Enrofloxacin + Silver Sulfadiazine

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455 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.
455
Total Reports
14
Deaths Reported
310.0%
Death Rate

Active Ingredients

EnrofloxacinEnrofloxacin + Silver SulfadiazineSilver Sulfadiazine

Administration Routes

UnknownAuricular (Otic)TopicalOralOphthalmicIntraocularIntra-ArticularOther

Species Affected

Dog 216
Unknown 175
Cat 48
Rabbit 7
Human 6
Guinea Pig 1
Rat 1
Cockatiel 1

Most Affected Breeds

Unknown 184
Retriever - Labrador 24
Domestic Shorthair 24
Crossbred Canine/dog 12
Terrier - Yorkshire 12
Retriever - Golden 10
Pug 9
Shih Tzu 8
Chihuahua 7
Cat (unknown) 7

Most Reported Reactions

Applicator, Abnormal 40
Lack of efficacy - NOS 34
Uncoded sign 25
Containers, Leaking 25
Ear discharge 24
Deafness 22
Dispenser, Abnormal 22
Other abnormal test result NOS 21
Vomiting 20
Behavioural disorder NOS 19
Loss of hearing 19
Pinnal erythema 17

Outcome Breakdown

Outcome Unknown
138 (49.3%)
Recovered/Normal
79 (28.2%)
Ongoing
47 (16.8%)
Euthanized
9 (3.2%)
Died
5 (1.8%)
Recovered with Sequela
2 (0.7%)

Data Summary

Metric Value
Total adverse event reports 455
Reports involving death 14
Case-fatality rate (reported events) 310.0%
Distinct species in reports 8
Distinct breeds in reports 20
Distinct reactions reported 20
Active ingredients on file 3

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

Enrofloxacin + Silver Sulfadiazine Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 455 adverse event reports referencing Enrofloxacin + Silver Sulfadiazine, including 14 reports in which the animal died — a 310.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredients on file: Enrofloxacin, Enrofloxacin + Silver Sulfadiazine, Silver Sulfadiazine. Reported administration routes include Unknown, Auricular (Otic), Topical, 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 Enrofloxacin + Silver Sulfadiazine reports are Dog (216 reports), Unknown (175 reports), Cat (48 reports), with Dog accounting for the largest share. Within those species, Unknown (184), Retriever - Labrador (24), Domestic Shorthair (24) 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 Enrofloxacin + Silver Sulfadiazine are Applicator, Abnormal (40), Lack of efficacy - NOS (34), Uncoded sign (25), Containers, Leaking (25). Of the 280 reports with a coded outcome, Outcome Unknown is the leading category at 49.3%. 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 Enrofloxacin + Silver Sulfadiazine.

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