FDA-filed SPL labeling · retrieved through openFDA

Epoprostenol

Epoprostenol is an intravenous prostacyclin vasodilator used to treat pulmonary arterial hypertension (PAH), helping patients breathe easier and exercise more.

Brand names FlolanVeletri
Drug class Prostacycline Vasodilator
Rx Form 1 Route Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 4 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 →

At a glance
Linked label effectiveNov 28, 2022
Clinical labels in scope 4
AvailabilityRx
Earliest approval/marketing year 1995
FDA-listed product records 25
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Epoprostenol at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Epoprostenol is a powerful, continuously infused IV medication for pulmonary arterial hypertension that widens the blood vessels in the lungs and reduces strain on the heart. It requires a permanent central IV line and a portable pump, and must never be stopped abruptly — sudden interruptions can be life-threatening. Work closely with your medical team to manage dosing, catheter care, and any side effects.

📖 Epoprostenol: Patient Information Guide

A plain-language walkthrough of Epoprostenol — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Epoprostenol is an intravenous prostacyclin vasodilator approved to treat pulmonary arterial hypertension (PAH). Here are the supported uses based on available products:

  • Epoprostenol for injection (generic) — treats pulmonary arterial hypertension (PAH, WHO Group 1) to improve exercise capacity, studied mainly in patients with moderate-to-severe symptoms (NYHA Class III–IV) and idiopathic, heritable, or connective-tissue-disease-associated PAH
  • Veletri (intravenous injection) — treats pulmonary arterial hypertension (PAH, WHO Group 1) to improve exercise capacity, in the same patient populations including those with PAH linked to connective tissue diseases
⚙️How it works

Epoprostenol is a synthetic version of prostacyclin, a natural compound the body makes to relax blood vessels. It works by directly widening (dilating) the arteries in the lungs and throughout the body, which lowers the pressure the right side of the heart has to work against. It also prevents platelets (small blood cells) from clumping together, which helps keep blood flowing more freely.

By reducing the resistance in the lung's blood vessels, epoprostenol makes it easier for the heart to pump blood through the lungs, improving the amount of oxygen-rich blood that reaches the rest of the body — and ultimately helping patients do more physical activity with less effort.

💊How it's taken

Epoprostenol is given as a continuous, around-the-clock intravenous infusion — it never stops running. For long-term use, it is delivered through a permanent central venous catheter (a tube in a large vein near the heart) connected to a small, wearable ambulatory infusion pump.

  • Treatment is started at a low rate and increased gradually by the care team based on how you respond and any side effects
  • Dose increases and decreases must be made slowly — abrupt changes are dangerous
  • The infusion solution must be prepared carefully according to specific reconstitution instructions; it cannot be mixed with other IV medications
  • Always follow your prescriber's instructions for the infusion rate — never adjust it on your own
🤒Side effects — in detail

Side effects are common with epoprostenol and may happen during the initial dose-finding period or during long-term use:

  • During dose initiation: flushing, headache, nausea and vomiting, low blood pressure (hypotension), dizziness, chest pain, anxiety, slow heartbeat (bradycardia), fast heartbeat (tachycardia), abdominal pain, muscle pain, shortness of breath
  • During long-term use: jaw pain, headache, flushing, diarrhea, nausea and vomiting, flu-like symptoms, anxiety or nervousness, low blood pressure, rash
  • Catheter-related: local infection or pain at the catheter site; serious bloodstream infection (sepsis) with long-term use

Contact your doctor right away if you experience serious bleeding, signs of infection (fever, chills, redness at the catheter site), sudden worsening shortness of breath, fainting, or any sign the infusion has stopped or been interrupted.

⚠️Warnings & precautions
  • Never stop abruptly: Sudden interruption or large dose reductions can cause a life-threatening rebound spike in lung blood pressure — symptoms include sudden shortness of breath, dizziness, and extreme weakness. One patient death in clinical trials was linked to an infusion interruption.
  • Infection risk: The permanent central venous catheter required for long-term use carries a real risk of serious bloodstream infection (sepsis). Strict sterile technique when preparing the infusion and caring for the catheter is critical.
  • Dose initiation must be monitored: Starting epoprostenol should happen in a setting equipped for close monitoring and emergency care; the team will watch blood pressure and heart rate carefully as the dose is adjusted.
  • Blood clot risk: Most patients on epoprostenol are also prescribed a blood thinner (anticoagulant) to reduce the risk of clots traveling to the lungs or through a heart defect — unless there is a specific reason to avoid it.
  • High output cardiac failure: Post-marketing reports have identified high output cardiac failure as a potential concern; if symptoms worsen, the dose may need to be reduced.
🔀What it interacts with

Epoprostenol can interact with several types of medications, so it is important to tell your care team everything you take:

  • Blood pressure-lowering drugs (antihypertensives, diuretics, other vasodilators) — combining these with epoprostenol can cause an extra or excessive drop in blood pressure
  • Blood thinners and antiplatelet agents (e.g., warfarin, heparin, aspirin, clopidogrel) — epoprostenol increases the risk of bleeding when used alongside these; monitor closely
  • Digoxin — epoprostenol can raise digoxin blood levels, which may be dangerous in patients who are sensitive to digoxin toxicity; levels should be monitored

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not use if you have congestive heart failure caused by severe left ventricular systolic dysfunction (the main pumping chamber is too weak) — a large clinical trial showed higher mortality with epoprostenol in this group
  • Do not use if you developed pulmonary edema (fluid in the lungs) when the drug was first started
  • Do not use if you have a known allergy to epoprostenol or closely related compounds
  • Pregnancy: Untreated PAH in pregnancy carries serious risks including heart failure, stroke, preterm delivery, and death for mother and baby; discuss risks and benefits carefully with your doctor
  • Breastfeeding: It is unknown whether epoprostenol passes into breast milk; weigh the benefits of breastfeeding against the risks with your doctor
  • Children: Safety and effectiveness have not been established in pediatric patients
  • Older adults: Use with caution; start at lower doses since older patients may have reduced heart, liver, or kidney function or take multiple other medications
  • Lifestyle readiness: Long-term therapy requires managing a permanent IV catheter and portable pump at home — discuss honestly with your team whether this is something you can manage
🚑If you take too much

Too much epoprostenol causes an exaggerated version of its normal effects: flushing, severe headache, very low blood pressure, fast heartbeat, nausea, vomiting, and diarrhea. In serious cases, overdose has led to unconsciousness, dangerously low oxygen levels, and respiratory arrest. If you suspect an overdose or the pump delivers too much medication, seek emergency medical help immediately — the usual response is to reduce or stop the infusion rate right away.

📡Pharmacodynamics — effects in the body

Epoprostenol lowers the resistance in the blood vessels of the lungs and the rest of the body, reducing the workload on both sides of the heart and increasing how much blood the heart pumps per beat (cardiac output and stroke volume). At lower doses it can slow the heart rate slightly, while at higher doses it may cause the heart rate to rise as a reflex response to the drop in blood pressure. It also prevents platelets from clumping, which helps keep blood flowing freely through narrowed vessels.

🔬Pharmacokinetics — how your body processes it

Epoprostenol breaks down extremely quickly in the bloodstream — its half-life (the time for half the drug to be cleared) in human blood is no more than about 6 minutes, which is why the infusion must run continuously without interruption. It is broken down both by the blood's natural chemistry and by enzymes, producing two main metabolites that have far less activity than the original drug. The breakdown products are eliminated mainly through the urine. Because the drug clears so rapidly, stopping the infusion — even briefly — causes drug levels to fall almost immediately.

📦How to store it

Unopened vials of VELETRI are stable until the date indicated on the package when stored at 68° to 77°F (20° to 25°C).

📄 Written from Epoprostenol’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

136

Supplements & herbs that interact with Epoprostenol

136 supplements and herbal products have documented interactions with Epoprostenol 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 · 4
  • Moderate · 111
  • Minor · 21
Every supplement checked against Epoprostenol — ranked by severity The full interaction hub: 4 major · 111 moderate · 21 minor · every one linked to its full report. Check Epoprostenol 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

Epoprostenol 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.

See the full Epoprostenol 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.

🩺 Pharmacist Counseling Corner

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

Why do I have to be on a continuous IV infusion — can't I just take a pill?
Epoprostenol breaks down in your bloodstream in about 6 minutes or less, so a pill would be gone before it could do anything. The only way to keep steady levels in your blood — and keep those lung blood vessels open — is a continuous IV drip running 24 hours a day. That's why you'll have a catheter placed in a large central vein connected to a portable pump you carry with you.
What happens if my pump stops or the tubing gets disconnected?
This is a serious situation. Because epoprostenol leaves your body so quickly, even a brief interruption can cause your lung blood pressure to spike back up — you may suddenly feel very short of breath, dizzy, or faint. Contact your medical team immediately if the pump alarms or the infusion stops. Make sure you always have backup supplies and know the emergency contact number for your care team.
What side effects should I expect, and which ones mean I need to call my doctor?
Some side effects are very common and expected — things like headache, flushing (redness and warmth), jaw pain, nausea, and diarrhea happen in a lot of people and often improve over time. However, you should call your doctor right away if you notice signs of infection at your catheter site (redness, swelling, fever), severe low blood pressure, unusual bleeding, or if your breathing suddenly gets much worse. Never try to adjust your infusion rate on your own.
I'm on a blood thinner — is it safe to use epoprostenol too?
Many people on epoprostenol are actually prescribed a blood thinner on purpose, because it helps prevent dangerous clots from forming in the lung's blood vessels. However, combining the two does increase your bleeding risk, so your team will monitor you closely. Make sure your doctor knows about every medication you take, including over-the-counter pain relievers like aspirin or ibuprofen that can also affect bleeding.
Is it safe to use this medication if I'm pregnant or planning to become pregnant?
Pregnancy with pulmonary arterial hypertension is very high-risk, with serious dangers for both you and your baby — regardless of whether you are on medication. Animal studies with epoprostenol did not show harm to the fetus, and limited human case reports have not identified clear birth defect risks, but the data are limited. This is a conversation to have directly with your PAH specialist and your obstetrician so you can weigh the risks carefully together.
Can I ever stop taking this medication if I start feeling better?
No — you should never stop epoprostenol on your own, even if you feel much better. The drug is keeping your lung blood pressure under control, and stopping it suddenly can cause a dangerous and rapid return of high lung blood pressure that can be life-threatening. Any changes to your dose or decisions about stopping treatment must be made slowly and only under your doctor's supervision.
Is Epoprostenol available over the counter?
Epoprostenol is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Epoprostenol first available?
Epoprostenol has been available in the United States since at least 1995, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Epoprostenol?
Epoprostenol is supplied by 12 manufacturers listed in the FDA NDC Directory, including Sun Pharmaceutical Industries, Inc., Actelion Pharmaceuticals US, Inc., GlaxoSmithKline LLC.

💬 Answers drafted from Epoprostenol’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Epoprostenol comes

Epoprostenol is available in 1 form. 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.

Injection

By injection · Into a vein
Brands Flolan Veletri
How this form is used
What it may be used for
  • Epoprostenol (generic) injection is used to treat pulmonary arterial hypertension (PAH, WHO Group 1) to improve exercise capacity
  • Veletri injection is indicated for pulmonary arterial hypertension (PAH, WHO Group 1) to improve exercise capacity
  • Clinical studies for both products focused on patients with moderate-to-severe PAH (NYHA Class III–IV) with idiopathic, heritable, or connective-tissue-disease-related PAH
Important instructions
  • Veletri must be reconstituted only with Sterile Water for Injection or Sodium Chloride 0.9% Injection — do not mix with any other solutions or medications
  • Epoprostenol for injection must be reconstituted only with Sterile Water for Injection or Sodium Chloride 0.9% Injection — do not mix with other parenteral solutions
  • Both Veletri and Epoprostenol for injection are given as a continuous intravenous infusion through a central venous catheter via an ambulatory infusion pump
  • Never stop or abruptly reduce the infusion rate of either product without a physician's direction — dose changes must be made gradually
Available strengths 4 strengths
19 FDA-listed product records

📊 Epoprostenol across the U.S. market

How Epoprostenol 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.

1
Dose forms
12
Manufacturers
4
Brand names
25
FDA-listed product records
1995
First marketed

Also listed with the FDA, not a patient dose form: Powder (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Sun Pharmaceutical Industries, Inc.20%
Actelion Pharmaceuticals US, Inc.16%
GlaxoSmithKline LLC16%
Gland Pharma Limited8%
Mylan Institutional LLC8%
Teva Parenteral Medicines, Inc.8%
Other makers24%

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

📈 How widely Epoprostenol is used

A general measure of how commonly Epoprostenol 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 Epoprostenol 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.

1,316
Medicaid prescriptions filled (Q1–Q4 2025)
$3.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Epoprostenol prescribed? Of the 1,596 medications we measure, Epoprostenol ranks #1,248 by Medicaid prescriptions — more than 22% of them.

Where Epoprostenol ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Epoprostenol 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.

epoprostenol 1.5 MG Injection

1,316 Medicaid prescriptions (Q1–Q4 2025) 100% of Epoprostenol prescriptions shown $3.9M gross reimbursement (before rebates) ≈ $2,928 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 562502

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 Epoprostenol, 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 2 of 6 listed Epoprostenol NDCs with Medicaid activity.

🔍 Compare Epoprostenol products

A representative set of FDA-listed product records for Epoprostenol — 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 25 of 25 products — FDA National Drug Code Directory. See every product, package size and price: browse all 25 Epoprostenol NDCs →

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) Epoprostenol RxCUI 8814 1 dose form · 2 strengths
  1. Dose form (SCDF) Injection RxCUI 1789858 In current FDA listings
    Clinical drug / strength (SCD) 0.5 MG RxCUI 562501 1.5 MG RxCUI 562502

Look up RxCUI 8814 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.

🏷️ Sold under these brand names

Flolan Veletri

🏭 Manufacturers & labelers

Sun Pharmaceutical Industries, Inc. 5 Actelion Pharmaceuticals US, Inc. 4 GlaxoSmithKline LLC 4 Gland Pharma Limited 2 Mylan Institutional LLC 2 Teva Parenteral Medicines, Inc. 2 Cayman Pharma s r.o. 1 Chirogate International Inc 1 EUROAPI Hungary Ltd. 1 MSN Laboratories Private Limited 1 Pharmacia and Upjohn Company LLC 1 Wasserburger Arzneimittelwerk GmbH 1

RxNorm drug class

Epoprostenol 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.

🔬 Where this comes from

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 Nov 28, 2022
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Epoprostenol.
📈
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 Epoprostenol after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
4
NDC products indexed
25
Distinct labelers/manufacturers represented
12
Linked representative label
Actelion Pharmaceuticals US, Inc.
Linked label effective
Nov 28, 2022
Composite sections available
22
Linked SPL Set ID
df502787-46ec-4dd1-a2c0-be90f6d95a5d
Linked SPL Document ID
39e8b7f8-f82a-4083-a284-ce571a87ce97
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 4 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Actelion Pharmaceuticals US, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.