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Tyvaso Side Effects

Generic Name: treprostinil

Note: This document contains side effect information about treprostinil. Some of the dosage forms listed on this page may not apply to the brand name Tyvaso.

For the Consumer

Applies to treprostinil: oral tablet extended release

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

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 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[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. Orenitram (treprostinil)." United Therapeutics Corporation, Silver Spring, MD.

2. "Product Information. Remodulin (treprostinil)." United Therapeutics Corp, Silver Spring, MD.

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Product Information. Tyvaso (treprostinil)." United Therapeutics Corporation, Silver Spring, MD.

Some side effects of Tyvaso may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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