Note: This document contains side effect information about treprostinil. Some dosage forms listed on this page may not apply 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
- 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
- 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
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]
