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
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- headache, severe
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
- feeling of warmth
- redness of the face, neck, arms, and occasionally, upper chest
For Healthcare Professionals
Applies to treprostinil: inhalation solution, injectable solution, oral tablet extended release
In general, the most common adverse effects have included infusion site pain and reactions.[Ref]
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 side effects have included diarrhea (up to 30%), nausea (up to 30%), abdominal discomfort (6%), and vomiting.[Ref]
Nervous system side effects have included headache (up to 63%), dizziness (9%), and insomnia.[Ref]
Cardiovascular side effects have included vasodilatation (11%), edema (9%), hypotension (4%), bradycardia, syncope, and flushing. Postmarketing reports include angioedema.[Ref]
Dermatologic reactions have included rash (14%) and pruritus (8%). Postmarketing reports have included angioedema.[Ref]
Musculoskeletal side effects have included pain in extremity (14%), jaw pain (13%), and foot pain.[Ref]
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 side effects of inhaled treprostinil have included cough, throat irritation, and pharyngolaryngeal pain.[Ref]
Common (1% to 10%): Hypokalemia (9%)
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.
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