"The U.S. Food and Drug Administration today approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transpla"...
Orenitram Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Orenitram (treprostinil) is a prostacyclin vasodilator used to treat pulmonary arterial hypertension (PAH) to improve exercise capacity. Common side effects include headache, nausea, and diarrhea.
The recommended starting dose of Orenitram is 0.25 mg twice daily with food, taken approximately 12 hours apart. Increase the dose as tolerated to achieve optimal response. The recommended increment is 0.25 or 0.5 mg twice daily every 3-4 days. Orenitram may interact with diuretics, antihypertensive drugs, other vasodilators, anticoagulants, and gemfibrozil. Tell your doctor all medications and supplements you use. During pregnancy, Orenitram should be taken only if prescribed. It is unknown if this drug passes into breast milk or if it will cause undesirable effects in a nursing infant. Consult your doctor before breastfeeding.
Our Orenitram (treprostinil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Orenitram FDA Prescribing Information: Side Effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In a 12-week placebo-controlled monotherapy study (Study 1; WHO Group 1; functional class IIIII), the most commonly reported adverse reactions that occurred in patients receiving Orenitram included: headache, nausea, and diarrhea. Table 1 lists the adverse reactions that occurred at a rate on Orenitram at least 5% higher than on placebo.
Orenitram patients in Table 1 for Study 1 (N = 151) had access to 0.25 mg tablets at randomization. Approximately 91% of such patients experienced an adverse reaction, but only 4% discontinued therapy for an adverse reaction (compared to 3% receiving placebo). The overall discontinuation rate for any reason was 17% for active and 14% for placebo.
Table 1: Adverse Reactions with Rates at Least 5%
Higher on Orenitram Monotherapy than on Placebo
|Pain in jaw||11%||4%|
|Pain in extremity||14%||8%|
Orenitram was studied in a long-term, open-label extension study in which 824 patients were dosed for a mean duration of approximately 2 years. About 70% of patients continued treatment with Orenitram for at least a year. The mean dose was 4.2 mg BID at one year. The adverse reactions were similar to those observed in the placebo-controlled trials.
Read the entire FDA prescribing information for Orenitram (Extended Release Osmotic Tablet) »
Additional Orenitram Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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