Fluocinonide: uses, dosing, side effects & brands

How fluocinonide is dosed

From the FDA label for Fluocinonide (application ANDA211111). Other fluocinonide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

For topical use only. Fluocinonide Cream, 0.1% is not for ophthalmic, oral, or intravaginal use. For psoriasis, apply a thin layer of Fluocinonide Cream, 0.1% once or twice daily to the affected skin areas as directed by a physician. Twice daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment. For atopic dermatitis, apply a thin layer of Fluocinonide Cream, 0.1% once daily to the affected skin areas as directed by a physician. Once daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [see Clinical Studies (14) ] . For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of Fluocinonide Cream, 0.1% once or twice daily to the affected areas as directed by a physician. For topical use only. Fluocinonide Cream, 0.1% is not for ophthalmic, oral, or intravaginal use. (2) Psoriasis: apply a thin layer once or twice daily to the affected skin areas. (2) Atopic Dermatitis: apply a thin layer once daily to the affected skin areas. (2) Corticosteroid Responsive Dermatoses, other than psoriasis or atopic dermatitis: apply a thin layer once or twice daily to the affected areas. (2)

Fluocinonide side effects

The most commonly reported adverse reactions (≥1%) were headache, application site burning, nasopharyngitis, and nasal congestion. (6) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 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 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, 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%) Nasopharyngitis 2 (0.9%) 3 (1.3%) 3 (1.4%) Nasal Congestion 3 (1.4%) 1 (0.4%) 0 Safety in patients 12 to 17 years of age was similar to that observed in adults. 6.2 Postmarketing Experience The following adverse reactions have been identified during post…

Every fluocinonide product we track (5)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Fluocinonide recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

• Fluocinonide

  Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

  SUN PHARMACEUTICAL INDUSTRIES INC · Mar 25, 2026

• Fluocinonide

  Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

  SUN PHARMACEUTICAL INDUSTRIES INC · Mar 25, 2026

• Fluocinonide

  Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

  SUN PHARMACEUTICAL INDUSTRIES INC · Mar 25, 2026