Orenitram Side Effects

Generic name: treprostinil

Medically reviewed by Drugs.com. Last updated on Oct 4, 2024.

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

Serious side effects of Orenitram

Along with its needed effects, treprostinil (the active ingredient contained in Orenitram) 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:

More common side effects

• decreased urine
• dry mouth
• increased thirst
• irregular heartbeat
• muscle pain or cramps
• nausea or vomiting
• pain in the jaw, arms, or legs
• unusual tiredness or weakness

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:

More common side effects

• abdominal or stomach discomfort
• diarrhea
• feeling of warmth
• headache
• redness of the face, neck, arms, and occasionally, upper chest

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]

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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer