What the label lists and what reports show
Fluocinolone side effects
Fluocinolone's FDA label lists its adverse reactions in its own words. FAERS holds 3,748 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 pruritus (217 reports).
- Generic listed
Check it at the source: the fluocinolone FDA label on DailyMed (effective February 26, 2023, Quagen Pharmaceuticals LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with fluocinolone acetonide topical oil, 0.01%. …
Table 1: Adverse Reactions in ≥2% Pediatric Subjects 3 Months to 2 Years of Age Treated with the Formulation of DERMA-SMOOTHE/FS Scalp Oil, N=30 Includes one subject who withdrew at Week 2
This table is printed in the DERMA-SMOOTHE/FS label published by Royal Pharmaceuticals of June 9, 2026; the label quoted above does not print one.
| Adverse Reaction | n (%) |
|---|---|
| Cough | 6 (20) |
| Rhinorrhea | 4 (13) |
| Pyrexia | 3 (10) |
| Nasopharyngitis | 2 (7) |
| Hypopigmentation | 2 (7) |
| Abscess | 1 (3) |
| Atopic Dermatitis | 1 (3) |
| Eczema | 1 (3) |
| Hyperpigmentation | 1 (3) |
| Molluscum | 1 (3) |
| Rash | 1 (3) |
| Diarrhea | 1 (3) |
| Otitis Media | 1 (3) |
| URI | 1 (3) |
| Vomiting | 1 (3) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Quagen Pharmaceuticals LLC, effective February 26, 2023 (SPL set fa5eba5b-57bf-4d46-b0e1-c7104542cb46), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,748 reports list fluocinolone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 69 are coded as a death and 429 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 18 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?
- Fluocinolone: 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