Drug · FAERS side-effect profile with label screen
Desonide side effects: what 4,949 FDA adverse event reports show
Who reports
4,949 reports · 55% serious · 195 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Desonide Cream, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.
FDA label, Indications and Usage
What it is
DESCRIPTION Desonide Cream, 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11β,16α)) a synthetic corticosteroid for topical dermatologic use.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Reporting / coding artifact 1No label text to screen 39
What the badges mean
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 249 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Macular degeneration | 787 | 299.8 280.4–320.5ROR 356.3 · χ² 218,520 / p <1e-300 | 277.9 EB05 262.0 · IC025 +7.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 313.8 · ♀ 100% (drug 65%) | no trial data cached |
| Vaginal discharge | 153 | 65.5 56.0–76.7ROR 67.6 · χ² 9,512 / p <1e-300 | 64.0 EB05 56.0 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=151 · ♀ 100% (drug 65%) | no trial data cached |
| Paraesthesia oral | 200 | 59.8 52.1–68.5ROR 62.3 · χ² 11,347 / p <1e-300 | 58.6 EB05 52.1 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 108.9 · ♀ 100% (drug 65%) | no trial data cached |
| Oral candidiasis (oral thrush) | 156 | 51.4 44.0–60.1ROR 53.1 · χ² 7,573 / p <1e-300 | 50.5 EB05 44.2 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 72.6 · ♀ 100% (drug 65%) | no trial data cached |
| Procedural pain | 183 | 28.2 24.5–32.5ROR 29.3 · χ² 4,751 / p <1e-300 | 28.0 EB05 24.7 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.9 · ♀ 100% (drug 65%) | no trial data cached |
| Frequent bowel movements | 162 | 25.7 22.0–29.9ROR 26.5 · χ² 3,796 / p <1e-300 | 25.4 EB05 22.3 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.6 · ♀ 97% (drug 65%) | no trial data cached |
| Dermatitis atopic | 240 | 20.4 18.1–23.1ROR 21.4 · χ² 4,409 / p <1e-300 | 20.3 EB05 18.3 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=40 | no trial data cached |
| Colitis | 167 | 18.9 16.2–21.9ROR 19.5 · χ² 2,800 / p <1e-300 | 18.7 EB05 16.5 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.9 · ♀ 96% (drug 65%) | no trial data cached |
| Rectal haemorrhage | 173 | 17.1 14.7–19.8ROR 17.6 · χ² 2,595 / p <1e-300 | 17.0 EB05 14.9 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.8 · ♀ 97% (drug 65%) | no trial data cached |
| Therapeutic product effect incomplete | 264 | 15.9 14.1–17.9ROR 16.7 · χ² 3,663 / p <1e-300 | 15.8 EB05 14.3 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 26.2 · ♀ 90% (drug 65%) | no trial data cached |
| Colitis ulcerative | 166 | 15.8 13.6–18.4ROR 16.3 · χ² 2,287 / p <1e-300 | 15.7 EB05 13.8 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.4 · ♀ 95% (drug 65%) | no trial data cached |
| Sleep disorder due to a general medical condition | 60 | 15.8 12.3–20.3ROR 16.0 · χ² 813 / p 4e-179 | 15.6 EB05 12.5 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial data cached |
| Haematochezia (blood in stool) | 174 | 13.4 11.6–15.5ROR 13.9 · χ² 1,986 / p <1e-300 | 13.3 EB05 11.7 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.2 · ♀ 96% (drug 65%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 200 | 12.9 11.2–14.7ROR 13.4 · χ² 2,177 / p <1e-300 | 12.8 EB05 11.3 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.4 · ♀ 97% (drug 65%) | no trial data cached |
| Skin fissures | 50 | 11.2 8.5–14.8ROR 11.4 · χ² 456 / p 2e-101 | 10.9 EB05 8.5 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=6 | no trial data cached |
| Eczema | 129 | 10.9 9.2–12.9ROR 11.2 · χ² 1,149 / p 4e-252 | 10.7 EB05 9.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.5 | no trial data cached |
| Dermatitis | 52 | 10.7 8.1–14.0ROR 10.8 · χ² 445 / p 5e-99 | 10.3 EB05 8.0 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.5 | no trial data cached |
| Conjunctivitis | 45 | 10.4 7.8–13.9ROR 10.5 · χ² 372 / p 3e-83 | 10.0 EB05 7.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 | no trial data cached |
| Psoriasis | 284 | 9.2 8.2–10.3ROR 9.7 · χ² 2,082 / p <1e-300 | 9.1 EB05 8.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 | no trial data cached |
| Skin haemorrhage | 30 | 8.8 6.2–12.6ROR 8.9 · χ² 200 / p 1e-45 | 8.1 EB05 5.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=6 | no trial data cached |
| Dyspepsia (indigestion) | 203 | 8.8 7.7–10.1ROR 9.1 · χ² 1,396 / p <1e-300 | 8.7 EB05 7.7 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.5 · ♀ 96% (drug 65%) | no trial data cached |
| Eye pruritus | 67 | 8.6 6.8–10.9ROR 8.7 · χ² 444 / p 8e-99 | 8.3 EB05 6.7 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | no trial data cached |
| Skin exfoliation | 163 | 8.3 7.2–9.7ROR 8.6 · χ² 1,045 / p 1e-229 | 8.2 EB05 7.2 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.6 | no trial data cached |
| Scab | 22 | 8.2 5.4–12.5ROR 8.3 · χ² 133 / p 6e-31 | 7.3 EB05 5.0 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Madarosis | 21 | 7.6 5.0–11.7ROR 7.6 · χ² 114 / p 7e-27 | 6.7 EB05 4.6 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial data cached |
| Eye discharge | 18 | 7.5 4.7–11.9ROR 7.5 · χ² 94 / p 1e-22 | 6.5 EB05 4.3 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=8 | no trial data cached |
| Skin infection | 18 | 6.8 4.3–10.9ROR 6.9 · χ² 84 / p 3e-20 | 5.9 EB05 3.9 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 | no trial data cached |
| Erythema (skin redness) | 314 | 6.5 5.8–7.2ROR 6.9 · χ² 1,465 / p <1e-300 | 6.4 EB05 5.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.3 | no trial data cached |
| Dermatitis contact | 17 | 6.4 3.9–10.2ROR 6.4 · χ² 71 / p 2e-17 | 5.5 EB05 3.6 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 | no trial data cached |
| Psoriatic arthropathy | 60 | 6.3 4.9–8.1ROR 6.4 · χ² 264 / p 1e-59 | 6.1 EB05 4.9 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.9 | no trial data cached |
| Dry skin | 182 | 5.9 5.1–6.8ROR 6.1 · χ² 734 / p 6e-162 | 5.8 EB05 5.1 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 | no trial data cached |
| Skin disorder | 46 | 5.9 4.4–7.8ROR 5.9 · χ² 181 / p 2e-41 | 5.6 EB05 4.3 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 | no trial data cached |
| Ocular hyperaemia | 64 | 5.8 4.6–7.4ROR 5.9 · χ² 250 / p 1e-56 | 5.6 EB05 4.5 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 | no trial data cached |
| Dry eye | 65 | 5.7 4.5–7.2ROR 5.8 · χ² 247 / p 6e-56 | 5.5 EB05 4.4 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Neuralgia | 31 | 5.4 3.8–7.7ROR 5.4 · χ² 107 / p 2e-25 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.0 | no trial data cached |
| Impaired quality of life | 18 | 5.3 3.3–8.4ROR 5.3 · χ² 59 / p 1e-14 | 4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial data cached |
| Skin lesion | 34 | 5.3 3.8–7.4ROR 5.3 · χ² 114 / p 6e-27 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 | no trial data cached |
| Tenderness | 13 | 5.3 3.1–9.1ROR 5.3 · χ² 41 / p 8e-11 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=8 | no trial data cached |
| Seasonal allergy | 17 | 5.1 3.2–8.2ROR 5.1 · χ² 52 / p 3e-13 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=7 | no trial data cached |
| Pharyngitis streptococcal | 13 | 5.1 3.0–8.8ROR 5.1 · χ² 39 / p 2e-10 | 4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,194 | 3.8 3.7–4.0ROR 4.7 · χ² 2,676 / p <1e-300 | 3.8 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 | no trial data cached |
| Macular degeneration | 787 | 299.8 280.4–320.5ROR 356.3 · χ² 218,520 / p <1e-300 | 277.9 EB05 262.0 · IC025 +7.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 313.8 · ♀ 100% (drug 65%) | no trial data cached |
| Off label use (used outside approved label) | 420 | 2.1 1.9–2.2ROR 2.1 · χ² 235 / p 3e-53 | 2.0 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Pain | 391 | 2.7 2.4–3.0ROR 2.8 · χ² 427 / p 4e-95 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 | no trial data cached |
| Pruritus (itching) | 343 | 3.8 3.5–4.3ROR 4.1 · χ² 733 / p 1e-161 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 | no trial data cached |
| Rash | 328 | 3.2 2.9–3.6ROR 3.4 · χ² 506 / p 2e-112 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | no trial data cached |
| Headache | 320 | 2.2 1.9–2.4ROR 2.2 · χ² 206 / p 6e-47 | 2.2 EB05 2.0 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 3.5 | no trial data cached |
| Erythema (skin redness) | 314 | 6.5 5.8–7.2ROR 6.9 · χ² 1,465 / p <1e-300 | 6.4 EB05 5.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.3 | no trial data cached |
| Pyrexia (fever) | 306 | 3.7 3.4–4.2ROR 3.9 · χ² 623 / p 7e-138 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 | no trial data cached |
| Psoriasis | 284 | 9.2 8.2–10.3ROR 9.7 · χ² 2,082 / p <1e-300 | 9.1 EB05 8.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 | no trial data cached |
| Malaise (feeling unwell) | 282 | 2.7 2.4–3.0ROR 2.8 · χ² 311 / p 6e-70 | 2.7 EB05 2.5 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 · ♀ 91% (drug 65%) | no trial data cached |
| Weight decreased (weight loss) | 276 | 4.2 3.7–4.7ROR 4.4 · χ² 677 / p 2e-149 | 4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 · ♀ 88% (drug 65%) | no trial data cached |
| Therapeutic product effect incomplete | 264 | 15.9 14.1–17.9ROR 16.7 · χ² 3,663 / p <1e-300 | 15.8 EB05 14.3 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 26.2 · ♀ 90% (drug 65%) | no trial data cached |
| Dermatitis atopic | 240 | 20.4 18.1–23.1ROR 21.4 · χ² 4,409 / p <1e-300 | 20.3 EB05 18.3 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=40 | no trial data cached |
| Abdominal pain | 222 | 4.0 3.6–4.6ROR 4.2 · χ² 512 / p 1e-113 | 4.0 EB05 3.6 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 · ♀ 86% (drug 65%) | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Desonide?
In FDA FAERS, the most frequently co-reported reaction terms for Desonide are macular degeneration, pain, pruritus, rash, headache, erythema. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Desonide have an FDA boxed warning?
No. The FDA label retrieved for Desonide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Desonide causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 1d7632a7-0f27-9e5d-e063-6294a90ad21f, effective 20240717; matched on
openfda.generic_name.exact:"DESONIDE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 289 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.