Hydrocortisone

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66 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.
66
Total Reports
6
Deaths Reported
910.0%
Death Rate

Active Ingredients

Hydrocortisone

Administration Routes

UnknownTopicalAuricular (Otic)OralCutaneous

Species Affected

Dog 53
Cat 12
Human 1

Most Affected Breeds

Domestic Shorthair 5
Retriever - Golden 5
Shih Tzu 4
Crossbred Canine/dog 4
Retriever - Labrador 3
Mastiff (unspecified) 3
Dog (unknown) 2
Terrier - Jack Russell 2
Terrier - West Highland White 2
Siamese 2

Most Reported Reactions

Lack of efficacy - NOS 11
Other abnormal test result NOS 9
Vomiting 8
Weight loss 8
Lethargy (see also Central nervous system depression in 'Neurological') 7
Behavioural disorder NOS 7
Ataxia 6
Seizure NOS 5
Hair loss NOS 5
Anorexia 4
Leucopenia NOS 4
Skin lesion NOS 4

Outcome Breakdown

Ongoing
25 (37.9%)
Outcome Unknown
18 (27.3%)
Recovered/Normal
15 (22.7%)
Euthanized
3 (4.5%)
Died
3 (4.5%)
Recovered with Sequela
2 (3.0%)

Data Summary

Metric Value
Total adverse event reports 66
Reports involving death 6
Case-fatality rate (reported events) 910.0%
Distinct species in reports 3
Distinct breeds in reports 20
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.

Hydrocortisone Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 66 adverse event reports referencing Hydrocortisone, including 6 reports in which the animal died — a 910.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Hydrocortisone. Reported administration routes include Unknown, Topical, Auricular (Otic), Oral. 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 Hydrocortisone reports are Dog (53 reports), Cat (12 reports), Human (1 reports), with Dog accounting for the largest share. Within those species, Domestic Shorthair (5), Retriever - Golden (5), Shih Tzu (4) 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 Hydrocortisone are Lack of efficacy - NOS (11), Other abnormal test result NOS (9), Vomiting (8), Weight loss (8). Of the 66 reports with a coded outcome, Ongoing is the leading category at 37.9%. 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 Hydrocortisone.

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