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Tinidazole

  • 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 Tinidazole does in the body

Trichomoniasis caused by Trichomonas vaginalis

From the FDA-approved label: Tinidazole is an antiprotozoal, antibacterial agent. 4) ]. Mechanism of Action Tinidazole is an antiprotozoal,antibacterial agent. The nitro-group of tinidazole is reduced by cell extracts of Trichomonas . The free nitro- radical generated as a result of this reduction may be responsible for the antiprotozoal activity. Chemically reduced tinidazole was shown to release nitrites and cause damage to purified bacterial DNA in vitro . Additionally, the drug caused DNA base changes in bacterial cells and DNA strand breakage in mammalian cells. The mechanism by which tinidazole exhibits activity against Giardia and Entamoeba species is not known.

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
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 · 033KF7V46H · read 2026-08-29

Where each sentence above came from

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

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 116 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.

Symptomatic resolution of the vaginal discharge according to the patient

The study did not show it

Who was studied
NCT00313131
How many people
1524
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

Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis

The study did not show it

Who was studied
NCT01042184
How many people
900
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

recurrence-free survival (RFS)

The study did not show it

Who was studied
NCT06722300
How many people
856
Study design
Not applicable
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

The different rate of H. pylori eradication among 3 different course of treatments (7-day, 10-day and 14-day) guided by AST in intention-to-treat (ITT) analysis.

The study did not show it

Who was studied
NCT02934048
How many people
700
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

Helicobacter pylori Eradication Rate

The study did not show it

Who was studied
NCT07746934
How many people
600
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

Cure of Bacterial Vaginosis

The study did not show it

Who was studied
NCT00334633
How many people
593
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.

  • & USAGE Tinidazole Tablets is a nitroimidazole antimicrobial indicated for: Trichomoniasis ( 1.1 ) Giardiasis: in patients age 3 and older ( 1.2 ) Amebiasis: in patients age 3 and older ( 1.3 ) Bacterial Vaginosis: in adult women ( 1.4, 8.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of tinidazole tablets and other antibacterial drugs, tinidazole tablets should be used only…

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: “Other than for use in the treatment of giardiasis and amebiasis in pediatric patients older than three years of age, safety and effectiveness of tinidazole in pediatric patients have not been established.”

    US prescribing information · 95ab57b2-5d7e-4986-abcd-65edf1728383 · read 2026-08-30

  • On older people, the label states: “Clinical studies of tinidazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”

    US prescribing information · 95ab57b2-5d7e-4986-abcd-65edf1728383 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Available published data from a case-control study and case report with tinidazole use in pregnant women are insufficient to identify a risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.”

    US prescribing information · 95ab57b2-5d7e-4986-abcd-65edf1728383 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Limited published literature, based on breast milk sampling, reports that tinidazole is present in human milk.”

    US prescribing information · 95ab57b2-5d7e-4986-abcd-65edf1728383 · read 2026-08-30

  • On people with reduced liver function, the label states: “There are no data on tinidazole pharmacokinetics in patients with impaired hepatic function.”

    US prescribing information · 95ab57b2-5d7e-4986-abcd-65edf1728383 · read 2026-08-30

  • On people with reduced kidney function, the label states: “Because the pharmacokinetics of tinidazole in patients with severe renal impairment (CrCL < 22 mL/min) are not significantly different from those in healthy subjects, no dose adjustments are necessary in these patients.”

    US prescribing information · 95ab57b2-5d7e-4986-abcd-65edf1728383 · 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

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

Sold as tablet, tablet, film coated, 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

  • 15 products list this as an active ingredient in the United States drug directory. 15 of them contain it and nothing else.

    FDA National Drug Code directory · 42799-207 · read 2026-08-29

  • They are sold as powder, tablet and tablet, film coated, taken oral.

    FDA National Drug Code directory · 42799-207 · read 2026-08-29

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

    FDA National Drug Code directory · 42799-207 · read 2026-08-29

  • 8 published labels name it as an active ingredient. 8 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 95ab57b2-5d7e-4986-abcd-65edf1728383 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 95ab57b2-5d7e-4986-abcd-65edf1728383 · read 2026-08-29

  • Tinidazole is oral at 3 DOSAGE FORMS & STRENGTHS Tablets: 250 mg and 500 mg ( 3 ) 250 mg tablets are pink, round, scored tablets debossed with "N" scored "L" on one side and "550" on the other side. 500 mg tablets are pink, oval, scored tabl…, recorded as fda label in effect 2022-02-14 in the United States.

    US prescribing information · 95ab57b2-5d7e-4986-abcd-65edf1728383 · read 2026-08-30

  • Recorded price in US: 1.57587–2.19872 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 8 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 Tinidazole 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 Tinidazole 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

  • 8 documents were read for this substance.

    RNAWiki source record

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

    RNAWiki source record

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

    RNAWiki source record

  • 8 of them state the same proteinBinding, and they agree.

    RNAWiki source record

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

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
033KF7V46H
RxNorm concept
199519

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

  • Not passed

    Safety mode resolved

    No register row and no identity class settled the question.

  • 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

  • 7 approved applications cover products containing this substance. The earliest was NDA021681, approved 20040517 to MISSION PHARMA.

    Drugs@FDA application register · NDA021681 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA021681 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20040517.

    FDA National Drug Code directory · 42799-207 · 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 Tinidazole label: indicated for what?


"Tinidazole is a nitroimidazole antimicrobial indicated for: Trichomoniasis ( 1.1 ) Giardiasis: in patients age 3 and older ( 1.2 ) Amebiasis: in patients age 3 and older ( 1.3 ) Bacterial Vaginosis: in non-pregnant, adult women ( 1.4 , 8.1 ) To reduce the development of drug-resistant bacteria and maintain the…": indications and usage on Tinidazole's label. DailyMed label · 7f552a9b-3190-4301-8352-36451a73b956 · 2026-08-19

22 registered trials of Tinidazole — at which phases?


Registered studies posting no result
20 of 22

22 registered studies of Tinidazole: 9 phase4, 4 phase2, 4 phase3, 3 na, 1 early phase1, 1 phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

356 with a PubMed record

Show the evidence
  • phase4
    9
  • phase2
    4
  • phase3
    4
  • na
    3
  • early phase1
    1
  • phase1
    1
6 more recorded rows
  • completed
    9
  • unknown
    7
  • not yet recruiting
    2
  • withdrawn
    2
  • recruiting
    1
  • terminated
    1

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

3 of Tinidazole's trials stopped: accrual/recruitment, other?


accrual/recruitment (2) and other (1): Tinidazole's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Study Terminated Prematurely"; 3 of 22 registered studies

Show the evidence

Trial

  • NCT00324142
    withdrawn; "Study Terminated Prematurely"
  • NCT02942485
    terminated; "Extremely slow enrollment"
  • NCT03021590
    withdrawn; "No Participants Enrolled"

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

Human studies of Tinidazole used Tinidazole 500Mg Tablet — over how long?


Human studies of Tinidazole used "Tinidazole 500Mg Tablet". ClinicalTrials.gov · 2026-09-01

3 recorded entries; human; also "Tinidazole 500mg", "Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by…"

Show the evidence

human

  • NCT03021590
    Tinidazole 500Mg Tablet
  • NCT04132479
    Tinidazole 500mg
  • NCT05863858
    Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID

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

Tinidazole's half-life is 12 to 14 hours — which schedules were studied?


12 to 14 hours, the half-life Tinidazole's label states: "Elimination The plasma half-life of tinidazole is approximately 12 to 14 hours." DailyMed label · 7f552a9b-3190-4301-8352-36451a73b956 · 2026-08-19

tmax 72 hours.

Show the evidence
  • half life pharmacokinetics
    12 to 14 hours; Elimination The plasma half-life of tinidazole is approximately 12 to 14 hours.
  • tmax pharmacokinetics
    72 hours; Oral administration of four 500 mg tablets of tinidazole tablets under fasted conditions produced a mean peak plasma concentration (C max ) of 47.7 (±7.5) μg/mL with a mean time to peak concentration (T max ) of 1.6 (±0.7) hours, and a mean area under the plasma concentration-time curve (AUC 0 to ∞ ) of 901.6 (± 126.5) μg hr/mL at 72 hours.
  • metabolism pharmacokinetics
    Metabolism: Tinidazole is significantly metabolized in humans prior to excretion.

recorded 2026-08-19 · last checked 2026-09-04

Which 8 trials of Tinidazole posted no result?


Posted no result
8 of 8 completed trials
Registrations
NCT00229216, NCT00811096, NCT00510614, NCT01591889, NCT02711176 and NCT04132479, and 2 more
Completion dates
oldest 2007-06; newest 2022-06-08
Show the evidence

Trial

  • NCT00229216
    2007-06
  • NCT00811096
    2009-04
  • NCT00510614
    2009-09
  • NCT01591889
    2009-09
  • NCT02711176
    2017-03-27
  • NCT04132479
    2019-04-09
2 further recorded trials
  • NCT04370145
    2022-04-01
  • NCT05863858
    2022-06-08

At the median, Tinidazole's trials enrolled 155 people — anything larger?


Median enrolment
155
Largest enrolment
600
Registered trials counted
22

What do 48 spontaneous reports say about Tinidazole — 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.

Tinidazole appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 48 reaction mentions were counted: drug effective for unapproved indication 10; tremor 9; dysphonia 5; pruritus generalised 5. FAERS via Open Targets · CHEMBL1220 · 2026-06-24

Show the evidence
  • drug effective for unapproved indication
    10
  • tremor
    9
  • dysphonia
    5
  • pruritus generalised
    5
  • vasculitis
    4
  • dystonia
    3
4 more recorded rows
  • peripheral motor neuropathy
    3
  • peripheral sensory neuropathy
    3
  • pseudomembranous colitis
    3
  • toxic encephalopathy
    3

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

Which 10 reactions does Tinidazole's label not list?


drug effective for unapproved indication, dysphonia and dystonia and 7 more reported for Tinidazole, absent from its label. FAERS via Open Targets · CHEMBL1220 · 2026-06-24

2 label terms; 10 reported and unlisted; 7f552a9b-3190-4301-8352-36451a73b956

Show the evidence
  • drug effective for unapproved indication
    count not stated
  • dysphonia
    count not stated
  • dystonia
    count not stated
  • peripheral motor neuropathy
    count not stated
  • peripheral sensory neuropathy
    count not stated
  • pruritus generalised
    count not stated
4 more recorded rows
  • pseudomembranous colitis
    count not stated
  • toxic encephalopathy
    count not stated
  • tremor
    count not stated
  • vasculitis
    count not stated

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

Tinidazole and CYP3A4, CYP1A2 and CYP2B6: shared by which compounds?


CYP3A4, CYP1A2 and CYP2B6 appear in Tinidazole's recorded interaction sentences, 7 in all. DailyMed label · 7f552a9b-3190-4301-8352-36451a73b956 · 2026-08-19

CYP1A2, CYP2B6, CYP2C9, CYP2D6, CYP2E1, CYP3A4; 7 shared nodes; drug_interactions, pharmacokinetics, clinical_pharmacology

Show the evidence

Interaction statement

  • drug_interactions
    The following drug interactions were reported for metronidazole, a chemically-related nitroimidazole and may therefore occur with tinidazole: Warfarin and other oral coumarin anticoagulants: Anticoagulant dosage may need adjustment during and up to 8 days after tinidazole therapy ( 7.1 ) Alcohol-containing beverages/preparations: Avoid during and up to 3 days after tinidazole therapy ( 7.1 )…
  • drug_interactions
    7.2 Potential Effects of Other Drugs on Tinidazole CYP3A4 Inducers and Inhibitors: Simultaneous administration of tinidazole with drugs that induce liver microsomal enzymes, i.e., CYP3A4 inducers such as phenobarbital, rifampin , phenytoin , and fosphenytoin (a pro-drug of phenytoin), may accelerate the elimination of tinidazole, decreasing the plasma level of tinidazole.
  • drug_interactions
    Simultaneous administration of drugs that inhibit the activity of liver microsomal enzymes, i.e., CYP3A4 inhibitors such as cimetidine and ketoconazole , may prolong the half-life and decrease the plasma clearance of tinidazole, increasing the plasma concentrations of tinidazole.
  • pharmacokinetics
    Tinidazole is biotransformed mainly by CYP3A4.
  • pharmacokinetics
    In an in vitro metabolic drug interaction study, tinidazole concentrations of up to 75 μg/mL did not inhibit the enzyme activities of CYP1A2, CYP2B6, CYP2C9, CYP2D6, CYP2E1, and CYP3A4.
  • clinical_pharmacology
    Tinidazole is biotransformed mainly by CYP3A4.
1 more recorded row
  • Interaction statement clinical_pharmacology
    In an in vitro metabolic drug interaction study, tinidazole concentrations of up to 75 μg/mL did not inhibit the enzyme activities of CYP1A2, CYP2B6, CYP2C9, CYP2D6, CYP2E1, and CYP3A4.
  • CYP1A2
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Golodirsen, Naldemedine
  • CYP2B6
    FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Sofpironium, Bupropion, Golodirsen, Naldemedine, Methylnaltrexone
  • CYP2C9
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Naldemedine, Pemetrexed
  • CYP2D6
    FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine
  • CYP2E1
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, Rasagiline, Naldemedine, Methylnaltrexone, Alosetron, Metaxalone, Uridine triacetate

CYP3A4

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium

recorded 2026-08-19 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1220
PubChem CID
5479
CAS number
19387-91-8
RxCUI
10612
InChIKey
HJLSLZFTEKNLFI-UHFFFAOYSA-N
Development code
CP-12,574, CP-12574, NSC-758189
Also called
Fasigin, Haisigyn, Tinidazol, Tricolam, Trimonase, TINIDAZOLE [EP MONOGRAPH], TINIDAZOLE [HSDB], TINIDAZOLE [JAN]
Trade name
Fasigyn, Simplotan, Symplotan, Tindamax, Tindazole, Tindamax / Tindazole
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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