82/100 · Critical
Manufactured by United Therapeutics Corporation
High Safety Concerns with Treprostinil, Particularly for Respiratory and Cardiovascular Reactions
313,927 FDA adverse event reports analyzed
Last updated: 2026-05-12
TREPROSTINIL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by United Therapeutics Corporation. Based on analysis of 313,927 FDA adverse event reports, TREPROSTINIL has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for TREPROSTINIL include DYSPNOEA, HEADACHE, DIARRHOEA, NAUSEA, COUGH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TREPROSTINIL.
Treprostinil has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 313,927 adverse event reports for this medication, which is primarily manufactured by United Therapeutics Corporation.
The most commonly reported adverse events include Dyspnoea, Headache, Diarrhoea. Of classified reports, 57.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Respiratory issues such as dyspnea and pneumonia are among the most common adverse events.
Cardiovascular events, including hypotension and right ventricular failure, are also frequent. Serious adverse events, including death and pulmonary arterial hypertension, are reported.
Patients taking Treprostinil should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Treprostinil can cause hypotension and should be used with caution in patients with pre-existing cardiovascular conditions. Drug interactions are not well-documented, but patients should inform their healthcare provider of all medications they are ta This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Treprostinil received a safety concern score of 82/100 (high concern). This is based on a 57.9% serious event ratio across 118,637 classified reports. The score accounts for 313,927 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 85,823, Male: 29,944, Unknown: 29. The most frequently reported age groups are age 66 (1,827 reports), age 64 (1,713 reports), age 65 (1,710 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 118,637 classified reports for TREPROSTINIL:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Treprostinil can cause hypotension and should be used with caution in patients with pre-existing cardiovascular conditions. Drug interactions are not well-documented, but patients should inform their healthcare provider of all medications they are ta
If you are taking Treprostinil, here are important things to know. The most commonly reported side effects include dyspnoea, headache, diarrhoea, nausea, cough. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of respiratory distress and cardiovascular issues, especially during the initial dosing period. Inform healthcare providers of any pre-existing conditions, particularly cardiovascular issues, before starting treprostinil. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of treprostinil and has not issued any specific warnings or changes to the labeling based on this data.
The FDA has received approximately 313,927 adverse event reports associated with Treprostinil. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Treprostinil include Dyspnoea, Headache, Diarrhoea, Nausea, Cough. By volume, the top reported reactions are: Dyspnoea (20,295 reports), Headache (16,274 reports), Diarrhoea (13,136 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Treprostinil.
Out of 118,637 classified reports, 68,747 (57.9%) were classified as serious and 49,890 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Treprostinil break down by patient sex as follows: Female: 85,823, Male: 29,944, Unknown: 29. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Treprostinil adverse events are: age 66: 1,827 reports, age 64: 1,713 reports, age 65: 1,710 reports, age 70: 1,696 reports, age 67: 1,691 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Treprostinil adverse event reports is United Therapeutics Corporation. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Treprostinil include: Dizziness, Fatigue, Death, Vomiting, Infusion Site Pain. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Treprostinil to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Treprostinil has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Respiratory issues such as dyspnea and pneumonia are among the most common adverse events.
Key safety signals identified in Treprostinil's adverse event data include: Dyspnea and pneumonia are the most frequently reported reactions.. Hypotension and right ventricular failure are significant cardiovascular concerns.. Death and pulmonary arterial hypertension are serious adverse events.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Treprostinil can cause hypotension and should be used with caution in patients with pre-existing cardiovascular conditions. Drug interactions are not well-documented, but patients should inform their healthcare provider of all medications they are ta Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Treprostinil.
Monitor patients for signs of respiratory distress and cardiovascular issues, especially during the initial dosing period. Inform healthcare providers of any pre-existing conditions, particularly cardiovascular issues, before starting treprostinil.
Treprostinil has 313,927 adverse event reports on file with the FDA. Cardiovascular events, including hypotension and right ventricular failure, are also frequent. The volume of reports for Treprostinil reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of treprostinil and has not issued any specific warnings or changes to the labeling based on this data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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