What the label lists and what reports show
Treprostinil side effects
Treprostinil's FDA label: “Most common adverse reactions (incidence >3%) reported in clinical studies with Treprostinil injection: subcutaneous infusion site pain and reaction, headache, diarrhea, nausea, jaw pain, vasodilatation, edema, and hypotension.” FAERS holds 124,759 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (21,363 reports).
- Generic listed
Check it at the source: the treprostinil FDA label on DailyMed (effective February 13, 2025, Alembic Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Orenitram?Orenitram can cause serious side effects, including worsening of PAH symptoms. Stopping Orenitram suddenly may cause worsening of your PAH symptoms. Do not change your dose or suddenly stop taking Orenitram without first talking to your healthcare provider. The most common side effects of Orenitram include: headache diarrhea nausea vomiting flushing pain in arms and legs jaw pain Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Orenitram. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label (Orenitram), United Therapeutics Corporation, effective November 20, 2024 (SPL set 8ed2003a-c801-411e-831e-d06079bb0d7c), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence >3%) reported in clinical studies with Treprostinil injection: subcutaneous infusion site pain and reaction, headache, diarrhea, nausea, jaw pain, vasodilatation, edema, and hypotension.
Table 4: Adverse Reactions in Controlled 12-Week Studies of Subcutaneous Treprostinil and at least 3% more frequent than on Placebo
This table is printed in the Treprostinil label published by Teva Parenteral Medicines, Inc. of May 1, 2022; the label quoted above does not print one.
| Ad verse Reaction | Treprostinil (N=236) P e rcent of Patients | P l acebo (N=233) P e rcent of Patients |
|---|---|---|
| Infusion Site Pain | 85 | 27 |
| Infusion Site Reaction | 83 | 27 |
| Headache | 27 | 23 |
| Diarrhea | 25 | 16 |
| Nausea | 22 | 18 |
| Rash | 14 | 11 |
| Jaw Pain | 13 | 5 |
| Vasodilatation | 11 | 5 |
| Edema | 9 | 3 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed elsewhere in labeling: Infections associated with intravenous administration [see Warnings and Precautions (5.1)]. Most common adverse reactions (incidence >3%) reported in clinical studies with Treprostinil injection: subcutaneous infusion site pain and reaction, headache, diarrhea, nausea, jaw pain, vasodilatation, edema, and hypotension. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 practice. Adverse Events with Subcutaneously Administered Treprostinil injection Patients receiving Treprostinil injection as a subcutaneous infusion reported a wide range of adverse events, many potentially related to the underlying disease (dyspnea, fatigue, chest pain, right ventricular heart failure, and pallor). During clinical trials with subcutaneous infusion of Treprostinil injection, infusion site pain and reaction were the most common adverse events among those treated with Treprostinil injection. …
Source: FDA drug label, Alembic Pharmaceuticals Inc., effective February 13, 2025 (SPL set 4a684b13-669d-4721-8ed4-30cc7762b0b8), via openFDA; the full label on DailyMed
What do FAERS reports show?
124,759 reports list treprostinil among the medicines taken, each a report of something that happened, not proof the medicine caused it; 14,973 are coded as a death and 51,473 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Treprostinil: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions