Treprostinil inhalation Side Effects

Please note - some side effects for Treprostinil inhalation 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 by Body System - for Healthcare Professionals

Applies to: inhalation solution; injectable solution

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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