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Atropine Sulfate

  • 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 Atropine Sulfate does in the body

Relaxation of the upper gastrointestinal tract and colon during hypotonic radiography

From the FDA-approved label: Atropine is an antimuscarinic agent since it antagonizes the muscarine-like actions of acetylcholine and other choline esters. Atropine inhibits the muscarinic actions of acetylcholine on structures innervated by postganglionic cholinergic nerves, and on smooth muscles which respond to endogenous acetylcholine but are not so innervated. , by using anticholinesterase agents which inhibit the enzymatic destruction of acetylcholine).

What happened in people

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

A fixed RNAWiki sentence

Where this came from

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

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

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · 7C0697DR9I · read 2026-08-29

Where each sentence above came from

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

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 84 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.

Postoperative Acute Kidney Injury

The study did not show it

Who was studied
NCT02726620
How many people
22435
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

Incidence of SER development of at least -1.0 dioptres (D)

The study did not show it

Who was studied
NCT04045951
How many people
2138
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

Incidence of SER development of at least -0.5 dioptres (D)

The study did not show it

Who was studied
NCT04044755
How many people
2138
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

Detection of obstructive CAD and prevalence of MACE in enrolled participants

The study did not show it

Who was studied
NCT06185530
How many people
2000
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

incidence of Postoperative myocardial injury after non-cardiac surgery(MINS)

The study did not show it

Who was studied
NCT05635877
How many people
2000
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

Mortality

The study did not show it

Who was studied
NCT03925025
How many people
1728
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
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

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

Who was studied

People similar to this profile were included.

  • & USAGE Atropine sulfate is given parenterally as a preanesthetic medication to decrease salivation and bronchial secretions. It is useful in pylorospasm and other spastic conditions of the gastrointestinal tract. For ureteral and biliary colic, atropine sulfate given with morphine may be indicated.

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: “Due to the potential for systemic absorption of atropine sulfate ophthalmic solution, the use of atropine sulfate ophthalmic solution, 1% in children under the age of 3 months is not recommended and the use in children under 3 years of age should be limited to no more than one drop per eye per day.”

    US prescribing information · 1b2d030e-c0ec-484b-a228-76011702cdd0 · read 2026-08-30

  • On older people, the label states: “No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.”

    US prescribing information · 1b2d030e-c0ec-484b-a228-76011702cdd0 · read 2026-08-30

  • On people who are pregnant, the label states: “Category C: There are no adequate and well-controlled studies of atropine sulfate in pregnant women.”

    US prescribing information · 1b2d030e-c0ec-484b-a228-76011702cdd0 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Traces of atropine have been found in human milk following administration of atropine solution for injection.”

    US prescribing information · 1b2d030e-c0ec-484b-a228-76011702cdd0 · read 2026-08-30

Where the result stopped carrying

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

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

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

Why it might seem to do nothing

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

It was studied in different people

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

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

The evidence may simply be wrong

Small early studies often do not hold up.

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

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

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

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

What taking it involves

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

How it is supplied

Prescription only

Quoted from a source

Where this came from

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

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral

Source-linked record

Where this came from

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

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

RNAWiki has not recorded a supervision or regulatory status for this substance.

Quoted from a source

Where this came from

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

No register row and no identity class settled the question.

No source is stored against this line.

What is in the pack

Sold as tablet, injectable, solution, solution/drops, given by the oral, injection, intravenous, intramuscular, subcutaneous, intraosseous, endotracheal 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

  • 170 products list this as an active ingredient in the United States drug directory. 101 of them contain it and nothing else.

    FDA National Drug Code directory · 71872-7252 · read 2026-08-29

  • They are sold as elixir, injection, injection, solution, liquid, ointment and powder, taken endotracheal, intramedullary, intramuscular and intravascular.

    FDA National Drug Code directory · 71872-7252 · read 2026-08-29

  • The regulator's established pharmacologic class for it is anticholinergic [epc], cholinergic antagonists [moa] and cholinergic muscarinic antagonist [epc].

    FDA National Drug Code directory · 71872-7252 · read 2026-08-29

  • 124 published labels name it as an active ingredient. 62 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · e9fd624a-9abd-dfea-e053-2a95a90a8e9d · read 2026-08-29

  • Those labels are classed as human otc drug and human prescription drug.

    US prescribing information · e9fd624a-9abd-dfea-e053-2a95a90a8e9d · read 2026-08-29

  • 1 marketed supplement label lists this ingredient, classed as fat/fatty acid.

    NIH Dietary Supplement Label Database · 73138 · 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 · 73138 · read 2026-08-29

  • Atropine is ophthalmic at 3., recorded as fda label in effect 2024-01-02 in the United States.

    US prescribing information · 1b2d030e-c0ec-484b-a228-76011702cdd0 · read 2026-08-30

  • Recorded price in US: 3.91597–19.99768 USD per one millilitre, across 20 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

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

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

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

What you could measure

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

RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.

Questions worth asking

  • Which of the trials of Atropine Sulfate 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 Atropine Sulfate 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

  • 61 documents were read for this substance.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
7C0697DR9I
RxNorm concept
1190536

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

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

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Not passed

    Safety mode resolved

    No register row and no identity class settled the question.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

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

  1. Withdrawn in United States, 2023, for "Presence of Particulate Matter; identified as glass" (openFDA drug enforcement Class I recall)

  2. Withdrawn in United States, 2017, for "SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent" (openFDA drug enforcement Class I recall)

What the approval register records

  • 75 approved applications cover products containing this substance. The earliest was NDA012462, approved 19600915 to PFIZER.

    Drugs@FDA application register · NDA012462 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA012462 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19600915.

    FDA National Drug Code directory · 71872-7252 · 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 Atropine Sulfate label: indicated for what?


"Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for: 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia Atropine is an anti-cholinergic indicated in adults and pediatric patients aged three (3) months…": indications and usage on Atropine Sulfate's label. DailyMed label · a116af5c-ba4c-408c-9a02-4bc33772aa8d · 2026-08-03

98 registered trials of Atropine Sulfate — at which phases?


Registered studies posting no result
79 of 98

98 registered studies of Atropine Sulfate: 26 phase4, 20 phase3, 19 na, 16 phase2, 12 phase1, 6 early phase1, 3 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

1729 with a PubMed record

Show the evidence
  • phase4
    26
  • phase3
    20
  • na
    19
  • phase2
    16
  • phase1
    12
  • early phase1
    6
9 more recorded rows
  • na or unstated
    3
  • completed
    68
  • unknown
    13
  • recruiting
    5
  • withdrawn
    4
  • active not recruiting
    3
  • terminated
    3
  • enrolling by invitation
    1
  • not yet recruiting
    1

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

7 of Atropine Sulfate's trials stopped: safety, accrual/recruitment, other?


safety (1), accrual/recruitment (3) and other (3): Atropine Sulfate's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Poor enrollment and infeasibility of ever reaching the necessary sample size"; 7 of 98 registered studies

Show the evidence

Trial

  • NCT00506675
    terminated; "Poor enrollment and infeasibility of ever reaching the necessary sample size"
  • NCT03322150
    terminated; "The research was terminated because the recruitment of the study subjects was not smooth and the overseas training of the investigator was scheduled."
  • NCT03718507
    withdrawn; "no recrutiment started"
  • NCT03972683
    withdrawn; "no participants enrolled"
  • NCT04393103
    withdrawn; "no avilable resorces"
  • NCT04777383
    terminated; "The study was terminated prematurely due to insufficient operational resources to continue trial conduct and completion. The decision was unrelated to safety concerns or study outcomes."
  • 1 further recorded trial NCT05481489
    withdrawn; "Due to sponsors convenience."

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

Human studies of Atropine Sulfate used Atropine (0.01mg/kg) — over how long?


Human studies of Atropine Sulfate used "Atropine (0.01mg/kg)". ClinicalTrials.gov · 2026-09-01

20 recorded entries; human; ophthalmic; also "Atropine sulfate ophthalmic solution 1%", "0.125% atropine (Sinphar Pharmaceutical, Ilan, Taiwan)", "Atropine 0.24 mg"

Show the evidence

human

  • NCT01191398
    Atropine (0.01mg/kg)
  • NCT01845636
    ophthalmic; Atropine sulfate ophthalmic solution 1%
  • NCT02055378
    0.125% atropine (Sinphar Pharmaceutical, Ilan, Taiwan)
  • NCT02082054
    Atropine 0.24 mg
  • NCT02186132
    Atropine 0.6 mg
  • NCT02186132
    Atropine 1.2 mg
14 more recorded rows
  • human NCT02445599
    Atropine 1 mg/ml
  • human NCT03374306
    Atropine (0.01%)
  • human NCT03508817
    Atropine Sulfate 0.01% Eye Drops
  • human NCT03544827
    Atropine 0.01%
  • human NCT03544827
    Atropine 0.1%
  • human NCT03593044
    0.01% concentration atropine drops
  • human NCT03918915
    SYD-101 0.01%
  • human NCT03918915
    SYD-101 0.03%
  • human NCT03984526
    atropine 0.5mg
  • human NCT04393103
    Atropine 1 mg / 1 ml
  • human NCT04777383
    Atropine, 10 mg/ml, Bausch & Lomb
  • human NCT05164367
    Atropine sulfate gel (0.01%)
  • human NCT05331664
    Atropine 1%
  • human NCT06366087
    Atropine Sulfate Ophthalmic Solution USP, 1%

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

Atropine Sulfate's half-life is 3 ± 1.2 hours — which schedules were studied?


3 ± 1.2 hours, the half-life Atropine Sulfate's label states: "Terminal half-life of l-hyoscamine was not affected by route of administration and was calculated to be 3 ± 1.2 hours (intravenous) and 2.5 ± 0.8 hours (topical ophthalmic)." DailyMed label · a116af5c-ba4c-408c-9a02-4bc33772aa8d · 2026-08-03

bioavailability 1 %.

Show the evidence
  • half life pharmacokinetics
    3 ± 1.2 hours; Terminal half-life of l-hyoscamine was not affected by route of administration and was calculated to be 3 ± 1.2 hours (intravenous) and 2.5 ± 0.8 hours (topical ophthalmic).
  • bioavailability pharmacokinetics
    1 %; The bioavailability of atropine sulfate ophthalmic solution 1% was assessed in six healthy subjects, 24 to 29 years of age.

recorded 2026-08-03 · last checked 2026-09-04

Which 46 trials of Atropine Sulfate posted no result?


Posted no result
46 of 46 completed trials
Registrations
NCT00468091, NCT00001864, NCT00094614, NCT00094692, NCT00575523 and NCT00921102, and 40 more
Completion dates
oldest 2000-09; newest 2024-09-01
Show the evidence

Trial

  • NCT00468091
    2000-09
  • NCT00001864
    2001-11
  • NCT00094614
    2003-04
  • NCT00094692
    2005-12
  • NCT00575523
    2008-01
  • NCT00921102
    2008-05
14 further recorded trials
  • NCT00121524
    2008-06
  • NCT00689208
    2008-11
  • NCT00623207
    2009-10
  • NCT01858090
    2010-01
  • NCT00947596
    2010-08
  • NCT00991627
    2010-08
  • NCT00834470
    2010-12
  • NCT01464489
    2011-09
  • NCT00251602
    2012-08
  • NCT02055378
    2012-12
  • NCT02186132
    2013-02
  • NCT01871922
    2013-06
  • NCT00000170
    2013-08
  • NCT02658721
    2013-08

At the median, Atropine Sulfate's trials enrolled 70 people — anything larger?


Median enrolment
70
Largest enrolment
22435
Registered trials counted
98

What do 802 spontaneous reports say about Atropine Sulfate — 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.

Atropine Sulfate appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 802 reaction mentions were counted: drug hypersensitivity 114; diarrhoea 111; hypotension 99; tachycardia 93. FAERS via Open Targets · CHEMBL2146146 · 2026-06-24

Show the evidence
  • drug hypersensitivity
    114
  • diarrhoea
    111
  • hypotension
    99
  • tachycardia
    93
  • bradycardia
    85
  • hypertension
    82
4 more recorded rows
  • toxicity to various agents
    70
  • cardiac arrest
    59
  • hyperhidrosis
    46
  • heart rate increased
    43

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

Which 10 reactions does Atropine Sulfate's label not list?


bradycardia, cardiac arrest and diarrhoea and 7 more reported for Atropine Sulfate, absent from its label. FAERS via Open Targets · CHEMBL2146146 · 2026-06-24

2 label terms; 10 reported and unlisted; a116af5c-ba4c-408c-9a02-4bc33772aa8d

Show the evidence
  • bradycardia
    count not stated
  • cardiac arrest
    count not stated
  • diarrhoea
    count not stated
  • drug hypersensitivity
    count not stated
  • heart rate increased
    count not stated
  • hyperhidrosis
    count not stated
4 more recorded rows
  • hypertension
    count not stated
  • hypotension
    count not stated
  • tachycardia
    count not stated
  • toxicity to various agents
    count not stated

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

Where it is registered

Where it’s registered

Withdrawn in United States, 2023, for "Presence of Particulate Matter; identified as glass" (openFDA drug enforcement Class I recall)

Withdrawn in United States, 2017, for "SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent" (openFDA drug enforcement Class I recall)

Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL2146146
CAS number
5908-99-6
RxCUI
153971
InChIKey
RKUNBYITZUJHSG-SPUOUPEWSA-N
Development code
NSC-755889, NSC-26671, SYD-101
Also called
Atropine
Salt form
Atropine sulfate anhydrous, Atropine sulfate ansyr plastic syringe, Atropine sulfate component of colonaid, Atropine sulfate component of di-atro, Atropine sulfate component of enlon-plus, Atropine sulfate component of logen, Atropine sulfate component of lomanate, Atropine sulfate component of lomotil, Atropine sulfate component of lonox, Atropine sulfate component of lo-trol, Atropine sulfate component of low-quel, Atropine sulfate component of motofen
Also called
Atropini sulfas, Atropinum sulphuricum, Atropt, atropine eye drops, Atropinum, Dl-hyoscyamine, ATROPINE SULFATE [ORANGE BOOK], ATROPINE SULFATE [USP MONOGRAPH], ATROPINE SULFATE [USP-RS], ATROPINE SULFATE [VANDF], ATROPINE SULFATE [WHO-IP], ATROPINI SULFAS [WHO-IP LATIN]
Trade name
Atropisol, Isopto atropine, Atroject, Atropen, Atrophate, Atropine component of atnaa, Atropine component of duodote, Atropen Auto-Injector, Atropen Auto-Injector / Atropen / Isopto Atropine / Atropine (Autoinjector), Ryjunea, Atropine sulfate FGK
Component
Atropine
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.