This page shows what was measured, who it was measured in, and what that does not settle.
What Treprostinil does in the body
Orenitram is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): To delay disease progression and to improve exercise capacity.
The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds, inhibition of platelet aggregation, and inhibition of smooth muscle cell proliferation.
Why people take it. Orenitram is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): To delay disease progression and to improve exercise capacity.
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 · H1FKG90039 · read 2026-08-29
Its recorded molecular formula is C23H34O5∙C4H11NO2, weighing 495.65.
US prescribing information · 8ed2003a-c801-411e-831e-d06079bb0d7c · read 2026-08-30
Where each sentence above came from
The use the label states, quoted from it. No plain-language version of this sentence has been written.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 90 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 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.
Change in Exercise Capacity at Month 12
✗ The study did not show it
Who was studied
NCT01027949
How many people
894
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
What a body can do day to day
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.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · a recorded source, not a stored snapshot
Time to First Clinical Worsening Event
✗ The study did not show it
Who was studied
NCT01560624
How many people
690
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.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · a recorded source, not a stored snapshot
Number of Adverse Events
✗ The study did not show it
Who was studied
NCT01560637
How many people
471
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.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · a recorded source, not a stored snapshot
6-minute Walk Distance (6MWD)
✗ The study did not show it
Who was studied
NCT00887978
How many people
310
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.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · a recorded source, not a stored snapshot
Change in 6MWD From Baseline to Week 24
✗ The study did not show it
Who was studied
NCT03037580
How many people
84
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.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · a recorded source, not a stored snapshot
Long-term Safety of Oral Treprostinil in Subjects With PH Associated With HFpEF for Subjects Who Completed Study TDE-HF-301
✗ The study did not show it
Who was studied
NCT03043651
How many people
48
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.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · 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 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
No description of who was studied is recorded.
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: “Safety and effectiveness in pediatric patients have not been established.”
US prescribing information · 8ed2003a-c801-411e-831e-d06079bb0d7c · read 2026-08-30
On older people, the label states: “Use of Orenitram in patients aged 65 years and over demonstrated slightly higher absolute and relative adverse event rates compared to younger patients.”
US prescribing information · 8ed2003a-c801-411e-831e-d06079bb0d7c · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Limited published data from case reports with Orenitram use in pregnant women are not sufficient to assess for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.”
US prescribing information · 8ed2003a-c801-411e-831e-d06079bb0d7c · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · 8ed2003a-c801-411e-831e-d06079bb0d7c · 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 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.
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 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
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No form or route is recorded.
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
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing is recorded about product quality.
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∅Nothing 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 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
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
The exact form studied is not recorded.
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
6 products list this as an active ingredient in the United States drug directory. 6 of them contain it and nothing else.
FDA National Drug Code directory · 83511-013 · read 2026-08-29
They are sold as powder.
FDA National Drug Code directory · 83511-013 · read 2026-08-29
Orenitram is oral at 3 DOSAGE FORMS AND STRENGTHS Orenitram (treprostinil) extended-release tablets are available in the following five strengths: - 0.125 mg [White tablet imprinted with UT 0.125] - 0.25 mg [Green tablet imprinted with UT 0…, recorded as fda label in effect 2024-11-20 in the United States.
US prescribing information · 8ed2003a-c801-411e-831e-d06079bb0d7c · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to 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 Treprostinil 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
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 Treprostinil 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.
Where else this substance is registered
FDA substance identifier (UNII)
H1FKG90039
CAS registry number
830354-48-8
PubChem compound
11179459
ChEMBL
CHEMBL1237119
RxNorm concept
1927409
EMA substance identifier
100000137549
DrugBank
DBSALT001333
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: Quoted from a stored source.
✗ 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 unclear◇Read 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
1 approved application covers products containing this substance. The earliest was NDA203496, approved 20131220 to UNITED THERAP.
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.
"Study closed due to limited availability of eligible subjects and competition by for enrollment by other studies"; 21 of 79 registered studies
Show the evidence
Trial
NCT00439946
terminated; "Study closed due to limited availability of eligible subjects and competition by for enrollment by other studies"
NCT00458042
terminated; "Low Enrollment"
NCT00494533
terminated; "Safety issues related to outpatient intravenous infusion in India"
NCT00643604
terminated; "Due to availability of eligible subjects at center and enrollment competition with other studies."
NCT00760916
withdrawn; "Study stopped prior to subject enrollment."
NCT01980979
withdrawn; "slow enrollment"
14 further recorded trials
NCT02178566
terminated; "Unable to enroll"
NCT02261883
terminated; "Sponsor Decision"
NCT02498444
terminated; "Interim futility analysis"
NCT02603068
withdrawn; "Study design was inadequate and would not achieve study endpoints"
NCT02633293
terminated; "Inhaled treprostinil became commercially available in the US following its approval for PH-ILD"
NCT02769624
terminated; "Study was stopped early due to inability to recruit additional participants"
NCT02882126
withdrawn; "Business decision"
NCT02893995
withdrawn; "Business decision"
NCT02999906
withdrawn; "For business reasons."
NCT03012646
withdrawn; "Business decision"
NCT03016468
withdrawn; "Business decision"
NCT03037580
terminated; "Terminated by sponsor"
NCT03043651
terminated; "Terminated by Sponsor"
NCT03055234
withdrawn; "Business decision"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Treprostinil used UT-15C 1 mg — over how long?
Human studies of Treprostinil used "UT-15C 1 mg". ClinicalTrials.gov · 2026-09-01
3 recorded entries; human; also "UT-15C 0.25 mg", "UT-15C 5 mg"
Show the evidence
human
NCT00760916
UT-15C 1 mg
NCT00760916
UT-15C 0.25 mg
NCT00760916
UT-15C 5 mg
recorded 2026-09-01 · last checked 2026-09-04
Q5
Treprostinil's half-life is 4 hours — which schedules were studied?
4 hours, the half-life Treprostinil's label states: "The elimination of treprostinil (following subcutaneous administration of treprostinil) is biphasic, with a terminal elimination half-life of approximately 4 hours using a 2-compartment model." DailyMed label · cbc31ab1-a80f-4b50-a3b1-39910b0fb609 · 2026-04-14
tmax 0.12 hr; bioavailability 64 %.
Show the evidence
half lifepharmacokinetics
4 hours; The elimination of treprostinil (following subcutaneous administration of treprostinil) is biphasic, with a terminal elimination half-life of approximately 4 hours using a 2-compartment model.
tmaxpharmacokinetics
0.12 hr; The mean C max at the target dose was 0.91 and 1.32 ng/mL with corresponding mean T max of 0.25 and 0.12 hr, respectively.
bioavailabilitypharmacokinetics
64 %; Mean estimates of the absolute systemic bioavailability of treprostinil after inhalation were approximately 64% (18 mcg) and 72% (36 mcg).
metabolismpharmacokinetics
Metabolism and Excretion Of subcutaneously administered treprostinil, only 4% is excreted unchanged in urine.
recorded 2026-04-14 · last checked 2026-09-04
Q6
Which running trial of Treprostinil could settle function?
NCT07285655 measures Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT), reading out 2031-12.
2 open trials; n 344; "A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD"
Show the evidence
Trial
NCT07285655
"A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD"; n 344; "Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)"; 2031-12
NCT07736846
"TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends"; n 300; "Mean Change From Baseline in 6-Minute Walk Distance at Month 12"; 2031-12
Q7
Which 14 trials of Treprostinil posted no result?
Posted no result
14 of 14 completed trials
Registrations
NCT00004497, NCT00058929, NCT00963027, NCT00963001, NCT01153386 and NCT01082484, and 8 more
Completion dates
oldest 2000-09; newest 2021-12-31
Show the evidence
Trial
NCT00004497
2000-09
NCT00058929
2005-08
NCT00963027
2009-10
NCT00963001
2009-11
NCT01153386
2010-08
NCT01082484
2011-01
8 further recorded trials
NCT01746485
2012-07
NCT02318758
2014-12
NCT06193031
2015-12-18
NCT01758744
2016-07
NCT04675944
2018-05-25
NCT02865733
2019-08-20
NCT01481974
2019-11-24
NCT02583789
2021-12-31
Q8
At the median, Treprostinil's trials enrolled 30 people — anything larger?
Median enrolment
30
Largest enrolment
1850
Registered trials counted
77
Q9
What do 18391 spontaneous reports say about Treprostinil — 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.
Treprostinil appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 18391 reaction mentions were counted: dyspnoea 3508; headache 2715; nausea 2374; diarrhoea 2303. FAERS via Open Targets · CHEMBL1237119 · 2026-06-24
Show the evidence
dyspnoea
3508
headache
2715
nausea
2374
diarrhoea
2303
dizziness
1449
fatigue
1411
4 more recorded rows
cough
1276
vomiting
1245
infusion site pain
1106
malaise
1004
recorded 2026-06-24 · last checked 2026-09-04
Q10
Which 10 reactions does Treprostinil's label not list?
7.3 Effect of Cytochrome P450 Inhibitors and Inducers In vitro studies of human hepatic microsomes showed that treprostinil does not inhibit cytochrome P450 (CYP) isoenzymes CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A.
drug_interactions
Additionally, treprostinil does not induce cytochrome P450 isoenzymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A.
drug_interactions
Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor, gemfibrozil, increases exposure (both C max and AUC) to treprostinil.
drug_interactions
Co-administration of the CYP2C8 enzyme inducer, rifampin, decreases exposure to treprostinil.
drug_interactions
It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8 [see Warnings and Precautions (5.3) ] .
pharmacokinetics
Treprostinil is substantially metabolized by the liver, primarily by CYP2C8.
1 more recorded row
Interaction statementclinical_pharmacology
Treprostinil is substantially metabolized by the liver, primarily by CYP2C8.
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
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