What the label lists and what reports show
Flurbiprofen side effects
Flurbiprofen's FDA label lists its adverse reactions in its own words. FAERS holds 1,567 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is angioedema (89 reports).
- Generic listed
Check it at the source: the flurbiprofen FDA label on DailyMed (effective July 24, 2024, Bausch & Lomb Incorporated); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of NSAIDs?NSAIDs can cause serious side effects, including: See " What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? new or worse high blood pressure heart failure liver problems including liver failure kidney problems including kidney failure low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness. […]
Source: FDA drug label (Flurbiprofen), Genus Lifesciences, effective February 3, 2026 (SPL set 4670cf21-eb0e-4f5a-ab22-41af85733525), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsTransient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of flurbiprofen sodium ophthalmic solution. Other adverse reactions reported with the use of flurbiprofen sodium ophthalmic solution include: fibrosis, hyphema, miosis, mydriasis, and ocular hyperemia. Increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported [see Warnings ]. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Source: FDA drug label, Bausch & Lomb Incorporated, effective July 24, 2024 (SPL set 11db354f-caf9-4567-811e-6c9beb1330c7), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,567 reports list flurbiprofen among the medicines taken, each a report of something that happened, not proof the medicine caused it; 185 are coded as a death and 627 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Flurbiprofen: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions