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Treprostinil

Treprostinil is a prostacyclin-based medicine used to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), available in inhaled, oral, and injectable forms.

Brand names OrenitramTyvasoRemodulinYutrepiaTyvaso DPI +1 more
Drug class Prostacycline Vasodilator
Rx Forms 3
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 5 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Other forms & routes:
Injection Oral inhalation
Treprostinil at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Treprostinil is a specialist drug for pulmonary arterial hypertension (high blood pressure in the lung arteries) and, in inhaled form, pulmonary hypertension from interstitial lung disease. It widens lung blood vessels and slows platelet clumping, has been on the market since about 2002, is available as a generic, and is often added when other PAH medicines are not enough. Side effects are common, especially while the dose is being built up, with headache, flushing, jaw pain and diarrhea leading the list. Never stop it or cut the dose suddenly, since PAH can worsen fast and dangerously, and with IV (into the vein) infusion treat any fever or chills as a possible bloodstream infection.

Clinical pearls

  • Swallow Orenitram tablets whole with food, and never crush, split or chew them.
  • Make sure every prescriber knows about it, because gemfibrozil can raise treprostinil levels and rifampin can lower them.
  • Pain at an under-the-skin infusion site is common, so report it to your PAH team rather than pausing the pump.
  • Because it blunts platelet clumping, mention it before surgery or dental work, and if you also take warfarin.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asInjection, Inhaler, Extended-release tablet
Earliest FDA record2002
Companies listing it with the FDA6
FDA label last updatedApr 6, 2023
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Treprostinil, written from its FDA label.

What Treprostinil is used for

▾

Treprostinil is approved for use across several products and routes. Here is the full set of supported indications:

  • Pulmonary arterial hypertension (PAH; WHO Group 1) — improving exercise ability: Supported by Tyvaso, Tyvaso DPI, Yutrepia (inhaled), and treprostinil injection / Remodulin (subcutaneous or IV)
  • PAH (WHO Group 1) — delaying disease progression and improving exercise capacity: Orenitram (extended-release oral tablet) only
  • PAH (WHO Group 1) — transitioning patients from epoprostenol: Treprostinil injection and Remodulin only
  • Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) — improving exercise ability: Tyvaso, Tyvaso DPI, and Yutrepia (inhaled forms) only

How Treprostinil works

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Treprostinil mimics a natural substance in the body called prostacyclin. It works by directly relaxing and widening the blood vessels in the lungs and throughout the body, which lowers the pressure the heart has to pump against. It also reduces the tendency of platelets (the tiny blood cells that form clots) to clump together, and may help slow the abnormal thickening of blood vessel walls that characterizes PAH.

Treprostinil dosage

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How treprostinil is taken varies significantly by product — always follow your prescriber's specific instructions.

  • Orenitram (tablet): Taken by mouth with food, multiple times per day; tablets must be swallowed whole
  • Tyvaso (inhaled solution): Inhaled using the Tyvaso Inhalation System in 4 sessions per day, spaced about 4 hours apart during waking hours
  • Tyvaso DPI (inhaled powder): Inhaled using the Tyvaso DPI Inhaler in 4 sessions per day, approximately 4 hours apart
  • Yutrepia (inhaled capsule): Inhaled — not swallowed — using the supplied device, 3 to 5 times per day
  • Remodulin / treprostinil injection: Given as a continuous infusion under the skin or into a vein, around the clock; doses are increased gradually

Never stop treprostinil suddenly or miss large portions of your dose without speaking to your doctor first — abrupt changes can be dangerous.

Dosing details from the FDA-approved label

From the Treprostinil prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • PAH WHO Group 1 in patients with NYHA Class II-IV symptoms (new to prostacyclin infusion therapy)
    • Initial dose 1.25 ng/kg/min
    • If not tolerated because of systemic effects, reduce the infusion rate to 0.625 ng/kg/min
    • Increase based on clinical response in increments of 1.25 ng/kg/min per week for the first four weeks of treatment and then 2.5 ng/kg/min per week for the remaining duration of infusion
    • Continuous subcutaneous infusion is preferred
    • Use in
    • Avoid abrupt cessation of infusion
  • Patients transitioning to an implantable intravenous infusion pump
    • The initial dose should be the same as the current dose the patient is receiving using the external infusion pump at the time of transition
  • Patients with mild or moderate hepatic insufficiency
    • Decrease the initial dose to 0.625 ng/kg/min ideal body weight
    • Not studied in severe hepatic insufficiency
  • Transition from epoprostenol
    • Increase the treprostinil injection dose gradually as the epoprostenol dose is decreased, based on constant observation of response
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION 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 injection 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 (4,000 ng/mL). Table 1: Selection of Diluent Diluent Storage Limits Administration Limits None See Section 16 16 weeks at 40°C Sterile Diluents for Treprostinil Injection, Flolan, or Epoprostenol 14 days at room temperature 48 hours at 40°C Sterile Water for Injection 0.9% Sodium Chloride for Injection 4 hours at room temperature or 24 hours refrigerated 48 hours at 40°C 2.2 Initial Dose for Patients New to Prostacyclin Infusion Therapy Treprostinil injection is indicated for subcutaneous (SC) or intravenous (IV) use only as a continuous infusion. Treprostinil injection is preferably infused subcutaneously, but can be administered by a central intravenous line if the subcutaneous route is not tolerated because of severe site pain or reaction. The infusion rate is initiated at 1.25 ng/kg/min. If this initial dose cannot be tolerated because of systemic effects, reduce the infusion rate to 0.625 ng/kg/min.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Treprostinil side effects

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Side effects vary by route, but here are the most commonly reported ones across treprostinil products:

Common side effects

  • Infusion site pain and skin reaction (with injectable forms)
  • Headache
  • Diarrhea
  • Nausea
  • Jaw pain
  • Flushing or vasodilation (feeling of warmth, skin redness)
  • Swelling (edema)
  • Low blood pressure (hypotension)
  • Rash

When to get medical help

  • Call your doctor or seek emergency care if you develop signs of a bloodstream infection: fever, chills, or feeling very unwell — especially with IV infusion
  • Do not suddenly stop or sharply reduce your dose; this can cause a rapid worsening of PAH symptoms
  • Get immediate help if you feel faint, dizzy, or have a significant drop in blood pressure
  • Tell your doctor right away if you notice unusual or prolonged bleeding, as treprostinil affects platelet function
  • Seek care promptly for any signs of severe infection at the catheter or infusion site

Treprostinil warnings and precautions

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  • Risk of serious bloodstream infection with IV use: Long-term IV infusion through a central venous catheter carries a risk of life-threatening blood infections and sepsis. Subcutaneous infusion is preferred for this reason. Watch for fever, chills, or sudden worsening and seek care immediately.
  • Never stop abruptly: Suddenly stopping or sharply reducing the dose can cause a rapid, dangerous worsening of PAH symptoms. Any dose changes must be made with medical guidance.
  • Low blood pressure risk: Treprostinil widens blood vessels throughout the body, which can cause symptomatic low blood pressure — especially in patients who already have low systemic blood pressure.
  • Increased bleeding risk: Because treprostinil inhibits platelet aggregation (clumping), it can increase the tendency to bleed. Report unusual bruising or bleeding to your doctor.
  • Liver disease caution: In patients with liver problems, treprostinil clears much more slowly, leading to higher drug levels and greater risk of side effects. Dose must be adjusted carefully; use is contraindicated in severe liver impairment.

Treprostinil interactions

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Treprostinil can be affected by certain other medicines — tell your prescriber and pharmacist everything you take:

  • Gemfibrozil (cholesterol medicine): Blocks the liver enzyme (CYP2C8) that clears treprostinil, roughly doubling drug levels — a significant interaction requiring medical attention
  • Rifampin (antibiotic): Speeds up treprostinil clearance through the same enzyme, reducing how much is in your body and potentially making it less effective
  • Blood pressure medicines and other vasodilators: Can add to treprostinil's blood pressure-lowering effect, increasing the risk of hypotension
  • Warfarin (blood thinner): Treprostinil does not appear to change warfarin levels or its INR effect, but treprostinil's own platelet-inhibiting action means bleeding risk should still be monitored
  • Bosentan and sildenafil: No significant pharmacokinetic interaction found in studies; these are frequently prescribed alongside treprostinil but your full medicine list should always be reviewed by your care team

Interactions listed in the FDA-approved label

From the Treprostinil prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Bosentan: No pharmacokinetic interactions between treprostinil and bosentan were observed in a study with bosentan (250 mg/day) and an oral formulation of treprostinil.
  • Sildenafil: No pharmacokinetic interactions between treprostinil and sildenafil were observed in a study with sildenafil (60 mg/day) and an oral formulation of treprostinil.
  • Gemfibrozil (CYP2C8 inhibitor): Co-administration increases exposure (both Cmax and AUC) to treprostinil, in studies with an oral formulation of treprostinil.
  • Rifampin (CYP2C8 inducer): Co-administration decreases exposure to treprostinil, in studies with an oral formulation of treprostinil.
  • Acetaminophen: Acetaminophen (4 g/day) did not show a clinically significant effect on the pharmacokinetics of treprostinil.
  • Warfarin: Warfarin (25 mg/day) did not show a clinically significant effect on treprostinil pharmacokinetics, and treprostinil does not affect the pharmacokinetics or pharmacodynamics of warfarin.
  • Fluconazole: Fluconazole (200 mg/day) did not show a clinically significant effect on the pharmacokinetics of treprostinil.
Read the label’s full interactions text

7 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 )].

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿291 supplements and herbs with documented Treprostinil interactions, ranked by severity Check Treprostinil against a supplement or herb →

Before taking Treprostinil

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  • Severe liver impairment (Child-Pugh Class C): Treprostinil is contraindicated — it cannot be used safely
  • Moderate liver impairment: Orenitram should be avoided; other forms require extra caution and lower starting doses
  • Mild liver impairment: Use with caution; lower starting doses and slow titration are required
  • Pregnancy: Animal studies showed fetal harm at relatively low doses; PAH in pregnancy itself carries serious risks to mother and baby — discuss risks and benefits carefully with your doctor before or if you become pregnant
  • Breastfeeding: It is unknown whether treprostinil passes into human milk; discuss with your doctor
  • Children: Safety and effectiveness have not been established in pediatric patients
  • Older adults: Higher rates of side effects have been observed; dose selection should be cautious, accounting for possible reduced liver or heart function
  • Kidney disease: No dose adjustment is required; treprostinil is not removed by dialysis

Treprostinil overdose

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Too much treprostinil causes an exaggerated version of its normal effects: flushing, headache, low blood pressure, nausea, vomiting, and diarrhea. In serious cases — particularly if a large accidental dose is delivered through an IV catheter — severe low blood pressure, near-fainting, or seizure-like activity can occur. Most overdose events in clinical trials resolved when the infusion was slowed or stopped. If you suspect an overdose, seek emergency medical care immediately.

What Treprostinil does in the body

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In the body, treprostinil relaxes the walls of blood vessels, lowering the resistance the heart pumps against and allowing cardiac output (the amount of blood the heart pumps) to increase. It can also cause the heart to beat faster (tachycardia). At high doses, it may reduce the strength and relaxation speed of heart muscle contractions. No major effects on the heart's electrical conduction system have been observed.

How your body processes Treprostinil

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When given by subcutaneous infusion, treprostinil is almost completely absorbed, reaching steady drug levels in roughly 10 hours. It is about 91% bound to proteins in the blood and is broken down primarily in the liver by an enzyme called CYP2C8. Most of the drug and its inactive breakdown products leave the body through the urine. The drug's half-life — the time it takes for the body to clear half of it — is approximately 4 hours after subcutaneous dosing. In patients with liver disease, clearance can be reduced by up to 80%, causing drug levels to build much higher than normal.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

291

Supplements & herbs that interact with Treprostinil

291 supplements and herbal products have documented interactions with Treprostinil in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 6
  • Moderate · 258
  • Minor · 27
ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major AMERICAN MISTLETOE Major DANSHEN Major PIRACETAM Major TYRAMINE Major ACONITE Moderate ADRAFINIL Moderate +283 more
Every supplement checked against Treprostinil — ranked by severity The full interaction hub: 6 major · 258 moderate · 27 minor · every one linked to its full report. Check Treprostinil against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Treprostinil has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

COENZYME Q10 Insufficient Evidence
See the full Treprostinil nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Treprostinil: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Treprostinil — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is treprostinil and why did my doctor prescribe it?

▾
Treprostinil mimics a natural substance your body makes to keep blood vessel walls relaxed. In pulmonary arterial hypertension (PAH) — and in some lung-disease-related forms of high lung pressure — those vessels become too narrow and stiff, forcing your heart to work dangerously hard. Treprostinil widens those vessels, lowers that pressure, and helps you tolerate activity better. Depending on which product you're on, it may also be aimed at slowing how fast your disease progresses.

I'm on the inhaled version — how often do I need to use it each day?

▾
The inhaled products are all used multiple times per day, spaced out across your waking hours. Tyvaso and Tyvaso DPI are typically used 4 times a day, roughly 4 hours apart. Yutrepia is used 3 to 5 times a day. The timing can be shifted a bit around planned activities since the effect does taper between sessions. Your prescriber and the instructions that come with your device will spell out the exact routine — stick to that schedule as closely as you can.

What side effects should I expect, and which ones mean I need to call someone?

▾
Headache, jaw pain, flushing, nausea, and diarrhea are common and tend to be most noticeable when your dose is being increased. If you're on the subcutaneous (under-the-skin) injection, site pain and redness are very common and can sometimes be quite bothersome. These effects are generally related to the drug relaxing blood vessels and tend to settle over time. Call your doctor or seek emergency care if you feel significantly dizzy or faint from low blood pressure, notice unusual bleeding, or — if you're on IV treprostinil — develop fever, chills, or signs of an infection.

Can I ever just stop taking it if I feel like I need a break?

▾
Please don't stop suddenly on your own — this is one of the most important things to know about treprostinil. Abruptly stopping or sharply cutting the dose can cause your PAH symptoms to worsen quickly and dangerously. If you're having side effects or struggling with the treatment, call your care team and they can help you adjust things safely. Any changes to your dose should always be made with medical guidance.

Are there medicines or supplements I should avoid while taking treprostinil?

▾
Yes — a few are worth flagging. Gemfibrozil, used for cholesterol, can roughly double the amount of treprostinil in your blood, raising the risk of side effects. Rifampin, an antibiotic, can push levels in the opposite direction and make treprostinil less effective. Any medicine that lowers blood pressure can add to treprostinil's own blood pressure-lowering effect. Make sure your full medicine list — including over-the-counter drugs and supplements — is reviewed by your pharmacist or prescriber.

Is it safe to get pregnant or breastfeed while on treprostinil?

▾
This is a really important conversation to have with your doctor before trying to get pregnant. Animal studies showed treprostinil can harm fetal development, and PAH itself carries serious risks during pregnancy — including heart failure, preterm birth, and stillbirth. As for breastfeeding, we don't currently have data on whether treprostinil passes into breast milk. Your care team can help you weigh the risks and benefits based on your specific situation.

Is Treprostinil available over the counter?

▾
No. Treprostinil is a prescription medicine: every Treprostinil product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Treprostinil first available?

▾
The earliest FDA record we hold for Treprostinil is from 2002: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Treprostinil was first used.

Who makes Treprostinil?

▾
6 companies currently list Treprostinil products in the FDA's NDC Directory, including United Therapeutics Corporation, Alembic Pharmaceuticals Inc., Dr.Reddy's Laboratories Inc.,. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Treprostinil on HelloPharmacist

📊Treprostinil supplement interactions291 checked — ranked by severity 🌿Drug & Supplement CheckerTreprostinil vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Treprostinil NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Treprostinil Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Treprostinil forms and strengths (how it comes)

Treprostinil is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Treprostinil inactive ingredients by manufacturer.

Injection

Into a vein · Under the skin
Brands Remodulin
How this form is used
What it may be used for
  • Remodulin and treprostinil injection are used to treat PAH (WHO Group 1) to reduce symptoms associated with exercise
  • Remodulin and treprostinil injection are used in PAH patients who need to transition from epoprostenol, to slow the rate of disease worsening
Important instructions
  • Remodulin and treprostinil injection are given as a continuous infusion — subcutaneous (under the skin) is the preferred route; intravenous (into a vein) is used when subcutaneous is not tolerated
  • Remodulin may be diluted with Sterile Diluent for Remodulin or a similar approved high-pH glycine diluent; treprostinil injection may be diluted with Sterile Diluent for Treprostinil or a similar approved diluent
  • Doses are started low and increased gradually based on response — never stop or sharply reduce the infusion suddenly
  • When transitioning from epoprostenol, Remodulin or treprostinil injection dose is increased slowly while epoprostenol is decreased, under close medical supervision
Available strengths 5 strengths
8 mg/20 mL 20 mg/20 mL 50 mg/20 mL 100 mg/20 mL 200 mg/20 mL
51 FDA-listed product records ⓘ

Inhaler

By mouth · Inhaled
Brands Tyvaso Tyvaso DPI Yutrepia
How this form is used
What it may be used for
  • Tyvaso is used to treat pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability
  • Tyvaso is used to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability
  • Tyvaso DPI is used to treat PAH (WHO Group 1) and PH-ILD (WHO Group 3) to improve exercise ability
  • Yutrepia is used to treat PAH (WHO Group 1) and PH-ILD (WHO Group 3) to improve exercise ability
Important instructions
  • Tyvaso is used only with the Tyvaso Inhalation System device and is administered in 4 separate sessions per day, spaced approximately 4 hours apart during waking hours
  • Tyvaso DPI is used only with the Tyvaso DPI Inhaler; each cartridge delivers one inhalation, and treatment is given in 4 sessions per day roughly 4 hours apart
  • Yutrepia capsules are for inhalation only using the supplied inhaler — do not swallow them; they are administered 3 to 5 times per day, with each capsule's contents inhaled in 2 breaths
  • Timing of inhaled sessions can be adjusted around planned activities, as effects diminish over the dosing interval
Available strengths 10 strengths
16 mcg 26.5 mcg 32 mcg 48 mcg 53 mcg 64 mcg
Show 4 more strengths Show fewer strengths
79.5 mcg 80 mcg 106 mcg 1.74 mg/2.9 mL
33 FDA-listed product records ⓘ

Extended-release tablet

By mouth
Brands Orenitram
How this form is used
What it may be used for
  • Orenitram is used to treat pulmonary arterial hypertension (PAH; WHO Group 1) to delay disease progression and improve exercise capacity
  • Orenitram was studied mainly in patients with WHO functional class II–III PAH symptoms
Important instructions
  • Orenitram must be taken with food every time
  • Swallow Orenitram tablets whole — do not crush, split, or chew them
  • Orenitram is typically taken multiple times per day; doses are spaced several hours apart as directed by your prescriber
  • If transitioning from IV or subcutaneous Remodulin, Orenitram dose is increased while the infusion is gradually decreased — do not manage this transition on your own
Available strengths 5 strengths
0.125 mg 0.25 mg 1 mg 2.5 mg 5 mg
15 FDA-listed product records ⓘ

Treprostinil on the U.S. market: products, makers and brands

How Treprostinil appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

6 companies list 52 Treprostinil product records with the FDA, mostly as injection, inhaler, extended-release tablet; the earliest marketing or approval year on record is 2002. Brand names on the directory include Orenitram, Tyvaso, Remodulin and 3 more; the rest are generics.

3
Dose forms ⓘ
6
Labelers (makers, repackagers, distributors)
6
Brand names
52
FDA-listed product records ⓘ
2002
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Kit (23) · Powder (19) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

United Therapeutics Corporation62%
Alembic Pharmaceuticals Inc.8%
Dr.Reddy's Laboratories Inc.,8%
Liquidia Technologies, Inc.8%
Sandoz Inc8%
Teva Parenteral Medicines, Inc.8%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Treprostinil is used (Medicaid data)

A general measure of how commonly Treprostinil is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Treprostinil is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

15,732
Medicaid prescriptions filled (Q1–Q4 2025)
$215.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Treprostinil prescribed? Of the 1,601 medications we measure, Treprostinil ranks #846 by Medicaid prescriptions — more than 47% of them.

Where Treprostinil ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #846 of 1,601
#841 Dalfampridine 16,062 Rx #842 Lemborexant 16,038 Rx #843 Propylthiouracil 15,946 Rx #844 Durvalumab Injection 15,800 Rx #845 Tinidazole 15,770 Rx #846 Treprostinil 15,732 Rx #847 Cisplatin Injection 15,540 Rx #848 Salmeterol Oral Inhala... 15,481 Rx #849 Oxiconazole 15,480 Rx #850 Acetylcysteine 15,447 Rx #851 Lenalidomide 15,430 Rx

Utilization by Treprostinil product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 10 mg/mL injectable solution is the most-dispensed Treprostinil product — about 23% of these Medicaid prescriptions.

treprostinil 10 MG/ML Injectable Solution Most dispensed

3,624 Medicaid prescriptions (Q1–Q4 2025) 23% of Treprostinil prescriptions shown $51.5M gross reimbursement (before rebates) ≈ $14,224 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349408

treprostinil 5 MG/ML Injectable Solution

1,680 Medicaid prescriptions (Q1–Q4 2025) 11% of Treprostinil prescriptions shown $14.9M gross reimbursement (before rebates) ≈ $8,859 per prescription (gross)

Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349410

treprostinil 1 MG/ML Injectable Solution

1,550 Medicaid prescriptions (Q1–Q4 2025) 10% of Treprostinil prescriptions shown $5.8M gross reimbursement (before rebates) ≈ $3,772 per prescription (gross)

Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349407

treprostinil 0.6 MG/ML Inhalation Solution

1,521 Medicaid prescriptions (Q1–Q4 2025) 10% of Treprostinil prescriptions shown $31.8M gross reimbursement (before rebates) ≈ $20,879 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 857795

12 HR treprostinil 1 MG Extended Release Oral Tablet

1,383 Medicaid prescriptions (Q1–Q4 2025) 9% of Treprostinil prescriptions shown $12M gross reimbursement (before rebates) ≈ $8,708 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1488674

treprostinil 0.064 MG Inhalation Powder

1,237 Medicaid prescriptions (Q1–Q4 2025) 8% of Treprostinil prescriptions shown $30.9M gross reimbursement (before rebates) ≈ $25,016 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2602764

12 HR treprostinil 0.25 MG Extended Release Oral Tablet

919 Medicaid prescriptions (Q1–Q4 2025) 6% of Treprostinil prescriptions shown $1.9M gross reimbursement (before rebates) ≈ $2,095 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1488670

12 HR treprostinil 5 MG Extended Release Oral Tablet

885 Medicaid prescriptions (Q1–Q4 2025) 6% of Treprostinil prescriptions shown $29.2M gross reimbursement (before rebates) ≈ $33,027 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1858831

treprostinil 2.5 MG/ML Injectable Solution

783 Medicaid prescriptions (Q1–Q4 2025) 5% of Treprostinil prescriptions shown $4.9M gross reimbursement (before rebates) ≈ $6,197 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349409

12 HR treprostinil 2.5 MG Extended Release Oral Tablet

782 Medicaid prescriptions (Q1–Q4 2025) 5% of Treprostinil prescriptions shown $9.6M gross reimbursement (before rebates) ≈ $12,241 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1488678

treprostinil 0.048 MG Inhalation Powder

317 Medicaid prescriptions (Q1–Q4 2025) 2% of Treprostinil prescriptions shown $8.4M gross reimbursement (before rebates) ≈ $26,544 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2602760

12 HR treprostinil 0.125 MG Extended Release Oral Tablet

259 Medicaid prescriptions (Q1–Q4 2025) 2% of Treprostinil prescriptions shown $115,400 gross reimbursement (before rebates) ≈ $446 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1488665

treprostinil 0.032 MG Inhalation Powder

229 Medicaid prescriptions (Q1–Q4 2025) 1% of Treprostinil prescriptions shown $5.6M gross reimbursement (before rebates) ≈ $24,472 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2602756

treprostinil 0.016 MG Inhalation Powder

105 Medicaid prescriptions (Q1–Q4 2025) <1% of Treprostinil prescriptions shown $2.6M gross reimbursement (before rebates) ≈ $25,136 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2602751

treprostinil 0.0795 MG Inhalation Powder

65 Medicaid prescriptions (Q3–Q4 2025) <1% of Treprostinil prescriptions shown $1.7M gross reimbursement (before rebates) ≈ $26,806 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2714670

treprostinil 0.106 MG Inhalation Powder

43 Medicaid prescriptions (Q2–Q4 2025) <1% of Treprostinil prescriptions shown $743,412 gross reimbursement (before rebates) ≈ $17,289 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2714674

treprostinil 0.053 MG Inhalation Powder

41 Medicaid prescriptions (Q3–Q4 2025) <1% of Treprostinil prescriptions shown $432,802 gross reimbursement (before rebates) ≈ $10,556 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2714666

treprostinil 0.0265 MG Inhalation Powder

25 Medicaid prescriptions (Q2–Q4 2025) <1% of Treprostinil prescriptions shown $274,301 gross reimbursement (before rebates) ≈ $10,972 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2714659

Other Treprostinil products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

284 Medicaid prescriptions (Q1–Q4 2025) 2% of Treprostinil prescriptions shown $2.8M gross reimbursement (before rebates) ≈ $9,739 per prescription (gross)

Summed across the 3 of 74 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Treprostinil, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 23 of 133 listed Treprostinil NDCs with Medicaid activity.

Compare Treprostinil products

A representative set of FDA-listed product records for Treprostinil — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 52 of 52 products — FDA National Drug Code Directory. See every product, package size and price: browse all 52 Treprostinil NDCs →

Treprostinil side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Treprostinil — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Treprostinil are dyspnoea, headache, diarrhoea; about 57% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

124,759
Reports mentioning it
57%
Reported as serious
12
Distinct effects shown
Most reported effects
Dyspnoea
21,362
Headache
17,283
Diarrhoea
13,822
Nausea
12,413
Cough
11,659
Dizziness
9,520
Fatigue
9,428
Death
8,990
Vomiting
6,324
Hypotension
5,727
Age groups
Adult · 15,080Elderly · 9,153Child · 642Adolescent · 412Infant · 154Neonate · 86

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Treprostinil in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Treprostinil FDA approval history

How Treprostinil went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Treprostinil was first approved by the FDA in 2002 (Brand: REMODULIN · United Therap); the first generic version was approved in 2017. It remains available in U.S. pharmacies today.

2002
Brand approved
Brand: REMODULIN · United Therap
2017
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Treprostinil recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Treprostinil recalls since July 2021.

✅No Treprostinil recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Treprostinil RxCUI 343048 4 dose forms · 20 strengths
  3. Dose form (SCDF) Inhalation Solution RxCUI 2108557 No current FDA listing
    Clinical drug / strength (SCD) 0.6 MG/ML RxCUI 857795
  4. Dose form (SCDF) Injectable Solution RxCUI 385082 In current FDA listings
    Clinical drug / strength (SCD) 0.4 MG/ML RxCUI 2667756 1 MG/ML RxCUI 349407 2.5 MG/ML RxCUI 349409 5 MG/ML RxCUI 349410 10 MG/ML RxCUI 349408

Look up RxCUI 343048 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Treprostinil brand names

Treprostinil is sold under 6 brand names in the FDA directory — Orenitram, Tyvaso, Remodulin, Yutrepia and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Orenitram Tyvaso Remodulin Yutrepia Tyvaso DPI Diluent

Who makes Treprostinil: manufacturers and labelers

6 companies list Treprostinil products with the FDA. By number of product records, the largest are United Therapeutics Corporation, Alembic Pharmaceuticals Inc., Dr.Reddy's Laboratories Inc.,. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

United Therapeutics Corporation 32 Alembic Pharmaceuticals Inc. 4 Dr.Reddy's Laboratories Inc., 4 Liquidia Technologies, Inc. 4 Sandoz Inc 4 Teva Parenteral Medicines, Inc. 4

Treprostinil drug class (RxNorm)

Treprostinil belongs to the Prostacycline Vasodilator class.

Pharmacologic class Prostacycline Vasodilator
Drug family (ATC) Platelet aggregation inhibitors excl. heparin

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Treprostinil page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 6, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Treprostinil.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Treprostinil after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
5
Finished products in the current FDA directory
52
Companies listing them (makers, repackagers, distributors)
6
FDA labeler codes behind them ⓘ
6
Linked representative label ⓘ
Sandoz Inc
Linked label effective
Apr 6, 2023
Composite sections available
22
Linked SPL Set ID
473297ca-a872-4052-a053-87dc8f0d3c13
Linked SPL Document ID
fe80d00e-9eba-4192-9515-f9a5ad686a53
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Sandoz Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →