Bisoprolol: adverse event reports filed with FDA

22,881

reports as suspect product

0.1% of all reports · about 1,017 a year

1,454

reports, 12 months to June 2026

1,815 in the 12 months before

99.1%

marked serious by the reporter

78.7% across the class

8.6%

record death among outcomes, as reported

1,969 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 reports recording the termmedian drug in beta-adrenergic blocker

1. Dyspnoeashortness of breath10.3%2,357
2. Hypotensionlow blood pressure9.3%2,136
3. Bradycardiaslow heart rate9.1%2,078
4. Dizzinesslight-headedness or unsteadiness7.7%1,772
5. Falla fall7.7%1,752
6. Fatiguetiredness7.1%1,615
7. Drug interactionan interaction between medicines6.8%1,555
8. Acute kidney injurysudden loss of kidney function6.4%1,473
9. Drug ineffectivethe medicine did not work as expected6.3%1,441
10. Atrial fibrillationan irregular heart rhythm5.4%1,240
11. Malaisegeneral feeling of being unwell5.2%1,180
12. Coughcough4.9%1,118
13. Syncopefainting4.9%1,117
14. Astheniaweakness or lack of energy4.9%1,115
15. Nauseafeeling sick4.8%1,087
16. Vomitingbeing sick4.5%1,038
17. Cardiac failureheart failure4.5%1,033
18. Headachehead pain4.1%932
19. Diarrhoealoose or frequent stools3.7%853
20. Blood pressure increaseda raised blood pressure reading3.5%803
21. Oedema peripheralswelling of the legs, ankles or hands3.4%788
22. Painpain, site not specified3.4%777
23. Off label useused for a purpose or in a way not on the label3.4%775
24. Pyrexiafever3.3%756
25. General physical health deteriorationgeneral decline in health3.3%746
26. Hypertensionhigh blood pressure3.2%726
27. Condition aggravatedthe condition being treated got worse3%685
28. Toxicity to various agentspoisoning or toxic effect of one or more substances3%683
29. Palpitationsawareness of the heartbeat3%675
30. Chest painchest pain2.9%657

Top 30 of 2,587 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. 1.6% 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 22,881 reports.

Drugs most often listed in the same reports

Other products listed in reports where Bisoprolol 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 as a suspect or interacting product; reports listing it only as a concomitant medication (80,699) 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.