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Desloratadine

  • 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 Desloratadine does in the body

The nasal and non-nasal symptoms of seasonal allergic rhinitis

From the FDA-approved label: Desloratadine is a long-acting tricyclic histamine antagonist with selective H 1 -receptor histamine antagonist activity. Receptor binding data indicates that at a concentration of 2 to 3 ng/mL (7 nanomolar), desloratadine shows significant interaction with the human histamine H 1 -receptor. Desloratadine inhibited histamine release from human mast cells in vitro . Results of a radiolabeled tissue distribution study in rats and a radioligand H 1 -receptor binding study in guinea pigs showed that desloratadine did not readily cross the blood brain barrier. The clinical significance of this finding is unknown.

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 · FVF865388R · read 2026-08-29

  • Its recorded molecular formula is C19H19ClN2, weighing 310.8.

    US prescribing information · cf7f838b-4595-4c81-97b9-e1594347e1bd · read 2026-08-30

Where each sentence above came from

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

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 117 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.

Mean Pruritus Severity Score Over the First Week of Treatment

The study did not show it

Who was studied
NCT00264303
How many people
886
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

RCSMS : Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score

The study did not show it

Who was studied
NCT07348302
How many people
736
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

Mean change from baseline of T4SS (four symptoms score) over two weeks of treatment

The study did not show it

Who was studied
NCT00160589
How many people
729
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

Compare the efficacy of the study treatments with respect to the change from Baseline in the mean AM self-rated instantaneous total symptom score (TSS) (not including nasal congestion) averaged over the 15 days of treatment

The study did not show it

Who was studied
NCT00783146
How many people
728
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

Compare the efficacy of the study treatments with respect to the change from Baseline in the mean AM self-rated instantaneous total symptom score (TSS) (not including nasal congestion) averaged over the 15 days of treatment

The study did not show it

Who was studied
NCT00783211
How many people
722
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

AUC of TSS

The study did not show it

Who was studied
NCT01108783
How many people
720
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
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.

  • Desloratadine Oral Solution is a histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older. (1.1) Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 6 months of age and older.

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 recommended dose of Desloratadine Oral Solution in the pediatric population is based on cross-study comparison of the plasma concentration of Desloratadine in adults and pediatric subjects.”

    US prescribing information · cf7f838b-4595-4c81-97b9-e1594347e1bd · read 2026-08-30

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

    US prescribing information · cf7f838b-4595-4c81-97b9-e1594347e1bd · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary The limited available data with Desloratadine in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage.”

    US prescribing information · cf7f838b-4595-4c81-97b9-e1594347e1bd · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Desloratadine passes into breast milk.”

    US prescribing information · cf7f838b-4595-4c81-97b9-e1594347e1bd · read 2026-08-30

  • On people with reduced liver function, the label states: “Dosage adjustment for patients with hepatic impairment is recommended [ see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ].”

    US prescribing information · cf7f838b-4595-4c81-97b9-e1594347e1bd · read 2026-08-30

  • On people with reduced kidney function, the label states: “Dosage adjustment for patients with renal impairment is recommended [ see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ].”

    US prescribing information · cf7f838b-4595-4c81-97b9-e1594347e1bd · 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, tablet, extended release, tablet, tablet, orally disintegrating, given by the oral, oral 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

  • 26 products list this as an active ingredient in the United States drug directory. 25 of them contain it and nothing else.

    FDA National Drug Code directory · 52408-0130 · read 2026-08-29

  • They are sold as powder, solution, tablet, tablet, extended release, tablet, film coated and tablet, orally disintegrating, taken oral.

    FDA National Drug Code directory · 52408-0130 · read 2026-08-29

  • The regulator's established pharmacologic class for it is histamine h1 receptor antagonists [moa] and histamine-1 receptor antagonist [epc].

    FDA National Drug Code directory · 52408-0130 · read 2026-08-29

  • 13 published labels name it as an active ingredient. 12 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 4d094001-b85a-47b3-bc67-a46660384ece · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 4d094001-b85a-47b3-bc67-a46660384ece · read 2026-08-29

  • Desloratadine is oral at 3 DOSAGE FORMS AND STRENGTHS Desloratadine Tablets are light blue round tablets debossed with "5" containing 5 mg desloratadine. • Desloratadine Tablets - 5 mg ( 3 ), recorded as fda label in effect 2025-11-06 in the United States.

    US prescribing information · cf7f838b-4595-4c81-97b9-e1594347e1bd · read 2026-08-30

  • Recorded price in US: 0.25526–4.78821 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 6 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 Desloratadine 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 Desloratadine 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

  • 13 documents were read for this substance.

    RNAWiki source record

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

    RNAWiki source record

  • 12 of them state the same tMax, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
FVF865388R
RxNorm concept
349420

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.

What the approval register records

  • 22 approved applications cover products containing this substance. The earliest was NDA021165, approved 20011221 to ORGANON.

    Drugs@FDA application register · NDA021165 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA021165 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20011221.

    FDA National Drug Code directory · 52408-0130 · 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 Desloratadine label: indicated for what?


"Desloratadine tablets are histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. ( 1.1 ) Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older.": indications and usage on Desloratadine's label. DailyMed label · 2a90b899-7746-43dc-ac8a-e754428eb30c · 2026-06-30

60 registered trials of Desloratadine — at which phases?


Registered studies posting no result
48 of 60

60 registered studies of Desloratadine: 26 phase4, 18 phase3, 7 phase2, 4 phase1, 3 na, 3 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

167 with a PubMed record

Show the evidence
  • phase4
    26
  • phase3
    18
  • phase2
    7
  • phase1
    4
  • na
    3
  • na or unstated
    3
6 more recorded rows
  • completed
    51
  • recruiting
    3
  • unknown
    3
  • not yet recruiting
    1
  • suspended
    1
  • terminated
    1

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

2 of Desloratadine's trials stopped: other?


other (2): Desloratadine's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Study could not be re-supplied with study medication in a timely manner."; 2 of 60 registered studies

Show the evidence

Trial

  • NCT00751166
    terminated; "Study could not be re-supplied with study medication in a timely manner."
  • NCT00967967
    suspended; "Awaiting results from sub analysis to decide if study continuesé"

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

Human studies of Desloratadine used Desloratadine 5 mg — over how long?


Human studies of Desloratadine used "Desloratadine 5 mg". ClinicalTrials.gov · 2026-09-01

8 recorded entries; human; also "desloratadine 5 mg", "Desloratadine 5 mg (Clarinex)", "Desloratadine 2.5 mg"

Show the evidence

human

  • NCT00783133
    Desloratadine 5 mg
  • NCT00794248
    desloratadine 5 mg
  • NCT00794495
    Desloratadine 5 mg (Clarinex)
  • NCT00816972
    Desloratadine 2.5 mg
  • NCT00816972
    Placebo for Desloratadine 2.5 mg
  • NCT01314339
    Clarinex® 5 mg
2 more recorded rows
  • human NCT01506037
    Clarinex ODT 5 mg
  • human NCT06217367
    5 mg Desloratadine

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

Desloratadine's half-life is 50 hours — which schedules were studied?


50 hours, the half-life Desloratadine's label states: "In pharmacokinetic studies (n=3748), approximately 6% of subjects were poor metabolizers of desloratadine (defined as a subject with an AUC ratio of 3-hydroxydesloratadine to desloratadine less than 0.1, or a subject with a desloratadine half-life exceeding 50 hours)." DailyMed label · 2a90b899-7746-43dc-ac8a-e754428eb30c · 2026-06-30

tmax 10 days.

Show the evidence
  • half life clinical_pharmacology
    50 hours; In pharmacokinetic studies (n=3748), approximately 6% of subjects were poor metabolizers of desloratadine (defined as a subject with an AUC ratio of 3-hydroxydesloratadine to desloratadine less than 0.1, or a subject with a desloratadine half-life exceeding 50 hours).
  • tmax pharmacokinetics
    10 days; Absorption Following oral administration of a desloratadine 5 mg tablet once daily for 10 days to normal healthy volunteers, the mean time to maximum plasma concentrations (T max ) occurred at approximately 3 hours post dose and mean steady state peak plasma concentrations (C max ) and AUC of 4 ng/mL and 56.9 ng∙hr/mL were observed, respectively.
  • metabolism clinical_pharmacology
    Metabolism Desloratadine (a major metabolite of loratadine) is extensively metabolized to 3-hydroxydesloratadine, an active metabolite, which is subsequently glucuronidated.

recorded 2026-06-30 · last checked 2026-09-04

Which 36 trials of Desloratadine posted no result?


Posted no result
36 of 36 completed trials
Registrations
NCT00867191, NCT00794248, NCT00794846, NCT00805584, NCT00783133 and NCT00794495, and 30 more
Completion dates
oldest 2003-04-01; newest 2020-12-01
Show the evidence

Trial

  • NCT00867191
    2003-04-01
  • NCT00794248
    2003-05
  • NCT00794846
    2003-05
  • NCT00805584
    2003-06
  • NCT00783133
    2003-06-01
  • NCT00794495
    2003-07
14 further recorded trials
  • NCT00794768
    2003-07
  • NCT00817076
    2003-07
  • NCT00794599
    2003-08
  • NCT00805324
    2003-08
  • NCT00757562
    2003-10-01
  • NCT00795158
    2004-01
  • NCT01108783
    2004-02
  • NCT00783354
    2004-04-01
  • NCT00789152
    2004-05-01
  • NCT00783146
    2004-10-01
  • NCT00783211
    2004-10-01
  • NCT00794378
    2004-11
  • NCT00794794
    2004-11
  • NCT00779636
    2004-11-01

At the median, Desloratadine's trials enrolled 120 people — anything larger?


Median enrolment
120
Largest enrolment
3011
Registered trials counted
60

What do 483 spontaneous reports say about Desloratadine — 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.

Desloratadine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 483 reaction mentions were counted: somnolence 81; urticaria 71; angioedema 67; tachycardia 48. FAERS via Open Targets · CHEMBL1172 · 2026-06-24

Show the evidence
  • somnolence
    81
  • urticaria
    71
  • angioedema
    67
  • tachycardia
    48
  • suicide attempt
    38
  • aggression
    37
4 more recorded rows
  • electrocardiogram qt prolonged
    37
  • hepatocellular injury
    35
  • rash maculo-papular
    35
  • eosinophilia
    34

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

Which 10 reactions does Desloratadine's label not list?


aggression, angioedema and electrocardiogram qt prolonged and 7 more reported for Desloratadine, absent from its label. FAERS via Open Targets · CHEMBL1172 · 2026-06-24

2 label terms; 10 reported and unlisted; 2a90b899-7746-43dc-ac8a-e754428eb30c

Show the evidence
  • aggression
    count not stated
  • angioedema
    count not stated
  • electrocardiogram qt prolonged
    count not stated
  • eosinophilia
    count not stated
  • hepatocellular injury
    count not stated
  • rash maculo-papular
    count not stated
4 more recorded rows
  • somnolence
    count not stated
  • suicide attempt
    count not stated
  • tachycardia
    count not stated
  • urticaria
    count not stated

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1172
PubChem CID
124087
CAS number
100643-71-8
RxCUI
275635
InChIKey
JAUOIFJMECXRGI-UHFFFAOYSA-N
Trade name
Aerius, Clarinex, Desloratadine component of clarinex-d, Desloratadine ratiopharm, Midetorin, Neoclarityn, Aerinaze
Also called
Allex, Azomyr, Dasselta, Denosin, Descarboethoxyloratadine, Desloratadina, Desloratadine actavis, Desloratadine teva, Loratadine related compound a, Loratadine related compound a rs, Opulis, clarinex 5 mg
Development code
NSC-759824, SCH 34117
Salt form
Desloratadine Oral Solution, Clarinex / Desloratadine Oral Solution
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · 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

How these records are assembled · Which registers were checked

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

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