Bromfenac: adverse event reports filed with FDA

673

reports as suspect product

0% of all reports · about 48 a year

39

reports, 12 months to June 2026

33 in the 12 months before

12.6%

marked serious by the reporter

71.8% across the class

0%

record death among outcomes, as reported

0 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 Bromfenac reports recording the termmedian drug in nonsteroidal anti-inflammatory drug

1. Treatment failurethe treatment did not work21.7%146
2. Product packaging quantity issue10.8%73
3. Product dose omission issuea dose was missed8.3%56
4. Off label useused for a purpose or in a way not on the label8.2%55
5. Eye irritationeye irritation7%47
6. Eye paineye pain6.1%41
7. Drug ineffectivethe medicine did not work as expected5.8%39
8. Product storage errorthe product was stored wrongly5.2%35
9. Product use issuea problem in how the product was used4.2%28
10. Poor quality product administered3.7%25
11. Product quality issuea problem with the product itself3.4%23
12. Product dose omissiona dose was missed3.3%22
13. Extra dose administered2.8%19
14. Product container issuea problem with the container2.7%18
15. Drug prescribing errora prescribing mistake2.2%15
16. Drug dose omissiona dose was missed2.1%14
17. No adverse eventno adverse event was reported2.1%14
18. Circumstance or information capable of leading to medication errora situation that could lead to a medication error1.9%13
19. Vision blurredblurred vision1.9%13
20. Incorrect dose administeredthe wrong dose was given1.8%12
21. Liquid product physical issue1.8%12
22. Product physical consistency issue1.6%11
23. Product physical issuea physical defect in the product1.6%11
24. Visual impairmentreduced vision1.5%10
25. Product dispensing error1.3%9
26. Headachehead pain1.2%8
27. Ocular hyperaemiaa red eye1%7
28. Painpain, site not specified1%7
29. Foreign body sensation in eyes0.9%6
30. Inappropriate schedule of product administrationthe product was taken at the wrong times0.9%6

Top 30 of 115 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 47 drugs in the nonsteroidal anti-inflammatory drug 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 548,672 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. 95.5% 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 673 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 nonsteroidal anti-inflammatory drug 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 Bromfenac as a suspect or interacting product; reports listing it only as a concomitant medication (323) 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.