What the label lists and what reports show
Flunisolide side effects
Flunisolide's FDA label lists its adverse reactions in its own words. FAERS holds 1,488 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 nausea (99 reports).
- Generic listed
Check it at the source: the flunisolide FDA label on DailyMed (effective January 16, 2025, Bausch & Lomb Incorporated); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsAdverse reactions reported in controlled clinical trials and long-term open studies in 595 patients treated with Flunisolide Nasal Solution are described below. Of these patients, 409 were treated for 3 months or longer, 323 for 6 months or longer, 259 for 1 year or longer, and 91 for 2 years or longer. In general, side effects elicited in the clinical studies have been primarily associated with the nasal mucous membranes. The most frequent complaints were those of mild transient nasal burning and stinging, which were reported in approximately 45% of the patients treated with Flunisolide Nasal Solution in placebo-controlled and long-term studies. These complaints do not usually interfere with treatment; in only 3% of patients was it necessary to decrease dosage or stop treatment because of these symptoms. …
Source: FDA drug label, Bausch & Lomb Incorporated, effective January 16, 2025 (SPL set 7c72c954-3758-40c3-9977-d03b25d71e0a), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,488 reports list flunisolide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 100 are coded as a death and 584 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 23 reactions below, 3 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?
- Flunisolide: 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