Opsumitmacitentan
According to the FDA label: OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH ( 1.1 ). 1.1 Pulmonary Arterial Hypertension OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH.
67,845 adverse event reports submitted to the FDA (2011–2026)
Top Reported Adverse Events
The most frequently reported events in association with Opsumit 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 11,817 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 8,182 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Death 7,329 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 →Diarrhoea 6,487 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 5,889 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 4,963 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 4,510 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Dizziness 4,457 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Hospitalisation 4,079 reports
A report that the person was admitted to a hospital. This records that a hospital stay occurred, which is one way the seriousness of an event is tracked. Also spelled hospitalization in American English.
Full definition in the glossary →Cough 3,862 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Fluid Retention 3,808 reports
A buildup of excess fluid in the body, which can cause swelling.
Full definition in the glossary →Malaise 3,571 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Hypotension 3,562 reports
Pulmonary Arterial Hypertension 3,274 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 →Vomiting 3,154 reports
Throwing up the contents of the stomach.
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 | 49,366 |
| Male | 16,207 |
| Unknown | 8 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 1,389 |
| 18-34 | 2,966 |
| 35-49 | 6,698 |
| 50-64 | 13,335 |
| 65-74 | 12,082 |
| 75+ | 9,726 |
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 Opsumit. 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 | 33,606 |
| Non-Serious | 19,423 |
| Other Serious | 15,967 |
| Death | 12,469 |
| Life-Threatening | 1,092 |
| Disability | 656 |
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 Opsumit. 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 |
|---|---|
| 2011 | 3 |
| 2012 | 4 |
| 2013 | 41 |
| 2014 | 1,865 |
| 2015 | 4,343 |
| 2016 | 4,810 |
| 2017 | 5,403 |
| 2018 | 6,645 |
| 2019 | 7,435 |
| 2020 | 6,747 |
| 2021 | 5,158 |
| 2022 | 6,937 |
| 2023 | 6,555 |
| 2024 | 5,890 |
| 2025 | 5,075 |
| 2026 (partial) | 934 |
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 Opsumit
In FDA adverse event reports that mention Opsumit, these medications appeared most often in the same report.
- Treprostinil (22,373 reports)
- Tadalafil (14,542 reports)
- Sildenafil (13,819 reports)
- Selexipag (9,423 reports)
- Riociguat (9,141 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