Letairisambrisentan
123,381 adverse event reports submitted to the FDA (2007–2026)
Top Reported Adverse Events
The most frequently reported events in association with Letairis 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
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Dyspnoea 19,050 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Death 11,318 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 →Headache 10,681 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 7,229 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Diarrhoea 7,038 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 →Fatigue 6,540 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 6,494 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 6,476 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fluid Retention 5,450 reports
A buildup of excess fluid in the body, which can cause swelling.
Full definition in the glossary →Malaise 5,304 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Cough 4,576 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Oedema Peripheral 4,178 reports
Swelling in the arms, legs, hands, or feet caused by fluid buildup. Oedema is also spelled edema in American English.
Full definition in the glossary →Peripheral Swelling 4,008 reports
Swelling in the arms, legs, hands, or feet, often from fluid buildup.
Full definition in the glossary → See all drugs reporting this event →Chest Pain 3,823 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 →Nasal Congestion 3,790 reports
A stuffy or blocked nose.
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 | 91,723 |
| Male | 29,394 |
| Unknown | 172 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 2,734 |
| 18-34 | 5,554 |
| 35-49 | 14,247 |
| 50-64 | 28,262 |
| 65-74 | 21,583 |
| 75+ | 17,299 |
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 Letairis. 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 | 52,118 |
| Other Serious | 44,113 |
| Non-Serious | 43,378 |
| Death | 16,948 |
| Life-Threatening | 1,121 |
| Disability | 659 |
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 Letairis. 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 |
|---|---|
| 2007 | 67 |
| 2008 | 595 |
| 2009 | 883 |
| 2010 | 1,542 |
| 2011 | 2,831 |
| 2012 | 4,290 |
| 2013 | 9,021 |
| 2014 | 27,939 |
| 2015 | 9,463 |
| 2016 | 9,456 |
| 2017 | 9,414 |
| 2018 | 9,831 |
| 2019 | 8,079 |
| 2020 | 4,916 |
| 2021 | 4,551 |
| 2022 | 5,429 |
| 2023 | 5,506 |
| 2024 | 5,133 |
| 2025 | 3,765 |
| 2026 (partial) | 670 |
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 Letairis
In FDA adverse event reports that mention Letairis, these medications appeared most often in the same report.
- Treprostinil (33,701 reports)
- Tadalafil (29,934 reports)
- Sildenafil (21,298 reports)
- Furosemide (11,374 reports)
- Selexipag (7,704 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