Adcircatadalafil
According to the FDA label: ADCIRCA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).
73,505 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Adcirca 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 11,291 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 9,273 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 7,312 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 6,024 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Death 5,366 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 5,066 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 4,553 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Cough 4,062 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 4,003 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Malaise 3,457 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Vomiting 3,225 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Fluid Retention 3,090 reports
A buildup of excess fluid in the body, which can cause swelling.
Full definition in the glossary →Pulmonary Arterial Hypertension 2,821 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 →Pain 2,782 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Pain in Extremity 2,764 reports
Pain in an arm or leg.
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 | 47,985 |
| Male | 22,412 |
| Unknown | 36 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 2,413 |
| 18-34 | 4,020 |
| 35-49 | 7,940 |
| 50-64 | 15,155 |
| 65-74 | 12,271 |
| 75+ | 8,967 |
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 Adcirca. 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 | 32,824 |
| Other Serious | 24,167 |
| Non-Serious | 23,544 |
| Death | 9,781 |
| Life-Threatening | 1,497 |
| Disability | 787 |
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 Adcirca. 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 | 24 |
| 2005 | 13 |
| 2006 | 15 |
| 2007 | 37 |
| 2008 | 26 |
| 2009 | 49 |
| 2010 | 206 |
| 2011 | 788 |
| 2012 | 1,251 |
| 2013 | 1,755 |
| 2014 | 6,366 |
| 2015 | 6,085 |
| 2016 | 5,849 |
| 2017 | 5,783 |
| 2018 | 6,736 |
| 2019 | 5,852 |
| 2020 | 4,944 |
| 2021 | 4,659 |
| 2022 | 4,940 |
| 2023 | 5,542 |
| 2024 | 5,548 |
| 2025 | 5,822 |
| 2026 (partial) | 1,215 |
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 Adcirca
In FDA adverse event reports that mention Adcirca, these medications appeared most often in the same report.
- Treprostinil (30,296 reports)
- Ambrisentan (29,615 reports)
- Macitentan (14,406 reports)
- Furosemide (9,240 reports)
- Selexipag (8,287 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