Ciclesonide

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294 adverse event reports submitted to the FDA

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
294
Total Reports
9
Deaths Reported
310.0%
Death Rate

Active Ingredients

Ciclesonide

Administration Routes

UnknownNasalRespiratory (Inhalation)Intramedullary

Species Affected

Unknown 197
Horse 94
Human 3

Most Affected Breeds

Unknown 201
Horse (unknown) 34
Quarter Horse 25
Paint 7
Miniature 4
Horse (other) 4
Tennessee Walking Horse 3
Morgan 3
Warmblood (unspecified) 3
Pony (unspecified) 2

Most Reported Reactions

Dispenser, Abnormal 89
Difficulty of Use 80
Lack of efficacy - NOS 42
Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle') 24
Inhaler, malfunction 23
Behavioural disorder NOS 20
Product problem 20
Underfilling, Container 13
Circumstance or info capable of leading to medication error 12
Administration device NOS, priming issue 7
Device breakage/fracture 6
Product Defect, General 6

Outcome Breakdown

Outcome Unknown
48 (49.5%)
Recovered/Normal
26 (26.8%)
Ongoing
12 (12.4%)
Died
5 (5.2%)
Euthanized
4 (4.1%)
Recovered with Sequela
2 (2.1%)

Data Summary

Metric Value
Total adverse event reports 294
Reports involving death 9
Case-fatality rate (reported events) 310.0%
Distinct species in reports 3
Distinct breeds in reports 17
Distinct reactions reported 20
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Ciclesonide Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 294 adverse event reports referencing Ciclesonide, including 9 reports in which the animal died — a 310.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Ciclesonide. Reported administration routes include Unknown, Nasal, Respiratory (Inhalation), Intramedullary. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Ciclesonide reports are Unknown (197 reports), Horse (94 reports), Human (3 reports), with Unknown accounting for the largest share. Within those species, Unknown (201), Horse (unknown) (34), Quarter Horse (25) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Ciclesonide are Dispenser, Abnormal (89), Difficulty of Use (80), Lack of efficacy - NOS (42), Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle') (24). Of the 97 reports with a coded outcome, Outcome Unknown is the leading category at 49.5%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Ciclesonide.

Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial