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Amiodarone

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

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

What Amiodarone does in the body

Like class I drugs, amiodarone blocks sodium channels at rapid pacing frequencies, and like class II drugs, amiodarone exerts a noncompetitive antisympathetic action.

From the FDA-approved label: Amiodarone is considered a class III antiarrhythmic drug, but it possesses electrophysiologic characteristics of all four Vaughan Williams classes. One of its main effects, with prolonged administration, is to lengthen the cardiac action potential, a class III effect. The negative chronotropic effect of amiodarone in nodal tissues is similar to the effect of class IV drugs.

Why people take it. NEXTERONE is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy.

What happened in people

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

A fixed RNAWiki sentence

Where this came from

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

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

No source is stored against this line.

The limit that matters most

Not recorded.

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

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · N3RQ532IUT · 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 use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 121 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.

First Hospitalization for Cardiovascular Reason or Death From Any Cause

The study did not show it

Who was studied
NCT00174785
How many people
4628
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

30-day ordinal composite of hospital mortality and days free of atrial fibrillation in ICU

The study did not show it

Who was studied
NCT07173855
How many people
3253
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

Overview of the Two Co-primary Outcomes

The study did not show it

Who was studied
NCT01151137
How many people
3236
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge

The study did not show it

Who was studied
NCT01401647
How many people
3024
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

A composite of cardiovascular death, stroke and hospitalization due to worsening of heart failure or due to acute coronary syndrome.

The study did not show it

Who was studied
NCT01288352
How many people
2789
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF.

The study did not show it

Who was studied
NCT00911508
How many people
2204
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

  • Amiodarone Hydrochloride Injection, USP is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone Hydrochloride Injection, USP also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication.

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 amiodarone in pediatric patients have not been established.”

    US prescribing information · e9108958-b8d7-4fba-87c3-9a32990de551 · read 2026-08-30

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

    US prescribing information · e9108958-b8d7-4fba-87c3-9a32990de551 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction.”

    US prescribing information · e9108958-b8d7-4fba-87c3-9a32990de551 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Amiodarone and one of its major metabolites, DEA, are present in breastmilk at between 3.5% and 45% of the maternal weight-adjusted dosage of amiodarone.”

    US prescribing information · e9108958-b8d7-4fba-87c3-9a32990de551 · read 2026-08-30

Where the result stopped carrying

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

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

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

Why it might seem to do nothing

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

It was studied in different people

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

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

The evidence may simply be wrong

Small early studies often do not hold up.

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

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

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

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

What taking it involves

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

How it is supplied

Prescription only

Quoted from a source

Where this came from

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

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral

Source-linked record

Where this came from

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

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

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

Quoted from a source

Where this came from

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

Suppression classes recorded: S1, S3, S6.

No source is stored against this line.

What is in the pack

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

Oral

Source-linked record

Where this came from

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

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 78 products list this as an active ingredient in the United States drug directory. 78 of them contain it and nothing else.

    FDA National Drug Code directory · 71872-7149 · read 2026-08-29

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

    FDA National Drug Code directory · 71872-7149 · read 2026-08-29

  • The regulator's established pharmacologic class for it is antiarrhythmic [epc], cytochrome p450 1a2 inhibitors [moa] and cytochrome p450 2c9 inhibitors [moa].

    FDA National Drug Code directory · 71872-7149 · read 2026-08-29

  • 51 published labels name it as an active ingredient. 51 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · e9108958-b8d7-4fba-87c3-9a32990de551 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · e9108958-b8d7-4fba-87c3-9a32990de551 · read 2026-08-29

  • 2 marketed supplement labels list this ingredient, classed as other combinations.

    NIH Dietary Supplement Label Database · 239677 · read 2026-08-29

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

    NIH Dietary Supplement Label Database · 239677 · read 2026-08-29

  • Nexterone is intravenous at 3 DOSAGE FORMS AND STRENGTHS Injection, 1.5 mg/mL (150 mg/100 mL) Premixed in Dextrose Injection, 1.8 mg/mL (360 mg/200 mL) Premixed in Dextrose Injection, 1.5 mg/mL (150 mg/100 mL) Premixed in Dextrose (3) Injection, 1…, recorded as fda label in effect 2024-04-16 in the United States.

    US prescribing information · e9108958-b8d7-4fba-87c3-9a32990de551 · read 2026-08-30

  • Recorded price in US: 0.12058–0.39377 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 26 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: 0.52115 USD per one millilitre, across 2 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

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

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

What you could measure

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

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

Questions worth asking

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

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

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

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

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

Missing populations

Which groups were under-represented in the studies has not been recorded.

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

What would answer it

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

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

Missing long-term data

No completed tested study window is recorded.

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

What would answer it

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

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

No reviewed conclusion

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

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

What would answer it

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

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

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

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

What would answer it

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

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

Formulation uncertainty

Several salts, forms or products of Amiodarone 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

  • 48 documents were read for this substance.

    RNAWiki source record

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

    RNAWiki source record

  • 28 of them state the same bioavailability, and they agree.

    RNAWiki source record

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

    RNAWiki source record

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

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
N3RQ532IUT
CAS registry number
1951-25-3
PubChem compound
2157
ChEMBL
CHEMBL633
ChEBI
2663
WHO international nonproprietary name list entry
2012
RxNorm concept
703
EMA substance identifier
100000089825
European Chemicals Agency number
217-772-1
DrugBank
DB01118

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: S1, S3, 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 United States, 2020, for "Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to…" (openFDA drug enforcement Class I recall)

  2. Withdrawn in United States, 2017, for "Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged" (openFDA drug enforcement Class I recall)

What the approval register records

  • 35 approved applications cover products containing this substance. The earliest was NDA018972, approved 19851224 to WYETH PHARMS.

    Drugs@FDA application register · NDA018972 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA018972 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19961016.

    FDA National Drug Code directory · 71872-7149 · 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 (11)

On the Amiodarone label: indicated for what?

"Amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot…": indications and usage on Amiodarone's label. DailyMed label · 51a88e8e-da02-4b97-9e7e-442fbffd908d · 2026-07-16

96 registered trials of Amiodarone — at which phases?

Registered studies posting no result
75 of 96

96 registered studies of Amiodarone: 32 phase3, 28 phase4, 19 na, 8 phase2, 6 na or unstated, 4 phase1, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

806 with a PubMed record

Show the evidence
  • phase3
    32
  • phase4
    28
  • na
    19
  • phase2
    8
  • na or unstated
    6
  • phase1
    4
10 more recorded rows
  • early phase1
    1
  • completed
    39
  • unknown
    25
  • terminated
    13
  • not yet recruiting
    7
  • recruiting
    7
  • withdrawn
    2
  • active not recruiting
    1
  • enrolling by invitation
    1
  • suspended
    1

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

14 of Amiodarone's trials stopped: safety, accrual/recruitment, funding/business, other?

safety (2), accrual/recruitment (7), funding/business (2) and other (3): Amiodarone's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Unable to accrual total number of participants during study period."; 14 of 96 registered studies

Show the evidence

Trial

  • NCT00300495
    terminated; "Unable to accrual total number of participants during study period."
  • NCT00392106
    suspended; "voluntarily by Sponsor to investigate an anticipated SAE"
  • NCT00589303
    terminated; "Lack of funding"
  • NCT01097330
    terminated; "Anticipated non-feasibility of recruitment objectives"
  • NCT01276093
    terminated; "DSMB recommendation; enrollment too slow"
  • NCT01558128
    terminated; "Insufficient Recruitment"
8 further recorded trials
  • NCT01576042
    terminated; "Main objectives of the study were met; consensus among investigators that continuing the study would not add new information beyond that already learned."
  • NCT01649544
    terminated; "End of commercialization of the medical device"
  • NCT02301390
    terminated; "could not meet enrollment goal"
  • NCT02341105
    terminated; "low recruitment rate"
  • NCT02668432
    terminated; "Investigator left institution"
  • NCT04208997
    terminated; "Study was terminated due to low accrual"
  • NCT04594746
    terminated; "we couldn't recruit enough participants"
  • NCT05004077
    terminated; "limited enrollment"

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

Human studies of Amiodarone used Amiodarone tab 200 mg x 3 — over how long?

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

9 recorded entries; human; also "Amiodarone tab 200 mg x 3", "Amiodarone Hydrochloride 200 MG", "Amiodarone Hydrochloride 100 MG"

Show the evidence

human

  • NCT01955759
    Amiodarone tab 200 mg x 3
  • NCT05841056
    Amiodarone Hydrochloride 200 MG
  • NCT07273994
    Amiodarone Hydrochloride 100 MG
  • NCT07487714
    Pharmacotherapy with amiodarone 200 mg per day
  • NCT07487714
    Amiodarone 200 mg
  • NCT07487714
    Treatment with Amiodarone at a dose 100 mg per day
3 more recorded rows
  • human NCT07487714
    Amiodarone 100 mg
  • human NCT07487714
    Treatment with Amiodarone at a dose 400 mg per day
  • human NCT07487714
    Amiodarone 400 mg

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

Amiodarone's half-life is 58 days — which schedules were studied?

58 days, the half-life Amiodarone's label states: "Elimination Following single dose administration in 12 healthy subjects, amiodarone hydrochloride exhibited multi-compartmental pharmacokinetics with a mean apparent plasma terminal elimination half-life of 58 days (range 15 to 142 days) for amiodarone and 36 days (range 14 to 75 days) for the active metabolite (DEA)." DailyMed label · 51a88e8e-da02-4b97-9e7e-442fbffd908d · 2026-07-16

bioavailability 50 %.

Show the evidence
  • half life pharmacokinetics
    58 days; Elimination Following single dose administration in 12 healthy subjects, amiodarone hydrochloride exhibited multi-compartmental pharmacokinetics with a mean apparent plasma terminal elimination half-life of 58 days (range 15 to 142 days) for amiodarone and 36 days (range 14 to 75 days) for the active metabolite (DEA).
  • bioavailability pharmacokinetics
    50 %; The bioavailability of amiodarone hydrochloride is approximately 50%.
  • metabolism pharmacokinetics
    Metabolism Amiodarone is metabolized to DEA by the cytochrome P450 (CYP) enzyme group, specifically CYP3A and CYP2C8.

recorded 2026-07-16 · last checked 2026-09-04

Which running trial of Amiodarone could settle lifespan?

NCT06835491 measures Rate of Mortality and severe ventricular arrhythmia, reading out 2027-03-15.

1 open trial; n 674; "Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm"

Show the evidence
  • Trial NCT06835491
    "Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm"; n 674; "Rate of Mortality and severe ventricular arrhythmia"; 2027-03-15

Which 23 trials of Amiodarone posted no result?

Posted no result
23 of 23 completed trials
Registrations
NCT00000556, NCT00007605, NCT00251706, NCT00000609, NCT00287209 and NCT00392431, and 17 more
Completion dates
oldest 2002-09; newest 2024-01-31
Show the evidence

Trial

  • NCT00000556
    2002-09
  • NCT00007605
    2003-12
  • NCT00251706
    2004-09
  • NCT00000609
    2005-04
  • NCT00287209
    2005-08
  • NCT00392431
    2007-03
14 further recorded trials
  • NCT00420953
    2007-04-23
  • NCT00654290
    2008-02
  • NCT00121524
    2008-06
  • NCT00668759
    2009-11
  • NCT00993382
    2011-05
  • NCT03413150
    2012-04
  • NCT00826826
    2014-01
  • NCT01173809
    2014-07
  • NCT00920244
    2015-04
  • NCT00729911
    2015-12
  • NCT00905853
    2015-12
  • NCT02248753
    2019-12
  • NCT02924285
    2021-03-04
  • NCT04351763
    2021-06-05

At the median, Amiodarone's trials enrolled 180 people — anything larger?

Median enrolment
180
Largest enrolment
5000
Registered trials counted
92

What do 4450 spontaneous reports say about Amiodarone — 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.

Amiodarone appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4450 reaction mentions were counted: drug interaction 983; bradycardia 635; hyperthyroidism 510; interstitial lung disease 437. FAERS via Open Targets · CHEMBL1083993 · 2026-06-24

Show the evidence
  • drug interaction
    983
  • bradycardia
    635
  • hyperthyroidism
    510
  • interstitial lung disease
    437
  • electrocardiogram qt prolonged
    388
  • atrial fibrillation
    375
4 more recorded rows
  • hypothyroidism
    345
  • international normalised ratio increased
    277
  • torsade de pointes
    259
  • syncope
    241

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

Which 10 reactions does Amiodarone's label not list?

atrial fibrillation, bradycardia and drug interaction and 7 more reported for Amiodarone, absent from its label. FAERS via Open Targets · CHEMBL1083993 · 2026-06-24

3 label terms; 10 reported and unlisted; 51a88e8e-da02-4b97-9e7e-442fbffd908d

Show the evidence
  • atrial fibrillation
    count not stated
  • bradycardia
    count not stated
  • drug interaction
    count not stated
  • electrocardiogram qt prolonged
    count not stated
  • hyperthyroidism
    count not stated
  • hypothyroidism
    count not stated
4 more recorded rows
  • international normalised ratio increased
    count not stated
  • interstitial lung disease
    count not stated
  • syncope
    count not stated
  • torsade de pointes
    count not stated

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

Amiodarone and CYP3A, CYP2C8 and CYP2C9: shared by which compounds?

CYP3A, CYP2C8 and CYP2C9 appear in Amiodarone's recorded interaction sentences, 8 in all. DailyMed label · 51a88e8e-da02-4b97-9e7e-442fbffd908d · 2026-07-16

CYP1A2, CYP2A6, CYP2B6, CYP2C19, CYP2C8, CYP2C8; 16 shared nodes; drug_interactions, pharmacokinetics

Show the evidence

Interaction statement

  • drug_interactions
    CYP3A Substrate lidocaine Sinus bradycardia has been reported with oral amiodarone in combination with lidocaine given for local anesthesia.
  • drug_interactions
    CYP3A Substrate fentanyl Fentanyl in combination with amiodarone may cause hypotension, bradycardia, and decreased cardiac output.
  • drug_interactions
    ( 7 ) Amiodarone is a substrate for CYP3A and CYP2C8, so inhibitors and inducers affect amiodarone exposure.
  • drug_interactions
    ( 7 ) Amiodarone inhibits P-glycoprotein and CYP1A2, CYP2C9, CYP2D6, and CYP3A, increasing exposure to other drugs.
  • pharmacokinetics
    Metabolism Amiodarone is metabolized to DEA by the cytochrome P450 (CYP) enzyme group, specifically CYP3A and CYP2C8.
  • pharmacokinetics
    The CYP3A isoenzyme is present in both the liver and intestines.
2 more recorded rows
  • Interaction statement pharmacokinetics
    In vitro , amiodarone and DEA exhibit a potential to inhibit CYP2C9, CYP2C19, CYP2D6, CYP3A, CYP2A6, CYP2B6 and CYP2C8.
  • Interaction statement pharmacokinetics
    Amiodarone and DEA have also a potential to inhibit some transporters such as P-glycoprotein and organic cation transporter (OCT2).
  • CYP1A2
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Golodirsen, Tinidazole
  • CYP2A6
    FINGOLIMOD LAURYL SULFATE, Rasagiline, Naldemedine, Methylnaltrexone, Tivozanib, Metaxalone, Selegiline, Trametinib
  • CYP2B6
    FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Sofpironium, Bupropion, Golodirsen, Tinidazole, Naldemedine
  • CYP2C19
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Naldemedine, Etravirine

CYP2C8

  • FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Golodirsen, Naldemedine, Methylnaltrexone, Lapatinib, Tivozanib
  • FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Golodirsen, Naldemedine, Methylnaltrexone, Lapatinib, Tivozanib

CYP2C9

  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Tinidazole, Naldemedine
  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Tinidazole, Naldemedine

CYP2D6

  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine

CYP3A

  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • OCT2
    TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Sofpironium, Golodirsen, Naldemedine, Eravacycline

P-gp

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine

recorded 2026-07-16 · last checked 2026-09-04

Where it is registered

Where it’s registered

Withdrawn in United States, 2020, for "Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to…" (openFDA drug enforcement Class I recall)

Withdrawn in United States, 2017, for "Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged" (openFDA drug enforcement Class I recall)

Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1083993
PubChem CID
29770
CAS number
19774-82-4
RxCUI
203114
InChIKey
IYIKLHRQXLHMJQ-UHFFFAOYSA-N
Also called
AMIODARONE HYDROCHLORIDE, Amiodar, Miodaron, Ortacrone, Ritmocardyl, Trangorex, Amiodarona, aads, pm101, AMIODARONE HYDROCHLORIDE [EP MONOGRAPH], AMIODARONE HYDROCHLORIDE [HSDB], AMIODARONE HYDROCHLORIDE [JAN]
Trade name
Amidox, Amyben, Cordarone, Cordarone x, Cordarone x 100, Cordarone x 200, Darmil, Nexterone, Pacerone, AMIODARONE HCI
Salt form
Amiodarone hcl, Amiodarone Hydrochloride / Pacerone / Nexterone / Cordarone / Nexterone (Amiodarone Hci)
Development code
L-3428, NSC-343341, NSC-85442, SK&F-33134-A, SKF 33134-A, VF-236
Sources (7)

Sources

1 more source

ChEMBL 37 — CC BY-SA 3.0 Unported · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work · openFDA enforcement — 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: 7 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.