Fluocinolone Acetonide: uses, dosing, side effects & brands
Fluocinolone Acetonide is a corticosteroid sold in the U.S. under 7 brand and generic names, for atopic dermatitis, facial dermatoses and foot dermatoses. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Corticosteroid
- Treats (across its forms)
- Atopic Dermatitis, Facial Dermatoses and Foot Dermatoses
- Available as
- Topical · Oil · Solution · Implant
- Sold as
- 7 products — Capex, Fluocinolone Acetonide and Fluonid, and others
- Prescription?
- Prescription only
- Generic available?
- Yes
How Iluvien is dosed
From the FDA label for Iluvien (application NDA201923). Other fluocinolone acetonide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For ophthalmic intravitreal injection. (2.1) The intravitreal injection procedure should be carried out under aseptic conditions. (2.2) Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. (2.2) 2.1 General Dosing Information For ophthalmic intravitreal injection. The initial prescription and renewal of the medication order of ILUVIEN should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. 2.2 Administration The intravitreal injection procedure should be carried out under aseptic conditions, which include use of sterile gloves, a sterile drape, a sterile caliper, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection. The injection procedure for ILUVIEN is as follows: The exterior of the tray should not be considered sterile. An assistant (non-sterile) should remove the tray from the carton and examine the tray and lid for damage. If damaged, do not use unit. If acceptable, the assistant should peel the lid from the tray without touching the interior surface. Visually check through the viewing window of the preloaded applicator to ensure that there is a drug implant inside. Remove the applicator…
Everything below is the FDA label for Iluvien (implant). Fluocinolone Acetonide is also sold as topical, oil and solution, and those are different medicines to take — follow the label for the one you were prescribed.
Iluvien side effects
The most common adverse reactions reported are cataract development and increases in intraocular pressure. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Alimera Sciences, Inc. at 1-844-445-8843 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions associated with ophthalmic steroids including ILUVIEN include cataract formation and subsequent cataract surgery, elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. Diabetic Macular Edema ILUVIEN was studied in two multicenter, randomized, sham-controlled, double-masked trials in which patients with diabetic macular edema (DME) were treated with either ILUVIEN (n=375) or sham (n=185). Table 1 summarizes safety data available when the last subject completed the last 36 month follow up visit for the two primary ILUVIEN trials. In these trials, subjects were eligible for retreatment no earlier than 12 months after study…
Who shouldn’t take Iluvien
Ocular or Periocular Infections (4.1) Glaucoma (4.2) Hypersensitivity (4.3) 4.1 Ocular or Periocular Infections ILUVIEN is contraindicated in patients with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases. 4.2 Glaucoma ILUVIEN is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8. 4.3 Hypersensitivity ILUVIEN is contraindicated in patients with known hypersensitivity to any components of this product.
Every fluocinolone acetonide product we track (7)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Topical | No data | — | View → | |
| 2 | Not yet rated | Prescription | Topical | No data | — | View → | |
| 3 | Not yet rated | Prescription | Topical | No data | — | View → | |
| 4 | Not yet rated | Prescription | Implant | No data | — | View → | |
| 5 | Not yet rated | Prescription | Implant | No data | — | View → | |
| 6 | Not yet rated | Prescription | Topical | No data | — | View → | |
| 7 | Not yet rated | Prescription | Topical | No data | — | View → |
Combination products containing fluocinolone acetonide
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Fluocinolone Acetonide recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Fluocinolone Acetonide Solution Topical Solution USP
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
SUN PHARMACEUTICAL INDUSTRIES INC · Dec 30, 2025
Fluocinolone Acetonide Oil
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Glenmark Pharmaceuticals Inc., USA · Jan 4, 2024
What people report to the FDA about fluocinolone acetonide
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,922 reports naming fluocinolone acetonide, and the FDA flagged 44% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- pruritus171 reports
- rash147 reports
- diarrhoea122 reports
- headache116 reports
- nausea104 reports
- psoriasis102 reports
- fatigue97 reports
- dermatitis atopic76 reports
Read these as a signal, not a rate. A report does not mean fluocinolone acetonide caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is Iluvien?
ILUVIEN is a sterile non-bioerodable intravitreal implant containing 0.19 mg (190 mcg) fluocinolone acetonide in a 36-month sustained-release drug delivery system. ILUVIEN is designed to release fluocinolone acetonide at an initial rate of 0.25 mcg/day. ILUVIEN is preloaded into a single-use applicator to facilitate injection of the implant directly into the vitreous. The drug substance is a synthetic corticosteroid, fluocinolone acetonide.
What kind of drug is fluocinolone acetonide?
The FDA classifies fluocinolone acetonide as a corticosteroid. Corticosteroids mimic the body's natural stress hormone cortisol: they enter cells and bind a glucocorticoid receptor that switches off genes for inflammatory chemicals, calming swelling, redness, and an overactive immune response. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take fluocinolone acetonide with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run fluocinolone acetonide against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is fluocinolone acetonide sold under?
We track 7 fluocinolone acetonide-containing products in the U.S.: Capex, Fluocinolone Acetonide, Fluonid, Iluvien, Retisert, Synalar and Synalar-Hp. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does fluocinolone acetonide come in?
Across the brands we track, fluocinolone acetonide is currently marketed as topical, oil, solution and implant, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic fluocinolone acetonide?
Yes. Our catalog lists 2 generic fluocinolone acetonide products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has fluocinolone acetonide been recalled?
The FDA's Enforcement database lists 2 recall records whose product description mentions fluocinolone acetonide. The most recent: Fluocinolone Acetonide Solution Topical Solution USP (Dec 30, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Fluocinolone Acetonide: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/fluocinolone-acetonide
- MLA
- “Fluocinolone Acetonide: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/fluocinolone-acetonide.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for fluocinolone acetonide on DailyMed (NIH) ↗.