Treprostinil Side Effects

Brand Names: Remodulin, Tyvaso

Please note - some side effects for Treprostinil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Treprostinil - for the Consumer

Treprostinil Inhalation Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Treprostinil Inhalation Solution:

Cough; diarrhea; dizziness; headache; muscle, jaw, or bone pain; nausea; reddening of the face and neck (flushing); throat irritation or pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; coughing up blood; dark, tarry, or bloody stools; fainting; fever, chills, or persistent sore throat; increased cough; new or worsening shortness of breath; pale skin; severe or persistent tiredness, weakness, dizziness, headache, or nausea; swelling of the ankles or feet; unusual bruising or bleeding; vomit that looks like coffee grounds; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Treprostinil Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Treprostinil Solution:

Diarrhea; dizziness; flushing or redness of the skin; headache; jaw pain; joint or muscle aches; lightheadedness; mild pain or redness at the injection site; nausea; pale skin; sweating; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; bone or stomach pain; burning, numbness, or tingling; changes in the appearance of the skin (eg, unusual paleness, blue/gray color); chest pain; dark, tarry stools; enlarged abdomen; fainting; fast, slow, or irregular heartbeat; fever; itching; mental or mood changes; pain, swelling, redness, heat, tenderness, or hard skin at the injection site; severe or persistent dizziness; shortness of breath; swelling of the hands, arms, ankles, or feet; unexplained weight gain; unusual bruising or bleeding; unusual fatigue or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

General

In general, the most common adverse effects have included infusion site pain and reactions.

Local

Local adverse effects have included infusion site pain (85%) and infusion site reactions (83%) such as erythema, induration, or rash. These effects were classified as severe in 39% and 38% of patients, respectively.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (25%), nausea (22%), and vomiting.

Nervous system

Nervous system side effects have included headache (27%), dizziness (9%), and insomnia.

Cardiovascular

Cardiovascular side effects have included vasodilatation (11%), edema (9%), hypotension (4%), bradycardia, syncope, and flushing.

Dermatologic

Dermatologic reactions have included rash (14%) and pruritus (8%).

Musculoskeletal

Musculoskeletal side effects have included jaw pain (13%).

Other

Complications associated with infusion systems were related to the pump (93%) or to the infusion set (7%). Side effects were reported in 8 patients (4 treprostinil and 4 placebo), including nausea (due to excess drug) and dyspnea (due to return of pulmonary arterial hypertension symptoms).

The following adverse events may be attributable to the IV mode of infusion including arm swelling, paresthesias, hematoma and pain. Using an indwelling central venous catheter to deliver chronic intravenous infusions of treprostinil is associated with the risk of blood stream infections and sepsis, which may be fatal.

Other

Other side effects have included jaw pain and foot pain.

Respiratory

Respiratory side effects of inhaled treprostinil have included cough, throat irritation, and pharyngolaryngeal pain.

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