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Treprostinil Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 31, 2024.

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]

References

1. Product Information. Remodulin (treprostinil). United Therapeutics Corporation. 2002.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Tyvaso (treprostinil). United Therapeutics Corporation. 2009.

4. Product Information. Orenitram (treprostinil). United Therapeutics Corporation. 2017.

Further information

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.