Gentamicin Sulfate, Betamethasone Valerate

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17 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.
17
Total Reports
2
Deaths Reported
1180.0%
Death Rate

Active Ingredients

Gentamicin Sulfate, Betamethasone Valerate

Administration Routes

TopicalUnknownAuricular (Otic)

Species Affected

Dog 14
Cat 3

Most Affected Breeds

Shih Tzu 3
Domestic Shorthair 2
Dachshund (unspecified) 1
Retriever (unspecified) 1
Domestic Longhair 1
Beagle 1
Retriever - Golden 1
Spaniel (unspecified) 1
Hound - Basset 1
Chihuahua 1

Most Reported Reactions

Anaemia NOS 3
Other abnormal test result NOS 3
Decreased appetite 3
Lack of efficacy - NOS 3
Not eating 3
Vomiting 2
Bacterial skin infection NOS 2
Overdose 2
INEFFECTIVE, ANTIBIOTIC 2
PR-SKIN, LESION(S) 2
Lethargy (see also Central nervous system depression in 'Neurological') 2
Erythema (for urticaria see Immune SOC) 2

Outcome Breakdown

Ongoing
9 (52.9%)
Outcome Unknown
4 (23.5%)
Recovered/Normal
2 (11.8%)
Died
1 (5.9%)
Euthanized
1 (5.9%)

Data Summary

Metric Value
Total adverse event reports 17
Reports involving death 2
Case-fatality rate (reported events) 1180.0%
Distinct species in reports 2
Distinct breeds in reports 14
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.

Gentamicin Sulfate, Betamethasone Valerate Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 17 adverse event reports referencing Gentamicin Sulfate, Betamethasone Valerate, including 2 reports in which the animal died — a 1180.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Gentamicin Sulfate, Betamethasone Valerate. Reported administration routes include Topical, Unknown, Auricular (Otic). 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 Gentamicin Sulfate, Betamethasone Valerate reports are Dog (14 reports), Cat (3 reports), with Dog accounting for the largest share. Within those species, Shih Tzu (3), Domestic Shorthair (2), Dachshund (unspecified) (1) 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 Gentamicin Sulfate, Betamethasone Valerate are Anaemia NOS (3), Other abnormal test result NOS (3), Decreased appetite (3), Lack of efficacy - NOS (3). Of the 17 reports with a coded outcome, Ongoing is the leading category at 52.9%. 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 Gentamicin Sulfate, Betamethasone Valerate.

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