Active ingredient · pooled across combinations
Prednisolone Acetate: adverse event reports, pooled
4 ingredient sets in reports · 7 FDA-approved applications in the Green Book
Prednisolone Acetate appears, alone or combined with other ingredients, in 340 reports in FDA's animal adverse event database (April 2011 to March 2026). The figures here pool all 4 ingredient sets that include it.
The Green Book lists 7 FDA-approved applications containing it. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand.
18 reports arrived in the 12 months to March 2026, close to the 17 of the 12 months before. FDA posts reports quarterly with a delay of three to six months, so the newest months are incomplete and usually grow in later releases. That is about 23 reports a year over its reporting history and 0% of all reports.
Pooled across every set, the terms listed most often are deafness (20.9%), loss of hearing (13.8%) and lethargy (9.7%). Many drugs combine several ingredients, and many reports list several drugs, so a term on this page may relate to any of them or to none.
Of reports that state seriousness, 49.1% were classed as serious (38.6% across the whole database); 6.2% record a death or euthanasia (6.4% overall). Ingredients used in older or sicker animals, or in anaesthesia and cancer care, carry higher shares for that reason alone.
Ingredient sets that include prednisolone acetate
| Active ingredients recorded for the drug | Reports | Share of this page's reports | Latest 12 months |
|---|---|---|---|
| Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate | 254 | 74.7% | 8 |
| Prednisolone Acetate | 59 | 17.4% | 9 |
| Miconazole Nitrate + Prednisolone Acetate | 26 | 7.6% | 1 |
| Polymyxin B Sulfate + Prednisolone Acetate | 1 | 0.3% | 0 |
Ordered by report count. FDA states that these data "cannot be used to estimate the risk associated with the product or compare one drug or device product with another"; counts follow sales volume and years on the market. A report can list more than one set, so shares can add to more than 100%.
Signs listed in reports, pooled
share of prednisolone acetate reports listing the termall reports in the database
- Deafness20.9%71
- Loss of hearing13.8%47
- Lethargy[unusually tired or inactive]9.7%33
- Lack of efficacy - NOS[the product did not have the expected effect]7.6%26
- Diarrhoea[diarrhea]7.1%24
- Vomiting6.5%22
- Behavioural disorder NOS[behaviour change, type not specified]5.9%20
- Emesis[vomiting]5.3%18
- Hearing decreased4.7%16
- Impaired hearing4.7%16
- Ear infection NOS[NOS: not otherwise specified]3.5%12
- Other abnormal test result NOS[abnormal laboratory result, type not specified]3.5%12
- Partial deafness3.5%12
- Polydipsia[drinking more than usual]3.5%12
- Anorexia[not eating]2.9%10
- Death by euthanasia[the animal was euthanized]2.9%10
- Decreased appetite2.9%10
- Not eating2.9%10
- Other ear disorder NOS[NOS: not otherwise specified]2.9%10
- Panting2.9%10
- Vocalisation[crying out or unusual noise]2.9%10
- Inappetence[reduced appetite]2.6%9
- Weight loss2.6%9
- Death2.4%8
- Ear discharge2.4%8
- Pruritus[itching]2.4%8
- Accidental exposure[exposure that was not intended]2.1%7
- Anxiety2.1%7
Pooled across every ingredient set and every report that names the ingredient. One report can list several terms and several drugs; a term here may relate to any of them or to none.
Monthly reports by species, five years
By month of receipt; each panel has its own scale. The newest months are incomplete because FDA posts reports with a delay of three to six months.
Outcomes, report types and ages
Outcome recorded in the report
What kind of report it was
Age of the animal
Coloured bar: reports naming prednisolone acetate. Grey bar: all 1,357,245 reports. Outcomes are as stated by the reporter; FDA has not necessarily determined whether any product played a part.
In context
| Measure | Prednisolone Acetate | All reports |
|---|---|---|
| Reports | 340 | 1,357,245 |
| Latest 12 months against the 12 before | +6% | -5% |
| Classed serious, of reports stating it | 49.1% | 38.6% |
| Death or euthanasia recorded, per 1,000 reports | 61.8 | 63.8 |
| Filed as lack of expected effectiveness (wholly or partly) | 6.2% | 23% |
Shares of reports, not of animals treated: how many animals receive the ingredient is not public. Ingredients used in anaesthesia, cancer care or in old animals carry more serious outcomes in their reports for that reason alone.
FDA-approved products containing prednisolone acetate (Green Book)
Reference information, not report statistics. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand. The list below is the FDA Green Book as of 1 Oct 2026; nothing on this page says which of these products, if any, a report concerned.
| Trade name | Active ingredients | Sponsor | Approved for | Application |
|---|---|---|---|---|
| Meticortelone Acetate | Prednisolone Acetate | Intervet, Inc. | Dogs, Cats, Horses | NADA 010-312 |
| Neo-Delta-Cortef with Tetracaine Ointment | Neomycin Sulfate, Prednisolone Acetate, Tetracaine Hydrochloride | Zoetis Inc. | Dogs, Cats | NADA 011-703 |
| Neo-Delta Cortef Sterile Solution | Neomycin Sulfate, Prednisolone Acetate | Zoetis Inc. | Dogs, Cats | NADA 091-534 |
| Surolan | Miconazole Nitrate, Polymyxin B Sulfate, Prednisolone Acetate | Elanco US Inc. | Dogs | NADA 141-298 |
| Prednisolone Aqueous Suspensionapproval voluntarily withdrawn | Prednisolone Acetate | Akorn, Inc. | — | NADA 012-444 |
| Optisoneapproval voluntarily withdrawn | Neomycin Sulfate, Prednisolone Acetate | Evsco Pharmaceuticals, An Affiliate of IGI, Inc. | Dogs, Cats | NADA 045-288 |
| Chlorasone Ophthalmic Ointmentapproval voluntarily withdrawn | Chloramphenicol, Prednisolone Acetate | Evsco Pharmaceuticals, An Affiliate of IGI, Inc. | Dogs, Cats | NADA 065-259 |
Species are the major species the Green Book search lists for the application ("—" where it lists another species or none). Approval dates are not part of the Green Book listing files and are not shown. Pioneer applications (NADA) come first, then generics (ANADA).
Questions about prednisolone acetate reports
How many FDA adverse event reports mention prednisolone acetate?
340 reports through March 2026, 18 of them in the latest 12 months, counting prednisolone acetate alone and in combinations.
Which brands do these reports concern?
That cannot be known from the public data. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand. The Green Book reference list on this page names approved products containing prednisolone acetate without any counts.
In which combinations is prednisolone acetate reported?
Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate (74.7% of these reports), Prednisolone Acetate (17.4% of these reports), Miconazole Nitrate + Prednisolone Acetate (7.6% of these reports) and Polymyxin B Sulfate + Prednisolone Acetate (0.3% of these reports).
What reactions are reported for prednisolone acetate?
deafness (20.9%), loss of hearing (13.8%), lethargy (9.7%), lack of efficacy - NOS (7.6%) and diarrhoea (7.1%). Shares are of reports naming the ingredient; one report can list several terms.
Which animals are these reports about?
dog (91.8%), cat (6.2%) and human exposure (0.9%).
Does a high count mean prednisolone acetate is a problem ingredient?
A count cannot show that. FDA states that "there is no certainty that the reported drug or device caused the adverse event" and that the event "may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources." Widely used ingredients collect more reports because more animals receive them.
How do I report a problem?
Call the drug company using the number on the label, or send Form FDA 1932a to FDA. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Animal & Veterinary adverse event bulk files released 28 Sep 2026, which hold reports FDA's Center for Veterinary Medicine received through 31 Mar 2026. openFDA masks brand and manufacturer names in these files, so drugs are counted by the active ingredients each record discloses and no figure is attributed to a brand, application or company. Ingredient names, and the separate reference lists of approved products, follow the FDA Green Book as of 1 Oct 2026. Ingredient names follow the Green Book; salts and forms are kept as FDA lists them. Drug entries are matched by the active ingredients their unmasked ingredient field discloses. No report text, lot numbers or reporter details are published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.