Adempas: adverse event reports filed with FDA

18,593

reports as suspect product

0.1% of all reports · about 1,275 a year

956

reports, 12 months to June 2026

1,709 in the 12 months before

82.6%

marked serious by the reporter

81% across the class

29%

record death among outcomes, as reported

5,394 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Adempas reports recording the termmedian drug in soluble guanylate cyclase stimulator

1. Deaththe patient died; cause not stated by this term24.3%4,520
2. Dyspnoeashortness of breath15.6%2,899
3. Headachehead pain13.2%2,462
4. Dizzinesslight-headedness or unsteadiness12%2,228
5. Hypotensionlow blood pressure11.9%2,219
6. Nauseafeeling sick10.9%2,018
7. Hospitalisationadmission to hospital10.2%1,892
8. Diarrhoealoose or frequent stools9.6%1,785
9. Fatiguetiredness8.9%1,649
10. Vomitingbeing sick6.1%1,134
11. Peripheral swellingswelling of the arms or legs5.5%1,024
12. Oedema peripheralswelling of the legs, ankles or hands5.4%998
13. Fluid retentionthe body holding extra fluid4.9%914
14. Coughcough4.9%907
15. Dyspepsiaindigestion4.7%865
16. Dyspnoea exertional4.4%822
17. Malaisegeneral feeling of being unwell4.4%821
18. Astheniaweakness or lack of energy4.2%789
19. Pneumonialung infection4.2%781
20. Chest painchest pain4%746
21. Falla fall3.7%689
22. Pain in extremitypain in an arm or leg3.6%669
23. Blood pressure decreaseda low blood pressure reading3.5%646
24. Syncopefainting3.4%641
25. Oxygen saturation decreased3.4%633
26. Oedemaswelling from fluid3.3%622
27. Decreased appetitereduced appetite3.3%607
28. Painpain, site not specified3.2%595
29. Weight decreasedweight loss3.2%589
30. Feeling abnormalfeeling odd or not right3%558

Top 30 of 1,543 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the soluble guanylate cyclase stimulator class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 19,864 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 85% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 18,593 reports.

Drugs most often listed in the same reports

Other products listed in reports where Adempas is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the soluble guanylate cyclase stimulator class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Adempas as a suspect or interacting product; reports listing it only as a concomitant medication (11,934) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.