pharmacopeia
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/api/v1/drug/fluocinolone

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Lipoxygenase Inhibitors.

Lipoxygenase

Indications

Sourced from openFDA
  • Fluocinolone Acetonide Topical Solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications

Sourced from openFDA
  • Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.contraindicated

Dosage & administration

Sourced from openFDA

Fluocinolone Acetonide Solution is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. In hairy sites, the hair should be parted to allow direct contact with the lesion. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Adverse reactions

Sourced from openFDA

The 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

Use in specific populations

Sourced from openFDA

Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Pharmacokinetics

Sourced from openFDA
Metabolism
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin.

Overdosage

Sourced from openFDA

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ) .

Approval history

Sourced from openFDA
  • Feb 15, 1963NDANDA012787Eurofarma
  • Jun 11, 1963ANDAANDA060700Eurofarma
  • Jun 19, 1963NDANDA013960Eurofarma
  • Feb 3, 1988NDANDA019452Hill Dermac
  • Jan 18, 2002NDANDA021112Galderma Labs Lp
  • Apr 8, 2005NDANDA021737Bausch And Lomb
  • Sep 26, 2014NDANDA201923Alimera Sciences Inc
  • Oct 12, 2018NDANDA210331Alimera Sciences Inc

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
4,215 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use60814%
  2. 2Drug Ineffective3819.0%
  3. 3Pruritus2606.2%
  4. 4Erythema2285.4%
  5. 5Product Dose Omission Issue2024.8%
  6. 6Intraocular Pressure Increased2014.8%
  7. 7Rash2004.7%
  8. 8Condition Aggravated1674.0%
  9. 9Device Dislocation1563.7%
  10. 10Device Failure1513.6%
  11. 11Circumstance Or Information Capable Of Leading To Medication Error1433.4%
  12. 12Skin Exfoliation1423.4%
  13. 13No Adverse Event1323.1%
  14. 14Diarrhoea1303.1%
  15. 15Psoriasis1293.1%

Clinical trials

View JSON

The 10 most recently updated of 77 ClinicalTrials.gov registrations naming Fluocinolone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Fluocinolone work?
Mechanism-of-action class: Lipoxygenase Inhibitors.
What is Fluocinolone used for?
According to FDA labeling, Fluocinolone carries indications including: Fluocinolone Acetonide Topical Solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Fluocinolone?
Fluocinolone is classified as Lipoxygenase Inhibitors, Decreased Immunologically Active Molecule Activity, Decreased Protein Synthesis, Vasoconstriction.
What are the brand names for Fluocinolone?
Fluocinolone is marketed under brand names including Capex, Derma-Smoothe FS, Dermotic, Flac, Iluvien, Neo-Synalar, Otovel, Retisert.
What are the contraindications for Fluocinolone?
Fluocinolone labeling lists contraindications including: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.. Always consult the full prescribing information and a clinician.
Note. Data for fluocinolone is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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