This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. ( 1 ) Limitation of Use: Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. ( 1 ) Avoid use on the face, groin, or axillae. ( 1.2 ) Avoid use in perioral dermatitis or rosacea. 1.1 Indication Fluocinonide cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [ see Use in Specific Populations (8.4) ]. 1.2 Limitation of Use Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of fluocinonide cream USP, 0.1% for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is see...
None. None ( 4 )
Fluocinonide cream USP, 0.1% has been shown to suppress the HPA axis. Systemic absorption of fluocinonide cream USP, 0.1% may produce reversible hypothalamic-pituitaryadrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia and unmask latent diabetes ( 5.1 ) Systemic absorption may require evaluation for HPA axis suppression ( 5.1 ) Modify use should HPA axis suppression develop ( 5.1 ) Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption ( 5.3 ) Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation and allergic contact dermatitis and may be more likely to occur with occlusive use or more potent corticosteroids ( 5.3 ) Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 ) 5.1 Effect on Endocrine System Systemic absorption of topical corticosteroids, including fluocinonide cream USP, 0.1%, can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topica...
The most commonly reported adverse reactions (≥1%) were headache, application site burning, nasopharyngitis, and nasal congestion. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In clinical trials, a total of 443 adult subjects with atopic dermatitis or plaque-type psoriasis were treated once daily or twice daily with fluocinonide cream USP, 0.1% for 2 weeks. The most commonly observed adverse reactions in these clinical trials were as follows: Table 1: Most Commonly Observed Adverse Reactions (≥1%) in Adult Clinical Trials Adverse Reaction Fluocinonide Cream USP, 0.1%, once daily (n=216) Fluocinonide Cream USP, 0.1%, 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%) Nasopharyngitis...
Source: FDA SPL label for Fluocinonide (Sun Pharmaceutical Industries, Inc.), effective 20250703. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 525 | 516 | 386 | 400 | 923 | 439 | 427 | 220 |
1,478 reports blaming this drug for every million Medicare prescriptions filled, which is 0.5× the typical drug on this site. (1,085 reports in 2024–2026, against 733,992 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 03/2026 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. |
| 03/2026 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. |
| 03/2026 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. |
| 09/2017 | Class III | Taro Pharmaceuticals U.S.A., Inc. | Cross contamination with other products: traces of Dapsone were found in the finished product. |
| 03/2017 | Class III | Taro Pharmaceuticals U.S.A., Inc. | Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Fluocinonide | 733,978 | $43 |
| Vanos | 14 | $2,463 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.