fluocinolone

Name: fluocinolone — FDA Drug Safety & Adverse Event Data
Creator: PlainMeds
License: https://creativecommons.org/publicdomain/zero/1.0/

Reviewed byPlainmeds Editorial, Drug Information Editorial Team · June 5, 2026

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Brand names: Synalar, Derma-Smoothe

Topical Corticosteroid Rx

Fluocinolone is a topical steroid medicine. It helps reduce swelling, itching, and redness of the skin.

Drug Pricing (NADAC)

Generic Price

$0.16/unit

Generic Available

Yes (23 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

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What it does

This medicine treats skin problems that cause swelling and itching.

Common side effects

Burning, Itching, Irritation

Key warnings

If you get an infection, stop using bandages and talk to your doctor about treatment.

How It Works

Fluocinolone is a corticosteroid. It works by reducing inflammation. This helps to relieve itching and other skin problems.

How to Take It

Apply a thin layer of fluocinolone solution to the affected skin. Do this two to four times each day, or as your doctor tells you. If you have hair in the area, part the hair so the medicine touches the skin. You can use a bandage if your doctor says it is okay.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant or breastfeeding before using this medicine. It is not known if fluocinolone can harm an unborn baby or pass into breast milk.

Missed Dose

If you miss a dose, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store at room temperature, between 68° to 77°F. Keep away from high heat and do not freeze.

Serious Warnings

If you get an infection, stop using bandages and talk to your doctor about treatment.

Common Questions

What is fluocinolone used for?

It is used to relieve skin swelling, itching, and redness.

How often should I apply it?

Apply a thin layer to the affected area two to four times a day, or as your doctor tells you.

Can I use a bandage with this medicine?

Yes, you can use a bandage if your doctor tells you to.

What should I do if I get an infection?

Stop using bandages and talk to your doctor right away.

Can I use this medicine if I am pregnant?

Talk to your doctor before using if you are pregnant or breastfeeding.

How should I store this medicine?

Store it at room temperature, away from heat and freezing temperatures.

What should I do if I miss a dose?

Apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose.

Can this medicine cause side effects?

Yes, some common side effects are burning, itching, irritation, and dryness.

Who should not use this medicine?

You should not take this if you are allergic to any of the ingredients.

What does this medicine contain?

Each mL contains 0.1 mg of Fluocinolone Acetonide.

What are the common side effects of fluocinolone?

The most commonly reported side effects of fluocinolone include Burning, Itching, Irritation, Dryness. Always consult your healthcare provider about potential side effects.

What drug class is fluocinolone?

fluocinolone belongs to the Topical Corticosteroid drug class. It requires a prescription (Rx). This medicine treats skin problems that cause swelling and itching.

Is fluocinolone safe during pregnancy?

Tell your doctor if you are pregnant or breastfeeding before using this medicine. It is not known if fluocinolone can harm an unborn baby or pass into breast milk. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

Has fluocinolone been recalled?

There is 1 recall associated with fluocinolone products. Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. Check the recalls section below for full details and affected products.

Active Recalls

Class III December 30, 2025

Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

SUN PHARMACEUTICAL INDUSTRIES INC

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What the FDA Data Shows for fluocinolone

The FDA label for fluocinolone (sold under brand names such as Synalar, Derma-Smoothe) classifies it as a prescription-only medication in the Topical Corticosteroid class. This medicine treats skin problems that cause swelling and itching. Official labeling lists 4 commonly reported side effects, including Burning, Itching, Irritation.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. Voluntary reports accumulate over the lifetime of a drug and reflect wide-ranging clinical use. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.16.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: July 3, 2025

Read our methodology — how this data is sourced, computed, and verified.

All federal data sources used on this page

FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages