Treprostinil: uses, dosing, side effects & brands
Treprostinil is a prostacycline vasodilator sold in the U.S. under 5 brand and generic names, for pulmonary hypertension. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Prostacycline Vasodilator
- Treats (across its forms)
- Pulmonary Hypertension
- Available as
- Injectable · Solution · Spray/Inhaler · Kit · Capsule
- Sold as
- 5 products — Treprostinil, Remodulin and Tyvaso, and others
- Prescription?
- Prescription only
- Generic available?
- Yes
How Treprostinil is dosed
From the FDA label for Treprostinil (application ANDA203649). Other treprostinil products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
PAH WHO Group 1 in patients with NYHA Class II-IV symptoms: • Initial dose for patients new to prostacyclin infusion therapy: 1.25 ng/kg/min; increase based on clinical response (increments of 1.25 ng/kg/min per week for the first 4 weeks of treatment, later 2.5 ng/kg/min per week). Avoid abrupt cessation. ( 2.2 , 2.4 ) • Mild to moderate hepatic insufficiency: Decrease initial dose to 0.625 ng/kg/min. Severe hepatic insufficiency: No studies performed. ( 2.5 ) Transition from Epoprostenol: Increase the treprostinil injection dose gradually as the epoprostenol dose is decreased, based on constant observation of response. ( 2.7 ) Administration: Continuous subcutaneous infusion is the preferred mode. Use intravenous (IV) infusion if subcutaneous infusion is not tolerated. ( 2.1 , 2.6 ) 2.1 General Treprostinil injection can be administered with or without further dilution with Sterile Diluent for treprostinil or similar approved high-pH glycine diluent (e.g., Sterile Diluent for Flolan or Sterile Diluent for Epoprostenol), Sterile Water for Injection, or 0.9% Sodium Chloride Injection prior to administration. See Table 1 below for storage and administration time limits for the different diluents. Diluted treprostinil injection has been shown to be stable at ambient temperature when stored for up to 14 days using high-pH glycine diluent at concentrations as low as 0.004 mg/mL…
Everything below is the FDA label for Treprostinil (injectable, solution). Treprostinil is also sold as spray/inhaler, kit and capsule, and those are different medicines to take — follow the label for the one you were prescribed.
Treprostinil side effects
The following adverse reactions are discussed elsewhere in labeling: Infections associated with intravenous administration [see Warnings and Precautions ( 5.1 )] . Most common adverse reactions (incidence >3%) reported in clinical studies with treprostinil injection: subcutaneous infusion site pain and reaction, headache, diarrhea, nausea, jaw pain, vasodilatation, edema, and hypotension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Events with Subcutaneously Administered Treprostinil Injection Patients receiving treprostinil injection as a subcutaneous infusion reported a wide range of adverse events, many potentially related to the underlying disease (dyspnea, fatigue, chest pain, right ventricular heart failure, and pallor). During clinical trials with subcutaneous infusion of treprostinil injection, infusion site pain and reaction were the most common adverse events among those treated with treprostinil injection. Infusion site reaction was defined as any local adverse event other…
Who shouldn’t take Treprostinil
None None
Treprostinil drug interactions
Treprostinil injection dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn. ( 7.1 ) 7.1 Effect of CYP2C8 Inhibitors and Inducers on Treprostinil Dose adjustment of treprostinil may be necessary when co-administered with CYP2C8 inducers or inhibitors. 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. Co-administration of the CYP2C8 enzyme inducer rifampin decreases exposure to treprostinil. It has not been determined if the changes in exposure of treprostinil with inhibitors or inducers of CYP2C8 observed for the oral administration of treprostinil would be similar for treprostinil administered via the parenteral route [see Clinical Pharmacology ( 12.3 )].
Every treprostinil product we track (5)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 68/100 | Prescription | Injectable | No data | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | No data | — | View → | |
| 3 | Not yet rated | Prescription | Spray/Inhaler | No data | — | View → | |
| 4 | Not yet rated | Prescription | Spray/Inhaler | No data | — | View → | |
| 5 | Not yet rated | Prescription | Capsule | No data | — | View → |
What treprostinil pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| LIQUIDIA;26;5 | 26.5 ug | yellow | capsule | — |
| LIQUIDIA;53 | 53 ug | green | capsule | — |
| LIQUIDIA;79;5 | 79.5 ug | blue | capsule | — |
| LIQUIDIA;106 | 106 ug | purple | capsule | — |
Treprostinil recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Can you crush or split treprostinil?
At least one treprostinilproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each treprostinil label says about crushing, splitting and chewingHow long treprostinil keeps
The date on a sealed pack is not the only one: some treprostinil labels start a second clock once the product is opened or mixed, as short as 3 days.
Does treprostinil expire? The in-use limits and storage rules from its labelsTreprostinil and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for treprostinil: levels in milk, effects in breastfed infants, and the drugs it would consider insteadThe amount of treprostinil in milk appears to be low and it is not well absorbed orally. Two infants have been breastfed during maternal treprostinil therapy, one infant for one year, without any complications. However, until more data are available, treprostinil should be used with careful infant monitoring during breastfeeding.
National Institute of Child Health and Human Development, record revised May 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about treprostinil
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 11,339 reports naming treprostinil, and the FDA flagged 76% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- dyspnoea1,957 reports
- headache1,772 reports
- diarrhoea1,588 reports
- nausea1,337 reports
- fatigue1,013 reports
- dizziness999 reports
- cough889 reports
- hypotension824 reports
Read these as a signal, not a rate. A report does not mean treprostinil caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 26, 2026.
Related calculators
Frequently asked questions
What is Treprostinil?
Treprostinil injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Treprostinil injection is supplied in 20 mL multi-dose vials in four strengths, containing 20 mg, 50 mg, 100 mg, or 200 mg (1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL strength which contains 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2.
What kind of drug is treprostinil?
The FDA classifies treprostinil as a prostacycline vasodilator. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take treprostinil with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run treprostinil against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is treprostinil sold under?
We track 5 treprostinil-containing products in the U.S.: Treprostinil, Remodulin, Tyvaso, Tyvaso Dpi and Yutrepia. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does treprostinil come in?
Across the brands we track, treprostinil is currently marketed as injectable, solution, spray/inhaler, kit and capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic treprostinil?
Yes. Our catalog lists 1 generic treprostinil product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has treprostinil been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions treprostinil. The most recent: Treprostinil Injection (Mar 4, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Treprostinil: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/treprostinil
- MLA
- “Treprostinil: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/treprostinil.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for treprostinil on DailyMed (NIH) ↗.