Acebutolol hydrochloride: adverse event reports filed with FDA

965

reports as suspect product

0% of all reports · about 43 a year

34

reports, 12 months to June 2026

26 in the 12 months before

96.1%

marked serious by the reporter

78.7% across the class

2.2%

record death among outcomes, as reported

21 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 Acebutolol hydrochloride reports recording the termmedian drug in beta-adrenergic blocker

1. Cognitive disorderproblems with thinking or memory64.8%625
2. Falla fall61.3%592
3. Orthostatic hypotension59.5%574
4. Balance disorderproblems with balance58.7%566
5. Hypotensionlow blood pressure57.8%558
6. Constipationconstipation57.7%557
7. Sedationdrowsiness from a medicine56.1%541
8. Mobility decreasedreduced ability to move about53.5%516
9. Depressed level of consciousness52.3%505
10. Sedation complication51.2%494
11. Blood calcium decreased50.4%486
12. Creatinine renal clearance decreased50.4%486
13. Painpain, site not specified49.8%481
14. Toxicity to various agentspoisoning or toxic effect of one or more substances48.9%472
15. Drug ineffectivethe medicine did not work as expected15.2%147
16. Hypertensionhigh blood pressure13.1%126
17. Multiple drug therapy10.2%98
18. Dyspnoeashortness of breath9.9%96
19. Drug intolerancethe medicine was not tolerated9.5%92
20. Asthmaasthma9.2%89
21. Drug interactionan interaction between medicines8.7%84
22. Psoriasispsoriasis, a skin condition8.2%79
23. Arthritis8%77
24. Depressionlow mood8%77
25. Endometriosisendometriosis8%77
26. Migrainemigraine8%77
27. Off label useused for a purpose or in a way not on the label8%77
28. Chronic kidney diseaselong-term kidney disease7.8%75
29. Product use in unapproved indicationused for a purpose not on the label7%68
30. Renal function test abnormal6.8%66

Top 30 of 117 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. 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 965 reports.

Drugs most often listed in the same reports

Other products listed in reports where Acebutolol hydrochloride 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 Acebutolol hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (383) 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.