Tyvasotreprostinil
According to the FDA label: Tyvaso is a prostacyclin mimetic indicated for the treatment of: Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). ( 1.1 ) Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.
42,693 adverse event reports submitted to the FDA (2005–2026)
Top Reported Adverse Events
The most frequently reported events in association with Tyvaso 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.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Dyspnoea 8,304 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Cough 6,385 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Headache 6,181 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 3,953 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 →Dizziness 3,836 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Nausea 3,818 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fatigue 3,659 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Death 3,339 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 →Off Label Use 3,264 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Pneumonia 2,288 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Hypotension 2,228 reports
Oxygen Saturation Decreased 2,024 reports
A reading showing a lower than normal level of oxygen in the blood.
Full definition in the glossary →Malaise 2,019 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Fluid Retention 1,955 reports
A buildup of excess fluid in the body, which can cause swelling.
Full definition in the glossary →Chest Pain 1,855 reports
Pain or discomfort in the chest. Chest pain has many causes, but it is always worth taking seriously and discussing with a doctor.
Full definition in the glossary → See all drugs reporting this event →
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 | 29,408 |
| Male | 12,302 |
| Unknown | 14 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 744 |
| 18-34 | 1,274 |
| 35-49 | 3,492 |
| 50-64 | 7,701 |
| 65-74 | 7,194 |
| 75+ | 6,008 |
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 Tyvaso. 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 | 17,475 |
| Non-Serious | 17,283 |
| Other Serious | 12,050 |
| Death | 5,666 |
| Life-Threatening | 582 |
| Disability | 128 |
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 Tyvaso. 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 |
|---|---|
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 9 |
| 2010 | 253 |
| 2011 | 804 |
| 2012 | 912 |
| 2013 | 811 |
| 2014 | 4,869 |
| 2015 | 4,314 |
| 2016 | 3,283 |
| 2017 | 2,627 |
| 2018 | 2,678 |
| 2019 | 2,668 |
| 2020 | 2,388 |
| 2021 | 2,920 |
| 2022 | 3,965 |
| 2023 | 3,405 |
| 2024 | 3,084 |
| 2025 | 3,074 |
| 2026 (partial) | 622 |
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 Tyvaso
In FDA adverse event reports that mention Tyvaso, these medications appeared most often in the same report.
- Ambrisentan (12,416 reports)
- Sildenafil (10,622 reports)
- Tadalafil (10,450 reports)
- Macitentan (6,986 reports)
- 0xygen (4,430 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