Drug
Bromfenac
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Product Packaging Quantity Issue | 73 | 141.2 | 152.2 | signal |
| 2 | Poor Quality Product Administered | 27 | 55.5 | 57.0 | signal |
| 3 | Treatment Failure | 146 | 37.4 | 43.6 | signal |
| 4 | Eye Inflammation | 12 | 26.7 | 27.0 | signal |
| 5 | Vitreous Floaters | 11 | 23.7 | 24.0 | signal |
| 6 | Eye Pain | 62 | 23.6 | 25.1 | signal |
| 7 | Eye Irritation | 57 | 21.5 | 22.7 | signal |
| 8 | Product Packaging Issue | 8 | 18.1 | 18.2 | signal |
| 9 | Drug Prescribing Error | 15 | 16.2 | 16.4 | signal |
| 10 | Ocular Discomfort | 8 | 15.5 | 15.6 | signal |
| 11 | Intraocular Pressure Increased | 9 | 14.7 | 14.8 | signal |
| 12 | Product Physical Issue | 13 | 13.7 | 13.9 | signal |
| 13 | Lacrimation Increased | 19 | 13.3 | 13.6 | signal |
| 14 | Ocular Hyperaemia | 25 | 11.2 | 11.5 | signal |
| 15 | Extra Dose Administered | 21 | 11.0 | 11.3 | signal |
| 16 | Circumstance Or Information Capable Of Leading To Medication Error | 17 | 10.6 | 10.8 | signal |
| 17 | Product Dispensing Error | 10 | 9.6 | 9.7 | signal |
| 18 | Impaired Healing | 15 | 9.6 | 9.7 | signal |
| 19 | Product Use Complaint | 7 | 9.5 | 9.5 | signal |
| 20 | Product Administration Error | 9 | 9.5 | 9.5 | signal |
| 21 | Product Storage Error | 39 | 9.5 | 9.8 | signal |
| 22 | Uveitis | 6 | 9.3 | 9.4 | signal |
| 23 | Retinal Detachment | 4 | 9.1 | 9.2 | signal |
| 24 | Paranoia | 7 | 8.5 | 8.5 | signal |
| 25 | Rebound Effect | 4 | 7.4 | 7.4 | signal |
| 26 | Drug Reaction With Eosinophilia And Systemic Symptoms | 9 | 7.4 | 7.4 | signal |
| 27 | Product Dose Omission | 23 | 7.3 | 7.4 | signal |
| 28 | Madarosis | 4 | 7.2 | 7.2 | signal |
| 29 | Hallucination, Visual | 7 | 7.0 | 7.0 | signal |
| 30 | Mydriasis | 4 | 6.5 | 6.6 | signal |
| 31 | Device Defective | 4 | 5.2 | 5.2 | signal |
| 32 | Eye Pruritus | 8 | 5.1 | 5.1 | signal |
| 33 | Product Quality Issue | 27 | 4.2 | 4.3 | signal |
| 34 | Incorrect Product Administration Duration | 4 | 4.1 | 4.1 | signal |
| 35 | Incorrect Drug Administration Duration | 3 | 2.2 | 2.2 | no signal |