Orenitram Side Effects
Generic Name: treprostinil
Note: This document contains side effect information about treprostinil. Some of the dosage forms listed on this page may not apply to the brand name Orenitram.
For the Consumer
Applies to treprostinil: oral tablet extended release
Other dosage forms:
Along with its needed effects, treprostinil (the active ingredient contained in Orenitram) 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:
- 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
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- headache, severe
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:
- 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
Oral tablets: The most frequently reported side effects were headache, diarrhea, nausea, and flushing.
Oral inhalation: The most frequently reported side effects were cough, headache, diarrhea, nausea, dizziness, throat irritation, pharyngolaryngeal pain, and flushing.
Very common (10% or more): Infusion site pain (up to 85%), infusion site reaction (up to 83%), Infusion site bleeding/bruising (33.5%)
Frequency not reported: Induration, erythema, infusion site infection
Postmarketing reports: Subcutaneous infusion site abscess[Ref]
Very common (10% or more): Diarrhea (up to 30%), nausea (up to 30%)
Frequency not reported: Gastrointestinal bleeding[Ref]
Very common (10% or more): Headache (up to 63%)
Very common (10% or more): Flushing (15%), vasodilation (up to 11%)
Frequency not reported: Systemic blood pressure decreased, pallor, right ventricular heart failure, supraventricular tachycardia, hematoma
Postmarketing reports: Thrombophlebitis[Ref]
Very common (10% or more): Rash (up to 83.1%), pruritus (up to 13.6%)
Uncommon (0.1% to 1%): Skin ulcer
Very common (10% or more): Pain in extremity (14%), pain in jaw (up to 13.1%)
Common (1% to 10%): Myalgia, back pain
Uncommon (0.1% to 1%): Neck pain, arthralgia, leg cramp, muscle pain
Postmarketing reports: Bone pain, muscle spasm[Ref]
Very common (10% or more): Cough (54%), throat irritation/pharyngolaryngeal pain (25%)
Uncommon (0.1% to 1%): Bronchitis
Very common (10% or more): Pain (11.9%)
Common (1% to 10%): Edema, infection, flu syndrome, asthenia, overdose, chest pain, fever, peripheral edema
Uncommon (0.1% to 1%): Viral infection, malaise
Frequency not reported: Infection, fatigue, BUN decreased, LDH decreased, bilirubin decreased, swelling arm[Ref]
Common (1% to 10%): Urinary tract infection[Ref]
Common (1% to 10%): Anemia
Uncommon (0.1% to 1%): Nervousness[Ref]
1. "Product Information. Orenitram (treprostinil)." United Therapeutics Corporation, Silver Spring, MD.
2. "Product Information. Remodulin (treprostinil)." United Therapeutics Corp, Silver Spring, MD.
3. Cerner Multum, Inc. "Australian Product Information." O 0
4. "Product Information. Tyvaso (treprostinil)." United Therapeutics Corporation, Silver Spring, MD.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
More about Orenitram (treprostinil)
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