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Orenitram (Treprostinil): Uses, Side Effects and Dosage

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Prescription (Rx)
Strength:
0.125 mg, 0.25 mg, 1 mg, 2.5 mg, 5 mg
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Orenitram

What is Orenitram?

  • Orenitram is a prescription medicine used to treat pulmonary arterial hypertension (PAH) which is high blood pressure in the arteries of your lungs.
  • Orenitram can help slow down the progression of your disease and improve your ability to exercise.

It is not known if Orenitram is safe and effective in children.

Do not take Orenitram if you have severe liver problems.

Before taking Orenitram, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver problems
  • have diverticulosis

  • are pregnant or plan to become pregnant. It is not known if Orenitram will harm your unborn baby.

  • are breastfeeding or plan to breastfeed. It is not known if Orenitram passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Orenitram.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Orenitram and other medicines may affect each other causing side effects. Do not start any new medicine until you check with your healthcare provider.

Especially tell your healthcare provider if you take another medicine that contains treprostinil, such as Remodulin®, Tyvaso®, or Tyvaso DPI®.

How should I take Orenitram?

  • Take Orenitram exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will slowly increase your dose to find the dose of Orenitram that is right for you.
  • If you take the medicine Remodulin and your healthcare provider is switching you to Orenitram, your healthcare provider will decrease your dose of Remodulin over a period of time when you start taking Orenitram.
  • Do not change your dose or suddenly stop taking Orenitram without first talking to your healthcare provider.
  • Orenitram is usually taken 3 times a day (about every 8 hours) or 2 times a day (about every 12 hours). Your healthcare provider will tell you how often you should take Orenitram. If you have side effects, your healthcare provider may tell you to change your dose or when you take Orenitram.
  • Take Orenitram with food.
  • Swallow Orenitram tablets whole. Do not split, chew, crush, or break your Orenitram tablets. Do not take Orenitram tablets that are damaged or broken. If Orenitram tablets are not taken whole, they may release too much medicine at one time. This can lead to side effects.
  • You may see the tablet shell in your stools (bowel movements). This is usually normal. The tablet shell is not digested. If you have diverticulosis, the tablet shell may get stuck in a blind pouch or diverticulum in your intestine.
  • If you miss your dose of Orenitram, take the missed dose as soon as possible with food.
  • If you miss 2 or more doses of Orenitram, call your healthcare provider to see if you need to change your dose.
  • If you take too much Orenitram, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of Orenitram?

Orenitram can cause serious side effects, including worsening of PAH symptoms.

  • Stopping Orenitram suddenly may cause worsening of your PAH symptoms. Do not change your dose or suddenly stop taking Orenitram without first talking to your healthcare provider.

The most common side effects of Orenitram include:

  • headache
  • diarrhea
  • nausea
  • vomiting
  • flushing
  • pain in arms and legs
  • jaw pain

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Orenitram. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Orenitram?

  • Store at 68°F to 77°F (20°C to 25°C).

Keep Orenitram and all medicines out of the reach of children.

General information about the safe and effective use of Orenitram.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet.

Do not use Orenitram for a condition for which it was not prescribed. Do not give Orenitram to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Orenitram that is written for health professionals.

What are the ingredients in Orenitram?

Active ingredient: treprostinil diolamine

Inactive ingredients: xylitol, maltodextrin, sodium lauryl sulfate, magnesium stearate, cellulose acetate, triethyl citrate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. In addition, tablets may contain colorants FD&C Blue #2, iron oxide yellow, and iron oxide red. The imprint ink contains shellac glaze, ethanol, isopropyl alcohol, iron oxide black, n-butyl alcohol, and propylene glycol.

United Therapeutics Corp., Research Triangle Park, NC 27709 USA

Copyright 2023, United Therapeutics Corp. All rights reserved.

ORENITRAM is a registered trademark of United Therapeutics Corp.

For more information, go to www.orenitram.com or call 1-877-864-8437.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 203496 · View the label on DailyMed

Revision date stated in the text: February 2023

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Orenitram

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Prostacycline Vasodilator
Active ingredient Treprostinil
Dosage form Tablet, extended release, Kit
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) UNITED THERAP
FDA approval NDA 203496New Drug Application (NDA) Approved December 20, 2013
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
0.125 mg – 100 in 1 bottle NDC 66302-300-01
0.125 mg – 10 in 1 bottle NDC 66302-300-10
0.125 mg – 10 in 1 blister pack / 1 in 1 carton NDC 66302-300-02
0.25 mg – 100 in 1 bottle NDC 66302-302-01
0.25 mg – 10 in 1 bottle NDC 66302-302-10
0.25 mg – 10 in 1 blister pack / 1 in 1 carton NDC 66302-302-02
1 mg – 100 in 1 bottle NDC 66302-310-01
1 mg – 10 in 1 bottle NDC 66302-310-10
1 mg – 10 in 1 blister pack / 1 in 1 carton NDC 66302-310-02
2.5 mg – 100 in 1 bottle NDC 66302-325-01
2.5 mg – 10 in 1 bottle NDC 66302-325-10
2.5 mg – 10 in 1 blister pack / 1 in 1 carton NDC 66302-325-02
Show more packages (6)+
5 mg – 100 in 1 bottle NDC 66302-350-01
5 mg – 10 in 1 bottle NDC 66302-350-10
5 mg – 10 in 1 blister pack / 1 in 1 carton NDC 66302-350-02
0.125 mg, 0.25 mg – 1 in 1 package NDC 66302-361-28
0.125 mg, 0.25 mg – 1 in 1 package NDC 66302-362-56
0.125 mg, 0.25 mg, 1 mg – 1 in 1 package NDC 66302-363-84

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.