This page shows what was measured, who it was measured in, and what that does not settle.
What Pseudoephedrine does in the body
A blocked nose and sinus pressure
The stuffiness of a cold is swollen tissue, not mucus: the nose is lined with spongy blood-filled spaces that fill up and squeeze the airway shut. Pseudoephedrine makes the muscle around those blood vessels tighten, so the spaces empty and the airway opens. It does this mostly by pushing out the body’s own noradrenaline from nerve endings rather than by acting on the vessel directly, which is why it also nudges heart rate and blood pressure everywhere else in the body.
What happened in people
Systolic blood pressure +0.99 mm Hg and heart rate +2.83 beats per minute across 45 treatment arms in 1,285 patients
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
FDA. Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products — proposed order OTC000036 removing oral… · a recorded source, not a stored snapshot
The limit that matters most
Marketed in the United States since 1963 and still the only oral decongestant on the monograph that the FDA has not proposed removing
Where it acts
Nasal venous sinusoids — the spongy blood-filled tissue in the turbinates whose swelling is what a blocked nose actually is
Kind of result
A number that stands in for health
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
7 registered substances share the start of this name, which is why a search for it can return more than one thing.
FDA substance registry · Y9DL7QPE6B · 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.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 112 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.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
Formulation
A formulation is the exact made-up form a substance comes in.
A picture of it, and where the picture fails
It is like the difference between a whole bean and instant coffee.
Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.
What people get wrong. Two products with the same name are assumed to behave the same. They often do not.
The specific composition and physical form of a product, including salt, excipients and release profile.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Subjective symptom scores for nasal congestion against placebo
✓ The study showed what it set out to show
Who was studied
Cochrane CD009612.pub2 — nasal decongestants in monotherapy for the common cold
How many people
1838
Study design
Systematic review and meta-analysis of 15 randomised trials
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Multi-dose SMD 0.49 (95% CI 0.07 to 0.92), p=0.02, low-quality evidence; single-dose not poolable
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. The multi-dose pooling rested on two studies, one oral and one topical, so oral and topical effects could not be separated. Fourteen of fifteen trials enrolled adults only.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, extended-release tablet and liquid, sold from behind the pharmacy counter
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
FDA. Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products — proposed order OTC000036 removing oral… · a recorded source, not a stored snapshot
DEA. Implementation of the Combat Methamphetamine Epidemic Act of 2005; Retail Sales. 85 FR 68450, 29 October 2020 (https://www.federalregister.gov/documents… · a recorded source, not a stored snapshot
Systolic and diastolic blood pressure and heart rate against placebo
✓ The study showed what it set out to show
Who was studied
Salerno 2005 meta-analysis (Arch Intern Med 165:1686-1694)
How many people
1285
Study design
Meta-analysis of 24 randomised placebo-controlled trials, 45 treatment arms
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
SBP +0.99 mm Hg (95% CI 0.08 to 1.90); HR +2.83 beats/min (95% CI 2.0 to 3.6); DBP +0.63 mm Hg (95% CI -0.10 to 1.35, not significant)
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. English-language trials only. Trials of this size and duration cannot detect the rare cerebrovascular events that later prompted European contraindications.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, extended-release tablet and liquid, sold from behind the pharmacy counter
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
FDA. Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products — proposed order OTC000036 removing oral… · a recorded source, not a stored snapshot
DEA. Implementation of the Combat Methamphetamine Epidemic Act of 2005; Retail Sales. 85 FR 68450, 29 October 2020 (https://www.federalregister.gov/documents… · a recorded source, not a stored snapshot
Adverse events, decongestant against placebo
✓ The study showed what it set out to show
Who was studied
Cochrane CD009612.pub2 adverse-event analysis
How many people
1838
Study design
Meta-analysis of 7 randomised trials reporting adverse events
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Odds ratio 0.98 (95% CI 0.68 to 1.40), p=0.90; oral only OR 0.95 (95% CI 0.65 to 1.39), p=0.80; low-quality evidence
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Short-term adult data. Absence of a signal at this scale is not evidence about rare events.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, extended-release tablet and liquid, sold from behind the pharmacy counter
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
FDA. Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products — proposed order OTC000036 removing oral… · a recorded source, not a stored snapshot
DEA. Implementation of the Combat Methamphetamine Epidemic Act of 2005; Retail Sales. 85 FR 68450, 29 October 2020 (https://www.federalregister.gov/documents… · a recorded source, not a stored snapshot
What we know
RNAWiki holds 3 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Pseudoephedrine
What a person takes: Oral tablet, extended-release tablet and liquid, sold from behind the pharmacy counter.
The measurement behind this step
Taken by mouth, so the vasoconstriction it produces is systemic rather than confined to the nose. Immediate-release preparations produced larger blood pressure rises than extended-release in the pooled analysis. Purchase requires photographic identification and a logbook entry, with daily and monthly quantity limits.
Getting in
Swallowed, and it goes everywhere
A tablet reaches the whole circulation, not just the nose. That is the reason it also touches heart rate and blood pressure, and the reason a spray does not.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Well absorbed orally with limited metabolism and largely renal excretion of unchanged drug, so exposure rises when urine is alkaline and when kidney function is reduced. Systemic distribution is unavoidable by this route, which is what separates it pharmacologically from a topical alpha agonist applied to the mucosa.
FDA. Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products — proposed order OTC000036 removing oral… · a recorded source, not a stored snapshot
Reaching the cell
It is carried into sympathetic nerve endings
Rather than acting on the blood vessel itself, the molecule is taken up into the nerve endings that control the vessel — using the same doorway the body uses to recycle its own signalling chemical.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Pseudoephedrine is a substrate for the noradrenaline transporter SLC6A2 and is carried into the sympathetic nerve terminal. Its own affinity for alpha-adrenergic receptors is weak; the transporter step, not receptor binding, is the committed step of its pharmacology.
FDA. Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products — proposed order OTC000036 removing oral… · a recorded source, not a stored snapshot
What it acts on
It pushes out the body’s own noradrenaline
Inside the nerve ending it displaces the stored signalling chemical into the gap between nerve and vessel. The vessel then receives a much stronger version of the message it normally gets.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Displacement of vesicular noradrenaline into the synaptic cleft produces indirect alpha-1 agonism at the vascular smooth muscle. Because the transmitter released is the body’s own, the effect is not confined to the nose: it is a generalised sympathomimetic action expressed most visibly where the tissue is most vascular.
FDA. Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products — proposed order OTC000036 removing oral… · a recorded source, not a stored snapshot
The change it makes
The blood spaces in the nose empty and the airway opens
The swollen spongy tissue in the nose shrinks as its blood vessels tighten, and there is suddenly room to breathe through. Nothing has been done to the infection or the allergy.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Alpha-1 mediated constriction of the venous sinusoids in the turbinates reduces mucosal volume and nasal airway resistance. The effect is purely mechanical and purely temporary; viral replication, inflammatory mediator release and mucus production are unaffected.
FDA. Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products — proposed order OTC000036 removing oral… · a recorded source, not a stored snapshot
What that does for a person
A small measured improvement, and an unsettled question about how much it matters
Pooled across trials, repeated doses improved how blocked people said they felt by a small amount. The reviewers were explicit that they could not say whether a difference that size is one a person would notice as worthwhile.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Standardised mean difference 0.49 (95% CI 0.07 to 0.92) for multi-dose against placebo, graded low-quality and pooled from two studies. Ten single-dose trials could not be pooled at all because congestion was measured and reported too diversely.
FDA. Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products — proposed order OTC000036 removing oral… · a recorded source, not a stored snapshot
What that does for a person
The systemic price of an oral route
Because the drug reaches the whole body, it raises the pulse slightly, nudges the top blood pressure number, and in rare cases has been linked to two conditions in which blood flow to the brain is disturbed.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Pooled systolic rise 0.99 mm Hg and heart rate rise 2.83 beats per minute across 45 treatment arms in 1,285 patients, greater with higher doses and immediate-release preparations. European regulators contraindicated the drug in severe or uncontrolled hypertension and severe renal disease in 2024 after reviewing posterior reversible encephalopathy syndrome and reversible cerebral vasoconstriction syndrome.
FDA. Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products — proposed order OTC000036 removing oral… · a recorded source, not a stored snapshot
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Adults and children, sold without a prescription but only from behind the pharmacy counter in the United States, with identification, a logbook entry and quantity limits.
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.
Where the result stopped carrying
Ten single-dose randomised trials could not be pooled at all because congestion was measured and reported too diversely
Europe contraindicated the drug in severe or uncontrolled hypertension and severe renal disease in 2024, after reviewing two cerebrovascular syndromes
The 2005 diversion-control law moved it behind the counter, and the substitute that filled the shelf is now proposed for removal as ineffective
The multi-dose efficacy conclusion rests on two studies, one of them topical, which is thin ground for a product sold in the hundreds of millions
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
A different form was studied
The studied form is not the form on the shelf.
On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
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 tablet, extended-release tablet and liquid, sold from behind the pharmacy counter
✎ 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
Taken by mouth, so the vasoconstriction it produces is systemic rather than confined to the nose. Immediate-release preparations produced larger blood pressure rises than extended-release in the pooled analysis. Purchase requires photographic identification and a logbook entry, with daily and monthly quantity limits.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Short-term adverse events in randomised trials were indistinguishable from placebo. The label forbids use with a prescription monoamine oxidase inhibitor or within two weeks of stopping one, and directs people with heart disease, high blood pressure, thyroid disease, diabetes or difficulty passing urine from prostatic enlargement to ask a doctor first; it tells users to stop for nervousness, dizziness or sleeplessness, or if symptoms persist beyond seven days or occur with fever. Since March 2024 the European Union contraindicates it in severe or uncontrolled hypertension and in severe acute or chronic kidney disease, after a review of posterior reversible encephalopathy syndrome and reversible cerebral vasoconstriction syndrome.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
FDA. Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products — proposed order OTC000036 removing oral… · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral tablet, extended-release tablet and liquid, sold from behind the pharmacy counter
✎ 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
Immediate-release preparations produced larger blood pressure rises than extended-release in the pooled analysis. Purchase requires photographic identification and a logbook entry, with daily and monthly quantity limits.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
396 products list this as an active ingredient in the United States drug directory. 105 of them contain it and nothing else.
FDA National Drug Code directory · 72162-1123 · read 2026-08-29
They are sold as capsule, capsule, gelatin coated, capsule, liquid filled, liquid, powder and solution, taken oral.
FDA National Drug Code directory · 72162-1123 · read 2026-08-29
The regulator's established pharmacologic class for it is adrenergic alpha-agonists [moa] and alpha-adrenergic agonist [epc].
FDA National Drug Code directory · 72162-1123 · read 2026-08-29
345 published labels name it as an active ingredient. 85 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 2521ecd3-28f3-a13c-e063-6394a90a7245 · read 2026-08-29
Those labels are classed as human otc drug and human prescription drug.
US prescribing information · 2521ecd3-28f3-a13c-e063-6394a90a7245 · read 2026-08-29
480 marketed supplement labels list this ingredient, classed as botanical, fat/fatty acid, non-nutrient/non-botanical and other combinations.
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.
SUDOGEST NASAL DECONGESTANT is oral at HOW SUPPLIED Product: 50090-4345 NDC: 50090-4345-1 1 TABLET, FILM COATED in a BLISTER PACK / 24 in a CARTON, recorded as fda label in effect 2024-11-07 in the United States.
US prescribing information · 09feb5f0-c22d-4a1b-97a0-d5767e5f7730 · read 2026-08-30
Recorded price in US: 0.07797–0.07845 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 3 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.
Evidence on this page does not automatically apply to this one.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Pseudoephedrine studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That the effect measured in adults applies to children — fourteen of fifteen trials enrolled adults only and the reviewers say it is undetermined
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the small standardised mean difference is a difference a patient would call worthwhile — no minimal clinically important difference is defined for this outcome
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the drug is dangerous to blood pressure in the way its reputation suggests — the pooled systolic rise is about one millimetre of mercury
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the open-shelf product that replaced it did the same job — the FDA has proposed removing oral phenylephrine as not effective
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Pseudoephedrine are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
A small effect on congestion, from evidence Cochrane graded low quality
In plain words
Pooling the randomised trials, taking repeated doses gave a modest improvement in how blocked people said their nose felt, about three hours after the last dose. The reviewers described the size as small and said they could not tell whether it was clinically meaningful.
What was measured
Standardised mean difference in subjective nasal congestion, multiple doses against placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Cochrane review of nasal decongestants in monotherapy for the common cold included 15 trials with 1,838 participants, nine of them using pseudoephedrine. For multiple doses against placebo, subjective congestion was significantly better in the treatment group approximately three hours after the last dose, standardised mean difference 0.49 (95% CI 0.07 to 0.92, p=0.02), graded low-quality evidence. That pooling rested on two studies only, one oral and one topical, so oral and topical effects could not be separated. For single doses, the ten available trials measured and reported congestion so diversely that no pooling was possible at all, and the authors drew no conclusion. There is no defined minimal clinically important difference for subjective congestion, so the reviewers used the standardised mean difference itself as the yardstick and classed 0.49 as small.
Written into the record, not signed off as a reviewed claim
The replacement it was pushed aside for is now proposed for removal as not effective
In plain words
Because the drug can be cooked into methamphetamine, a 2005 law moved it behind the pharmacy counter. Manufacturers reformulated the open-shelf products around phenylephrine instead. In 2024 the FDA proposed taking oral phenylephrine out of the rulebook altogether, on the ground that it does not work.
What was measured
That the open-shelf decongestant which replaced pseudoephedrine was pharmacologically equivalent — the FDA has proposed removing it as not effective, so the practical result of the diversion-control law was to move consumers from a weakly effective drug to an ineffective one
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Combat Methamphetamine Epidemic Act of 2005 was signed in March 2006, and the DEA implemented retail restrictions by interim final rule on 26 September 2006, finalised at 85 FR 68450 on 29 October 2020: identification, logbooks, and daily and monthly quantity limits. Manufacturers responded by substituting oral phenylephrine in open-shelf formulations. On 8 November 2024 the FDA announced proposed administrative order OTC000036 at 89 FR 88787, which if finalised amends Final Administrative Order OTC000026 to remove orally administered phenylephrine hydrochloride and phenylephrine bitartrate in an effervescent dosage as nasal decongestant active ingredients "because they are not effective." Pseudoephedrine was not part of that action. As of this audit the phenylephrine order is proposed and not final.
Source
FDA, Amending Over-the-Counter Monograph M012, proposed order OTC000036, 89 FR 88787, 8 November 2024; DEA, Implementation of the Combat Methamphetamine Epidemic Act of 2005; Retail Sales, 85 FR 68450, 29 October 2020
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The blood pressure effect is real, and much smaller than its reputation
In plain words
People are routinely told to avoid this drug if their blood pressure is high. Pooling 24 randomised trials, the average rise in the top blood pressure number was about one point, and the pulse rose by under three beats a minute. In people whose high blood pressure was controlled, the rise was the same size.
What was measured
Weighted mean difference in systolic and diastolic blood pressure and heart rate against placebo across 45 treatment arms
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
A meta-analysis of English-language randomised placebo-controlled trials of oral pseudoephedrine in adults found 24 trials with extractable vital signs, comprising 45 treatment arms and 1,285 patients. Random-effects weighted mean differences were: systolic blood pressure +0.99 mm Hg (95% CI 0.08 to 1.90), heart rate +2.83 beats per minute (95% CI 2.0 to 3.6), diastolic blood pressure +0.63 mm Hg (95% CI -0.10 to 1.35, not significant). In patients with controlled hypertension the systolic rise was of similar magnitude, +1.20 mm Hg (95% CI 0.56 to 1.84). Higher doses and immediate-release preparations produced greater rises; shorter duration of use was associated with greater increases; studies with more women showed less effect.
Written into the record, not signed off as a reviewed claim
Europe added outright contraindications in 2024 for two brain blood-flow syndromes
In plain words
European regulators reviewed reports of two rare conditions in which blood flow to the brain is disturbed, and concluded the drug can cause them. They banned its use in severe or uncontrolled high blood pressure and in severe kidney disease, and told patients which symptoms mean stop immediately.
What was measured
Regulatory risk assessment outcome — new contraindications and warning symptoms
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee reviewed pseudoephedrine-containing medicines and recommended new measures on 30 November 2023; the CHMP endorsed them on 25 January 2024 and the European Commission issued its decision in March 2024. The risks identified were posterior reversible encephalopathy syndrome and reversible cerebral vasoconstriction syndrome, both involving reduced blood supply to the brain with potentially life-threatening complications, described as rare and usually resolving with prompt treatment. The medicines are now contraindicated in severe or uncontrolled hypertension and in severe acute or chronic kidney disease or renal failure. Patients are to stop treatment and seek help for sudden severe headache, nausea, vomiting, confusion, seizures or visual disturbance. The United States label carries no equivalent contraindication; it directs people with high blood pressure to ask a doctor before use.
Source
European Medicines Agency, referral procedure on pseudoephedrine-containing medicinal products, PRAC recommendation 30 November 2023, CHMP 25 January 2024, Commission decision March 2024
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Nobody has shown it works in children, and it is sold for them anyway
In plain words
Of the fifteen randomised trials in the systematic review, fourteen enrolled only adults. The reviewers stated plainly that effectiveness and safety in children remain to be determined.
What was measured
That an effect measured almost entirely in adults transfers to children — the systematic review says explicitly that it has not been determined
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Cochrane review reports that fourteen of its fifteen included studies enrolled adults aged 18 and over only, and concludes that the effectiveness and safety of nasal decongestants in children, and the clinical relevance of the small effect seen in adults, are yet to be determined. Separately, the FDA announced in 2011 its intention to take enforcement action against unapproved and misbranded oral prescription-labelled cold, cough and allergy products, noting that many were inappropriately labelled for use in infants and young children (76 FR 11794).
Written into the record, not signed off as a reviewed claim
Short-term adverse events were no more common than on placebo
In plain words
Across the trials that recorded them, side effects happened about as often on the drug as on the dummy. Roughly one person in eight reported something in each group.
What was measured
Pooled odds ratio for adverse events, decongestant against placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Seven of the fifteen Cochrane-included trials recorded adverse events, six with an oral decongestant and one topical. Meta-analysis found no statistical difference between groups: 125 events per 1,000 in the treatment group against 126 per 1,000 on placebo, odds ratio 0.98 (95% CI 0.68 to 1.40, p=0.90), graded low-quality evidence. Restricting to oral decongestants only gave an odds ratio of 0.95 (95% CI 0.65 to 1.39, p=0.80). These are short-term data in adults; they say nothing about the rare neurological events that prompted the European contraindications, which no trial of this size and duration could detect.
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What is not here
7 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.
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.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A mixed-acting sympathomimetic that constricts the swollen blood spaces in the nasal lining, mostly by releasing the body’s own noradrenaline — the pooled randomised evidence gives a standardised mean difference of 0.49 (95% CI 0.07 to 0.92) for multiple doses against placebo, which the Cochrane authors called a small effect of unknown clinical relevance, and a meta-analysis of 24 trials in 1,285 patients puts its effect on systolic blood pressure at 0.99 mm Hg and on heart rate at 2.83 beats per minute.
Recorded evidence blocks (7)
Q1
On the Pseudoephedrine label: indicated for what?
"Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure": indications and usage on Pseudoephedrine's label. DailyMed label · 1fdb1ba5-4072-4baf-9e30-f01d57bf6d82 · 2026-08-15
Q2
31 registered trials of Pseudoephedrine — at which phases?
Registered studies posting no result
22 of 31
31 registered studies of Pseudoephedrine: 7 na, 7 phase1, 7 phase3, 5 phase4, 3 phase2, 1 early phase1, 1 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01
Human studies of Pseudoephedrine used Pseudoephedrine 120 mg — over how long?
Human studies of Pseudoephedrine used "Pseudoephedrine 120 mg". ClinicalTrials.gov · 2026-09-01
5 recorded entries; human; also "pseudoephedrine hydrochloride 30 mg tablets", "Pseudoephedrine + 480 ml water", "Pseudoephedrine + 50 ml water"
Show the evidence
human
NCT00648973
Pseudoephedrine 120 mg
NCT01744106
pseudoephedrine hydrochloride 30 mg tablets
NCT02149901
Pseudoephedrine + 480 ml water
NCT02149901
Pseudoephedrine + 50 ml water
NCT04332211
Pseudoephedrine 60 MG
recorded 2026-09-01 · last checked 2026-09-04
Q5
Which 15 trials of Pseudoephedrine posted no result?
Posted no result
15 of 15 completed trials
Registrations
NCT00334698, NCT00517946, NCT00648973, NCT01062360, NCT00378144 and NCT00673062, and 9 more
Completion dates
oldest 2006-09; newest 2023-04-04
Show the evidence
Trial
NCT00334698
2006-09
NCT00517946
2007-04
NCT00648973
2007-05
NCT01062360
2007-05-14
NCT00378144
2008-03
NCT00673062
2008-07
9 further recorded trials
NCT01306721
2011-04
NCT00963443
2012-03
NCT01744106
2016-04
NCT00179023
2017-01
NCT00223691
2017-01
NCT03644576
2018-09-12
NCT01925729
2019-03-22
NCT04682184
2021-03-25
NCT05692869
2023-04-04
Q6
At the median, Pseudoephedrine's trials enrolled 66 people — anything larger?
Median enrolment
66
Largest enrolment
1179
Registered trials counted
31
Q7
What do 11261 spontaneous reports say about Pseudoephedrine — 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.
Pseudoephedrine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 11261 reaction mentions were counted: pain 1252; abdominal discomfort 1245; alopecia 1223; pemphigus 1201. FAERS via Open Targets · CHEMBL1200724 · 2026-06-24
Show the evidence
pain
1252
abdominal discomfort
1245
alopecia
1223
pemphigus
1201
systemic lupus erythematosus
1191
rheumatoid arthritis
1171
4 more recorded rows
fatigue
1019
glossodynia
1019
swelling
990
hand deformity
950
recorded 2026-06-24 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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
✗ 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
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.