Orenitram Side Effects

Generic name: treprostinil

Medically reviewed by Drugs.com. Last updated on Feb 27, 2025.

Note: This document provides detailed information about Orenitram Side Effects associated with treprostinil. Some dosage forms listed on this page may not apply specifically to the brand name Orenitram.

Applies to treprostinil: oral tablet extended release.

Other dosage forms:

• inhalation powder, inhalation solution
• injection solution

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood tests may be needed to check for unwanted effects.

You should not use other medicines that also contain treprostinil (the active ingredient contained in Orenitram) This includes Remodulin® or Tyvaso®. Using these medicines together may increase your chance for more serious side effects.

Do not suddenly stop using this medicine. Stopping or changing the dose of this medicine suddenly may bring on symptoms of your condition and can be dangerous. Check with your doctor before stopping or changing your dose.

This medicine may increase risk of bleeding, especially in patients receiving blood thinners. Tell your doctor if you are taking a blood thinner (such as warfarin).

While taking the medicine, part of the tablet may pass into your stools. This is usually normal. But, if you have diverticulosis (bowel problem), the tablet shell may get stuck in a blind pouch or diverticulum in your intestine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Orenitram

Along with its needed effects, treprostinil may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking treprostinil:

Get emergency help immediately if any of the following symptoms of overdose occur while taking treprostinil:

Symptoms of overdose

• blurred vision
• confusion
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• headache, severe
• sweating

Other side effects of Orenitram

Some side effects of treprostinil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to treprostinil: inhalation powder, inhalation solution, injectable solution, oral tablet extended release.

General adverse events

Oral tablets: The most frequently reported side effects were headache, diarrhea, nausea, and flushing.

Oral inhalation: The most frequently reported side effects were cough, headache, diarrhea, nausea, dizziness, throat irritation, pharyngolaryngeal pain, and flushing.

Parenteral: The most frequently reported side effects were subcutaneous infusion site pain and reaction, headache, diarrhea, nausea, jaw pain, vasodilation, edema, and hypotension.^[Ref]

Local

• Very common (10% or more): Infusion site pain (up to 85%), infusion site reaction (up to 83%), Infusion site bleeding/bruising (33.5%)
• Frequency not reported: Induration, erythema, infusion site infection
• Postmarketing reports: Subcutaneous infusion site abscess^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 30%), nausea (up to 30%)
• Common (1% to 10%): Abdominal discomfort, rectal hemorrhage, melena, vomiting, abdominal pain, dyspepsia
• Frequency not reported: Gastrointestinal bleeding^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 63%)
• Common (1% to 10%): Syncope, paresthesia, dizziness^[Ref]

Cardiovascular

• Very common (10% or more): Flushing (15%), vasodilation (up to 11%)
• Common (1% to 10%): Hypotension, tachycardia, palpitation, hypertension, heart failure, bradycardia, hemorrhage
• Frequency not reported: Systemic blood pressure decreased, pallor, right ventricular heart failure, supraventricular tachycardia, hematoma
• Postmarketing reports: Thrombophlebitis^[Ref]

Dermatologic

• Very common (10% or more): Rash (up to 83.1%), pruritus (up to 13.6%)
• Common (1% to 10%): Contact dermatitis, sweating, ecchymosis, cellulitis
• Uncommon (0.1% to 1%): Skin ulcer
• Postmarketing reports: Angioedema, macular rash, popular rash^[Ref]

Musculoskeletal

• Very common (10% or more): Pain in extremity (14%), pain in jaw (up to 13.1%)
• Common (1% to 10%): Myalgia, back pain
• Uncommon (0.1% to 1%): Neck pain, arthralgia, leg cramp, muscle pain
• Postmarketing reports: Bone pain, muscle spasm^[Ref]

Respiratory

• Very common (10% or more): Cough (54%), throat irritation/pharyngolaryngeal pain (25%)
• Common (1% to 10%): Hypoxia, epistaxis, pharyngitis, dyspnea, sinusitis, pulmonary hypertension, rhinitis, hemoptysis
• Uncommon (0.1% to 1%): Bronchitis
• Frequency not reported: Wheezing, pneumonia^[Ref]

Other

• Very common (10% or more): Pain (11.9%)
• Common (1% to 10%): Edema, infection, flu syndrome, asthenia, overdose, chest pain, fever, peripheral edema
• Uncommon (0.1% to 1%): Viral infection, malaise
• Frequency not reported: Infection, fatigue, BUN decreased, LDH decreased, bilirubin decreased, swelling arm^[Ref]

Metabolic

• Common (1% to 10%): Hypokalemia, anorexia, dehydration, gout^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection^[Ref]

Hematologic

• Common (1% to 10%): Anemia
• Frequency not reported: Bleeding, thrombocytopenia, WBC decreased, RBC decreased, hemoglobin decreased, hematocrit decreased, eosinophils increased, platelet count increased^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia, anxiety, depression
• Uncommon (0.1% to 1%): Nervousness^[Ref]

See also:

Further information

Orenitram side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer