What the label lists and what reports show
Fluocinonide side effects
Fluocinonide's FDA label lists its adverse reactions in its own words. FAERS holds 5,594 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 psoriasis (545 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the fluocinonide FDA label on DailyMed (effective September 30, 2024, Teva Pharmaceuticals USA, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects with fluocinonide cream?Fluocinonide cream may cause side effects, including: • Symptoms of a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment or after stopping treatment. Your doctor may do blood tests to check you for adrenal insufficiency while you are using fluocinonide cream. Tell your doctor if you have any of these symptoms of adrenal insufficiency: o tiredness that worsens and does not go away o nausea or vomiting o dizziness or fainting o muscle weakness o irritability and depression o loss of appetite o weight loss • Cushing’s syndrome, when the body is exposed to too much of the hormone cortisol. Your doctor may do tests to check for this. […]
Source: FDA drug label (Fluocinonide), Glenmark Pharmaceuticals Inc., USA, effective September 30, 2014 (SPL set 50f1c216-78c6-4b93-b732-b3beeb78bd62), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Perioral dermatitis Itching Allergic contact dermatitis Irritation Maceration of the skin Dryness Secondary infection Folliculitis Skin atrophy Hypertrichosis Striae Acneiform eruptions Miliaria Hypopigmentation
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the Fluocinonide label published by Glenmark Pharmaceuticals Inc., USA of September 30, 2014; the label quoted above does not print one.
| Adverse Reaction | Fluocinonide cream once daily (n=216) | Fluocinonide cream twice daily (n=227) | Vehicle Cream once or twice daily (n=211) |
|---|---|---|---|
| Headache | 8 (3.7%) | 9 (4.0%) | 6 (2.8%) |
| Application Site Burning | 5 (2.3%) | 4 (1.8%) | 14 (6.6%) |
| Naso-pharyngitis | 2 (0.9%) | 3 (1.3%) | 3 (1.4%) |
| Nasal Congestion | 3 (1.4%) | 1 (0.4%) | 0 |
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, Teva Pharmaceuticals USA, Inc., effective September 30, 2024 (SPL set 986c1ba3-2103-4773-a35c-2c0121a01783), via openFDA; the full label on DailyMed
What do FAERS reports show?
5,594 reports list fluocinonide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 259 are coded as a death and 1,021 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 19 reactions below, 2 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?
- Fluocinonide: 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