Tenormin: adverse event reports filed with FDA

1,786

reports as suspect product

0% of all reports · about 79 a year

14

reports, 12 months to June 2026

28 in the 12 months before

80.2%

marked serious by the reporter

78.7% across the class

5.8%

record death among outcomes, as reported

103 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 Tenormin reports recording the termmedian drug in beta-adrenergic blocker

1. Bradycardiaslow heart rate8.8%158
2. Drug ineffectivethe medicine did not work as expected6.7%119
3. Drug interactionan interaction between medicines6.3%112
4. Hypertensionhigh blood pressure5.4%96
5. Hypotensionlow blood pressure5.4%96
6. Dizzinesslight-headedness or unsteadiness5.3%94
7. Malaisegeneral feeling of being unwell4.6%83
8. Dyspnoeashortness of breath4%72
9. Falla fall3.9%70
10. Blood pressure increaseda raised blood pressure reading3.5%62
11. Headachehead pain3.3%59
12. Atrial fibrillationan irregular heart rhythm3.2%57
13. Fatiguetiredness3.2%57
14. Syncopefainting3.1%55
15. Loss of consciousnesspassing out2.9%51
16. Astheniaweakness or lack of energy2.7%49
17. Drug hypersensitivityan allergic-type reaction to a medicine2.5%45
18. Off label useused for a purpose or in a way not on the label2.2%39
19. Nauseafeeling sick2.1%38
20. Renal failurekidney failure2.1%37
21. Palpitationsawareness of the heartbeat2%36
22. Arthralgiajoint pain2%35
23. Chest painchest pain2%35
24. Suicide attempta suicide attempt1.9%34
25. Paraesthesiatingling or pins and needles1.8%33
26. Intentional overdosea deliberate overdose1.8%32
27. Sinus bradycardia1.8%32
28. Diarrhoealoose or frequent stools1.7%30
29. Coughcough1.6%29
30. Orthostatic hypotension1.6%28

Top 30 of 596 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. 34.9% 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 1,786 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 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 Tenormin as a suspect or interacting product; reports listing it only as a concomitant medication (8,357) 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.