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Ferumoxytol

  • Prescription medicine
  • Given by a clinician
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Ferumoxytol does in the body

Since extravasation of the large ferumoxytol molecules is slow, parenchymal enhancement is seen in the delayed phase, approximately 24 hours post-administration of FERABRIGHT.

From the FDA-approved label: Ferumoxytol is a superparamagnetic iron oxide coated with a carbohydrate shell that develops a magnetic moment when placed in a magnetic field. The magnetic moment alters the relaxation rates of water protons in its vicinity in the body, leading to an increase in signal intensity (brightness) of tissues on T1-weighted MRI. Disruption of the blood-brain barrier allows distribution of ferumoxytol into lesions such as neoplasms.

Why people take it. Magnetic resonance imaging (MRI) of the brain

What happened in people

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

A fixed RNAWiki sentence

Where this came from

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

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

No source is stored against this line.

The limit that matters most

Not recorded.

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

What the registries record it as

  • The substance registry classes this as specifiedsubstanceg1.

    FDA substance registry · R8DG7T2D3A · read 2026-08-29

Where each sentence above came from

A person wrote this explanation into the record, with the studies named in the path below.

The recorded use, written for a reader without medical training. Not signed off.

No statement of the main limit is recorded.

The four opening statements run to 110 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Biomarker

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

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

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

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

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

Placebo

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

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

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

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

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

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension

The study did not show it

Who was studied
NCT02694978
How many people
2014
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous

Interval reported. Not recorded in this summary

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

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

Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5

The study did not show it

Who was studied
NCT01114139
How many people
812
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous

Interval reported. Not recorded in this summary

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

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

Safety evaluated by physical examinations, vital signs, laboratory tests and patient monitoring and evaluation.

The study did not show it

Who was studied
NCT00255450
How many people
750
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous

Interval reported. Not recorded in this summary

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

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

Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol

The study did not show it

Who was studied
NCT01114217
How many people
634
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous

Interval reported. Not recorded in this summary

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

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

Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5

The study did not show it

Who was studied
NCT01114204
How many people
605
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous

Interval reported. Not recorded in this summary

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

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

The mean change in hemoglobin from baseline.

The study did not show it

Who was studied
NCT00255424
How many people
304
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • FERABRIGHT is indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.

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 and effectiveness of Feraheme in pediatric patients (less than 18 years old) have not been established.”

    US prescribing information · 32b0e320-a739-11dc-a704-0002a5d5c51b · read 2026-08-30

  • On older people, the label states: “In controlled clinical trials, 833 patients ≥ 65 years of age were treated with Feraheme.”

    US prescribing information · 32b0e320-a739-11dc-a704-0002a5d5c51b · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Limited available data with ferumoxytol use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.”

    US prescribing information · 32b0e320-a739-11dc-a704-0002a5d5c51b · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of ferumoxytol in human milk, the effects on the breastfed child, or the effects on milk production.”

    US prescribing information · 32b0e320-a739-11dc-a704-0002a5d5c51b · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied in different people

The people in the studies were not much like the reader.

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

The evidence may simply be wrong

Small early studies often do not hold up.

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

Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

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

Intravenous

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

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

Quoted from a source

Where this came from

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

Suppression classes recorded: S6.

No source is stored against this line.

What is in the pack

Sold as solution, injection, given by the intravenous route.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Nothing found in the sources checked

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

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

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

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

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Intravenous

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 3 products list this as an active ingredient in the United States drug directory. 3 of them contain it and nothing else.

    FDA National Drug Code directory · 24338-510 · read 2026-08-29

  • They are sold as injection and liquid, taken intravenous.

    FDA National Drug Code directory · 24338-510 · read 2026-08-29

  • The regulator's established pharmacologic class for it is iron [cs] and parenteral iron replacement [epc].

    FDA National Drug Code directory · 24338-510 · read 2026-08-29

  • 3 published labels name it as an active ingredient. 3 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 32b0e320-a739-11dc-a704-0002a5d5c51b · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 32b0e320-a739-11dc-a704-0002a5d5c51b · read 2026-08-29

  • Feraheme is intravenous at 3 DOSAGE FORMS AND STRENGTHS Feraheme Injection is available in single-dose vials., recorded as fda label in effect 2026-05-31 in the United States.

    US prescribing information · 32b0e320-a739-11dc-a704-0002a5d5c51b · read 2026-08-30

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

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

Questions worth asking

  • Which of the trials of Ferumoxytol studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

How much did people take in the studies?

The sources RNAWiki checked hold nothing for this field.

Why it matters. A result belongs to an amount. Without the amount the result floats free.

What would answer it

A stored source that records 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 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 Ferumoxytol are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

How many documents were read

  • 3 documents were read for this substance.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
R8DG7T2D3A
CAS registry number
1309-38-2
ChEMBL
CHEMBL1201867
ChEBI
46726
DrugBank
DB06215

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

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

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

  1. Withdrawn, in European Union; no reason is published (EMA Medicine.csv)

What the approval register records

  • 3 approved applications cover products containing this substance. The earliest was NDA022180, approved 20090630 to AZURITY.

    Drugs@FDA application register · NDA022180 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA022180 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20090630.

    FDA National Drug Code directory · 24338-510 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

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

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

What is not here

9 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

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

The record as stored

The full record, for auditing

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

Recorded evidence blocks (9)

On the Ferumoxytol label: indicated for what?


"Ferumoxytol is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: • who have intolerance to oral iron or have had unsatisfactory response to oral iron or • who have chronic kidney disease (CKD). Ferumoxytol is an iron replacement product indicated for the treatment of iron deficiency anemia…": indications and usage on Ferumoxytol's label. DailyMed label · cf94c7fc-13a0-4ac9-bb85-9c38aa704d35 · 2026-08-14

88 registered trials of Ferumoxytol — at which phases?


Registered studies posting no result
56 of 88

88 registered studies of Ferumoxytol: 17 phase2, 16 phase1, 15 phase3, 14 na, 11 early phase1, 10 phase4, 8 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

47 with a PubMed record

Show the evidence
  • phase2
    17
  • phase1
    16
  • phase3
    15
  • na
    14
  • early phase1
    11
  • phase4
    10
8 more recorded rows
  • na or unstated
    8
  • completed
    45
  • recruiting
    14
  • terminated
    14
  • withdrawn
    9
  • unknown
    4
  • active not recruiting
    1
  • enrolling by invitation
    1

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

22 of Ferumoxytol's trials stopped: safety, accrual/recruitment, funding/business, other?


safety (1), accrual/recruitment (13), funding/business (3) and other (5): Ferumoxytol's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Loss of funding"; 22 of 88 registered studies

Show the evidence

Trial

  • NCT00659126
    terminated; "Loss of funding"
  • NCT00659776
    terminated; "Due to staffing shortages and lack of funding during Covid."
  • NCT00769093
    terminated; "Inadequate enrollment"
  • NCT01155375
    terminated; "Several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the AMAG-FER-CKD-251 study as designed."
  • NCT01155388
    terminated; "Several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the AMAG-FER-CKD-252 study as designed."
  • NCT01264679
    terminated; "Several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the AMAG-FER-CKD-253 study as designed."
14 further recorded trials
  • NCT01663090
    withdrawn; "Inability to accrue."
  • NCT01895829
    terminated; "Study halted prematurely and will not resume"
  • NCT01973517
    withdrawn; "Logistical factors affecting recruitment"
  • NCT02070705
    terminated; "Loss of funding"
  • NCT02189889
    terminated; "Initial patients were seen at St Paul Hospital. Enrollment changes occurred with the move to Clements Hospital. We were unable to identify an infusion room at CUH despite an exhaustive search for alternatives and forced to terminate early."
  • NCT02689401
    withdrawn; "Awaiting additional safety data"
  • NCT02857218
    withdrawn; "Inadequate enrollment"
  • NCT03179449
    withdrawn; "Accrual Factor"
  • NCT03234309
    withdrawn; "No enrollments"
  • NCT03280277
    terminated; "low accrual"
  • NCT03325166
    terminated; "Low accrual"
  • NCT03347617
    terminated; "Principal investigator transition"
  • NCT03777514
    withdrawn; "Study wasn't started."
  • NCT04080908
    terminated; "Unable to meet enrollment goals."

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

Ferumoxytol's half-life is 15 hours — which schedules were studied?


15 hours, the half-life Ferumoxytol's label states: "Ferumoxytol exhibited dose-dependent, capacity-limited elimination from plasma with a half-life of approximately 15 hours in humans." DailyMed label · cf94c7fc-13a0-4ac9-bb85-9c38aa704d35 · 2026-08-14

tmax 0.32 hr.

Show the evidence
  • half life pharmacokinetics
    15 hours; Ferumoxytol exhibited dose-dependent, capacity-limited elimination from plasma with a half-life of approximately 15 hours in humans.
  • tmax pharmacokinetics
    0.32 hr; The C max and time of maximum concentration (t max ) were 206 mcg/mL and 0.32 hr, respectively.

recorded 2026-08-14 · last checked 2026-09-04

Which 22 trials of Ferumoxytol posted no result?


Posted no result
22 of 22 completed trials
Registrations
NCT00360425, NCT01665846, NCT01323296, NCT01942460, NCT01296139 and NCT02319278, and 16 more
Completion dates
oldest 2006-08; newest 2024-09-03
Show the evidence

Trial

  • NCT00360425
    2006-08
  • NCT01665846
    2012-06
  • NCT01323296
    2012-10
  • NCT01942460
    2014-06
  • NCT01296139
    2015-03-19
  • NCT02319278
    2016-11
14 further recorded trials
  • NCT02452216
    2017-01-12
  • NCT02678767
    2017-09
  • NCT02466828
    2018-04
  • NCT02253602
    2018-05
  • NCT02549898
    2018-06
  • NCT03678012
    2018-08-16
  • NCT02977637
    2018-11
  • NCT02511028
    2019-01-29
  • NCT02791568
    2020-07-31
  • NCT02359097
    2021-03-12
  • NCT03657433
    2022-04-01
  • NCT03173066
    2022-05-31
  • NCT02631733
    2023-05-24
  • NCT05357833
    2023-09-01

At the median, Ferumoxytol's trials enrolled 29.5 people — anything larger?


Median enrolment
29.5
Largest enrolment
2014
Registered trials counted
88

What do 1302 spontaneous reports say about Ferumoxytol — 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.

Ferumoxytol appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1302 reaction mentions were counted: dyspnoea 282; flushing 150; hypotension 135; nausea 132. FAERS via Open Targets · CHEMBL1201867 · 2026-06-24

Show the evidence
  • dyspnoea
    282
  • flushing
    150
  • hypotension
    135
  • nausea
    132
  • back pain
    124
  • hypersensitivity
    100
4 more recorded rows
  • chest pain
    98
  • anaphylactic reaction
    97
  • chest discomfort
    93
  • infusion related reaction
    91

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

Which 10 reactions does Ferumoxytol's label not list?


anaphylactic reaction, back pain and chest discomfort and 7 more reported for Ferumoxytol, absent from its label. FAERS via Open Targets · CHEMBL1201867 · 2026-06-24

2 label terms; 10 reported and unlisted; cf94c7fc-13a0-4ac9-bb85-9c38aa704d35

Show the evidence
  • anaphylactic reaction
    count not stated
  • back pain
    count not stated
  • chest discomfort
    count not stated
  • chest pain
    count not stated
  • dyspnoea
    count not stated
  • flushing
    count not stated
4 more recorded rows
  • hypersensitivity
    count not stated
  • hypotension
    count not stated
  • infusion related reaction
    count not stated
  • nausea
    count not stated

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

Where do the label and the trials disagree about Ferumoxytol?


"withdrawn" against "approved": withdrawal status vs register status for Ferumoxytol.

EMA_MEDICINE_REGISTER, Drugs@FDA; 1 recorded pair

Show the evidence
  • EMA_MEDICINE_REGISTER EMEA/H/C/002215
    withdrawn; 2026-09-04
  • Drugs@FDA NDA219868
    approved; 2026-08-28
Where it is registered

Where it’s registered

Withdrawn, in European Union; no reason is published (EMA Medicine.csv)

Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201867
CAS number
1309-38-2
Development code
CODE 7228, RIENSO
Trade name
Feraheme, Ferabright, Ferabright / Feraheme
Also called
ferumoxytol non-stoichiometric magnetite, superparamagnetic iron oxide nanoparticles, uspio, FERUMOXYTOL [MART.], FERUMOXYTOL [MI], FERUMOXYTOL [ORANGE BOOK], FERUMOXYTOL [USAN], FERUMOXYTOL [VANDF], Ferumoxytol [WHO-DD]
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ClinicalTrials.gov — US Government work · EMA medicine register · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 6 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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