This page shows what was measured, who it was measured in, and what that does not settle.
What Tacrolimus Anhydrous does in the body
Stopping the body rejecting a transplanted organ, and severe eczema that has not responded to steroid creams
When an immune cell spots something foreign, calcium floods in and switches on an enzyme that releases the cell’s instruction to multiply and call for reinforcements. Tacrolimus does not touch that enzyme directly. It first grabs a small carrier protein inside the cell, and the pair of them together jam the enzyme. The instruction never gets sent, so the immune attack never assembles. The same carrier protein and the same enzyme exist in kidney and pancreas cells too, which is why the drug damages kidneys and raises blood sugar at doses close to the ones that protect the transplant.
What happened in people
New-onset diabetes or impaired fasting glucose 33.6% against 26.0% on cyclosporine at six months, P=0.046
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
That late arteriolar hyalinosis and glomerulosclerosis on protocol biopsy are caused by the calcineurin inhibitor — an attribution disputed in print by the same journal
Where it acts
The cytoplasm of T lymphocytes, where the drug-protein complex blocks a phosphatase before the cell has committed to making interleukin-2
Kind of result
A number that stands in for health
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 · WM0HAQ4WNM · read 2026-08-29
Its recorded molecular formula is C44H69NO12•H2O.
US prescribing information · 61dee012-43af-0e9a-3843-9b9b91e022c4 · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 137 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.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
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.
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.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Healthy ageing
…Waiting for a reviewer2 registered study measure of this kind. No reviewed result yet.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Healthy ageing
treatment related mortality; transplant related mortality
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
… Waiting for a reviewer
2 registered study measure of this kind. No reviewed result yet.
∅ Nothing in the sources checked
No registered study lists a performance measure for this goal.
— Not recorded
Harms were not a registered measure for this goal.
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.
Patient and graft survival at one year after first liver transplant
Patient survival 88% in both arms (P=0.85, 95% CI -5.4 to +6.6); graft survival 82% against 79% (P=0.55). Corticosteroid-resistant rejection 43 against 82 patients (P<0.001); refractory rejection 6 against 32 (P<0.001)
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. Withdrawal for adverse events was 37 against 13 patients (P<0.001), primarily for nephrotoxicity and neurotoxicity. The primary endpoint was survival and it was identical; the rejection advantage is a secondary endpoint.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Immediate-release oral capsules, granules for oral suspension, extended-release capsules and tablets, intravenous solution, and 0.03% and 0.1% topical ointment
Interval reported. 95% CI -5
Written into the record, not signed off as a reviewed claim.
Estimated glomerular filtration rate by Cockcroft-Gault at 12 months after renal transplantation
✓ The study showed what it set out to show
Who was studied
ELITE-Symphony (NCT00231764)
How many people
1645
Study design
Phase 4, randomised, open-label, four-arm
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Mean GFR 65.4 mL/min on low-dose tacrolimus against 56.7 to 59.4 in the other three arms; biopsy-proven acute rejection 12.3% against 24.0% to 37.2%; allograft survival 94.2%, P=0.02 across arms
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. Open-label, and the four arms differ in more than one component — the standard-dose cyclosporine arm had no induction agent while the three low-dose arms all received daclizumab, so the comparison is between regimens rather than between drugs.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Immediate-release oral capsules, granules for oral suspension, extended-release capsules and tablets, intravenous solution, and 0.03% and 0.1% topical ointment
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
New-onset diabetes after transplant or impaired fasting glucose at 6 months, by ADA/WHO criteria
✗ The study did not show it
Who was studied
DIRECT (Vincenti 2007)
How many people
682
Study design
Phase 4, randomised, open-label, multicentre
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
33.6% on tacrolimus against 26.0% on cyclosporine microemulsion, P=0.046
Repeated elsewhere
Replicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. Open-label, six months only, and glucose endpoints in the first months after transplantation are heavily influenced by corticosteroid exposure, which was reported as similar between arms. Cyclosporine produced significantly worse lipids, which the diabetes headline tends to displace.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Immediate-release oral capsules, granules for oral suspension, extended-release capsules and tablets, intravenous solution, and 0.03% and 0.1% topical ointment
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Natural history of chronic allograft nephropathy on serial protocol biopsy to ten years
✓ The study showed what it set out to show
Who was studied
Nankivell protocol biopsy cohort (2003)
How many people
120
Study design
Prospective protocol-biopsy cohort study, not randomised
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
961 biopsies; mild chronic allograft nephropathy in 94.2% at one year, severe in 58.4% at ten years with 37.3% glomerulosclerosis; calcineurin inhibitor nephrotoxicity described as almost universal at ten years
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Observational, in 120 patients almost all of whom received simultaneous kidney-pancreas transplants for type 1 diabetes — a population with its own vascular risk. Attribution of the late arteriolar hyalinosis to the drug rather than to donor age, hypertension or diabetes has been formally disputed.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Immediate-release oral capsules, granules for oral suspension, extended-release capsules and tablets, intravenous solution, and 0.03% and 0.1% topical ointment
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 happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.11 registered measures of this kind. No reviewed result.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.1 registered measure of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.4 registered measures inside human tissue.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat, Non-human primate. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
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.
Where a source records it acting
Immune and lymphatic system: Inhibits the phosphatase activity of calcineurin; the net result recorded in the label is inhibition of T-lymphocyte activation and proliferation as well as the T-helper-cell-dependent B-cell response
US prescribing information · 08cf2861-2483-405d-a872-a88a5c235f9a · read 2026-08-28
Kidneys: Recorded use is prophylaxis of organ rejection in kidney transplant patients, in combination with other immunosuppressants
US prescribing information · 08cf2861-2483-405d-a872-a88a5c235f9a · read 2026-08-28
Start
Tacrolimus Anhydrous
What a person takes: Immediate-release oral capsules, granules for oral suspension, extended-release capsules and tablets, intravenous solution, and 0.03% and 0.1% topical ointment.
The measurement behind this step
Oral absorption is incomplete and highly variable between people and within the same person, and is substantially reduced by food. Clearance is almost entirely hepatic and intestinal CYP3A4 and CYP3A5, with P-glycoprotein efflux, so any CYP3A inhibitor or inducer moves concentrations. The immediate-release, extended-release and once-daily products are not bioequivalent to one another and are not interchangeable milligram for milligram. The topical ointment exploits the molecule’s size: at 804 g/mol it penetrates inflamed skin adequately and intact skin poorly, which limits systemic absorption as the barrier repairs.
Getting in
A fungal-scale molecule that has to be fermented
Tacrolimus is far too complicated to build in a factory from simple chemicals. It is made by growing the bacterium that produces it naturally, in a soil organism found in Japan in 1984.
╌╌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
A 23-membered macrolide lactone of 804 g/mol with fourteen stereocentres, produced by Streptomyces tsukubaensis as a polyketide-nonribosomal peptide hybrid. Absorption is variable and substantially reduced by food; clearance is almost entirely through CYP3A4 and CYP3A5 with P-glycoprotein efflux.
Inside the T cell, it grabs a small carrier protein
On its own the drug does nothing useful. Its first move is to bind a small protein that is abundant inside cells, and that pair is the actual working unit.
╌╌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
Binds FK506-binding protein 12, a peptidyl-prolyl isomerase, forming a composite surface neither molecule has alone. Rapamycin binds the same protein and forms a different composite surface, which is why two drugs sharing an intracellular partner have entirely different targets.
The pair jams the enzyme that reads the calcium signal
When a T cell recognises something foreign, calcium floods in and switches on an enzyme. The drug-protein pair sits on that enzyme and stops it working.
╌╌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 tacrolimus-FKBP12 complex binds at the interface of the calcineurin A catalytic and calcineurin B regulatory subunits, blocking substrate access to the phosphatase active site. Calcineurin is a calcium- and calmodulin-dependent serine-threonine phosphatase, and this inhibition is non-competitive with respect to substrate.
That enzyme’s job is to unlock a transcription factor so it can enter the nucleus and turn on the gene for the immune system’s main recruitment signal. Blocked, the factor stays in the cytoplasm and the gene stays off.
╌╌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
Nuclear factor of activated T cells remains phosphorylated and cytoplasmic, so transcription of IL2, IL4, IFNG, TNF and CD40LG is not initiated. The block is at the earliest committed step of T-cell activation, upstream of the proliferation the antimetabolites in this batch act on.
The transplant is not attacked, and less often needs rescuing
Rejection episodes happen less often than with the older drug in the class, and when they do happen they respond to steroids more often.
──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
In 529 randomised liver transplant patients, corticosteroid-resistant rejection occurred in 43 against 82 and refractory rejection in 6 against 32 with cyclosporine. In 1,645 kidney recipients, biopsy-proven acute rejection was 12.3% on low-dose tacrolimus against 24.0% to 37.2% in the other three arms.
Calcineurin is also in the kidney and the pancreatic beta cell
The same enzyme does other jobs elsewhere. In the kidney it helps control the tone of small arteries; in the pancreas it is part of how insulin is produced. Blocking it there is where the two big harms come from.
╌╌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
Afferent arteriolar vasoconstriction produces acute, reversible falls in glomerular filtration; chronic exposure is associated with arteriolar hyalinosis, striped interstitial fibrosis and glomerulosclerosis, described as almost universal at ten years on protocol biopsy and subsequently disputed as an attribution. Calcineurin-NFAT signalling in the pancreatic beta cell supports insulin gene transcription and beta-cell mass, which is the mechanistic basis of the 33.6% against 26.0% new-onset diabetes finding.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 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 it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
incidence of biopsy confirmed acute rejection at 6 months
freedom from biopsy proven acute rejection
biopsy confirmed acute rejection at 12 months follow up
serum creatinine levels
biopsy proven acute rejection
Meaningful
Things that change how a life goes, not only a number.
disease free survival
overall survival
treatment related mortality
progression free survival
who have graft loss or death
transplant related mortality
relapse rate
overall survival at one year post kidney transplant
overall kidney graft survival at one year post transplant
graft survival
and 1 more.
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (24)
maximum tolerated dose
safety and efficacy of sirolimus
graft function measurnment
overall response rate
donor chimerism in treated
nankivell glomerular filtration rate
engraftment
toxicity
incidence of grades iii iv acute gvhd
day 100 trm
day 100 best response
rate of allograft rejection
acute rejections in all enrolled
treatment failure during 12 months post transplantation
efficacy
grades ii iv acute gvhd
graft vs host disease response
glomerular filtration rate at 12 months posttransplant
endothelial progenitor cells from baseline to month 24
an average auc between 30 60 x hr
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 38 ± 3 hours hours
Read from the label, which states: “The elimination half-life of tacrolimus after oral administration of 4 mg tacrolimus extended-release capsules daily for 10 days was 38 ± 3 hours in 24 healthy subjects.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
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.
Recipients of liver, kidney, heart and lung transplants, generally for the rest of the graft’s life; people with severe eczema, as an ointment; and, off-licence, people with myasthenia gravis, membranous nephropathy and several other autoimmune conditions.
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: “Additionally, 122 pediatric patients were studied in an uncontrolled trial of tacrolimus in living related donor liver transplantation.”
US prescribing information · 61dee012-43af-0e9a-3843-9b9b91e022c4 · read 2026-08-30
On older people, the label states: “Clinical trials of tacrolimus did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”
US prescribing information · 61dee012-43af-0e9a-3843-9b9b91e022c4 · read 2026-08-30
On people who are pregnant, the label states: “Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to tacrolimus during pregnancy.”
US prescribing information · 61dee012-43af-0e9a-3843-9b9b91e022c4 · read 2026-08-30
On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential Contraception Tacrolimus can cause fetal harm when administered to pregnant women.”
US prescribing information · 61dee012-43af-0e9a-3843-9b9b91e022c4 · read 2026-08-30
On people with reduced liver function, the label states: “The mean clearance of tacrolimus was substantially lower in patients with severe hepatic impairment (mean Child-Pugh score: >10) compared to healthy volunteers with normal hepatic function.”
US prescribing information · 61dee012-43af-0e9a-3843-9b9b91e022c4 · read 2026-08-30
On people with reduced kidney function, the label states: “The pharmacokinetics of tacrolimus in patients with renal impairment was similar to that in healthy volunteers with normal renal function.”
US prescribing information · 61dee012-43af-0e9a-3843-9b9b91e022c4 · read 2026-08-30
Where the result stopped carrying
DIRECT met its primary safety endpoint against tacrolimus: a third of patients developed diabetes or impaired fasting glucose by six months
The calcineurin-free sirolimus arm of ELITE-Symphony was worst of four on rejection, graft survival, kidney function and serious adverse events
Nephrotoxicity and neurotoxicity forced nearly three times as many withdrawals as cyclosporine in the pivotal liver trial
Twenty years of trying to withdraw calcineurin inhibitors on nephrotoxicity grounds has not displaced low-dose tacrolimus as the standard
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 for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
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 (10)
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
Immediate-release oral capsules, granules for oral suspension, extended-release capsules and tablets, intravenous solution, and 0.03% and 0.1% topical ointment
✎ 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: S1, S6.
No source is stored against this line.
What is in the pack
Oral absorption is incomplete and highly variable between people and within the same person, and is substantially reduced by food. Clearance is almost entirely hepatic and intestinal CYP3A4 and CYP3A5, with P-glycoprotein efflux, so any CYP3A inhibitor or inducer moves concentrations. The immediate-release, extended-release and once-daily products are not bioequivalent to one another and are not interchangeable milligram for milligram. The topical ointment exploits the molecule’s size: at 804 g/mol it penetrates inflamed skin adequately and intact skin poorly, which limits systemic absorption as the barrier repairs.
✎ 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.
The recorded stepping schedule
What follows is the schedule printed on the label, recorded as it is written there. It is a record of what was done, not a recommendation.
US prescribing information · 08cf2861-2483-405d-a872-a88a5c235f9a · read 2026-08-28
First dose (pre-operative), within 12 hours prior to reperfusion — adults given mycophenolate mofetil and steroids without basiliximab induction: 0.1 mg/kg
US prescribing information · 08cf2861-2483-405d-a872-a88a5c235f9a · read 2026-08-28
Subsequent doses (post-operative), at least 4 hours after the pre-operative dose and within 12 hours after reperfusion: 0.2 mg/kg once daily
US prescribing information · 08cf2861-2483-405d-a872-a88a5c235f9a · read 2026-08-28
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
Boxed warning for malignancies and serious infections due to immunosuppression, including lymphoma; for the extended-release products, an additional boxed warning against use in liver transplant recipients because of increased mortality in female patients in a trial. Nephrotoxicity is dose-related and both acute and chronic. New-onset diabetes after transplantation occurred in 33.6% against 26.0% on cyclosporine in a dedicated trial. Neurotoxicity ranges from tremor and headache to posterior reversible encephalopathy syndrome. Hyperkalaemia, hypertension, hypomagnesaemia, QT prolongation, pure red cell aplasia and anaphylaxis to the intravenous vehicle are all labelled. The topical ointment carries a boxed warning about long-term safety and reported cases of lymphoma and skin malignancy.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
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.
Tacrolimus Anhydrous appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 16521 reaction mentions were counted. One report can name several reactions.
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
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
Immediate-release oral capsules, granules for oral suspension, extended-release capsules and tablets, intravenous solution, and 0.03% and 0.1% topical ointment
✎ 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
Clearance is almost entirely hepatic and intestinal CYP3A4 and CYP3A5, with P-glycoprotein efflux, so any CYP3A inhibitor or inducer moves concentrations. The immediate-release, extended-release and once-daily products are not bioequivalent to one another and are not interchangeable milligram for milligram. The topical ointment exploits the molecule’s size: at 804 g/mol it penetrates inflamed skin adequately and intact skin poorly, which limits systemic absorption as the barrier repairs.
✎ 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
140 products list this as an active ingredient in the United States drug directory. 140 of them contain it and nothing else.
FDA National Drug Code directory · 0469-0677 · read 2026-08-29
They are sold as capsule, capsule, coated, extended release, capsule, extended release, capsule, gelatin coated, granule, for suspension and injection, taken intravenous, oral and topical.
FDA National Drug Code directory · 0469-0677 · read 2026-08-29
The regulator's established pharmacologic class for it is calcineurin inhibitor immunosuppressant [epc] and calcineurin inhibitors [moa].
FDA National Drug Code directory · 0469-0677 · read 2026-08-29
47 published labels name it as an active ingredient. 47 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 61dee012-43af-0e9a-3843-9b9b91e022c4 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 61dee012-43af-0e9a-3843-9b9b91e022c4 · read 2026-08-29
Tacrolimus extended-release capsules is extended-release capsules at Capsules: 0.5 mg, 1 mg, 5 mg, recorded as prescription product; fda label in effect 2024-02-07 in the United States.
US prescribing information · 08cf2861-2483-405d-a872-a88a5c235f9a · read 2026-08-28
Recorded price in US: 0.12557–0.6591 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 50 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: 0.7954–0.9615 USD per one gram, across 22 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
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.
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 Tacrolimus Anhydrous studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or 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 late arteriolar hyalinosis and glomerulosclerosis on protocol biopsy are caused by the calcineurin inhibitor — an attribution disputed in print by the same journal
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 conventional trough target ranges are the ranges that maximise graft survival; they come from association and early experience, not from a randomised comparison of targets
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the topical ointment causes lymphoma, on a boxed warning derived from animal data and case reports and an observational ratio of 3.74 with a lower bound of 1.00
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the survival benefit follows from the rejection benefit — survival was identical in the trial that measured both
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
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 Tacrolimus Anhydrous are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in 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.
Five hundred and twenty-nine liver transplant patients were randomly given tacrolimus or cyclosporine. The same proportion were alive a year later. But rejection that resisted steroid treatment happened half as often on tacrolimus, and rejection that resisted everything happened five times less often.
What was measured
Patient and graft survival at one year, and rates of acute, corticosteroid-resistant and refractory rejection, against cyclosporine
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
An open-label randomised multicentre trial assigned 478 adults and 51 children receiving a first liver transplant to tacrolimus (n=263) or cyclosporine (n=266) and followed them for a year. One-year patient survival was 88% in both groups (P=0.85, 95% CI for the difference -5.4 to +6.6) and graft survival 82% against 79% (P=0.55, 95% CI -4.8 to +9.7). Acute rejection occurred in 154 against 173 patients (P<0.002), corticosteroid-resistant rejection in 43 against 82 (P<0.001) and refractory rejection in 6 against 32 (P<0.001). Withdrawal for adverse events, primarily nephrotoxicity and neurotoxicity, was 37 against 13 patients (P<0.001).
Written into the record, not signed off as a reviewed claim
ELITE-Symphony: best kidney function, lowest rejection, best graft survival of four arms
In plain words
A trial of 1,645 kidney transplant patients compared four regimens head to head. Low-dose tacrolimus came first on every measure that mattered: kidney function, rejection rate and graft survival. This is the trial that made it the default.
What was measured
Estimated glomerular filtration rate at 12 months, biopsy-proven acute rejection and allograft survival, four-arm randomised comparison
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ELITE-Symphony randomised 1,645 renal transplant recipients to standard-dose cyclosporine with mycophenolate mofetil and corticosteroids, or to daclizumab induction with mycophenolate mofetil and corticosteroids plus low-dose cyclosporine, low-dose tacrolimus or low-dose sirolimus. Mean calculated glomerular filtration rate at 12 months, the primary endpoint, was 65.4 mL/min on low-dose tacrolimus against 56.7 to 59.4 in the other three arms. Biopsy-proven acute rejection was 12.3% against 25.8% for standard-dose cyclosporine, 24.0% for low-dose cyclosporine and 37.2% for low-dose sirolimus. Allograft survival differed across arms (P=0.02) and was highest on low-dose tacrolimus at 94.2%. Serious adverse events were commonest in the sirolimus arm at 53.2%.
Written into the record, not signed off as a reviewed claim
DIRECT: more new-onset diabetes than cyclosporine
In plain words
A trial designed specifically to measure blood sugar problems found that a third of patients on tacrolimus had developed diabetes or pre-diabetes by six months, against a quarter on cyclosporine. The rejection rates were not significantly different.
What was measured
New-onset diabetes after transplant or impaired fasting glucose at 6 months by ADA/WHO criteria, against cyclosporine
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
DIRECT was a six-month, open-label, randomised multicentre study using American Diabetes Association and WHO criteria, in 682 de novo renal transplant patients (336 cyclosporine microemulsion with C2 monitoring, 346 tacrolimus), 567 of whom were non-diabetic at baseline, all with mycophenolic acid, steroids and basiliximab. The primary safety endpoint — new-onset diabetes after transplant or impaired fasting glucose at 6 months — occurred in 73 cyclosporine patients (26.0%) and 96 tacrolimus patients (33.6%, P=0.046). The primary efficacy endpoint of biopsy-proven acute rejection, graft loss or death was 12.8% against 9.8% (P=0.211). Mean GFR did not differ significantly (63.6 against 65.9 mL/min/1.73 m2, P=0.285) though serum creatinine did (139 against 133 micromol/L, P=0.005). Total cholesterol, LDL and triglycerides were significantly higher on cyclosporine.
Written into the record, not signed off as a reviewed claim
Calcineurin nephrotoxicity: called almost universal, then called overstated
In plain words
A landmark Australian study took kidney biopsies from transplant patients every year for a decade and found drug-related kidney damage in essentially all of them by ten years. That finding drove a generation of attempts to withdraw the drug. A rebuttal in the same journal argued the damage had been attributed to the drug when other causes fit as well.
What was measured
That the arteriolar and glomerular damage seen on late protocol biopsies is caused by the calcineurin inhibitor — the histology is real and consistent, the attribution rests on association rather than on a randomised comparison, and it has been formally disputed in print
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Nankivell and colleagues obtained 961 protocol biopsies from 120 kidney-pancreas recipients from transplantation to ten years. They described two phases: early tubulointerstitial damage from ischaemic injury and rejection, present as mild disease in 94.2% by one year; then a later phase of microvascular and glomerular injury with progressive high-grade arteriolar hyalinosis accompanied by calcineurin inhibitor use, with nephrotoxicity "almost universal at 10 years, even in grafts with excellent early histologic findings". Severe chronic allograft nephropathy was present in 58.4% at ten years with sclerosis of 37.3% of glomeruli. Matas subsequently argued in the same journal that chronic progressive calcineurin nephrotoxicity is an overstated concept, on the grounds that arteriolar hyalinosis is not specific to calcineurin inhibitors, that donor age, hypertension and diabetes produce the same histology, and that trials of calcineurin withdrawal did not reliably improve long-term function.
Written into the record, not signed off as a reviewed claim
A boxed malignancy warning on the ointment, from animal data and case reports
In plain words
The eczema ointment carries a warning about lymphoma and skin cancer. It was added on the basis of animal studies and scattered case reports rather than a study showing it happens in people. A large European cohort later found a raised lymphoma rate in children, on very small numbers, and the authors themselves listed several explanations other than the drug.
What was measured
That topical tacrolimus causes lymphoma — a boxed warning built on animal photocarcinogenicity and case reports, with the largest observational study finding a wide, barely significant ratio on very small numbers and offering three non-causal explanations for it
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The JOELLE cohort study across databases in the Netherlands, Denmark, Sweden and the United Kingdom included 19,948 children and 66,127 adults initiating topical tacrolimus, 23,840 children and 37,417 adults initiating pimecrolimus, 584,121 topical corticosteroid users and 257,074 untreated subjects. Lymphoma incidence per 100,000 person-years was 10.4 in children and 41.0 in adults on tacrolimus. The incidence rate ratio for lymphoma against topical corticosteroids was 3.74 (95% CI 1.00 to 14.06) in children and 1.27 (0.94 to 1.71) in adults. Adults using moderate- to high-potency topical corticosteroids had a markedly raised cutaneous T-cell lymphoma rate against untreated subjects (IRR 10.66, 95% CI 2.60 to 43.75), which points to reverse causation — early cutaneous lymphoma misdiagnosed and treated as eczema. The authors concluded that the low absolute incidence means that even a causal excess would be small per patient, and named residual confounding by eczema severity, increased monitoring and reverse causation as alternative explanations.
Written into the record, not signed off as a reviewed claim
The window is narrow enough that food and grapefruit are clinical events
In plain words
The gap between too little and too much is small, and both ends are serious: too little means the transplant is rejected, too much means the kidney is damaged. What a person ate, and which version of the tablet the pharmacy handed over, can move levels across that gap.
What was measured
Whole-blood trough concentration as the routine surrogate governing every dosing decision for this drug
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Tacrolimus is metabolised almost entirely by CYP3A4 and CYP3A5 and is a P-glycoprotein substrate, giving high inter-individual and intra-individual variability in exposure from the same dose. Food substantially reduces absorption. CYP3A5 expressers, more common in people of African ancestry, require substantially higher doses to reach the same trough concentration, and the label addresses this. Strong CYP3A inhibitors — azole antifungals, some macrolides, grapefruit — raise concentrations, and inducers such as rifampicin and St John’s wort lower them. Immediate-release, extended-release and once-daily formulations are not bioequivalent to one another. Whole-blood trough monitoring is therefore continuous and lifelong rather than an initial titration exercise.
Source
PROGRAF (tacrolimus) United States prescribing information, Clinical Pharmacology, Drug Interactions and Dosage sections
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Trough concentration is a surrogate that has never been validated against outcomes
In plain words
Every tacrolimus dose in the world is decided by a blood level taken just before the next dose. That single number is a convenient stand-in for total drug exposure, and no trial has shown that targeting one range rather than another changes how long grafts survive.
What was measured
That the conventional trough target ranges are the ranges that maximise graft survival — they were derived from association and early experience, and no randomised comparison of target ranges against a hard endpoint has established them
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The trough concentration correlates reasonably with the area under the concentration-time curve, which is the exposure measure that pharmacology would prefer, but it is a single point on a curve. The target ranges in use were derived from early trial experience and from association studies relating troughs to rejection and toxicity, not from randomised comparisons of one target against another with graft survival as an endpoint. Randomised trials of genotype-guided initial dosing have shown faster attainment of target concentration without demonstrating better clinical outcomes, which illustrates the same gap: the surrogate can be hit more reliably without the thing the surrogate stands for improving. This does not mean monitoring is useless — the toxicity relationship is real — but the specific numbers are convention supported by association.
Written into the record, not signed off as a reviewed claim
Every attempt to get off it has cost something
In plain words
If calcineurin inhibitors damage kidneys over years, the obvious answer is to stop using them. Every large trial that tried a substitute paid for it somewhere: more rejection with the mTOR inhibitors, an absolute contraindication and monthly infusions with the costimulation blocker.
What was measured
Biopsy-proven acute rejection, allograft survival and GFR in the calcineurin-free arm of a four-arm randomised comparison
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
In ELITE-Symphony the low-dose sirolimus arm — the calcineurin-free option — had biopsy-proven acute rejection of 37.2% against 12.3% for low-dose tacrolimus, allograft survival of 89.3% against 94.2%, a mean GFR of 56.7 to 59.4 rather than 65.4 mL/min, and serious adverse events in 53.2% against 43.4% to 44.3% elsewhere. Belatacept avoids calcineurin inhibition and produces better long-term measured renal function, at the cost of higher early acute rejection rates, indefinite monthly intravenous administration, and an absolute contraindication in Epstein-Barr-seronegative recipients because of post-transplant lymphoproliferative disease. Twenty years after the nephrotoxicity literature made calcineurin withdrawal an explicit goal, low-dose tacrolimus remains the standard, which is itself the finding.
This order is fixed in code and does not count clicks or time on the page.
What is not here
3 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 it may clash with — found nothing in the sources checked.
Other ways to the same goal — 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.
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 macrolide from a Japanese soil bacterium that binds FKBP12 and, as that complex, blocks calcineurin so T cells cannot switch on interleukin-2 — it reduced corticosteroid-resistant liver-transplant rejection from 82 to 43 patients out of 529 randomised against cyclosporine with identical one-year survival, gave the best kidney function and lowest rejection rate of four regimens in 1,645 kidney recipients, and caused new-onset diabetes or impaired fasting glucose in 33.6% against 26.0% on cyclosporine at six months.
Recorded evidence blocks (14)
Q2
What did Tacrolimus Anhydrous's largest trial (4874 people) and its longest (25 years) measure?
4874 people in Tacrolimus Anhydrous's largest registered study, 25 years in its longest registered window, measuring Treatment-related mortality. ClinicalTrials.gov · 2026-09-01
381 phase2, 202 phase4, 143 phase3, 134 phase1, 55 na, 40 na or unstated, 11 early phase1; NCT00544115; 2027-03-29; no ageing endpoint recorded. Last human test completed 2026, NCT05669001.
Interpretation These counts include studies where Tacrolimus Anhydrous was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase2
381
phase4
202
phase3
143
phase1
134
na
55
na or unstated
40
2 more recorded rows
early phase1
11
Last recorded human testNCT05669001
2026-04-10
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Tacrolimus Anhydrous shown lifespan?
15 recorded entries; human; capsule; also "tacrolimus ointment 0.1%", "Tacrolimus Ointment 0.1%", "Tacrolimus ointment 0.1%"
Show the evidence
human
NCT00236106
tacrolimus ointment 0.1%
NCT00534508
Tacrolimus Ointment 0.1%
NCT00560378
Tacrolimus ointment 0.1%
NCT00608894
1,2,and 5mg tacrolimus tablets
NCT00690105
tacrolimus 0.1%
NCT01080456
capsule; Tacrolimus 1 mg capsule
9 more recorded rows
humanNCT01080469
Tacrolimus 1 mg Capsule
humanNCT01080482
Tacrolimus 5 mg Capsule
humanNCT01910077
capsule; Prograf capsule 1mg
humanNCT03828058
ENVARSUS XR 0.75Mg Extended-Release Tablet
humanNCT03828058
ENVARSUS XR 1Mg Extended-Release Tablet
humanNCT03828058
ENVARSUS XR 4Mg Extended-Release Tablet
humanNCT05324618
Tacrolimus (Tacrolimus 0.03%®) was manufactured by AL-Andalous company for pharmaceutical and chemical industries, Egypt.
humanNCT05546047
Tacrolimus 1.0 mg
humanNCT06280950
Tacrolimus (maintain 50% reduction)
recorded 2026-09-01 · last checked 2026-09-04
Q6
Tacrolimus Anhydrous's half-life is 38 ± 3 hours — which schedules were studied?
38 ± 3 hours, the half-life Tacrolimus Anhydrous's label states. openfda-label · 94461af3-11f1-4670-95d4-2965b9538ae3 · 2026-08-28
Show the evidence
half life
38 ± 3 hours hours; The elimination half-life of tacrolimus after oral administration of 4 mg tacrolimus extended-release capsules daily for 10 days was 38 ± 3 hours in 24 healthy subjects.
recorded 2026-08-28 · last checked 2026-09-04
Q7
Which of 6 month acute antibody mediated rejection rate, 6 month acute cellular mediated rejection rate and acute rejections in all enrolled did Tacrolimus Anhydrous's trials measure?
6 month acute antibody mediated rejection rate, 6 month acute cellular mediated rejection rate and acute rejections in all enrolled lead 40 outcome terms across Tacrolimus Anhydrous's trials. ClinicalTrials.gov · 2026-09-01
Interpretation graft function measurnment, overall response rate, overall survival, treatment related mortality, donor chimerism in treated and progression free survival follow.
Show the evidence
maximum tolerated dose
1
safety and efficacy of sirolimus
1
disease free survival
1
graft function measurnment
1
overall response rate
1
overall survival
1
14 more recorded rows
treatment related mortality
1
donor chimerism in treated
1
progression free survival
1
nankivell glomerular filtration rate
1
engraftment
1
toxicity
1
incidence of grades iii iv acute gvhd
1
day 100 trm
1
day 100 best response
1
rate of allograft rejection
1
acute rejections in all enrolled
1
treatment failure during 12 months post transplantation
1
efficacy
1
grades ii iv acute gvhd
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Tacrolimus Anhydrous's 125 ongoing trials reports first?
Neutrophil Engraftment - The Days Till ANC Recovery; Treatment Emergent Adverse Events; latest 2043-02-28
Show the evidence
Trial
NCT00544115
"Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders"; n 260; "Neutrophil Engraftment - The Days Till ANC Recovery"; 2027-03-29
NCT00679042
"Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol"; n 21; "Treatment Emergent Adverse Events"; 2026-06-14
NCT00792948
"Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia"; n 97; "Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation"; 2027-01-06
NCT00882895
"Tandem Stem Cell Transplantation for Non-Hodgkin's Lymphoma"; n 18; "Determine the event free survival"; 2028-06-01
NCT01659606
"Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita"; n 40; "Primary engraftment"; 2034-12
NCT01804634
"Reduced Intensity Haploidentical BMT for High Risk Solid Tumors"; n 60; "Safety of Shortened duration of tacrolimus as assessed by number of participants with NRM and Grade III-IV acute GVHD at Day 120"; 2030-01
14 further recorded trials
NCT01861106
"Allogeneic Hematopoietic Stem Cell Transplant for GATA2 Mutations"; n 144; "To determine whether allogeneic HSCT approach results in engraftment and restores normal hematopoiesis by one year in patients with mutations GATA2."; 2028-12-31
NCT01885689
"Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia"; n 72; "Progression-free Survival at 2 Years"; 2026-09-21
NCT02081755
"Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer"; n 336; "Disease free survival (DFS) defined as the time from randomization to the time of tumor recurrence or death, whichever occurs first."; 2027-03
NCT02395497
"Human Penile Allotransplantation"; n 60; "Allograft Survival"; 2039-06
NCT02782546
"Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantation"; n 60; "Kaplan-Meier Estimate of Leukemia-free Survival Rate (LFS)"; 2028-02-13
NCT02790515
"Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation"; n 170; "The number of patients engrafted by day +30 post-transplant"; 2026-07-01
NCT02861417
"Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant"; n 204; "Non-relapse mortality rate"; 2028-08-31
NCT02936505
"Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD."; n 249; "Number of patients with incidence of CLAD"; 2026-10-30
NCT03118492
"Combination Chemotherapy, Total Body Irradiation, and Donor Blood Stem Cell Transplant in Treating Patients With Secondary Myelofibrosis"; n 22; "Incidence of adverse events"; 2027-04-29
NCT03121014
"Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes"; n 38; "Relapse free survival of approximately 30% in high-risk patients conditioned with the Fludarabine/ Busulfan regimen"; 2026-04
NCT03178149
"A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration"; n 42; "Safety as assessed by incidence, frequency and severity of treatment emergent adverse events (TEAES)"; 2026-06-30
NCT03247088
"Sorafenib, Busulfan and Fludarabine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant"; n 74; "Maximum tolerated dose (MTD) as defined by toxicity (Phase I)"; 2027-12-31
NCT03249831
"A Blood Stem Cell Transplant for Sickle Cell Disease"; n 3; "Toxicity per NCI-Common Terminology Criteria for Adverse Events version 4.0"; 2027-01-25
NCT03266393
"Envarsus XR® in Adolescent Renal Transplant Recipients"; n 28; "Incidence of clinical or subclinical allograft injury at any timepoint as assessed by the appearance of de novo donor specific anti-HLA antibody (dnDSA) OR biopsy proven allograft rejection."; 2023-03-31
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Tacrolimus Anhydrous could settle lifespan?
NCT03121014 measures Relapse free survival of approximately 30% in high-risk patients conditioned with the Fludarabine/ Busulfan regimen, reading out 2026-04.
32 open trials; n 38; "Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes"
Show the evidence
Trial
NCT03121014
"Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes"; n 38; "Relapse free survival of approximately 30% in high-risk patients conditioned with the Fludarabine/ Busulfan regimen"; 2026-04
NCT05622318
"De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis"; n 56; "The number of subjects who experience GVHD-free survival."; 2026-09
NCT01885689
"Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia"; n 72; "Progression-free Survival at 2 Years"; 2026-09-21
NCT04187105
"BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)"; n 27; "Rate of 1 year Graft-Versus-Host Disease (GVHD) free, relapse free survival (GRFS) survival"; 2026-12
NCT04904588
"HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide"; n 300; "Overall Survival"; 2026-12
NCT06438679
"3T Therapy in the Treatment of MDA5-positive Dermatomyositis"; n 133; "Overall survival rate"; 2026-12
14 further recorded trials
NCT06001385
"HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis"; n 313; "Infection Free Survival"; 2026-12-30
NCT06084780
"Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)"; n 20; "Overall Rate of Survival"; 2026-12-31
NCT00792948
"Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia"; n 97; "Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation"; 2027-01-06
NCT05736419
"A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT)"; n 24; "Number of participants with treatment related mortality/TRM or primary graft failure"; 2027-02-09
NCT02081755
"Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer"; n 336; "Disease free survival (DFS) defined as the time from randomization to the time of tumor recurrence or death, whichever occurs first."; 2027-03
NCT07249346
"Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation"; n 124; "Severe acute GVHD-free Survival (SGFS)"; 2027-06-01
NCT05303727
"Allogeneic Hematopoietic Stem Cell Transplantation for 4/M Neuroblastoma"; n 64; "overall survival(OS) at 3 year"; 2027-08
NCT02782546
"Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantation"; n 60; "Kaplan-Meier Estimate of Leukemia-free Survival Rate (LFS)"; 2028-02-13
NCT05088356
"Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft"; n 66; "Determine the GVHD-free relapse-free survival (GRFS) post-HCT ( Arm-A)"; 2028-05
NCT00882895
"Tandem Stem Cell Transplantation for Non-Hodgkin's Lymphoma"; n 18; "Determine the event free survival"; 2028-06-01
NCT07634536
"Automated Total Marrow and Lymphoid Irradiation for Allogeneic Hematopoietic Cell Transplant"; n 30; "Non-Relapse Mortality (NRM)"; 2028-08
NCT02861417
"Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant"; n 204; "Non-relapse mortality rate"; 2028-08-31
NCT06680661
"ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis"; n 20; "Severe aGVHD free survival"; 2028-10-31
NCT07359859
"A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant"; n 40; "assess cGVHD-free survival"; 2029-01
Q10
Which 275 trials of Tacrolimus Anhydrous posted no result?
Posted no result
275 of 275 completed trials
Registrations
NCT00004904, NCT00510913, NCT00534508, NCT00519116, NCT00006350 and NCT00003572, and 269 more
Completion dates
oldest 2000-07; newest 2024-07-01
Show the evidence
Trial
NCT00004904
2000-07
NCT00510913
2000-09
NCT00534508
2001-07
NCT00519116
2001-08
NCT00006350
2001-11
NCT00003572
2002-04
14 further recorded trials
NCT00518271
2002-06
NCT00002831
2002-12-31
NCT00006747
2003-02
NCT00268515
2003-03
NCT00002792
2003-04
NCT00146614
2003-04
NCT00004255
2003-05
NCT00666159
2003-05
NCT00666302
2003-11
NCT00667160
2003-11
NCT00002809
2003-12
NCT00036153
2004-01
NCT00007787
2004-03
NCT00693524
2004-03
Q11
At the median, Tacrolimus Anhydrous's trials enrolled 48 people — anything larger?
Median enrolment
48
Largest enrolment
4874
Registered trials counted
868
Q12
What do 16521 spontaneous reports say about Tacrolimus Anhydrous — 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.
Tacrolimus Anhydrous appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 16521 reaction mentions were counted: transplant rejection 2370; cytomegalovirus infection 2176; acute kidney injury 1972; blood creatinine increased 1878. open-targets-adr · CHEMBL269732 · 2026-06-24
Show the evidence
transplant rejection
2370
cytomegalovirus infection
2176
acute kidney injury
1972
blood creatinine increased
1878
renal impairment
1731
toxicity to various agents
1689
4 more recorded rows
post transplant lymphoproliferative disorder
1297
kidney transplant rejection
1142
covid-19
1133
thrombotic microangiopathy
1133
recorded 2026-06-24 · last checked 2026-09-04
Q13
Tacrolimus Anhydrous and CYP3A5: shared by which compounds?
CYP3A5 appear in Tacrolimus Anhydrous's recorded interaction sentences, 1 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP3A5pharmacokinetics
Elimination Metabolism Tacrolimus is extensively metabolized by the mixed-function oxidase system, primarily the cytochrome P-450 system (CYP3A 4 and CYP3A5).
recorded 2026-08-30 · last checked 2026-09-04
Q14
Was Tacrolimus Anhydrous studied with fasting and exercise?
fasting and exercise are named in Tacrolimus Anhydrous's label sentences: "Forty healthy subjects were randomized into two groups, namely a sequence 1 group (N = 20 in test-reference-test-reference) or sequence 2 (N = 20, reference-test-reference-test) received a test tacrolimus (Ruibeirong®; Chengdu Shengdi Medicine Co., Ltd.) and a reference tacrolimus (Astagraf XL®,…" openfda-label+europepmc · 2026-08-30
2 recorded statements; fasting, exercise
Show the evidence
fasting
Forty healthy subjects were randomized into two groups, namely a sequence 1 group (N = 20 in test-reference-test-reference) or sequence 2 (N = 20, reference-test-reference-test) received a test tacrolimus (Ruibeirong®; Chengdu Shengdi Medicine Co., Ltd.) and a reference tacrolimus (Astagraf XL®, Astellas Ireland Co., Ltd.) under the fasting condition with a wash-out period of ≥14 days between…
exercise
This randomized, double-blind, crossover study aimed to investigate the acute effects of caffeine consumption on physiological responses and performance during a strength-focused CrossFit workout. <b>Methods</b>: Twelve healthy men, aged 29.2 ± 3.8 years (mean ± SD throughout), with 4.9 ± 1.9 years of CrossFit experience, completed two sessions of a specific CrossFit training program (four rounds…
recorded 2026-08-30 · last checked 2026-09-04
Q15
What is recorded about Tacrolimus Anhydrous and mTOR?
"In the animal models of tacrolimus-related cardiotoxicity, myocardial fibrosis and epithelial-mesenchymal transition (EMT) occurred and CXCR2, Src-mediated PI3K/Akt/mTOR pathway were activated (P < 0.05 or P < 0.01)." — where Tacrolimus Anhydrous and mTOR appear together. Europe PMC · pathway abstract search · 2026-03-20
mTOR, autophagy; PMID 41864010
Show the evidence
mTOR
PMID 41864010
"In the animal models of tacrolimus-related cardiotoxicity, myocardial fibrosis and epithelial-mesenchymal transition (EMT) occurred and CXCR2, Src-mediated PI3K/Akt/mTOR pathway were activated (P < 0.05 or P < 0.01)."
PMID 41864010
"The present study demonstrates that CXCR2 promotes tacrolimus-related cardiotoxicity via activating the Src-mediated PI3K/Akt/mTOR pathway for the first time."
PMID 41864010
"CXCR2 antagonist may be used as intervention for potential tacrolimus-related cardiotoxicity via inactivating the Src-mediated PI3K/Akt/mTOR pathway to alleviate myocardial fibrosis and reverse myocardial EMT."
autophagy
"Conclusion Our findings revealed that tacrolimus induces lysosomal accumulation in cells through autophagy, indicating potential lysosomal dysfunction and subsequent apoptosis.</p>"
recorded 2026-03-20 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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