Bisoprolol fumarate: adverse event reports filed with FDA

8,292

reports as suspect product

0% of all reports · about 369 a year

546

reports, 12 months to June 2026

663 in the 12 months before

98.2%

marked serious by the reporter

78.7% across the class

11.5%

record death among outcomes, as reported

950 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 Bisoprolol fumarate reports recording the termmedian drug in beta-adrenergic blocker

1. Dyspnoeashortness of breath12.7%1,049
2. Fatiguetiredness11.2%931
3. Dizzinesslight-headedness or unsteadiness10.6%882
4. Malaisegeneral feeling of being unwell10.2%844
5. Nauseafeeling sick9.6%797
6. Vomitingbeing sick9.1%753
7. Hypotensionlow blood pressure8.7%725
8. Diarrhoealoose or frequent stools8.3%686
9. Falla fall8%666
10. Headachehead pain7.8%650
11. Pruritusitching7.7%636
12. Bradycardiaslow heart rate7.6%633
13. Arthralgiajoint pain7.2%594
14. Tachycardiafast heart rate7.1%592
15. Pyrexiafever6.8%563
16. Drug interactionan interaction between medicines6.6%550
17. Insomniadifficulty sleeping6.6%550
18. Off label useused for a purpose or in a way not on the label6.6%548
19. Blindnessloss of sight6%498
20. Syncopefainting5.9%493
21. Tinnitusringing in the ears5.9%486
22. Abdominal pain upperupper stomach pain5.8%480
23. Astheniaweakness or lack of energy5.7%474
24. Chest painchest pain5.7%470
25. Diplopiadouble vision5.6%465
26. Myocardial infarctionheart attack5.3%437
27. Drug ineffectivethe medicine did not work as expected5.2%434
28. Dehydrationdehydration5.2%428
29. Painpain, site not specified5.2%428
30. Anxietyanxiety5.1%427

Top 30 of 1,488 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 22 drugs in the beta-adrenergic 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 148,208 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. 3% 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 8,292 reports.

Drugs most often listed in the same reports

Other products listed in reports where Bisoprolol fumarate 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 beta-adrenergic 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 Bisoprolol fumarate as a suspect or interacting product; reports listing it only as a concomitant medication (26,949) 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.