Drug · FAERS side-effect profile with label screen
Desoximetasone side effects: what 18,941 FDA adverse event reports show
Who reports
18,941 reports · 95% serious · 5,061 with death outcome · 89% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Desoximetasone topical spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older. Desoximetasone topical spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older ( 1 ).
FDA label, Indications and Usage
What it is
Desoximetasone Topical Spray, 0.25% for dermatologic use contains desoximetasone as the active ingredient. Desoximetasone is a corticosteroid with the chemical name of pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-, (11ß,16α)-.
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
Labeled adverse reaction 1Reporting / coding artifact 1Lab value / disease marker 7Not in label — unassessed 31
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,027 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 |
|---|---|---|---|---|---|---|
| Anti-cyclic citrullinated peptide antibody positive | 5,430 | 3,739.1 3,542.1–3,947.0ROR 5,241.3 · calibrated p 7e-27 ✓ | 843.1 EB05 824.4 · IC025 +9.6 3/3 methods agree vs other Corticosteroids: PRR 1.9 (1.8–1.9) | Lab value / disease marker | serious PRR 512.4 · 93% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 495 | 3,294.2 2,762.6–3,928.2ROR 3,382.6 · calibrated p 7e-24 ✓ | 795.1 EB05 738.1 · IC025 +8.7 3/3 methods agree vs other Corticosteroids: PRR 1.3 (1.2–1.4) | Lab value / disease marker | serious n=495 · 96% clinician | not reported in cached trials |
| Swollen joint count increased | 2,230 | 2,866.8 2,652.3–3,098.5ROR 3,249.2 · calibrated p 7e-24 ✓ | 785.8 EB05 758.8 · IC025 +9.3 3/3 methods agree vs other Corticosteroids: PRR 1.4 (1.3–1.4) | Lab value / disease marker | serious n=2,229 · 95% clinician | not reported in cached trials |
| Rheumatic fever | 3,101 | 2,794.8 2,619.3–2,982.1ROR 3,341.7 · calibrated p 5e-24 ✓ | 781.8 EB05 759.0 · IC025 +9.4 3/3 methods agree vs other Corticosteroids: PRR 1.3 (1.3–1.4) | Not in label — unassessed | serious n=3,100 · 94% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 4,932 | 2,326.2 2,218.8–2,438.9ROR 3,144.8 · calibrated p 1e-23 ✓ | 741.4 EB05 724.2 · IC025 +9.4 3/3 methods agree vs other Corticosteroids: PRR 1.7 (1.6–1.7) | Not in label — unassessed | serious PRR 448.5 · 93% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 1,310 | 2,284.0 2,078.7–2,509.5ROR 2,453.6 · calibrated p 4e-22 ✓ | 731.2 EB05 698.6 · IC025 +9.1 3/3 methods agree vs other Corticosteroids: PRR 1.1 (1.1–1.2) | Not in label — unassessed | serious n=1,310 · 94% clinician | not reported in cached trials |
| Pemphigus | 8,003 | 2,047.0 1,978.0–2,118.5ROR 3,543.9 · calibrated p 2e-24 ✓ | 711.3 EB05 698.3 · IC025 +9.4 3/3 methods agree vs other Corticosteroids: PRR 2.2 (2.1–2.2) | Not in label — unassessed | serious PRR 431.6 · 91% clinician | not reported in cached trials |
| Lupus vulgaris | 766 | 2,044.1 1,814.4–2,302.8ROR 2,130.2 · calibrated p 3e-21 ✓ | 699.6 EB05 659.0 · IC025 +8.8 3/3 methods agree vs other Corticosteroids: PRR 1.1 (1.1–1.2) | Not in label — unassessed | serious n=766 · 96% clinician | not reported in cached trials |
| C-reactive protein | 567 | 1,881.0 1,643.3–2,153.0ROR 1,939.0 · calibrated p 1e-20 ✓ | 675.4 EB05 630.0 · IC025 +8.6 3/3 methods agree vs other Corticosteroids: PRR 1.1 (1.0–1.2) | Lab value / disease marker | serious n=567 · 96% clinician | not reported in cached trials |
| Grip strength | 136 | 1,596.1 1,226.5–2,076.9ROR 1,607.6 · calibrated p 3e-19 ✓ | 594.2 EB05 515.0 · IC025 +7.3 3/3 methods agree vs other Corticosteroids: PRR 1.5 (1.3–1.8) | Not in label — unassessed | serious n=136 · 94% clinician | not reported in cached trials |
| Rheumatoid factor positive | 3,349 | 1,558.0 1,480.9–1,639.3ROR 1,892.5 · calibrated p 9e-21 ✓ | 640.0 EB05 622.1 · IC025 +9.1 3/3 methods agree vs other Corticosteroids: PRR 1.5 (1.5–1.6) | Lab value / disease marker | serious n=3,347 · 94% clinician | not reported in cached trials |
| Facet joint syndrome | 1,760 | 1,420.8 1,325.5–1,522.9ROR 1,566.2 · calibrated p 1e-19 ✓ | 613.7 EB05 590.0 · IC025 +9.0 3/3 methods agree vs other Corticosteroids: PRR 1.1 (1.1–1.2) | Not in label — unassessed | serious n=1,760 · 95% clinician | not reported in cached trials |
| Hand deformity | 7,047 | 1,311.2 1,270.4–1,353.2ROR 2,087.3 · calibrated p 3e-21 ✓ | 595.2 EB05 583.6 · IC025 +9.1 3/3 methods agree vs other Corticosteroids: PRR 2.0 (2.0–2.1) | Not in label — unassessed | serious PRR 391.6 · 92% clinician | not reported in cached trials |
| Hepatic enzyme | 71 | 1,156.6 828.6–1,614.5ROR 1,160.9 · calibrated p 3e-17 ✓ | 487.8 EB05 399.8 · IC025 +6.4 3/3 methods agree vs other Corticosteroids: PRR 4.4 (3.3–5.8) | Not in label — unassessed | serious n=71 · 100% clinician | not reported in cached trials |
| Swollen joint count | 122 | 1,100.4 856.1–1,414.5ROR 1,107.6 · calibrated p 2e-17 ✓ | 504.8 EB05 434.0 · IC025 +7.1 3/3 methods agree vs other Corticosteroids: PRR 1.5 (1.2–1.8) | Not in label — unassessed | serious n=122 · 95% clinician | not reported in cached trials |
| Helicobacter infection | 4,879 | 1,027.4 990.7–1,065.5ROR 1,383.5 · calibrated p 5e-19 ✓ | 528.6 EB05 516.3 · IC025 +8.9 3/3 methods agree vs other Corticosteroids: PRR 1.6 (1.6–1.7) | Not in label — unassessed | serious PRR 338.1 · 94% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 949 | 995.0 912.2–1,085.2ROR 1,047.4 · calibrated p 2e-17 ✓ | 515.5 EB05 488.6 · IC025 +8.6 3/3 methods agree vs other Corticosteroids: PRR 1.1 (1.0–1.1) | Not in label — unassessed | serious n=949 · 96% clinician | not reported in cached trials |
| X-ray abnormal | 770 | 847.2 771.9–929.8ROR 883.0 · calibrated p 1e-16 ✓ | 471.8 EB05 444.5 · IC025 +8.4 3/3 methods agree vs other Corticosteroids: PRR 1.1 (1.0–1.1) | Lab value / disease marker | serious n=770 · 97% clinician | not reported in cached trials |
| Dislocation of vertebra | 941 | 818.4 752.9–889.4ROR 861.1 · calibrated p 2e-16 ✓ | 463.7 EB05 439.3 · IC025 +8.4 3/3 methods agree vs other Corticosteroids: PRR 1.1 (1.0–1.1) | Not in label — unassessed | serious n=941 · 95% clinician | not reported in cached trials |
| Muscle injury | 3,369 | 777.1 745.2–810.2ROR 944.9 · calibrated p 5e-17 ✓ | 453.1 EB05 440.4 · IC025 +8.7 3/3 methods agree vs other Corticosteroids: PRR 1.6 (1.5–1.6) | Not in label — unassessed | serious PRR 297.3 · 94% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 2,514 | 714.4 680.7–749.6ROR 823.5 · calibrated p 2e-16 ✓ | 430.7 EB05 416.8 · IC025 +8.6 3/3 methods agree vs other Corticosteroids: PRR 1.6 (1.5–1.7) | Not in label — unassessed | serious n=2,513 · 94% clinician | not reported in cached trials |
| Retinitis | 634 | 682.4 618.6–752.8ROR 706.0 · calibrated p 2e-15 ✓ | 415.0 EB05 388.6 · IC025 +8.2 3/3 methods agree vs other Corticosteroids: PRR 1.1 (1.0–1.2) | Not in label — unassessed | serious n=634 · 96% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 206 | 677.2 569.5–805.3ROR 684.6 · calibrated p 3e-15 ✓ | 402.6 EB05 358.5 · IC025 +7.5 3/3 methods agree vs other Corticosteroids: PRR 1.2 (1.0–1.4) | Not in label — unassessed | serious n=206 · 98% clinician | not reported in cached trials |
| Folliculitis | 3,857 | 664.2 639.8–689.5ROR 833.8 · calibrated p 2e-16 ✓ | 412.4 EB05 401.6 · IC025 +8.6 3/3 methods agree vs other Corticosteroids: PRR 1.5 (1.4–1.5) | Labeled adverse reaction exact term | serious PRR 293.4 · 94% clinician | NCT01018134: 1/29 (3.4%) on Desoximetasone |
| Synovitis | 6,585 | 640.2 623.2–657.6ROR 980.8 · calibrated p 3e-17 ✓ | 403.4 EB05 395.3 · IC025 +8.6 3/3 methods agree vs other Corticosteroids: PRR 1.7 (1.7–1.8) | Not in label — unassessed | serious PRR 255.5 · 92% clinician | not reported in cached trials |
| Anticipatory anxiety | 98 | 632.9 493.7–811.4ROR 636.2 · calibrated p 1e-14 ✓ | 371.8 EB05 314.0 · IC025 +6.7 3/3 methods agree vs other Corticosteroids: only this drug | Not in label — unassessed | serious n=98 | not reported in cached trials |
| Pericarditis | 5,987 | 624.7 607.2–642.7ROR 912.9 · calibrated p 7e-17 ✓ | 397.2 EB05 388.8 · IC025 +8.5 3/3 methods agree vs other Corticosteroids: PRR 1.7 (1.7–1.8) | Not in label — unassessed | serious PRR 242.1 · 93% clinician | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 7,754 | 591.4 577.6–605.6ROR 1,000.6 · calibrated p 2e-17 ✓ | 383.5 EB05 376.4 · IC025 +8.5 3/3 methods agree vs other Corticosteroids: PRR 2.1 (2.1–2.2) | Not in label — unassessed | serious PRR 335.7 · 91% clinician | not reported in cached trials |
| Peripheral venous disease | 1,275 | 521.8 488.8–556.9ROR 559.4 · calibrated p 2e-14 ✓ | 351.5 EB05 335.6 · IC025 +8.2 3/3 methods agree vs other Corticosteroids: PRR 1.0 (1.0–1.1) | Not in label — unassessed | serious n=1,275 · 95% clinician | not reported in cached trials |
| Pain assessment | 10 | 519.7 244.8–1,103.5ROR 520.0 · calibrated p 2e-11 ✓ | 211.0 EB05 122.5 · IC025 +3.2 3/3 methods agree vs other Corticosteroids: only this drug | Not in label — unassessed | serious n=10 | not reported in cached trials |
| C-reactive protein abnormal | 1,902 | 469.4 445.7–494.4ROR 521.7 · calibrated p 4e-14 ✓ | 327.5 EB05 315.3 · IC025 +8.2 3/3 methods agree vs other Corticosteroids: PRR 1.1 (1.0–1.1) | Lab value / disease marker | serious n=1,902 · 92% clinician | not reported in cached trials |
| Seronegative arthritis | 320 | 443.2 389.5–504.3ROR 450.8 · calibrated p 2e-13 ✓ | 309.7 EB05 282.2 · IC025 +7.5 3/3 methods agree vs other Corticosteroids: PRR 1.7 (1.5–1.9) | Not in label — unassessed | serious n=320 · 94% clinician | not reported in cached trials |
| Hypocholesterolaemia | 75 | 357.5 275.5–463.8ROR 358.9 · calibrated p 4e-12 ✓ | 252.2 EB05 207.8 · IC025 +6.2 3/3 methods agree vs other Corticosteroids: PRR 1.1 (0.9–1.4) | Not in label — unassessed | serious n=75 · 97% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, hypersomnia type | 24 | 349.3 220.6–552.9ROR 349.7 · calibrated p 2e-11 ✓ | 218.9 EB05 154.8 · IC025 +4.7 3/3 methods agree vs other Corticosteroids: PRR 9.9 (5.7–17.2) | Not in label — unassessed | serious n=24 · 100% clinician | not reported in cached trials |
| Wound | 6,606 | 346.1 338.0–354.4ROR 530.9 · calibrated p 3e-14 ✓ | 262.8 EB05 257.5 · IC025 +8.0 3/3 methods agree vs other Corticosteroids: PRR 1.7 (1.7–1.8) | Not in label — unassessed | age-adj. PRR 265.3 · serious PRR 189.1 · 92% clinician | not reported in cached trials |
| Systemic lupus erythematosus | 8,263 | 338.4 331.7–345.3ROR 599.5 · calibrated p 8e-15 ✓ | 258.4 EB05 253.8 · IC025 +8.0 3/3 methods agree vs other Corticosteroids: PRR 1.9 (1.8–1.9) | Not in label — unassessed | age-adj. PRR 256.4 · serious PRR 160.2 · 91% clinician | not reported in cached trials |
| Bone erosion | 793 | 320.1 296.1–346.0ROR 334.0 · calibrated p 4e-12 ✓ | 246.3 EB05 232.2 · IC025 +7.6 3/3 methods agree vs other Corticosteroids: PRR 1.4 (1.3–1.5) | Not in label — unassessed | serious n=793 · 96% clinician | not reported in cached trials |
| Breast cancer stage iii | 1,419 | 314.0 296.5–332.5ROR 339.4 · calibrated p 3e-12 ✓ | 243.3 EB05 232.8 · IC025 +7.7 3/3 methods agree vs other Corticosteroids: PRR 1.1 (1.1–1.2) | Not in label — unassessed | serious n=1,419 · 94% clinician | not reported in cached trials |
| Contraindicated product administered | 6,118 | 282.3 275.6–289.3ROR 416.6 · calibrated p 4e-13 ✓ | 224.4 EB05 219.7 · IC025 +7.7 3/3 methods agree vs other Corticosteroids: PRR 1.9 (1.8–2.0) | Reporting / coding artifact | age-adj. PRR 220.1 · serious PRR 168.9 · 91% clinician | not reported in cached trials |
| Lip dry | 1,704 | 260.5 247.6–274.1ROR 286.1 · calibrated p 2e-11 ✓ | 210.0 EB05 201.8 · IC025 +7.6 3/3 methods agree vs other Corticosteroids: PRR 1.1 (1.0–1.1) | Not in label — unassessed | serious n=1,704 · 95% clinician | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Liver injury | 7,639 | 28.728.2–29.3 | signal |
| Interstitial lung disease | 1,471 | 17.216.4–18.1 | signal |
| Hyperglycaemia / diabetes | 3,859 | 12.512.1–12.8 | signal |
| Serious infection | 5,807 | 8.48.2–8.6 | signal |
| Depression | 1,936 | 7.77.3–8.0 | signal |
| Tendon disorder | 135 | 3.93.3–4.7 | signal |
| Pancreatitis | 266 | 3.73.2–4.1 | signal |
| Opportunistic infection | 415 | 3.43.1–3.7 | signal |
| Rhabdomyolysis / myopathy | 221 | 3.02.7–3.4 | signal |
| Gi bleeding | 450 | 2.72.5–3.0 | signal |
| Fall / fracture | 894 | 2.62.4–2.8 | signal |
| Anaphylaxis / angioedema | 280 | 2.52.2–2.8 | signal |
| Thrombocytopenia | 278 | 1.41.2–1.6 | raised |
| Venous thromboembolism | 239 | 1.21.1–1.4 | raised |
| Anaemia | 311 | 1.11.0–1.3 | raised |
| Dependence / withdrawal | 273 | 1.00.9–1.1 | no difference |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Desoximetasone as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).
- NCT01018134 — Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study (N=151, PHASE2; 21 AE terms posted; arms: Desoximetasone 0.05% Once Daily; Desoximetasone 0.05% Twice Daily; Desoximetasone 0.25% Once Daily; Desoximetasone 0.25% Twice Daily)
- NCT01206387 — Effects of Desoximetasone Spray 0.25% on Moderate to Severe Plaque Psoriasis (N=120, PHASE3; 11 AE terms posted; arms: Desoximetasone Spray 0.25%; Placebo)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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) | 10,007 | 8.5 8.4–8.6ROR 16.8 · calibrated p 0.004 ✓ | 8.4 EB05 8.3 · IC025 +3.0 3/3 methods agree vs other Corticosteroids: PRR 0.5 (0.4–0.5) | Reporting / coding artifact | age-adj. PRR 9.3 · serious PRR 14.2 | not reported in cached trials |
| Pain | 9,038 | 16.5 16.2–16.7ROR 30.6 · calibrated p 2e-4 ✓ | 16.3 EB05 16.0 · IC025 +4.0 3/3 methods agree vs other Corticosteroids: PRR 0.8 (0.8–0.8) | Not in label — unassessed | age-adj. PRR 13.9 · serious PRR 15.5 | NCT01018134: 1/30 (3.3%) on Desoximetasone |
| Fatigue (tiredness) | 8,954 | 12.9 12.7–13.1ROR 23.6 · calibrated p 9e-4 ✓ | 12.8 EB05 12.5 · IC025 +3.6 3/3 methods agree vs other Corticosteroids: PRR 0.6 (0.6–0.6) | Not in label — unassessed | age-adj. PRR 10.0 · serious PRR 14.6 | not reported in cached trials |
| Rheumatoid arthritis | 8,336 | 88.1 86.6–89.6ROR 156.6 · calibrated p 3e-9 ✓ | 81.6 EB05 80.1 · IC025 +6.3 3/3 methods agree vs other Corticosteroids: PRR 1.3 (1.2–1.3) | Not in label — unassessed | age-adj. PRR 66.0 · serious PRR 60.3 · 90% clinician | not reported in cached trials |
| Alopecia (hair loss) | 8,331 | 48.9 48.1–49.7ROR 86.6 · calibrated p 3e-7 ✓ | 46.9 EB05 46.0 · IC025 +5.5 3/3 methods agree vs other Corticosteroids: PRR 1.5 (1.5–1.5) | Not in label — unassessed | age-adj. PRR 35.9 · serious PRR 60.5 | not reported in cached trials |
| Systemic lupus erythematosus | 8,263 | 338.4 331.7–345.3ROR 599.5 · calibrated p 8e-15 ✓ | 258.4 EB05 253.8 · IC025 +8.0 3/3 methods agree vs other Corticosteroids: PRR 1.9 (1.8–1.9) | Not in label — unassessed | age-adj. PRR 256.4 · serious PRR 160.2 · 91% clinician | not reported in cached trials |
| Pemphigus | 8,003 | 2,047.0 1,978.0–2,118.5ROR 3,543.9 · calibrated p 2e-24 ✓ | 711.3 EB05 698.3 · IC025 +9.4 3/3 methods agree vs other Corticosteroids: PRR 2.2 (2.1–2.2) | Not in label — unassessed | serious PRR 431.6 · 91% clinician | not reported in cached trials |
| Abdominal discomfort | 7,923 | 55.1 54.1–56.0ROR 93.9 · calibrated p 2e-7 ✓ | 52.5 EB05 51.5 · IC025 +5.7 3/3 methods agree vs other Corticosteroids: PRR 1.5 (1.4–1.5) | Not in label — unassessed | age-adj. PRR 44.4 · serious PRR 71.1 · 91% clinician | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 7,754 | 591.4 577.6–605.6ROR 1,000.6 · calibrated p 2e-17 ✓ | 383.5 EB05 376.4 · IC025 +8.5 3/3 methods agree vs other Corticosteroids: PRR 2.1 (2.1–2.2) | Not in label — unassessed | serious PRR 335.7 · 91% clinician | not reported in cached trials |
| Swelling | 7,262 | 93.4 91.6–95.2ROR 150.8 · calibrated p 4e-9 ✓ | 86.1 EB05 84.4 · IC025 +6.4 3/3 methods agree vs other Corticosteroids: PRR 1.5 (1.5–1.5) | Not in label — unassessed | age-adj. PRR 71.2 · serious PRR 84.3 · 92% clinician | not reported in cached trials |
| Hand deformity | 7,047 | 1,311.2 1,270.4–1,353.2ROR 2,087.3 · calibrated p 3e-21 ✓ | 595.2 EB05 583.6 · IC025 +9.1 3/3 methods agree vs other Corticosteroids: PRR 2.0 (2.0–2.1) | Not in label — unassessed | serious PRR 391.6 · 92% clinician | not reported in cached trials |
| Rash | 6,985 | 18.1 17.8–18.5ROR 28.1 · calibrated p 4e-4 ✓ | 17.8 EB05 17.5 · IC025 +4.1 3/3 methods agree vs other Corticosteroids: PRR 0.7 (0.7–0.7) | Not in label — unassessed | age-adj. PRR 15.5 · serious PRR 23.8 · 90% clinician | NCT01018134: 1/15 (6.7%) on Desoximetasone |
| Arthropathy | 6,884 | 156.0 152.8–159.3ROR 244.5 · calibrated p 6e-11 ✓ | 136.6 EB05 133.9 · IC025 +7.0 3/3 methods agree vs other Corticosteroids: PRR 1.7 (1.7–1.7) | Not in label — unassessed | age-adj. PRR 126.0 · serious PRR 100.6 · 93% clinician | not reported in cached trials |
| Drug intolerance | 6,783 | 83.9 82.3–85.6ROR 130.2 · calibrated p 1e-8 ✓ | 78.0 EB05 76.5 · IC025 +6.2 3/3 methods agree vs other Corticosteroids: PRR 1.4 (1.3–1.4) | Reporting / coding artifact | age-adj. PRR 86.9 · serious PRR 76.8 | not reported in cached trials |
| Wound | 6,606 | 346.1 338.0–354.4ROR 530.9 · calibrated p 3e-14 ✓ | 262.8 EB05 257.5 · IC025 +8.0 3/3 methods agree vs other Corticosteroids: PRR 1.7 (1.7–1.8) | Not in label — unassessed | age-adj. PRR 265.3 · serious PRR 189.1 · 92% clinician | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Rheumatic fever — n=3,101, PRR 2,794.8
- Duodenal ulcer perforation — n=4,932, PRR 2,326.2
- Deep vein thrombosis postoperative — n=1,310, PRR 2,284.0
- Pemphigus — n=8,003, PRR 2,047.0
- Lupus vulgaris — n=766, PRR 2,044.1
- Grip strength — n=136, PRR 1,596.1
- Facet joint syndrome — n=1,760, PRR 1,420.8
- Hand deformity — n=7,047, PRR 1,311.2
- Hepatic enzyme — n=71, PRR 1,156.6
- Swollen joint count — n=122, PRR 1,100.4
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 Desoximetasone?
In FDA FAERS, the most frequently co-reported reaction terms for Desoximetasone are pain, fatigue, rheumatoid arthritis, alopecia, systemic lupus erythematosus, pemphigus. 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 Desoximetasone have an FDA boxed warning?
No. The FDA label retrieved for Desoximetasone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Desoximetasone 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 23b53d98-71fe-4e64-b546-9d7c8ec21a6c, effective 20240404; matched on
openfda.generic_name.exact:"DESOXIMETASONE" 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, 1,067 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 - ClinicalTrials.gov API v2 (query
DESOXIMETASONE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.