TB (all forms - PTB / EPTB) as per NTEP guidelines

The study did not show it

Who was studied
NCT05330884
How many people
9200
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

Retention in Care at 12 Months

The study did not show it

Who was studied
NCT03101592
How many people
9118
Study design
Not applicable
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

Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants Less Than [<]18 Years of Age at 33 Months After Enrollment

The study did not show it

Who was studied
NCT00023452
How many people
8053
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

TB screening

The study did not show it

Who was studied
NCT05342064
How many people
6500
Study design
Not applicable
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.

  • Isoniazid tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication, is inadequate therapy.

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 people who are pregnant, the label states: “Teratogenic Effects Pregnancy Category C Isoniazid has been shown to have an embryocidal effect in rats and rabbits when given orally during pregnancy.”

    US prescribing information · d5039796-6ba0-4fa8-84f7-e47c63d45163 · read 2026-08-30

  • On people who are breastfeeding, the label states: “The small concentrations of isoniazid in breast milk do not produce toxicity in the nursing newborn; therefore, breast feeding should not be discouraged.”

    US prescribing information · d5039796-6ba0-4fa8-84f7-e47c63d45163 · 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: S6.

No source is stored against this line.

What is in the pack

Sold as tablet, injectable, injectable, syrup, given by the oral, injection, injection 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

  • 35 products list this as an active ingredient in the United States drug directory. 35 of them contain it and nothing else.

    FDA National Drug Code directory · 81665-108 · read 2026-08-29

  • They are sold as injection, solution, powder, solution and tablet, taken intramuscular and oral.

    FDA National Drug Code directory · 81665-108 · read 2026-08-29

  • The regulator's established pharmacologic class for it is antimycobacterial [epc].

    FDA National Drug Code directory · 81665-108 · read 2026-08-29

  • 23 published labels name it as an active ingredient. 23 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · d5039796-6ba0-4fa8-84f7-e47c63d45163 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · d5039796-6ba0-4fa8-84f7-e47c63d45163 · read 2026-08-29

  • 3 marketed supplement labels list this ingredient, classed as botanical and other combinations.

    NIH Dietary Supplement Label Database · 23671 · read 2026-08-29

  • Those labels carry all other, nutrient and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.

    NIH Dietary Supplement Label Database · 23671 · read 2026-08-29

  • Isoniazid is oral at HOW SUPPLIED Product: 50090-0370 NDC: 50090-0370-3 30 TABLET in a BOTTLE NDC: 50090-0370-0 50 TABLET in a BOTTLE, recorded as fda label in effect 2025-04-02 in the United States.

    US prescribing information · d5039796-6ba0-4fa8-84f7-e47c63d45163 · read 2026-08-30

  • Recorded price in US: 1.73222–3.49169 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 12 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 Isoniazid 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 Isoniazid 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.

Where else this substance is registered

FDA substance identifier (UNII)
V83O1VOZ8L
RxNorm concept
197832

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: Quoted from a stored source.

  • 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: S6.

  • 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

  • 48 approved applications cover products containing this substance. The earliest was NDA008662, approved 19520929 to SANDOZ.

    Drugs@FDA application register · NDA008662 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA008662 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19720901.

    FDA National Drug Code directory · 81665-108 · 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 (9)

On the Isoniazid label: indicated for what?


"Isoniazid is recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance.": indications and usage on Isoniazid's label. DailyMed label · 93252cc8-c8d4-401b-bde5-ca8a3b57651e · 2026-04-27

123 registered trials of Isoniazid — at which phases?


Registered studies posting no result
84 of 123

123 registered studies of Isoniazid: 41 phase2, 39 phase3, 20 na, 16 phase1, 15 phase4, 4 na or unstated, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

898 with a PubMed record

Show the evidence
  • phase2
    41
  • phase3
    39
  • na
    20
  • phase1
    16
  • phase4
    15
  • na or unstated
    4
9 more recorded rows
  • early phase1
    1
  • completed
    69
  • unknown
    16
  • terminated
    13
  • not yet recruiting
    10
  • recruiting
    8
  • active not recruiting
    5
  • suspended
    1
  • withdrawn
    1

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

15 of Isoniazid's trials stopped: safety, futility/efficacy, accrual/recruitment, sponsor decision unspecified, other?


safety (1), futility/efficacy (2), accrual/recruitment (7), sponsor decision unspecified (2) and other (3): Isoniazid's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Data Safety Monitoring Board (DSMB) recommended stopping study due to futility"; 15 of 123 registered studies

Show the evidence

Trial

  • NCT00080119
    terminated; "Data Safety Monitoring Board (DSMB) recommended stopping study due to futility"
  • NCT00571753
    terminated; "Enrolling participants has halted prematurely due to a low recruitment rate."
  • NCT00737724
    terminated; "Other published trials showed definitive expected superiority of Group 1"
  • NCT01550705
    terminated; "Interim analysis demonstrated the treatment was not effective"
  • NCT01601626
    terminated; "The study was stopped early due to feasibility concerns."
  • NCT01761201
    terminated; "Recruitment rythm not sufficent to reach the simple size needed."
9 further recorded trials
  • NCT01838200
    terminated; "Slow recruitment due to changes in standard of care"
  • NCT02099240
    terminated; "Not enough patient enrollment and lack of staffing"
  • NCT03266991
    terminated; "Recruitment issues"
  • NCT03334734
    terminated; "Very slow enrollment"
  • NCT03498534
    withdrawn; "Due to administrative procedures"
  • NCT04150367
    terminated; "According to Sponsor decision."
  • NCT04272242
    terminated; "Opening of Arm 2 was dependent upon assessment of DTG pharmacokinetics (PK) data from participants in Arm 1. Arm 1 is complete and results are reported. Arm 2 was not conducted based on the Arm 1 PK assessment."
  • NCT04311502
    terminated; "Accrual was permanently closed due to futility in the experimental arm on June 22, 2023. Follow-up in the experimental arm was extended to 117 weeks."
  • NCT04694586
    suspended; "Suspended 15th of Nov 2023 due to conditions affecting recruitment process."

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

Human studies of Isoniazid used Placebo of Isoniazid tablets 300mg — over how long?


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

7 recorded entries; human; also "Placebo of Isoniazid tablets 300mg", "Isoniazid 300 mg Oral Tablet", "Isoniazid 300 Mg ORAL TABLET"

Show the evidence

human

  • NCT00130325
    Placebo of Isoniazid tablets 300mg
  • NCT03278483
    Isoniazid 300 mg Oral Tablet
  • NCT03302299
    Isoniazid 300 Mg ORAL TABLET
  • NCT03498534
    Isoniazid 300Mg Tab
  • NCT03498534
    Isoniazid 300 MG
  • NCT03498534
    Isoniazid 300 mg per day
1 more recorded row
  • human NCT04150367
    Isoniazid, Tablets, 300mg.

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

Which running trial of Isoniazid could settle lifespan?


NCT05122026 measures Mortality, reading out 2025-12-31.

3 open trials; n 252; "Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics of Dolutegravir (DTG) in Pregnant People With HIV"

Show the evidence

Trial

  • NCT05122026
    "Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics of Dolutegravir (DTG) in Pregnant People With HIV"; n 252; "Mortality"; 2025-12-31
  • NCT05917340
    "Intensified Short Course Regimen for TBM in Adults"; n 372; "Mortality rate"; 2027-09
  • NCT06253715
    "Shortened Regimen for Drug-susceptible TB in Children"; n 860; "TB disease-free survival at 48-weeks"; 2027-09-30

Which 34 trials of Isoniazid posted no result?


Posted no result
34 of 34 completed trials
Registrations
NCT00000959, NCT00001033, NCT00000636, NCT00000796, NCT00000638 and NCT00023335, and 28 more
Completion dates
oldest 1996-06; newest 2024-04-16
Show the evidence

Trial

  • NCT00000959
    1996-06
  • NCT00001033
    1997-07
  • NCT00000636
    1997-10
  • NCT00000796
    1998-10
  • NCT00000638
    1999-09
  • NCT00023335
    2001-03
14 further recorded trials
  • NCT00023387
    2001-05
  • NCT00023348
    2002-11
  • NCT00317330
    2005-06
  • NCT00513396
    2006-12
  • NCT00164463
    2007-08
  • NCT00144417
    2007-12
  • NCT00057122
    2009-06
  • NCT00130325
    2009-06
  • NCT00293228
    2009-06
  • NCT00463086
    2011-11
  • NCT00330304
    2011-11-15
  • NCT01119521
    2013-07
  • NCT00170209
    2015-05
  • NCT01825031
    2016-03

At the median, Isoniazid's trials enrolled 300 people — anything larger?


Median enrolment
300
Largest enrolment
8053
Registered trials counted
122

What do 3248 spontaneous reports say about Isoniazid — 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.

Isoniazid appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3248 reaction mentions were counted: hypoglycaemia 571; drug reaction with eosinophilia and systemic symptoms 430; pyrexia 428; drug-induced liver injury 421. FAERS via Open Targets · CHEMBL64 · 2026-06-24

Show the evidence
  • hypoglycaemia
    571
  • drug reaction with eosinophilia and systemic symptoms
    430
  • pyrexia
    428
  • drug-induced liver injury
    421
  • paradoxical drug reaction
    291
  • premature baby
    270
4 more recorded rows
  • drug resistance
    230
  • hepatotoxicity
    222
  • alanine aminotransferase increased
    202
  • jaundice
    183

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

Which 10 reactions does Isoniazid's label not list?


alanine aminotransferase increased, drug-induced liver injury and drug reaction with eosinophilia and systemic symptoms and 7 more reported for Isoniazid, absent from its label. FAERS via Open Targets · CHEMBL64 · 2026-06-24

3 label terms; 10 reported and unlisted; 93252cc8-c8d4-401b-bde5-ca8a3b57651e

Show the evidence
  • alanine aminotransferase increased
    count not stated
  • drug-induced liver injury
    count not stated
  • drug reaction with eosinophilia and systemic symptoms
    count not stated
  • drug resistance
    count not stated
  • hepatotoxicity
    count not stated
  • hypoglycaemia
    count not stated
4 more recorded rows
  • jaundice
    count not stated
  • paradoxical drug reaction
    count not stated
  • premature baby
    count not stated
  • pyrexia
    count not stated

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL64
PubChem CID
3767
CAS number
54-85-3
RxCUI
6038
InChIKey
QRXWMOHMRWLFEY-UHFFFAOYSA-N
Also called
Isoniazide, Armazid, Armazide, Atcotibine, Cedin, Cotinazin, Dianicotyl, Eralon, Ertuban, Hidrasonil, Hydrazid, Ipcazide
Trade name
Dow-isoniazid, Hyzyd, Inh, Isoniazid component of rifamate, Isoniazid component of rifater, Laniazid, Nicotibine, Nydrazid, Rimifon, Stanozide, Laniazid / Rimifon / Hyzyd / Nydrazid / Stanozide / Dow-Isoniazid
Development code
NSC-9659
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

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.