Treprostinil Side Effects

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

For the Consumer

Applies to treprostinil: oral tablet extended release

Along with its needed effects, treprostinil 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

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 (up to 30%), nausea (up to 30%), abdominal discomfort (6%), and vomiting.

Nervous system

Nervous system side effects have included headache (up to 63%), dizziness (9%), and insomnia.

Cardiovascular

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

Dermatologic

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

Musculoskeletal

Musculoskeletal side effects have included pain in extremity (14%), jaw pain (13%), and foot pain.

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 side effects include anorexia, vomiting, infusion site infection, asthenia, flushing (up to 15%), and abdominal pain.

Respiratory

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

Metabolic

Common (1% to 10%): Hypokalemia (9%)

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