Remodulintreprostinil
According to the FDA label: Treprostinil injection is a prostacyclin vasodilator indicated for: Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).
62,303 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Remodulin in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Dyspnoea 9,546 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Headache 6,850 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 6,626 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Nausea 5,946 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Infusion Site Pain 5,586 reports
Pain at the spot where a medication was given through an IV infusion.
Full definition in the glossary →Death 5,126 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Fatigue 3,843 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Dizziness 3,659 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Vomiting 3,283 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →- Infusion Site Erythema 3,219 reports
Pain in Extremity 2,863 reports
Pain in an arm or leg.
Full definition in the glossary →Pulmonary Arterial Hypertension 2,776 reports
High blood pressure in the arteries of the lungs, which makes the heart work harder. It often appears in reports as a condition being treated.
Full definition in the glossary →Hypotension 2,731 reports
Malaise 2,723 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Pneumonia 2,587 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 46,617 |
| Male | 13,735 |
| Unknown | 19 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 2,639 |
| 18-34 | 4,277 |
| 35-49 | 8,501 |
| 50-64 | 12,806 |
| 65-74 | 7,738 |
| 75+ | 3,432 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Remodulin. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Hospitalization | 29,936 |
| Non-Serious | 22,045 |
| Other Serious | 17,089 |
| Death | 8,810 |
| Life-Threatening | 1,237 |
| Disability | 151 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Remodulin. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 31 |
| 2005 | 58 |
| 2006 | 86 |
| 2007 | 39 |
| 2008 | 30 |
| 2009 | 63 |
| 2010 | 889 |
| 2011 | 1,615 |
| 2012 | 643 |
| 2013 | 998 |
| 2014 | 4,571 |
| 2015 | 5,440 |
| 2016 | 4,819 |
| 2017 | 4,835 |
| 2018 | 5,286 |
| 2019 | 4,950 |
| 2020 | 4,256 |
| 2021 | 4,001 |
| 2022 | 4,300 |
| 2023 | 5,018 |
| 2024 | 4,575 |
| 2025 | 4,841 |
| 2026 (partial) | 959 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Remodulin
In FDA adverse event reports that mention Remodulin, these medications appeared most often in the same report.
- Ambrisentan (17,125 reports)
- Tadalafil (16,557 reports)
- Sildenafil (15,093 reports)
- Macitentan (13,041 reports)
- Furosemide (6,275 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026