Fluocinolone
/api/v1/drug/fluocinoloneMechanism of action
Sourced from openFDAMechanism-of-action class: Lipoxygenase Inhibitors.
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 openFDAFluocinolone 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 openFDAThe 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 openFDAPregnancy 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 openFDATopically 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
- 1Off Label Use60814%
- 2Drug Ineffective3819.0%
- 3Pruritus2606.2%
- 4Erythema2285.4%
- 5Product Dose Omission Issue2024.8%
- 6Intraocular Pressure Increased2014.8%
- 7Rash2004.7%
- 8Condition Aggravated1674.0%
- 9Device Dislocation1563.7%
- 10Device Failure1513.6%
- 11Circumstance Or Information Capable Of Leading To Medication Error1433.4%
- 12Skin Exfoliation1423.4%
- 13No Adverse Event1323.1%
- 14Diarrhoea1303.1%
- 15Psoriasis1293.1%
Clinical trials
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.
- Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation RetinopathyRecruiting · Phase 3 · Interventional · 600 enrolled · Jaeb Center for Health ResearchNCT05844982updated 2026-05-18
- Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective StudyRecruiting · Phase 4 · Interventional · 250 enrolled · Wake Forest University Health SciencesNCT04207931updated 2026-03-31
- The Therapeutic Effect of Curcumin in Nanogels Compared to 0.1% FAO in the Management of Oral Lichen PlanusRecruiting · Interventional · 30 enrolled · Chulalongkorn UniversityNCT06932848updated 2026-03-06
- Frequency and Intensity of Inflammatory Relapses in Patients With Non-infectious Posterior Uveitis Treated With a Fluocinolone Acetonide ImplantNot yet recruiting · Observational · 100 enrolled · Nantes University HospitalNCT07423442updated 2026-02-20
- Imaging of Uveitis Patients Receiving Injectable Fluocinolone Acetonide ImplantCompleted · Observational · 30 enrolled · The Cleveland ClinicNCT04340505updated 2026-02-05
- Comparison of Efficacy of Metformin Gel 30% vs Triple Combination Cream (Hydroquinone 4%, Flucinolone Acetonide 0.01%, Tretinoin 0.025%) in Treatment of Melasma in Tertiary Care Hospital KarachiCompleted · Interventional · 34 enrolled · Jinnah Postgraduate Medical CentreNCT07345507updated 2026-01-21
- A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic DermatitisActive not recruiting · Phase 3 · Interventional · 1,533 enrolled · AbbVieNCT03568318updated 2025-12-23
- Baricitinib Versus Azathioprine in Patients With Moderate-to-Severe Atopic DermatitisCompleted · Interventional · 40 enrolled · Mazandaran University of Medical SciencesNCT05969730updated 2025-12-15
- Effect of Lidocaine-Dexmedetomidine on Pain, Inflammation, and Oxidative Stress After Bariatric Surgery.Recruiting · Phase 4 · Interventional · 104 enrolled · Instituto Mexicano del Seguro SocialNCT07073846updated 2025-11-28
- A Study of Yutiq Steroid Insert During Glaucoma Tube Implant SurgeryActive not recruiting · Early phase 1 · Interventional · 5 enrolled · Sanjay AsraniNCT04918121updated 2025-11-10
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.
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.