Propranolol: adverse event reports filed with FDA

13,733

reports as suspect product

0.1% of all reports · about 611 a year

1,177

reports, 12 months to June 2026

1,790 in the 12 months before

87.1%

marked serious by the reporter

78.7% across the class

21.2%

record death among outcomes, as reported

2,915 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 Propranolol reports recording the termmedian drug in beta-adrenergic blocker

1. Off label useused for a purpose or in a way not on the label20.1%2,763
2. Drug ineffectivethe medicine did not work as expected13.7%1,888
3. Product use in unapproved indicationused for a purpose not on the label12.1%1,662
4. Toxicity to various agentspoisoning or toxic effect of one or more substances9.7%1,332
5. Completed suicidedeath by suicide9%1,240
6. Product use issuea problem in how the product was used7.6%1,049
7. Hypotensionlow blood pressure6.7%918
8. Bradycardiaslow heart rate6.4%883
9. Nauseafeeling sick5.8%793
10. Headachehead pain5.6%773
11. Drug interactionan interaction between medicines5.5%757
12. Dizzinesslight-headedness or unsteadiness4.9%670
13. Cardiac arrestthe heart stopped4.6%628
14. Overdosea dose above the recommended amount4.4%599
15. Intentional overdosea deliberate overdose4.2%578
16. Somnolencedrowsiness4.1%557
17. Coma4%552
18. Drug ineffective for unapproved indication3.9%535
19. Fatiguetiredness3.9%535
20. Hyperhidrosisexcessive sweating3.7%512
21. Drug intolerancethe medicine was not tolerated3.7%511
22. Dyspnoeashortness of breath3.6%499
23. Cardio-respiratory arrestthe heart and breathing stopped3.5%481
24. Nightmarenightmares3.3%450
25. Sedationdrowsiness from a medicine3.1%430
26. Vomitingbeing sick3.1%428
27. Diarrhoealoose or frequent stools3%408
28. Falla fall2.7%373
29. Nephrolithiasiskidney stones2.5%347
30. Astheniaweakness or lack of energy2.5%345

Top 30 of 1,653 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. 36.8% 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 13,733 reports.

Drugs most often listed in the same reports

Other products listed in reports where Propranolol 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 Propranolol as a suspect or interacting product; reports listing it only as a concomitant medication (34,484) 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.