This page shows what was measured, who it was measured in, and what that does not settle.
What Fluconazole does in the body
The half-finished sterols that pile up cannot do the job, so the membrane becomes leaky and disordered and the fungus stops growing.
Fungal cells build their outer membrane out of a fat called ergosterol, which they have to manufacture themselves. Fluconazole jams one specific enzyme on that production line. Human cells build cholesterol using a related enzyme, which is why the dose matters and why the drug interacts with so many others.
Why people take it. Used for thrush, other yeast infections and some serious fungal infections.
What happened in people
In African adults with HIV-related fungal meningitis, fluconazole plus another tablet matched two weeks of medicine given into a vein on early deaths.
✓ Reviewed first-read answer
Where this came from
A person wrote this and a reviewer approved it against this exact record. It carries no effect size.
A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.
No source is stored against this line.
The limit that matters most
One tablet can treat simple vaginal thrush, while serious fungal disease needs longer, combined treatment.
Where it acts
Fungal endoplasmic reticulum, where ergosterol is synthesised
Kind of result
The kind of result is not recorded
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 8VZV102JFY · read 2026-08-29
Its recorded molecular formula is C13H12F2N6O, weighing 306.3.
US prescribing information · afde17e7-b95b-4cd5-97eb-e361724014bd · read 2026-08-30
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
A reviewer approved this sentence against this exact record and its sources.
The limit a reviewer approved as the one that matters most here.
The four opening statements run to 106 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
All-cause mortality at 2 weeks in HIV-associated cryptococcal meningitis
✓ The study showed what it set out to show
Who was studied
ACTA (ISRCTN45035509)
How many people
721
Study design
Phase 3 randomised, open-label, non-inferiority with factorial partner-drug randomisation
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Non-inferiority met (upper one-sided 97.5% bound 4.2 percentage points against a 10-point margin); P = 0.002 for flucytosine over fluconazole as the partner drug
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. The partner-drug comparison showed 45.0% ten-week mortality with fluconazole against 31.1% with flucytosine, a difference not visible in the headline non-inferiority result.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, oral suspension and intravenous infusion
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 4 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Fluconazole
What a person takes: Oral tablet, oral suspension and intravenous infusion.
The measurement behind this step
A single 150 mg tablet for uncomplicated vaginal candidiasis; daily dosing for oropharyngeal, oesophageal and invasive disease; 1,200 mg daily as part of combination induction for cryptococcal meningitis. Because oral bioavailability exceeds 90% and is unaffected by food or gastric acid, the intravenous and oral routes are interchangeable at the same dose.
Getting in
Absorbed almost completely and reaching the brain
Fluconazole is water-soluble enough to be swallowed and still reach the fluid around the brain, which is why it can treat fungal meningitis.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Oral bioavailability exceeds 90% and is unaffected by food or gastric acidity, unlike itraconazole. Protein binding is low, around 11%, and cerebrospinal fluid concentrations approach plasma concentrations. Elimination is largely renal as unchanged drug, so dosing follows creatinine clearance.
Enters the fungal cell and reaches the endoplasmic reticulum
The drug crosses into the fungus and travels to where membrane fats are made.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Uptake is by facilitated diffusion. Efflux through the Candida CDR1, CDR2 and MDR1 transporters is one of the main resistance mechanisms and is upregulated by repeated exposure, which is the pharmacological reason repeated single doses select for resistance.
A triazole nitrogen coordinates the enzyme haem iron
One of the drug nitrogen atoms grips the iron atom at the heart of the enzyme, blocking the spot where the reaction happens.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The N-4 nitrogen of one triazole ring coordinates the haem iron of lanosterol 14-alpha-demethylase (Erg11p, CYP51), while the difluorophenyl group occupies the substrate channel. ERG11 point mutations and gene overexpression are the second major resistance route.
Ergosterol synthesis stalls and toxic sterols accumulate
The production line stops, and the half-finished parts pile up and cause their own damage.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Depletion of ergosterol and accumulation of 14-alpha-methylated sterols, principally 14-alpha-methyl-3,6-diol, disorders the membrane and inhibits growth. The effect is fungistatic against Candida species, not fungicidal, which is why relapse follows if the immune system cannot finish the job.
Fungal growth stops, and human CYP enzymes are inhibited too
The infection is controlled. At higher doses the drug also slows some of the enzymes your liver uses to clear other medicines.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Fluconazole inhibits human CYP2C9, CYP2C19 and, at higher doses, CYP3A4, raising concentrations of warfarin, phenytoin, sulfonylureas and many other drugs. It also prolongs the QT interval. The selectivity for fungal CYP51 over human CYP enzymes is real but is a matter of degree rather than of kind.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Women with vulvovaginal candidiasis, people with oral or oesophageal thrush, patients with candidaemia, and adults with cryptococcal meningitis as part of a combination and consolidation regimen.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety profile of fluconazole has been studied in 577 pediatric patients from 1 day to 17 years of age who received doses ranging from 1 to 15 mg/kg/day for 1 to 1,616 days.”
US prescribing information · afde17e7-b95b-4cd5-97eb-e361724014bd · read 2026-08-30
On older people, the label states: “Controlled clinical trials of fluconazole did not include sufficient numbers of patients aged 65 and older to evaluate whether they respond differently from younger patients in each indication.”
US prescribing information · afde17e7-b95b-4cd5-97eb-e361724014bd · read 2026-08-30
On people who are pregnant, the label states: “Potential for Fetal Harm: Use in pregnancy should be avoided except in patients with severe or potentially life-threatening fungal infections in whom fluconazole may be used if the anticipated benefit outweighs the possible risk to the fetus.”
US prescribing information · afde17e7-b95b-4cd5-97eb-e361724014bd · read 2026-08-30
On people who are breastfeeding, the label states: “Fluconazole was present in low levels in breast milk following administration of a single 150 mg dose, based on data from a study in 10 breastfeeding women who temporarily or permanently discontinued breastfeeding 5 days to 19 months postpartum.”
US prescribing information · afde17e7-b95b-4cd5-97eb-e361724014bd · read 2026-08-30
Where the result stopped carrying
Fluconazole as the partner drug for amphotericin B: 45.0% ten-week mortality against 31.1% for flucytosine in the same randomised trial
Fluconazole monotherapy for cryptococcal meningitis was already known to be inadequate and was not given an arm in ACTA
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral tablet, oral suspension and intravenous infusion
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
A single 150 mg tablet for uncomplicated vaginal candidiasis; daily dosing for oropharyngeal, oesophageal and invasive disease; 1,200 mg daily as part of combination induction for cryptococcal meningitis. Because oral bioavailability exceeds 90% and is unaffected by food or gastric acid, the intravenous and oral routes are interchangeable at the same dose.
✎ 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 take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
The dominant practical issue is drug interaction: fluconazole inhibits CYP2C9 and CYP2C19 and, at higher doses, CYP3A4, raising levels of warfarin, phenytoin, sulfonylureas and many others. QT prolongation is documented. Hepatotoxicity and rare severe cutaneous reactions occur. In pregnancy, Danish registry analyses associated oral exposure with tetralogy of Fallot and with spontaneous abortion, and intravaginal azoles are preferred where a local option will do.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral tablet, oral suspension and intravenous infusion
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Because oral bioavailability exceeds 90% and is unaffected by food or gastric acid, the intravenous and oral routes are interchangeable at the same dose.
✎ 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 which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
184 products list this as an active ingredient in the United States drug directory. 184 of them contain it and nothing else.
FDA National Drug Code directory · 72189-342 · read 2026-08-29
They are sold as injection, injection, solution, powder, powder, for suspension and tablet, taken intravenous and oral.
FDA National Drug Code directory · 72189-342 · read 2026-08-29
The regulator's established pharmacologic class for it is azole antifungal [epc], azoles [cs] and cytochrome p450 2c19 inhibitors [moa].
FDA National Drug Code directory · 72189-342 · read 2026-08-29
102 published labels name it as an active ingredient. 102 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · c2c7242d-d172-4733-e053-2995a90acb2e · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · c2c7242d-d172-4733-e053-2995a90acb2e · read 2026-08-29
Fluconazole is uncoated tablets at 150 mg (unit dose package of 1), recorded as prescription product; fda label in effect 2025-11-17 in the United States.
US prescribing information · 01df20c4-7b94-044e-e063-6394a90a406a · read 2026-08-27
Recorded price in US: 0.19932–0.43349 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 57 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: 0.28232–0.52297 USD per one millilitre, across 7 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Fluconazole studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That the safety and convenience of a single 150 mg dose for vaginal candidiasis describes fluconazole in general, when the cryptococcal regimen is 1,200 mg daily for two weeks in combination
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That non-inferiority of an oral regimen means fluconazole is as good as flucytosine — the same trial randomised that question separately and answered it in the other direction
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Fluconazole are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
ACTA: an all-oral fluconazole and flucytosine regimen was non-inferior to two weeks of amphotericin B
In plain words
In 721 African adults with HIV-associated cryptococcal meningitis, two weeks of oral fluconazole plus flucytosine matched two weeks of intravenous amphotericin B on death at two weeks.
What was measured
All-cause mortality at 2 weeks, with 10-week mortality as a secondary outcome
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Randomised trial in HIV-infected adults with cryptococcal meningitis. Two-week mortality was 18.2% (41 of 225) in the oral regimen group, 21.9% (49 of 224) with one week of amphotericin B and 21.4% (49 of 229) with two weeks; ten-week mortality was 35.1%, 36.2% and 39.7%. The upper limit of the one-sided 97.5% confidence interval for the oral regimen versus two-week amphotericin B was 4.2 percentage points, inside the prespecified 10-point non-inferiority margin. Severe anaemia was more frequent with two weeks of amphotericin B than with the oral regimen.
Written into the record, not signed off as a reviewed claim
In the same trial, fluconazole was clearly the inferior partner drug for amphotericin B
In plain words
Patients given amphotericin B with flucytosine died substantially less often than those given amphotericin B with fluconazole.
What was measured
All-cause mortality at 10 weeks by partner-drug randomisation
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Within ACTA, each patient assigned amphotericin B was separately randomised to fluconazole or flucytosine as the partner drug. Ten-week mortality was 71 deaths (31.1%) with flucytosine and 101 deaths (45.0%) with fluconazole, hazard ratio for death 0.62 (95% CI 0.45 to 0.84; P=0.002). One week of amphotericin B plus flucytosine had the lowest ten-week mortality of any arm at 24.2% (95% CI 16.2 to 32.1). Fluconazole monotherapy, which the trial was explicitly designed to improve upon, was not an arm because it was already known to be inadequate.
Written into the record, not signed off as a reviewed claim
First-trimester exposure and tetralogy of Fallot in Danish registry data
In plain words
A national registry study of nearly a million pregnancies found no overall increase in birth defects, and one specific heart malformation that was more common.
What was measured
Adjusted prevalence odds ratio for specific birth defects
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Registry cohort of liveborn infants in Denmark. Birth defects occurred in 210 of 7,352 fluconazole-exposed pregnancies (2.86%) and 25,159 of 968,236 unexposed (2.60%), adjusted prevalence odds ratio 1.06 (95% CI 0.92 to 1.21). Fourteen of fifteen specific defects previously linked to azoles showed no significant increase. Tetralogy of Fallot did: 7 cases (0.10%) versus 287 (0.03%), adjusted prevalence odds ratio 3.16 (95% CI 1.49 to 6.71). Most exposures were at the common 150 mg or 300 mg doses. Seven events is a small numerator and the confidence interval is correspondingly wide.
Written into the record, not signed off as a reviewed claim
Spontaneous abortion: a 48% relative increase against unexposed pregnancies
In plain words
A second Danish registry analysis found more miscarriages among women who took oral fluconazole in pregnancy, including when compared with women who used topical antifungals instead.
What was measured
Hazard ratio for spontaneous abortion and stillbirth
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
From a cohort of 1,405,663 pregnancies, 3,315 women exposed to oral fluconazole between 7 and 22 weeks were compared with 13,246 propensity-matched unexposed women: 147 versus 563 spontaneous abortions, hazard ratio 1.48 (95% CI 1.23 to 1.77). Against topical azole exposure as the comparator, 130 of 2,823 versus 118 of 2,823, hazard ratio 1.62 (95% CI 1.26 to 2.07). Stillbirth was not significantly increased (hazard ratio 1.32, 95% CI 0.82 to 2.14). The topical-azole comparison is what makes confounding by indication a weaker explanation than it would otherwise be.
Written into the record, not signed off as a reviewed claim
AMBITION then moved the standard again, to a single dose of liposomal amphotericin
In plain words
Four years after the oral regimen was shown to be non-inferior, a single high dose of a different drug plus two weeks of fluconazole and flucytosine did better still.
What was measured
All-cause mortality at 10 weeks
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Phase 3 non-inferiority trial in five African countries, 844 randomised and 814 in the intention-to-treat population. A single 10 mg/kg dose of liposomal amphotericin B plus 14 days of flucytosine and fluconazole gave 10-week mortality of 24.8% (95% CI 20.7 to 29.3) against 28.7% (95% CI 24.4 to 33.4) for the then-recommended WHO regimen, difference -3.9 percentage points, upper one-sided 95% bound 1.2 points, P<0.001 for non-inferiority. Grade 3 or 4 adverse events occurred in 50.0% versus 62.3%. Fluconazole is a component of the new standard rather than a competitor to it.
Written into the record, not signed off as a reviewed claim
Single-dose convenience is an efficacy claim about one infection, not about all of them
In plain words
One 150 mg tablet clears most simple vaginal yeast infections. Nothing about that generalises to serious fungal disease, which needs weeks of combination therapy.
What was measured
That the convenience and safety of a single 150 mg dose describes fluconazole as a drug rather than one indication
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The dose used in the Danish registry studies for the commonest indication was 150 mg (56% of exposed pregnancies) or 300 mg (31%). The dose used in ACTA and AMBITION for cryptococcal meningitis was 1,200 mg per day for two weeks, as part of a combination, with ten-week mortality still around a quarter of patients. The same molecule spans an eightfold daily dose range and two entirely different evidence bases, and a claim proved at one end says nothing about the other.
This order is fixed in code and does not count clicks or time on the page.
What is not here
7 questions this page could not answer
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Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
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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.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A triazole that stalls fungal membrane synthesis at one enzyme, effective and convenient in candidiasis, measurably inferior to flucytosine as the partner drug in cryptococcal meningitis (45.0% versus 31.1% ten-week mortality), and associated in Danish registry data with tetralogy of Fallot and with spontaneous abortion in pregnancy.
Recorded evidence blocks (10)
Q1
On the Fluconazole label: indicated for what?
"Fluconazole Tablets are indicated for the treatment of: Vaginal candidiasis (vaginal yeast infections due to Candida ). Oropharyngeal and esophageal candidiasis.": indications and usage on Fluconazole's label. DailyMed label · 91adb548-9875-47e9-8054-578ed8c7572e · 2026-06-10
Q2
188 registered trials of Fluconazole — at which phases?
Registered studies posting no result
147 of 188
188 registered studies of Fluconazole: 53 phase1, 48 phase3, 32 na, 31 phase2, 21 phase4, 10 na or unstated, 2 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
817 with a PubMed record
Show the evidence
phase1
53
phase3
48
na
32
phase2
31
phase4
21
na or unstated
10
8 more recorded rows
early phase1
2
completed
145
unknown
17
recruiting
11
terminated
8
withdrawn
3
active not recruiting
2
not yet recruiting
2
recorded 2026-09-01 · last checked 2026-09-04
Q3
11 of Fluconazole's trials stopped: safety, accrual/recruitment, funding/business, other?
safety (2), accrual/recruitment (2), funding/business (1) and other (6): Fluconazole's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"Limited clinical staff"; 11 of 188 registered studies
Show the evidence
Trial
NCT00166166
terminated; "Limited clinical staff"
NCT00304772
withdrawn; "Subjects were not recruited as intended."
NCT00675714
terminated; "At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data."
NCT01562132
terminated; "Stopped in accordance with pre-specified stopping rules for poor recruitment."
NCT01950507
terminated; "Slow/Insufficient accrual"
NCT01953744
terminated; "Low cure rate in the study (fluconazole) group"
5 further recorded trials
NCT02532192
withdrawn; "Withdrawal of study support."
NCT02663674
terminated; "Study terminated due to lack of feasibility of study design."
NCT03002012
terminated; "SAEs with n=1 serotonin syndrome, n=2 SAEs after sertraline interruption."
NCT04464577
withdrawn; "Business objectives have changed."
NCT05178862
terminated; "Strategic decision not related to safety or efficacy concerns for Ibrexafungerp."
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Fluconazole used Fluconazole 200mg tab — over how long?
Human studies of Fluconazole used "Fluconazole 200mg tab". ClinicalTrials.gov · 2026-09-01
8 recorded entries; human; capsule; also "Fluconazole capsule 50mg", "Fluconazole 150mg capsule", "Fluconazole (BAYT006267) 150 mg capsules"
Show the evidence
human
NCT03002012
Fluconazole 200mg tab
NCT03821480
capsule; Fluconazole capsule 50mg
NCT03840616
capsule; Fluconazole 150mg capsule
NCT03929861
Fluconazole (BAYT006267) 150 mg capsules
NCT03929861
Fluconazole 150 mg capsules (DiflucanTM)
NCT04122560
Fluconazole 2 MG/ML
2 more recorded rows
humanNCT04734405
Fluconazole 150 mg
humanNCT05602597
Fluconazole 400 mg
recorded 2026-09-01 · last checked 2026-09-04
Q5
Fluconazole's half-life is 2 hours — which schedules were studied?
2 hours, the half-life Fluconazole's label states: "Peak plasma concentrations (C max ) in fasted normal volunteers occur between 1 and 2 hours with a terminal plasma elimination half-life of approximately 30 hours (range: 20 to 50 hours) after oral administration." DailyMed label · 91adb548-9875-47e9-8054-578ed8c7572e · 2026-06-10
tmax 2 hours; bioavailability 90 %.
Show the evidence
half lifepharmacokinetics
2 hours; Peak plasma concentrations (C max ) in fasted normal volunteers occur between 1 and 2 hours with a terminal plasma elimination half-life of approximately 30 hours (range: 20 to 50 hours) after oral administration.
tmaxpharmacokinetics
2 hours; Peak plasma concentrations (C max ) in fasted normal volunteers occur between 1 and 2 hours with a terminal plasma elimination half-life of approximately 30 hours (range: 20 to 50 hours) after oral administration.
bioavailabilitypharmacokinetics
90 %; In normal volunteers, the bioavailability of orally administered fluconazole is over 90% compared with intravenous administration.
metabolismpharmacokinetics
and Metabolism The pharmacokinetic properties (PK) of fluconazole are similar following administration by the intravenous or oral routes.
recorded 2026-06-10 · last checked 2026-09-04
Q6
Which 76 trials of Fluconazole posted no result?
Posted no result
76 of 76 completed trials
Registrations
NCT00000676, NCT00000788, NCT00000627, NCT00000744, NCT00004938 and NCT00000776, and 70 more
Completion dates
oldest 1993-11; newest 2024-07-01
Show the evidence
Trial
NCT00000676
1993-11
NCT00000788
1994-06
NCT00000627
1994-11
NCT00000744
1995-12
NCT00004938
1996-08
NCT00000776
1996-09
14 further recorded trials
NCT00000639
1997-09
NCT00000826
1999-05
NCT00001937
2000-12
NCT00012467
2001-07
NCT00001542
2001-11
NCT00000951
2002-05
NCT00003883
2002-07
NCT01511757
2002-07
NCT01511770
2002-09
NCT00645242
2003-03
NCT00666185
2004-02
NCT00056368
2004-10
NCT00001107
2005-11
NCT00353561
2006-04
Q7
At the median, Fluconazole's trials enrolled 68 people — anything larger?
Median enrolment
68
Largest enrolment
40110
Registered trials counted
169
Q8
What do 2550 spontaneous reports say about Fluconazole — 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.
Fluconazole appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2550 reaction mentions were counted: drug interaction 868; drug hypersensitivity 419; electrocardiogram qt prolonged 199; abortion spontaneous 176. FAERS via Open Targets · CHEMBL106 · 2026-06-24
Show the evidence
drug interaction
868
drug hypersensitivity
419
electrocardiogram qt prolonged
199
abortion spontaneous
176
drug reaction with eosinophilia and systemic symptoms
175
pancytopenia
157
4 more recorded rows
stevens-johnson syndrome
153
international normalised ratio increased
141
rash maculo-papular
132
torsade de pointes
130
recorded 2026-06-24 · last checked 2026-09-04
Q9
Which 10 reactions does Fluconazole's label not list?
(See CONTRAINDICATIONS .) Fluconazole is a moderate CYP2C9 and CYP3A4 inhibitor.
drug_interactions
Patients treated with fluconazole, who are also concomitantly treated with drugs with a narrow therapeutic window metabolized through CYP2C9 and CYP3A4, should be monitored for adverse reactions associated with the concomitantly administered drugs.
drug_interactions
In addition to the observed/documented interactions mentioned below, there is a risk of increased plasma concentration of other compounds metabolized by CYP2C9, CYP2C19, and CYP3A4 co-administered with fluconazole.
drug_interactions
Clinically or potentially significant drug interactions between fluconazole and the following agents/classes have been observed and are described in greater detail below: Abrocitinib: Drug interaction studies indicate that when co-administered with fluconazole (strong inhibitor of CYP2C19; moderate inhibitor of CYP2C9 and CYP3A4), the systemic exposure of abrocitinib and its active metabolites…
drug_interactions
A possible mechanism of action is fluconazole's inhibition of CYP3A4.
drug_interactions
Calcium channel blockers: Certain calcium channel antagonists (nifedipine, isradipine, amlodipine, verapamil, and felodipine) are metabolized by CYP3A4.
2 more recorded rows
Interaction statementdrug_interactions
HMG-CoA reductase inhibitors: The risk of myopathy and rhabdomyolysis increases when fluconazole is co-administered with HMG-CoA reductase inhibitors metabolized through CYP3A4, such as atorvastatin and simvastatin, or through CYP2C9, such as fluvastatin (decreased hepatic metabolism of the statin).
Interaction statementdrug_interactions
Ibrutinib: Moderate inhibitors of CYP3A4 such as fluconazole may increase plasma ibrutinib concentrations and increase risk of adverse reactions associated with ibrutinib.
ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
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