Generic name
Desonide: adverse event reports filed with FDA
1,270 reports list it as a suspect or interacting product, 2004–2026. Class: Corticosteroid. Also reported as Desonide Cream.
- 1,270
- reports as suspect product
- 0% of all reports · about 57 a year
- 57
- reports, 12 months to June 2026
- 118 in the 12 months before
- 76.8%
- marked serious by the reporter
- 77.7% across the class
- 0.8%
- record death among outcomes, as reported
- 10 reports · not verified by FDA
1,270 adverse event reports received by FDA list desonide, a generic name as a suspect or interacting product, from May 2004 to June 2026. A further 3,718 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 57 reports listed it, down 52% from 118 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 57 reports a year and 0% of the 20,646,523 reports in the database, and 0.2% of the reports for the corticosteroid class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are drug ineffective (72.5%), macular degeneration (60%) and off label use (18.7%). A report can list several reactions, so shares add to more than 100%; 233 different terms appear across these reports. Drug ineffective is recorded in 72.5% of these reports, a larger share than in the median corticosteroid drug (13.4%).
76.8% of the reports are marked serious by the reporter (77.7% across the class); 0.8% record death among the outcomes and 22.5% record hospitalisation, as reported. 46.9% of the reports came from other health professionals, and the largest patient age group is 65 to 74 (18.3%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Desonide reports recording the termmedian drug in corticosteroid
- Drug ineffectivethe medicine did not work as expected72.5%921
- Macular degenerationa disease of the central retina60%762
- Off label useused for a purpose or in a way not on the label18.7%237
- Painpain, site not specified17%216
- Erythemaskin redness16.5%209
- Chronic sinusitis16%203
- Pyrexiafever15.2%193
- Malaisegeneral feeling of being unwell15.1%192
- Weight decreasedweight loss15.1%192
- Nauseafeeling sick15%191
- Paraesthesia oral14.8%188
- Infusion related reactiona reaction during or soon after an infusion13.8%175
- Dyspepsiaindigestion13.3%169
- Procedural painpain from a procedure13.2%168
- Haematocheziablood in the stool12.1%154
- Rectal haemorrhage12%153
- Female genital tract fistula11.8%150
- Radiculopathy11.7%148
- Colitisinflamed bowel11.6%147
- Colitis ulcerative11.6%147
- Abdominal painstomach or belly pain11.5%146
- Constipationconstipation11.3%144
- Headachehead pain11.3%144
- Anaemialow red blood cells11.3%143
- Frequent bowel movements11.3%143
- Oral candidiasisoral thrush11.2%142
- Vaginal discharge11.2%142
- Vaginal flatulence11.2%142
- Proctitis11.1%141
Top 30 of 233 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 74 drugs in the corticosteroid class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 808,789 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 32.1% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Psoriasis | 144 | 11.3% |
| Eczema | 34 | 2.7% |
| Dermatitis atopic | 27 | 2.1% |
| Cutaneous t-cell lymphoma | 5 | 0.4% |
| Pruritus | 5 | 0.4% |
| Skin disorder | 5 | 0.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,270 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Desonide reports |
|---|---|---|
| Prednisone | 782 | 61.6% |
| Alprazolam | 766 | 60.3% |
| Metronidazole | 765 | 60.2% |
| Nadolol | 761 | 59.9% |
| Clotrimazole | 756 | 59.5% |
| Clarithromycin | 750 | 59.1% |
| Bisacodyl | 733 | 57.7% |
| Pregabalin | 721 | 56.8% |
| Triamcinolone acetonide | 719 | 56.6% |
| Nicoderm Cq | 716 | 56.4% |
Other products listed in reports where Desonide is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Desonide | Corticosteroid | All reports |
|---|---|---|---|
| Reports as suspect product | 1,270 | 808,789 | 20,646,523 |
| Share of that pool | — | 0.2% | 0% |
| Reports, latest 12 months | 57 | — | 1,332,454 |
| Marked serious | 76.8% | 77.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 8 | 146 | 91 |
| Hospitalisation recorded, per 1,000 reports | 225 | 336 | 213 |
| Consumer-filed share | 33.7% | 29.1% | 45.8% |
| Top term, share of reports | Drug ineffective 72.5% | median 13.4% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the corticosteroid class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Prednisone | generic | 183,867 | 15,614 | 91.4% |
| Dexamethasone | generic | 129,677 | 9,216 | 95.1% |
| Prednisolone | generic | 87,806 | 6,624 | 97.6% |
| Methylprednisolone | generic | 49,537 | 4,430 | 95.2% |
| Symbicort | brand | 39,119 | 1,177 | 50.6% |
| Breo Ellipta | brand | 22,220 | 628 | 31.7% |
| Hydrocortisone | generic | 21,263 | 2,386 | 89.5% |
| Advair Diskus | brand | 20,518 | 120 | 29% |
| Advair Hfa | brand | 19,622 | 589 | 54.9% |
| Budesonide | generic | 14,714 | 1,083 | 82.2% |
| Desoximetasone | generic | 12,209 | 1,525 | 99.2% |
| Flovent | brand | 10,772 | 171 | 42.1% |
| Methylprednisolone sodium succinate | generic | 10,772 | 1,630 | 97.8% |
| Solu-medrol | generic | 10,288 | 432 | 88.8% |
| Cipro | brand | 9,791 | 108 | 57.3% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Desonide reports
How many adverse event reports has FDA received for Desonide?
1,270 reports list Desonide as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 57 of them arrived in the latest 12 months. Another 3,718 list it only as a concomitant medication.
What reactions are recorded in Desonide reports?
drug ineffective (72.5%), macular degeneration (60%), off label use (18.7%), therapeutic product effect incomplete (18.1%) and pain (17%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Desonide was responsible.
How serious are the reports?
76.8% are marked serious by the reporter. Among the outcomes recorded, 0.8% of reports include death and 22.5% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (46.9%), consumer or non-health professional (33.7%) and physician (16.5%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Desonide rising?
57 reports in the 12 months to June 2026, down 52% from 118 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Desonide was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Desonide?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Desonide as a suspect or interacting product; reports listing it only as a concomitant medication (3,718) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.