Filspari: adverse event reports filed with FDA

5,598

reports as suspect product

0% of all reports · about 1,642 a year

2,908

reports, 12 months to June 2026

1,531 in the 12 months before

16.1%

marked serious by the reporter

67.6% across the class

0.5%

record death among outcomes, as reported

28 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 Filspari reports recording the termmedian drug in angiotensin 2 receptor blocker

1. Dizzinesslight-headedness or unsteadiness14.7%824
2. Fatiguetiredness13.6%759
3. Hypotensionlow blood pressure11.3%633
4. Nauseafeeling sick6.9%387
5. Product use in unapproved indicationused for a purpose not on the label6.4%359
6. Off label useused for a purpose or in a way not on the label6%338
7. Headachehead pain5.8%326
8. Product administration errora mistake in giving the product5.7%321
9. Peripheral swellingswelling of the arms or legs5.4%300
10. Pruritusitching5%280
11. Product dose omission issuea dose was missed4.1%228
12. Blood pressure decreaseda low blood pressure reading3.8%211
13. Glomerular filtration rate decreasedreduced kidney filtering3.7%207
14. Blood creatinine increasedraised creatinine, a kidney test3.5%194
15. Drug ineffectivethe medicine did not work as expected3.4%192
16. Hypertensionhigh blood pressure3.2%180
17. Blood potassium increased3.1%172
18. Abdominal pain upperupper stomach pain3%166
19. Nasopharyngitisa cold2.9%160
20. Vomitingbeing sick2.9%160
21. Joint swellinga swollen joint2.7%152
22. Renal impairmentreduced kidney function2.7%152
23. Abdominal discomfortstomach discomfort2.7%151
24. Feeling abnormalfeeling odd or not right2.7%151
25. Dyspnoeashortness of breath2.6%146
26. Illness2.5%141
27. Diarrhoealoose or frequent stools2.4%135
28. Arthralgiajoint pain2.4%134
29. Astheniaweakness or lack of energy2.3%131
30. Back painback pain2.3%131

Top 30 of 643 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 24 drugs in the angiotensin 2 receptor blocker 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 243,200 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. 95.7% 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 5,598 reports.

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 angiotensin 2 receptor blocker 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 Filspari as a suspect or interacting product; reports listing it only as a concomitant medication (194) 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.