Treprostinil Side Effects

It is possible that some side effects of treprostinil may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to treprostinil: oral tablet extended release

As well as its needed effects, treprostinil may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking treprostinil, check with your doctor immediately:

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

If any of the following symptoms of overdose occur while taking treprostinil, get emergency help immediately:

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 treprostinil side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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.[Ref]

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.[Ref]

Gastrointestinal

Gastrointestinal side effects have included diarrhea (up to 30%), nausea (up to 30%), abdominal discomfort (6%), and vomiting.[Ref]

Nervous system

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

Cardiovascular

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

Dermatologic

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

Musculoskeletal

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

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.[Ref]

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

Respiratory

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

Metabolic

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

References

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

2. McLaughlin VV, Gaine SP, Barst RJ, et al. "Efficacy and safety of treprostinil: an epoprostenol analog for primary pulmonary hypertension." J Cardiovasc Pharmacol 41 (2003): 293-9

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

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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