desonide
Pharmaranks rates Desonide 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Desonide is a corticosteroid used to treat Facial Dermatoses, Foot Dermatoses, Hand Dermatoses, Inflammation.
Corticosteroid · by Fougera Pharms
Generic of Desowen
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Desonide
- Drug class
- Corticosteroid
- Form
- Topical
- Strength
- Desonide 0.05%
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- facial dermatoses, foot dermatoses, hand dermatoses
- Manufacturer
- Fougera Pharms
- What the pharmacy pays
- ~$0.28 per gm — not your price
- FDA application
- ANDA075751
What is Desonide?
From the FDA label:Desonide Gel, 0.05% contains desonide [(pregna-1, 4-diene-3, 20-dione,11, 21-dihydroxy-16,17-[(1-methylethylidene) bis(oxy)]-,(11β,16α)]- a synthetic nonfluorinated corticosteroid for topical dermatologic use. Chemically, desonide is C 24 H 32 O 6 . It has the following structural formula: Desonide has the molecular weight of 416.52. It is a white to off-white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of Desonide Gel, 0.05% contains 0.5 mg of desonide in an aqueous gel base of purified water, glycerin, propylene glycol, edetate disodium, methylparaben, propylparaben, sodium hydroxide, and Carbopol ® 974 P. structure
How to use
Apply a thin layer to the affected areas two times daily and rub in gently. Discontinue use when control is achieved. If no improvement is seen within 4 weeks, reassessment of diagnosis may be necessary. Treatment beyond 4 consecutive weeks is not recommended. Do not use with occlusive dressings. Avoid contact with eyes or other mucous membranes. For topical use only. Not for oral, ophthalmic, or intravaginal use. • Apply as a thin layer to the affected areas two times daily and rub in gently. ( 2 ) • Therapy should be discontinued when control is achieved. ( 2 ) • If no improvement is seen within 4 weeks, reassessment of diagnosis may be necessary. ( 2 ) • Should not be used with occlusive dressings. ( 2 ) • Treatment beyond 4 consecutive weeks is not recommended. ( 2 ) • For topical use only. Not for oral, ophthalmic, or intravaginal use. ( 2 )
Side effects
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. In controlled clinical studies of 425 Desonide Gel, 0.05%-treated subjects and 157 Vehicle-treated subjects, adverse events occurred at the application site in 3% of subjects treated with Desonide Gel, 0.05% and the incidence rate was not higher compared with vehicle-treated subjects. The most common local adverse events in Desonide Gel, 0.05% treated subjects were application site burning in 1% (4/425) and rash in 1% (3/425) followed by application site pruritus in <1% (2/425). Adverse events that resulted in premature discontinuation of study drug in Desonide Gel, 0.05% treated subjects were telangiectasia and worsening of atopic dermatitis in one subject each. Additional adverse events observed during clinical trials for patients treated with Desonide Gel, 0.05% included headache in 2% (8/425) compared with 1% (2/157) in those treated with vehicle. The following additional local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate…
Warnings
Important safety information
Topical corticosteroids can produce reversible hypothalamic pituitary adrenal (HPA) axis suppression, Cushing’s syndrome and unmask latent diabetes. ( 5.1 ) • Systemic absorption may require evaluation for HPA axis suppression. ( 5.1 ) • Modify use should HPA axis suppression develop ( 5.1 ) • Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption ( 5.1 ) • Local adverse reactions may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis and may be more likely with occlusive use or more potent corticosteroids. ( 5.2 , 5.4 , 6 ) • Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 ) 5.1 Effects on Endocrine System Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. The effect of Desonide Gel, 0.05% on HPA axis function was investigated in pediatric subjects, 6 months to 6 years old, with atopic dermatitis covering at least 35% of their body, who were treated with Desonide Gel, 0.05% twice daily for 4 weeks. One of 37 subjects (3%) displayed adrenal suppression after 4 weeks of use, based on the cosyntropin stimulation test. As follow-up evaluation of the subject’s adrenal axis was not performed, it is unknown whether the suppression was reversible [see Use In Specific Populations ( 8.4 ) and Clinical Pharmacology ( 12.2 )]. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Desonide Gel, 0.05% due to their larger skin surface-to-body mass ratios [see Use In Specific Populations ( 8.4 )]. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure. 5.2 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include skin atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. 5.3 Concomitant Skin Infections If concomitant skin infections are present or develop during treatment, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Desonide Gel, 0.05% should be discontinued until the infection is adequately controlled. 5.4 Skin Irritation If irritation develops, Desonide Gel, 0.05% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.
Who should not take Desonide
Desonide Gel, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. History of hypersensitivity to any of the components of the preparation.
Overdose — what happens if you take too much
Topically applied Desonide Gel, 0.05% can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions ( 5.1 )] .
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Drug class
How this class works, per Corticosteroids - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Desonide ranks — best-rated corticosteroid for:
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Desonide treat?
- Desonide (Desonide) may be used to treat facial dermatoses, foot dermatoses, hand dermatoses, inflammation, leg dermatoses, scalp dermatoses, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Desonide work?
- Desonide is 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.
- How is Desonide rated?
- pharmaranks gives Desonide a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Desonide cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.28 per gm, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Cortenema — about $0.14 on the same basis.
- Is there a coupon or discount for Desonide?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Desonide. To pay less, Desonide is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Desonide?
- Desonide is marketed by Fougera Pharms. You can see Fougera Pharms's full profile, rating, and other products on pharmaranks.
- Is Desonide a brand-name or generic drug?
- Desonide is a generic medication; its active ingredient is Desonide. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Desonide available over the counter?
- No. Desonide is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Desonide come in?
- Desonide is currently marketed as topical, per the FDA's National Drug Code Directory.
- What class of drug is Desonide?
- Desonide is classified as corticosteroid, per the FDA's Established Pharmacologic Class.
- Is Desonide FDA-registered?
- Desonide is on record with the U.S. FDA under application number ANDA075751. You can verify this on its official FDA label.
- Has Desonide been recalled by the FDA?
- Desonide has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Desonide safe?
- There's no single safe-or-not verdict. pharmaranks gives Desonide a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Desonide?
- Desonide's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
What people report to the FDA about Desonide
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 5,247 reports naming Desonide, and the FDA flagged 55% 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:
- macular degeneration794 reports
- nausea388 reports
- pruritus362 reports
- rash351 reports
- erythema336 reports
- headache333 reports
- pyrexia318 reports
- malaise291 reports
Read these as a signal, not a rate. A report does not mean Desonide 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.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
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desonide
72/100